TRADITIONAL CHINESE MEDICINE COMPOSITION FOR TREATING PSORIASIS, PREPARATION METHOD THEREFOR AND USE THEREOF

Abstract

A traditional Chinese medicine composition for treating psoriasis, a preparation method therefor and a use thereof. The traditional Chinese medicine composition comprises: water buffalo horn powder, Japanese honeysuckle flower, gypsum, red peony root, peony bark, charred cape jasmine fruit, baical skullcap root, raw garden burnet root, and liquorice root. The preparation method comprises: proportionally weighing out the baical skullcap root, the Japanese honeysuckle flower, the red peony root, the peony bark, the gypsum, the charred cape jasmine fruit, the garden burnet root and the liquorice root, adding water and decocting 1 to 3 times, each time using 4 to 10 times the amount (weight to volume ratio) of water and decocting for 0.5 to 3 hours; combining decoctions, filtering, vacuum concentrating the filtrate, drying same, adding the water buffalo horn powder and mixing until evenly distributed.

Claims

1. A traditional Chinese medicine composition for treating psoriasis, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 5 to 25 parts by weight of buffalo horn powder, 5 to 15 parts by weight of Japanese honeysuckle flower, 5 to 15 parts by weight of gypsum, 2 to 10 parts by weight of red peony root, 2 to 10 parts by weight of tree peony bark, 1 to 4 parts by weight of charred cape jasmine fruit, 2 to 10 parts by weight of baical skullcap root, 5 to 15 parts by weight of garden burnet root and 0.5 to 3 parts by weight of liquorice root.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 9 to 15 parts by weight of buffalo horn powder, 9 to 12 parts by weight of Japanese honeysuckle flower, 9 to 12 parts by weight of gypsum, 3 to 6 parts by weight of red peony root, 4 to 8 parts by weight of tree peony bark, 1 to 3 parts by weight of charred cape jasmine fruit, 2 to 6 parts by weight of baical skullcap root, 9 to 12 parts by weight of garden burnet root and 1 to 2 parts by weight of liquorice root.

3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 12 parts by weight of buffalo horn powder, 10 parts by weight of Japanese honeysuckle flower, 10 parts by weight of gypsum, 5 parts by weight of red peony root, 6 parts by weight of tree peony bark, 2 parts by weight of charred cape jasmine fruit, 5 parts by weight of baical skullcap root, 10 parts by weight of garden burnet root and 1.5 parts by weight of liquorice root.

4. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is in any pharmaceutical preparation form.

5. The traditional Chinese medicine composition according to claim 4, wherein the traditional Chinese medicine composition is in a pharmaceutical preparation form as follows: tablet, capsule, oral lozenge, granule, pill, powder, grease, pellets, suspension, solution, injection, suppository, ointment, spray, drops, drop pill and patch.

6. The traditional Chinese medicine composition according to claim 4, wherein the pharmaceutical preparation form is an oral preparation.

7. The traditional Chinese medicine composition according to claim 4, wherein the pharmaceutical preparation comprises pharmaceutically active material and pharmaceutically acceptable carrier, and the weight of the pharmaceutically acceptable carrier is 0.01% to 99.99% of the total weight of the preparation.

8. Use of the traditional Chinese medicine composition according to claim 1 in preparing a medicament for treating psoriasis.

9. The use according to claim 8, wherein the medicament for treating psoriasis is a medicament for treating psoriasis vulgaris.

10. A preparation method of the traditional Chinese medicine composition according to claim 1, which comprises the following steps: weighing baical skullcap root, Japanese honeysuckle flower, red peony root, tree peony bark, gypsum, charred cape jasmine fruit, garden burnet root and liquorice root, decocting with water 1 to 3 times, 0.5 to 3 hours for each, 4 to 10 times quantities of water for each; combining the decoctions, filtering, concentrating the filtrate under reduced pressure, drying, adding the buffalo horn powder and mixing uniformly.

Description

DETAILED DESCRIPTION

[0053] In order to make the objects, technical solutions and advantages of the present application clearer, the examples of present application will be described in detail below. It should be noted that the following examples of the present application and the features of the examples may be arbitrarily combined with each other provided that there is no confliction.

Example 1

[0054] 1 kg of baical skullcap root, 2 kg of Japanese honeysuckle flower, 1 kg of red peony root, 1.2 kg of tree peony bark, 2 kg of gypsum, 0.4 kg of charred cape jasmine fruit, 2 kg of garden burnet root and 0.3 kg of liquorice root were decocted with water twice. In the first decoction, they were decocted with 8 times amount of water (79.2 L) for 1 hour. In the second decoction, they were decocted with 6 times amount of water (59.4 L) for 1.5 hours. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 2.4 kg of buffalo horn powder, appropriate amount of dextrin and stevioside were added to make granules, and the granules were sealed and packaged.

Example 2

[0055] 0.4 kg of baical skullcap root, 1 kg of Japanese honeysuckle flower, 0.4 kg of red peony root, 0.4 kg of tree peony bark, 1 kg of gypsum, 0.2 kg of charred cape jasmine fruit, 1 kg of garden burnet root and 0.1 kg of liquorice root were decocted with water three times. In the first decoction, they were decocted with 7 times amount of water (31.5 L) for 1 hour. In the second decoction, they were decocted with 6 times amount of water (27 L) for 1 hour. In the third decoction, they were decocted with 6 times amount of water (27 L) for 1.5 hour. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 1 kg of buffalo horn powder, appropriate amount of dextrin and stevioside were added to make concentrated pills, and the concentrated pills were sealed and packaged.

Example 3

[0056] 2 kg of baical skullcap root, 3 kg of Japanese honeysuckle flower, 2 kg of red peony root, 2 kg of tree peony bark, 3 kg of gypsum, 0.8 kg of charred cape jasmine fruit, 3 kg of garden burnet root and 0.6 kg of liquorice root were decocted with water three times. In the first decoction, they were decocted with 9 times amount of water (147.6 L) for 2 hours. In the second decoction, they were decocted with 8 times amount of water (131.2 L) for 1 hour. In the third decoction, they were decocted with 8 times amount of water (131.2 L) for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 5 kg of buffalo horn powder, appropriate amount of dextrin and stevioside were added to make tablets, and the tablets were sealed and packaged.

Example 4

[0057] 1.5 kg of baical skullcap root, 2.5 kg of Japanese honeysuckle flower, 1.5 kg of red peony root, 1.5 kg of tree peony bark, 2.5 kg of gypsum, 0.6 kg of charred cape jasmine fruit, 2.5 kg of garden burnet root and 0.5 kg of liquorice root were decocted with water twice. In the first decoction, they were decocted with 10 times amount of water (131 L) for 2 hour. In the second decoction, they were decocted with 9 times amount of water (117.9 L) for 1.5 hours. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 3 kg of buffalo horn powder was added, mixed evenly, and 110-130 g of refined honey was added to each 100 g of powder to make big honeyed pills, and the big honeyed pills were sealed and packaged.

Example 5

[0058] 0.6 kg of baical skullcap root, 1.5 kg of Japanese honeysuckle flower, 0.6 kg of red peony root, 0.6 kg of tree peony bark, 1.5 kg of gypsum, 0.3 kg of charred cape jasmine fruit, 1.5 kg of garden burnet root and 0.2 kg of liquorice root were decocted with water three times. In the first decoction, they were decocted with 5 times amount of water (34 L) for 0.5 hours. In the second decoction, they were decocted with 4 times amount of water (27.2 L) for 1 hour. In the third decoction, they were decocted with 4 times amount of water (27.2 L) for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 5 kg of buffalo horn powder and appropriate amount of dextrin were added to make capsules, and the capsules were sealed and packaged.

Example 6

[0059] 0.2 kg of baical skullcap root, 0.9 kg of Japanese honeysuckle flower, 0.3 kg of red peony root, 0.4 kg of tree peony bark, 0.9 kg of gypsum, 0.1 kg of charred cape jasmine fruit, 0.9 kg of garden burnet root and 0.1 kg of liquorice root were decocted with water three times. In the first decoction, they were decocted with 5 times amount of water (34 L) for 0.5 hour. In the second decoction, they were decocted with 4 times amount of water (27.2 L) for 1 hour. In the third decoction, they were decocted with 4 times amount of water (27.2 L) for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 0.9 kg of buffalo horn powder, appropriate amount of dextrin were added to make capsules, and the capsules were sealed and packaged.

Example 7

[0060] 0.6 kg of baical skullcap root, 1.2 kg of Japanese honeysuckle flower, 0.6 kg of red peony root, 0.8 kg of tree peony bark, 1.2 kg of gypsum, 0.3 kg of charred cape jasmine fruit, 1.2 kg of garden burnet root and 0.2 kg of liquorice root were decocted with water three times. In the first decoction, they were decocted with 5 times amount of water (34 L) for 0.5 hours. In the second decoction, they were decocted with 4 times amount of water (27.2 L) for 1 hour. In the third decoction, they were decocted with 4 times amount of water (27.2 L) for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure and dried. 1.5 kg of buffalo horn powder and appropriate amount of dextrin were added to make capsules, and the capsules were sealed and packaged.

Beneficial Effects

[0061] In order to better illustrate the beneficial effects of the traditional Chinese medicine composition of the present application, it is demonstrated by the following testing examples.

[0062] I. Screening experiments of drug efficacy of various groups were carried out on guinea pig ear-psoriasis model.

[0063] Researching subjects: 120 clean-grade Hartley guinea pigs from 3 to 4 weeks old were provided by Beijing Huafukang Biotechnology Co., Ltd. (SCXK (Beijing) 2014-0004). The Hartley guinea pigs have weight of about 300 g, standard feed, animal room temperature 25° C. to 28° C., humidity 40% to 50%.

[0064] 1. Experimental Method

[0065] 1.1 Establishment of guinea pig ear-psoriasis-like animal model: 5% imiquimod cream (20 mg/cm.sup.2 was applied) was evenly applied on the back of right ear of the guinea pig, three times a day for 10 days to induce psoriasis-like guinea pig ear model.

[0066] 1.2 Animal grouping and medicament administration: on the basis of CN1954847A thirteen-ingredient formula (called the 13-ingredient macules-eliminating prescription), five medicinals (rehmannia root, Paris rhizome, lalang grass rhizome, Chinese cork-tree, and Danshen root) were removed in turn, and the medicinal garden burnet root was added. The various groups of modified prescriptions were as follows:

[0067] Modified prescription group 1: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+Danshen root+liquorice root+Chinese cork-tree+lalang grass rhizome+Paris rhizome (removing rehmannia root from the 13-ingredient-prescription), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0068] Modified prescription group 2: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+Danshen root+liquorice root+Chinese cork-tree+lalang grass rhizome (removing rehmannia root and Paris rhizome from the 13-ingredient-prescription), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0069] Modified prescription group 3: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+Danshen root+liquorice root+Chinese cork-tree (removing rehmannia root, Paris rhizome and lalang grass rhizome from the 13-ingredient-prescription), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0070] Modified prescription group 4: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+Danshen root+liquorice root (removing rehmannia root, Paris rhizome, lalang grass rhizome and Chinese cork-tree from the 13-ingredient-prescription), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0071] Modified prescription group 5: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+liquorice root (removing rehmannia root, Paris rhizome, lalang grass rhizome, Chinese cork-tree and Danshen root from the 13-ingredient-prescription), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0072] Modified prescription group 6: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+liquorice root+raw garden burnet root (removing rehmannia root, Paris rhizome, lalang grass rhizome, Chinese cork-tree and Danshen root from the 13-ingredient-prescription, and adding garden burnet root thereinto), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0073] In the above nine medicinals, buffalo horn powder, Japanese honeysuckle flower and baical skullcap root play a role as the sovereign; red peony root and tree peony bark play a role as the minister; charred cape jasmine fruit, gypsum and garden burnet root are used as assistants; and liquorice root plays a role as the guide.

[0074] Considering that there are still medicinals that can be removed, according to the importance of sovereign, minister, assistant, and guide, the guide, assistant and minister medicinals are removed in turn, and the following groups of modified prescriptions are obtained:

[0075] Modified prescription group 7: buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+raw garden burnet root (removing liquorice root from modified prescription group 6), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0076] Modified prescription group 8: buffalo horn powder+Japanese honeysuckle flower+red peony root+tree peony bark+baical skullcap root (removing charred cape jasmine fruit, gypsum, garden burnet root and liquorice root from modified prescription group 6), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0077] Modified prescription group 9: buffalo horn powder+Japanese honeysuckle flower+baical skullcap root (removing charred cape jasmine fruit, gypsum, raw garden burnet root, liquorice root, red peony root and tree peony bark from modified prescription group 6), and 19.52 g crude medicine/kg/d was administrated by gavage.

[0078] The traditional Chinese medicine raw materials shared in the above nine groups of modified prescriptions and in the 13-ingredient macules-eliminating prescription in CN1954847A had the same proportions, and the extraction method was the same as that in CN1954847A.

[0079] The above nine prescriptions were used as the experimental groups to carry out experiments at the same time, and the experiments also included: model control group: administration with equal volume of saline by gavage, and normal control group: freely drinking water and free diet. The group of the 13-ingredient macules-eliminating prescription (i.e. prepared according to the specific method in CN1954847A): 19.52 g crude medicine/kg/d was administrated by gavage.

[0080] 120 guinea pigs successfully modeled were divided into 12 groups by a method using a random number table according to the above grouping, with 10 guinea pigs in each group, which were administered with the medicine continuously for 4 weeks.

[0081] 1.3 Sampling: guinea pigs in the experimental groups were sacrificed after reaching the experimental observation requirements. Ear samples were taken, immersed and fixed in formalin solution for 2 days. The samples were embedded in paraffin, sliced and stained with HE.

[0082] 1.4 Measurement of the thickness of the epidermis on the back of guinea pigs' ears and scoring of tissues by Baker's method.

[0083] 1.4.1 Measurement of the thickness of the epidermis on the back of guinea pigs' ears: the epidermal thickness of the back of guinea pigs' ears after the establishment of psoriasis model and the intervention by metformin were measured, and the epidermal thickness of five different fields of vision (10×10) in each slice was selected, and five values were measured in each field of vision, then their respective average value was calculated and statistically analyzed.

[0084] 1.4.2 Baker's method for scoring tissue: HE stained sections were taken for collecting images under microscope, 5 visual fields in each group were randomly selected, and then histopathological changes were scored by Baker's method. Each slice was scored according to the pathological scoring standard of psoriasis vulgaris, and the comprehensive score of pathological changes was statistically analyzed. The evaluation criteria of histological score of psoriasis by Baker's method are shown in Table 1 below:

TABLE-US-00002 TABLE 1 Baker's scoring standard Items Histological scoring (points) Stratum Munro microabscess 1.5 corneum Parakeratosis 0.5 to 1.5 (mild to severe) Hyperkeratosis 0.5 Epidermal Epidermal processes extend 0.5 to 1.5 (mild to severe) layer into a rod shape Spinous layer hypertrophy 1.0 Particle layer disappearance 1.0 Dermal Inflammatory cell infiltration 0.5 to 1.5 (mild to severe) cortex Upward clubbing of mastoid 1.0 process Capillary dilatation 0.5

[0085] 2. Statistical processing: the experimental data is expressed as (.sup.x±S), which is processed by SPSS17 software. The mean of the two samples were compared by t test, P<0.05 means significant difference, and P<0.01 means highly significant difference.

[0086] 3. Experimental Results:

[0087] 3.1 General Conditions:

[0088] In the normal control group, guinea pigs have docile behavior and are mentally normal with thick hair and skin luster in both ears, and they have normal drinking, diet and defecation. The guinea pigs in the model control group scratched their ears after 2 weeks, and the hair on the back of the ears where the medicine was applied is partially shed, and the skin on the back of the ears of some animals is reddened, and the capillaries are obviously dilated. After 4 weeks, the hair shedding, vasodilation and ear scratching of guinea pigs in the model control group are aggravated. The above symptoms are significantly alleviated after 4 weeks of gavage administration in the group of 13-ingredient macules-eliminating prescription and the experimental group (groups of modified prescriptions 1 to 9), and modified prescription group 6 in the experimental group shows the most significant improvement. The improvement effect of 13-ingredient macules-eliminating prescription group, modified prescription groups 1-5 and modified prescription groups 7-9 is weaker than that of modified prescription group 6.

[0089] Morphology of both ears: guinea pigs in the normal control group have thick hairs and normal skin. Ear skin symptoms of the model guinea pigs in the control group after 4 weeks: hair shedding, rough skin, local capillary dilation, reddish skin, etc. appeared where 5% imiquimod cream was applied. It was observed that hair shedding was reduced, capillary dilatation was reduced, and local pigmentation appeared after 4 weeks of gavage administration in the 13-ingredient macules-eliminating prescription group and modified prescription groups 1-9. Modified prescription group 6 has the most significant improvement in symptoms. The improvement effect of 13-ingredient-macules-eliminating-prescription group, modified prescription groups 1-5 and modified prescription groups 7-9 is less effective than that of modified prescription group 6.

[0090] 2. Measurement of the Thickness of the Epidermis on the Back of Guinea Pigs' Ears and the Results of Scoring the Tissues by Baker's Method:

[0091] Measurements of the thickness of the epidermis on the back of guinea pigs' ears are shown in Table 2. Compared with the normal control group, the thickness of the epidermis on the back of guinea pigs' ears in the model control group is significantly increased (P<0.001), which indicates that the modeling is successful. Compared with the model control group, the thickness of the epidermis on the back of guinea pigs' ears in the 13-ingredient macules-eliminating prescription group and modified prescription groups 1-9 decreased significantly (P<0.05), with the most significant symptom improvement for modified prescription group 6 (P<0.001), and modified prescription group 6 has significant difference with respect to 13-ingredient macules-eliminating prescription group (P<0.05). Compared with modified prescription groups 1-5 and modified prescription groups 7-9, modified prescription group 6 has significant improvement (P<0.05).

[0092] The results of Baker scoring are shown in Table 3. Compared with the normal control group, the Baker score in the model control group is significantly increased (P<0.001), which indicates that the modeling is successful. Compared with the model group, the Baker score in the 13-ingredient macules-eliminating prescription group and modified prescription groups 1-9 decreased significantly (P<0.05), wherein the most significant symptom improvement was in modified prescription group 6 (P<0.001), and modified prescription group 6 has significant difference with respect to 13-ingredient macules-eliminating prescription group (P<0.05). Compared with modified prescription groups 1-5 and modified prescription groups 7-9, modified prescription group 6 has significant improvement (P<0.05) and significant difference. It is suggested from the results that modified prescription group 6 can significantly improve the pathological changes of guinea pig ear psoriasis model, and the therapeutic effect is significantly better than that of the 13-ingredient macules-eliminating prescription group.

[0093] The above experimental results show that, after removing rehmannia root, Paris rhizome, lalang grass rhizome, Chinese cork-tree and Danshen root, while adding garden burnet root on the basis of the original 13-ingredient macules-eliminating prescription, the inhibitory effect on guinea pig ear psoriasis model can be significantly enhanced (P<0.05). On this basis, however, the inhibitory effect on guinea pig ear psoriasis model was significantly weakened after the guide medicinal (liquorice root), assistant medicinals (charred cape jasmine fruit, gypsum, raw garden burnet root) and minister medicinals (red peony root and tree peony bark) were removed in turn (P<0.05). Therefore, modified prescription group 6 is the relatively good modified prescription screened out.

TABLE-US-00003 TABLE 2 Measurement of the thickness of the epidermis on the back of guinea pigs' ears Number Thickness of Groups of animals Dosage epidermis (μm) Normal control 10 — 57.29 ± 5.12f group Model control 10 — 165.21 ± 12.13a group 13-ingredient 10 19.52 g crude 74.08 ± 3.21d macules-eliminating medicine/kg prescription group Modified 10 19.52 g crude 77.82 ± 2.85d prescription group 1 medicine/kg Modified 10 19.52 g crude 75.39 ± 4.96d prescription group 2 medicine/kg Modified 10 19.52 g crude 76.76 ± 4.51d prescription group 3 medicine/kg Modified 10 19.52 g crude 78.21 ± 5.10d prescription group 4 medicine/kg Modified 10 19.52 g crude 75.44 ± 2.46d prescription group 5 medicine/kg Modified 10 19.52 g crude 69.32 ± 1.18e prescription group 6 medicine/kg Modified 10 19.52 g crude 92.74 ± 6.42c prescription group 7 medicine/kg Modified 10 19.52 g crude 118.17 ± 1.94c  prescription group 8 medicine/kg Modified 10 19.52 g crude 127.24 ± 8.51b  prescription group 9 medicine/kg Note: As for the letters a-f, the same letter indicates that there is no significant difference between the two groups (p > 0.05).

TABLE-US-00004 TABLE 3 Baker scoring method results on histology Number of Baker scoring Groups animals Dosage (score) Normal control 10 — 0.57 ± 0.12f group Model control 10 — 6.02 ± 0.86a group 13-ingredient 10 19.52 g crude 1.30 ± 0.05d macules-eliminating medicine/kg prescription group Modified 10 19.52 g crude 1.53 ± 0.11d prescription group 1 medicine/kg Modified 10 19.52 g crude 1.32 ± 0.04d prescription group 2 medicine/kg Modified 10 19.52 g crude 1.43 ± 0.06d prescription group 3 medicine/kg Modified 10 19.52 g crude 1.61 ± 0.03d prescription group 4 medicine/kg Modified 10 19.52 g crude 1.59 ± 0.04d prescription group 5 medicine/kg Modified 10 19.52 g crude 1.05 ± 0.01e prescription group 6 medicine/kg Modified 10 19.52 g crude 2.96 ± 0.15c prescription group 7 medicine/kg Modified 10 19.52 g crude 3.38 ± 0.62b prescription group 8 medicine/kg Modified 10 19.52 g crude 4.53 ± 1.02b prescription group 9 medicine/kg Note: As for the letters a-f, the same letter indicates that there is no significant difference between the two groups (p > 0.05).

[0094] 4. Conclusion:

[0095] In view of the above, compared with the model control group and each modified prescription group, the modified prescription group 6 (buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+raw garden burnet root+liquorice root) can significantly improve the symptoms on appearance and pathological changes of guinea pig ear psoriasis model, significantly reduce local inflammatory response and reduce local vasodilation. There was significant difference compared with the original 13-ingredient macules-eliminating prescription group. The therapeutic effect of modified prescription group 6 on guinea pig ear psoriasis model was significantly enhanced. Through this experiment, it is confirmed that the original 13-ingredient macules-eliminating prescription group has significantly enhanced efficacy of improving the guinea pig ear psoriasis model when having the five medicinals of rehmannia root, Paris rhizome, lalang grass rhizome, Chinese cork-tree and Danshen root removed, and having garden burnet root added at the same time. That is, the 9-ingredient macules-eliminating prescription (buffalo horn powder+Japanese honeysuckle flower+gypsum+red peony root+tree peony bark+charred cape jasmine fruit+baical skullcap root+raw garden burnet root+liquorice root) can replace the 13-ingredient macules-eliminating prescription to play an anti-psoriasis role.

[0096] Through the above screening experiments, it is found that the medicine composition of the present application (9-ingredient macules-eliminating prescription) has a preliminary anti-psoriasis effect, and the following experiments can be further carried out.

[0097] II. Pharmacodynamic Experiment of the Medicine Composition of the Present Application on Mice Psoriasis-Like Skin Lesion Model Induced by Imiquimod.

[0098] Researching subjects: SPF Grade, Female C57BL/6 mice, weighing 18 g to 20 g, provided by Shanghai Slac Experimental Animal Co., Ltd. (2015000562136). The mice were fed with standard diet and the animal room was kept at the temperature of 23±2° C. and the humidity of 40% to 70%.

[0099] Experimental Method

[0100] Animal grouping: 70 female C57BL/6 mice were randomly divided into 7 groups according to their body weight, with 10 mice in each group: group 1 is the blank control group, group 2 is the model group, group 3 is the methotrexate (Shanghai Xinyi Pharmaceutical Factory) group, group 4 is the prior art product in the market Yujinyinxie Tablet (Shaanxi Xiangju Pharmaceutical Co., Ltd.) group, and groups 5 to 7 are the 9-ingredient macules-eliminating prescription groups prepared by the method of Example 1 of the present application, among which group 5 is the high-dosage group of 9-ingredient macules-eliminating prescription, group 6 is the medium-dosage group of 9-ingredient macules-eliminating prescription, and group 7 is the low-dosage group of 9-ingredient macules-eliminating prescription.

[0101] The high-dose group of 9-ingredient macules-eliminating prescription: daily dosage of crude medicine for human use was 61.5 g/day (extracted by the method of Example 1, the extraction rate was about 0.52), and the high-dose group was twice the clinical equivalent dose. The medium-dosage group of 9-ingredient macules-eliminating prescription: clinical equivalent dose. The low-dosage group of 9-ingredient macules-eliminating prescription: the dosage in the low-dosage group was ¼ of that in the high-dosage group.

TABLE-US-00005 TABLE 4 Grouping and administration Extract Administration dosage concentration (g of Administration of the Administration Animal extract/ volume extract Administration frequency * Groups Group: medicine Number kg) (ml/kg) (g/ml) route cycle 1 Blank control 10 — 10 — i.g. Qd * 1 weeks group 2 Model group: 10 — 10 i.g. Qd * 1 weeks sterile water 3 Methotrexate 10 1 mg/kg 10 0.1 mg/ml i.g. Qd * 1 weeks group 4 Yujinyinxie tablet 10 0.72g/kg 10 0.072 i.g. Qd * 1 weeks group 5 High-dosage 10 11.24 10 1.124 i.g. Qd * 1 weeks group of 9-ingredient macules-eliminating prescription 6 Middle-dosage 10 5.62 10 0.562 i.g. Qd * 1 weeks group of 9-ingredient macules-eliminating prescription 7 Low-dosage 10 2.81 10 0.281 i.g. Qd * 1 weeks group of 9-ingredient macules-eliminating prescription

[0102] Modeling method and treatment: After C57BL/6 mice had their back hair shaved (the area was about 2.5 cm×2.5 cm), 80 μl of 5% imiquimod cream was applied to the shaved area of each mouse once a day for one week. At the same time of modeling, the corresponding medicine was subjected to intragastrical (I.G.) administration orally once a day for 7 days. 24 hours after the seventh topical application of imiquimod cream and the corresponding medicine, the skin of lesion was taken, fixed with 10% formalin, embedded in paraffin, sliced, stained with HE, and was pathologically scored (epidermal thickness, epidermal cell keratinization degree, dermal thickness and dermal inflammatory cell infiltration degree).

[0103] Experimental Observation

[0104] Clinical symptoms: observe any clinical symptoms of each animal at the beginning and during the experiment. Any abnormal response should be recorded.

[0105] Measurement Indicator

[0106] 1) Overall observation score of skin lesion (PASI method): once a day, a trend line was plotted, and the change of skin lesions of mice in each group was observed.

[0107] PASI method: photos of the skin lesions were taken every day, and the erythema, scales and infiltration thickening degree at the skin lesions were scored, and the three scores were added up to obtain the total scores.

[0108] PASI scoring standard: 0, none; 1 point, mild; 2 points, moderate; 3 points, severe; and 4 points, extremely severe.

[0109] 2) At the end of the experiment, samples were taken at local skin lesions, fixed with HE staining, and pathologically scored (epidermal thickness, epidermal cell keratinization degree, dermal thickness and dermal inflammatory cell infiltration degree).

[0110] End of experiment: after the experiment, the animals were sacrificed by CO.sub.2 deep anesthesia, and the corresponding tissues were collected.

[0111] Statistics of data: the experimental data are expressed by Mean±SD, and the data between two groups are tested by T test, P<0.05 is considered as significant difference.

[0112] Experimental Results:

[0113] 1) The effect of gavage of 9-ingredient macules-eliminating prescription for 7 days on the weight of C57BL/6 mice model with psoriasis of back skin induced by imiquimod.

[0114] Imiquimod-treated mice were given extract of the high, medium and low-dosage (11.24 g extract/kg, 5.62 g extract/kg and 2.81 g of extract/kg) of 9-ingredient macules-eliminating prescription by gavage for 7 days and it has no significant effect on the weight, and there was no statistically significant difference compared with the model group (Table 5). As for the positive medicine methotrexate group (1 mg/kg), imiquimod-treated mice were given methotrexate by gavage for 7 days and it reduced the weight, and there was a statistically significant difference compared with the model group (P<0.05 or P<0.01 v.s model group).

TABLE-US-00006 TABLE 5 The effect of gavage of the 9-ingredient macules-eliminating prescription for 7 days on the weight of C57BL/6 mice model with psoriasis of back skin induced by imiquimod (x ± s) Extract N dosage (g of (Number BW (g) BW (g) Groups extract/kg) of animals) Day l Day 8 Blank control group — 10 20.10 ± 0.60 21.07 ± 1.20 Model group — 10 20.04 ± 0.37 20.61 ± 1.01 Methotrexate group   1 mg/kg 10 20.29 ± 0.68  17.99 ± 2.71* Yujinyinxie tablet group 0.72 g/kg 10 20.06 ± 0.66 20.62 ± 0.97 High-dosage group of 11.24 10 20.54 ± 0.65 20.25 ± 1.17 9-ingredient macules-eliminating prescription Medium-dosage group of 5.62 10 20.25 ± 0.42 20.79 ± 0.27 9-ingredient macules-eliminating prescription Low-dosage group of 2.81 10 20.36 ± 0.63 20.77 ± 1.03 9-ingredient macules-eliminating prescription *P < 0.05 v.s model group

[0115] 2) The effect of gavage administration of the 9-ingredient macules-eliminating prescription for 7 days on the total observation score of skin lesion of C57BL/6 mice model with psoriasis of back skin induced by imiquimod.

[0116] On the 4th day of modeling, erythema, scales and increased skin thickness were observed on the back skin of model group mice, and there was a statistically significant difference in the total score compared with the blank control group (P<0.01 v.s blank control group). The results show that imiquimod induced the C57BL/6 mouse back skin psoriasis model successfully.

[0117] Gavage administration in high (11.24 g of extract/kg), medium (5.62 g of extract/kg) and low-dosages (2.81 of g extract/kg) of 9-ingredient macules-eliminating prescription for 7 days has improvement visible to naked eye on the skin lesions of C57BL/6 mouse back skin psoriasis model induced by 5% imiquimod. The total score of skin lesions from day 4 to day 8 is lower than that of the model group, and there was a statistically significant difference compared with the model group (P<0.01 or 0.05 v.s the model group).

TABLE-US-00007 TABLE 6 The effect of gavage of the 9-ingredient macules-eliminating prescription for 7 days on the total score of skin lesion of C57BL/6 mice with psoriasis of back skin induced by imiquimod (x ± s) Extract dosage N(Number (g of of extract/ anima Severity index Groups kg) is) Day 4 Day 5 Day 6 Day 7 Day 8 Blank — 10 0.00 ± 0.00** 0.00 ± 0.00** 0.00 ± 0.00** 0.00 ± 0.00 0.00 ± 0.00 control group Model — 10 1.75 ± 0.59 2.70 ± 0.54 3.55 ± 0.64 5.10 ± 0.64## 5.30 ± 2.56## group Methotrexate img/kg 10 1.65 ± 0.58 2.20 ± 0.48* 1.90 ± 0.39** 3.60 ± 0.63 3.05 ± 1.82* group Yujinyinxie 0.72g/kg 10 1.45 ± 0.44 1.90 ± 0.66** 1.75 ± 0.79** 2.50 ± 0.53** 2.65 ± 2.06* tablet group High-dosage 11.24 10 1.15 ± 0.41* 1.40 ± 0.61** 1.70 ± 0.42** 3.00 ± 0.39* 2.50 ± 1.26** group of 9-ingredient macules- eliminating prescription Middle- 5.62 10 1.11 ± 0.46* 1.46 ± 0.86** 1.73 ± 0.79** 3.04 ± 0.49* 2.46 ± 1.02** dosage group of 9-ingredient macules- eliminating Low-dosage 2.81 10 1.65 ± 0.75 1.95 ± 0.55** 2.20 ± 0.67** 3.05 ± 0.40* 3.70 ± 1.75* group of 9-ingredient macules- eliminating *P < 0.05 v.s model group, **P < 0.01 v.s model group; ##P < 0.01 v.s blank control group

[0118] 3) The Effect of Gavage of 9-Ingredient Macules-Eliminating Prescription for 7 Days on Pathological Changes of Skin of C57BL/6 Mice Model with Psoriasis of Back Skin Induced by Imiquimod

[0119] The results of HE staining shows that excessive keratinization of the epidermis, epidermal thickening, dermal thickening and inflammatory cell infiltration were found in the mice of the model group, and there was a statistically significant difference compared with the blank control group (P<0.01 v.s blank control group), which indicated that imiquimod successfully induced the C57BL/6 mouse back skin psoriasis model.

[0120] Compared with the model group, the pathological results of mice skin in the high-dosage group (11.24 g of extract/kg) and the medium-dosage group (5.62 g of extract/kg) of the 9-ingredient macules-eliminating prescription shows that the keratinization of epidermal cells and the degree of epidermal thickening are significantly reduced, with statistically significant differences (P<0.05 v.s the model group), while the degree of dermal thickening and dermal inflammatory cell infiltration are slightly reduced, but there is no statistically significant difference (P>0.05 v.s the model group). Compared with the model group, the total skin pathological score of mice in the high-dosage group (11.24 g extract/kg) and the medium-dosage group (5.62 g extract/kg) of the 9-ingredient macules-eliminating prescription is significantly lower, with statistically significant difference (P<0.01 v.s the model group). The results show that gavage administration for 7 days in the high-dosage group (11.24 g extract/kg) and the middle-dosage group (5.62 g extract/kg) of the 9-ingredient macules-eliminating prescription has obvious improvement on the pathology of psoriasis on the back skin of C57BL/6 mice induced by imiquimod (Table 7).

TABLE-US-00008 TABLE 7 The effect of gavage of the 9-ingredient macules-eliminating prescription for 7 days on the skin lesions of C57BL/6 mice model with psoriasis on back skin induced by imiquimod (x ± s) Pathological score Extract Dermal dosage N inflammatory (g of (Number Epidermal cells extract/ of cell Epidermal Dermal infiltration Total Groups kg) anim keratinization thickness thickness degree score Blank control — 10 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 group Model group — 10 2.40 ± 0.70## 2.00 ± 0.47## 1.90 ± 0.57## 1.50-0.53## 7.80 ± 1.40## Methotrexate 1 mg/kg 10 1.60 ± 0.84* 1.60 ± 0.52, 1.50 ± 0.53 1.10 ± 0.32, 5.80 ± 1.14** group p = 0.09 p = 0.05 Yujinyinxie 0.72 g/kg 10 1.50 ± 0.53** 1.50 ± 0.53* 1.60 ± 0.52 1.30 ± 0.48 5.90 ± 1.20** tablet group High-dosage 11.24 10 1.10 ± 0.88** 1.50 ± 0.67* 1.60 ± 0.52 1.10 ± 0.63 5.30 ± 1.96** groupof 9-ingredient macules-elim inating prescription Middle-dosag 5.62 10 1.15 ± 0.71** 1.48 ± 0.35 1.63 ± 0.52 1.17 ± 0.41 5.43 ± 0.82** e group of 9-ingredient macules-elim inating prescription Low-dosage 2.81 10 2.10 ± 0.74 1.60 ± 0.52, 1.70 ± 0.48 1.50 ± 0.53 6.90 ± 1.10 groupof p = 0.09 9-ingredient macules-elim inating prescription *P < 0.05 v.s model group, **P < 0.01 v.s model group; ##P < 0.01 v.s blank control group

[0121] Conclusion: gavage administration of the 9-ingredient macules-eliminating prescription for 7 days at 11.24 g/kg and 5.62 g/kg has obvious improvement on the psoriasis of C57BL/6 mice back skin induced by imiquimod. Moreover, the efficacy of the medium-dosage group (5.62 g/kg) is equivalent to that of the high-dosage group (11.24 g/kg), indicating that when the dosage is increased to a certain extent, the efficacy will not increase significantly and there may be a risk of increasing toxicity. Gavage administration of 9-ingredient macules-eliminating prescription for 7 days at 2.81 g/kg has a weak improvement effect on the psoriasis of C57BL/6 mice back skin induced by imiquimod. The relatively good dosage of the 9-ingredient macules-eliminating prescription is 5.62 g/kg, that is, daily dosage of 61.5 g for human.

[0122] III. Study on Long-Term Toxicity of the 9-Ingredient Macules-Eliminating Prescription and 13-Ingredient Macules-Eliminating Prescription to Normal Rats

[0123] Experiment animals: ninety SPF grade male SD rats, weighing from 150 g to 200 g, were used and provided by Beijing Huafukang Biotechnology Co., Ltd. (SCXK (Beijing) 2014-0004). They were fed with standard diet, and the animal room was kept at the temperature of 25° C. to 28° C. and the humidity of 40% to 50%.

[0124] Experimental Method:

[0125] Animal Grouping and Administration:

[0126] 90 SD rats were randomly divided into groups with 30 rats in each group. Normal group was given 10 mL/kg/d of normal saline every day by gavage, the dosage in the 9-ingredient macules-eliminating prescription group (prepared according to the method of Example 1 of the present application) was 64.1 g crude medicine/kg, and the dosage of the 13-ingredient macules-eliminating prescription group (prepared according to the method in the embodiment of CN1954847A) was 219.8 g crude medicine/kg. The rats were administrated continuously for 12 weeks, and given standard feed and purified water, and the weight, diet and water intake of the rats were measured and recorded every day. At the 12th week, ⅔ of the animals were sacrificed and dissected. The administration of medicine was suspended for the remaining ⅓ animals in each group and continued to observe for 2 weeks, and the treatment was the same as mentioned before. They were fasted but drank water for 12 hours before sacrifice.

[0127] Sampling

[0128] Blood sampling: Blood was taken from femoral artery of each rat into 10 mL EP tubes, centrifuged at 3500 rpm/10 min, and the supernatant was stored in −20° C. refrigerator for later use.

[0129] Tissue sampling: the rats were weighed and cut off on their necks for sacrifice, and the visceral organ index was calculated.

Visceral organ index=(visceral organ weight/body weight)×1000

[0130] Biochemical Index Test

[0131] Liver function test: alanine aminotransferase (ALT) kit, aspartate aminotransferase (AST) kit, alkaline phosphatase (ALP) kit and γ-glutamyltranspeptidase (γ-GGT) kit, purchased from Nanjing Jiancheng Bioengineering Research Institute Co., Ltd., were used for testing.

[0132] Kidney function test: Urea nitrogen (BUN) kit purchased from Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. and creatinine (Cr) kit purchased from Shanghai Baili Biotechnology Co., Ltd. were used for testing.

[0133] Statistical processing: the experimental data is expressed as (.sup.x±S), which is processed by SPSS17 software. The mean of the two samples were compared by t test, P<0.05 means significant difference, and P<0.01 means highly significant difference.

[0134] Experimental Results:

[0135] General Physiological Index

[0136] Compared with the normal group, after 10 weeks of administration, the weight of the 13-ingredient macules-eliminating prescription group decreased significantly (P<0.05), but there was no significant change in the 9-ingredient macules-eliminating prescription group, and the weight of the rats in the 9-ingredient macules-eliminating prescription group was higher than that in the 13-ingredient macules-eliminating prescription group.

[0137] From around the 6th week, compared with the normal group, the water intake of rats in the 13-ingredient macules-eliminating prescription group decreased significantly (P<0.05); At the eighth week, the water intake of rats in the 9-ingredient macules-eliminating prescription group tended to decrease, but there was no significant difference, and it was significantly higher than that of rats in the 13-ingredient macules-eliminating prescription group (P<0.05).

[0138] During the whole experiment, starting from around the 8th week, the food intake of the 13-ingredient macules-eliminating prescription group was significantly lower than that of the normal group (P<0.05), and there was no significant difference between the 9-ingredient macules-eliminating prescription group and the normal group (P>0.05).

[0139] After two weeks the medicine was suspended, the weight, water intake and food intake of rats in the 9-ingredient macules-eliminating prescription group showed a significant recovery trend, and recovered to the level that had no significant difference compared with the normal group (P>0.05). The weight, water intake and food intake of rats in the 13-ingredient macules-eliminating prescription group showed a recovery trend in the recovery period after two weeks the medicine was suspended, but the recovery was not obvious, and there was a significant difference compared with the normal group (P<0.05).

TABLE-US-00009 TABLE 8 Changes of weight, water intake and food intake of male rats in long-term toxicity test Weight (g) Water intake (g) Food intake (g) 9-ingredient 13-ingredient 9-ingredient 13-ingredient 9-ingredient 13-ingredient macules- macules- macules- macules- macules- macules- eliminating eliminating eliminating eliminating eliminating eliminating Time Normal prescription prescription Normal prescription prescription Normal prescription prescription (weeks) group group group group group group group group group 0 168.00 ± 169.67 ± 167.67 ± — — — — — — 5.51a 2.73a 2.03a 2 213.67 ± 215.33 ± 202.33 ± 39.88 ± 40.18 ± 40.43 ± 24.52 ± 25.58 ± 25.43 ± 4.10a 8.25a 8.09a 2.38b 4.86b 4.14b 0.74a 0.84a 0.90a 4 311.67 ± 309.67 ± 300.00 ± 48.92 ± 49.67 ± 42.79 ± 25.05 ± 30.02 ± 25.44 ± 15.30a 9.33a 8.33a 2.55a 2.12a 10.13a 1.05a 1.08a 0.48a 6 343.33 ± 339.00 ± 320.33 ± 48.90 ± 48.70 ± 34.10 ± 26.17 ± 24.92 ± 22.41 ± 12.71a 15.04a 15.31a 0.40a 3.98a 5.14b 0.40a 4.34a 3.26a 8 405.67 ± 388.67 ± 362.33 ± 49.71 ± 46.17 ± 27.00 ± 26.69 ± 26.12 ± 20.00 ± 6.06a 14.55a 4.91a 1.13 a 0.48 a 2.31c 0.37a 1.09a 1.15b 10 447.67 ± 431.67 ± 386.67 ± 47.00+ 44.00 ± 32.38 ± 27.88 ± 21.28 ± 19.55 ± 2.60a 16.48a 14.68b 0.14a 4.47 a 1.23b 0.13a 0.07a 2.11b 12 461.60 ± 440.53 ± 401.41 ± 48.64 ± 40.78 ± 33.68 ± 25.27 ± 26.80 ± 15.93 ± 1.19a 10.05a 4.21b 0.72a 1.14a 2.38 b 0.59a 2.37a 1.60b Recovery 472.24 ± 465.87 ± 408.39 ± 47.37 ± 46.64 ± 35.91 ± 27.77 ± 27.01 ± 17.32+ period 4.35a 5.7a 6.42b 1.23a 2.5 a 3.47b 0.67a 1.43a 1.48b after two weeks of suspending the medicine a-c: represent that there is no significant difference for the same letters.

[0140] Visceral organ index: After 90 days of gavage, the rats in each group were sampled. Visceral organ index comparison: the liver and kidney indexes of rats in the 13-ingredient macules-eliminating prescription group were significantly higher than those in the normal group (P<0.05), but there was no significant difference among other groups. Two weeks after the medicine was suspended, the liver and kidney indexes of rats in the 13-ingredient macules-eliminating prescription group showed a recovery trend, but they were still significantly higher than those in the normal group (P<0.05).

TABLE-US-00010 TABLE 9 Results of visceral organ index in rats 9-ingredient 13-ingredient Measurement macules-eliminating macules-eliminating Indicator Time Normal group prescription group prescription group Cardiac index 12 weeks 1.23 ± 0.01 1.26 ± 0.02 1.24 ± 0.01 Recovery 1.25 ± 0.02 1.26 ± 0.01 1.25 ± 0.04 period after two weeksof suspending the medicine Lung index 12 weeks 1.36 ± 0.05 1.47 ± 0.10 1.58 ± 0.11 Recovery 1.34 ± 0.06 1.40 ± 0.08 1.53 ± 0.13 period after two weeksof suspending the medicine Liver index 12 weeks 10.10 ± 0.42  10.18 ± 0.13  12.86 ± 0.48* Recovery 10.13 ± 0.21  10.15 ± 0.22  12.47 ± 0.38* period after two weeksof suspending the medicine Thymus index 12 weeks 0.30 ± 0.02 0.27 ± 0.02 0.32 ± 0.03 Recovery 0.31 ± 0.01 0.28 ± 0.02 0.28 ± 0.01 period after two weeksof suspending the medicine Spleen index 12 weeks 0.52 ± 0.03 0.55 ± 0.06 0.51 ± 0.03 Recovery 0.53 ± 0.41 0.55 ± 0.07 0.50 ± 0.02 period after two weeksof suspending the medicine Stomach 12 weeks 1.90 ± 0.03 1.98 ± 0.05 1.97 ± 0.08 index Recovery 1.91 ± 0.01 1.94 ± 0.02 1.96 ± 0.05 period after two weeksof suspending the medicine Kidney index 12 weeks 2.48 ± 0.09 2.26 ± 0.05  2.70 ± 0.09* Recovery 2.45 ± 0.07 2.27 ± 0.01  2.65 ± 0.01* period after two weeksof suspending the medicine *Compared with the normal group, there was significant difference (P < 0.05)

[0141] Enzymology test of serum for liver and kidney function of rats: After 12 weeks of administration, compared with the normal group, the contents of ALP, ALT, AST/γ-GGT in the serum of rats in the 13-ingredient macules-eliminating prescription group were significantly increased (P<0.05, P<0.001). 2 weeks after the administration of medicine was suspended, the contents of ALP, ALT, and AST/γ-GGT all had a decreasing trend, but there were still significant differences compared with the normal group (P<0.05, P<0.001). As for the 9-ingredient macules-eliminating prescription group, only the AST content in serum increased significantly, while the others did not change significantly, and recovered to normal level after 2 weeks of suspension of the administration. It shows that long-term administration of the 13-ingredient macules-eliminating prescription has harmful effects on the liver function of rats, while the 9-ingredient macules-eliminating prescription has low toxicity and is easy to recover to normal after suspension of the administration. At the same time, compared with the normal group, the contents of BUN and Cr in the serum of rats in the 13-ingredient macules-eliminating prescription group were significantly increased, but there was no significant change in the 9-ingredient macules-eliminating prescription group. This indicates that long-term administration of the 13-ingredient macules-eliminating prescription has harmful effects on the liver function of rats, while the 9-ingredient macules-eliminating prescription has no such toxic and side effects.

TABLE-US-00011 TABLE 10 Results of enzymology test of serum for liver and kidney function in rats 9-ingredient 13-ingredient macules-eliminatin macules-eliminat Measurement gprescription ing prescription Indicator Time Normal group group group ALP(U/gprot) 12 weeks  8.51 ± 0.28  8.51 ± 0.78 11.04 ± 0.69* Recovery period  8.53 ± 0.14  8.50 ± 0.32 10.38 ± 0.54* after two weeks of suspending the medicine ALT(U/gprot) 12 weeks 12.24 ± 4.75 18.56 ± 1.54 41.29 ± 8.23* Recovery period 12.27 ± 2.14 14.39 ± 3.65 35.11 ± 6.91  after two weeks of suspending the medicine AST(U/gprot) 12 weeks 141.7 ± 15.5 161.3 ± 0.2* 244.7 ± 3.4** Recovery period 142.5 ± 11.2 150.2 ± 5.4  209.3 ± 4.1*  after two weeks of suspending the medicine γ-GGT(U/L) 12 weeks 12.32 ± 4.14 16.44 ± 3.27 35.66 ± 7.27* Recovery period 12.01 ± 2.20 14.39 ± 2.87 29.37 ± 5.14* after two weeks of suspending the medicine BUN(mmol/L) 12 weeks 447.8 ± 8.1  467.4 ± 7.6   591.2 ± 75.1** Recovery period 449.5 ± 5.4  455.9 ± 8.2   553.0 ± 23.4** after two weeks of suspending the medicine Cr(μmol/L) 12 weeks 53.79 ± 0.57 56.16 ± 6.00 64.57 ± 2.91* Recovery period 50.34 ± 2.38 54.03 ± 4.99 61.21 ± 0.38* after two weeks of suspending the medicine *represents that there is significant difference compared with the normal group (P < 0.05); **represents that there is a highly significant difference compared with the normal group (P < 0.001)

[0142] Conclusion: Through long-term observation of general physiological indexes and visceral organ indexes and testing of serum enzymes related to liver and kidney function of rats in each group, it is found that the 13-ingredient macules-eliminating prescription group could induce the increase of liver and kidney indexes inrats, which has a significant impact on serum enzymes related to liver and kidney function. It indicates that long-term administration of the 13-ingredient macules-eliminating prescription could cause liver and kidney toxicity. However, the 9-ingredient macules-eliminating prescription group has low toxicity, no obvious effect after long-term administration, and it is easy to recover to normal level after suspending the medicine. This result may be related to the fact that the 13-ingredient macules-eliminating prescription contains Paris rhizome, which is slightly toxic and belongs to the liver meridian, and has toxic and side effects after long-term and large dose administration.

[0143] IV. Clinical Experimental Data of the 9-Ingredient Macules-Eliminating Prescription

[0144] 1. Case Selection

[0145] (1) Diagnostic Criteria

[0146] {circle around (1)} Diagnostic criteria of psoriasis vulgaris: “Guiding Principles of Clinical Research on New Traditional Chinese Medicine”, “Criteria for Diagnosis and Efficacy of Common Diseases” (China Traditional Chinese Medicine Press, October 1999), “Criteria for Diagnosis and Improvement of Clinical Diseases” (People's Military Medical Press, June 1998) were referred to. The skin lesions caused by this disease are mainly red inflammatory papules, maculopapules and patches of different sizes, covered with multilayer of silvery-white scales. A bright film can be seen after the scales are scraped off, and there may be punctate bleeding under the film (Auspitz sign).

[0147] The rash can be in the form of drops, coins, maps and mixtures, etc., with obvious boundary.

[0148] Rash can appear all over the body surface. When the rash appears in the scalp, the hair is bunched; and when the rash appears on the nail plate (fingers, toes), there may be punctate pits in the shape of thimble or the nail plate is uneven, yellow and thickens.

[0149] It may be accompanied by different degrees of itching.

[0150] {circle around (2)} Diagnostic criteria of blood-heat psoriasis in syndrome of Chinese medicine:

[0151] Related types include wind-heat and dry-blood condition, wind-heat condition and internal retention of blood-heat condition; lesioned and red skin; continuously increasing or rapidly expanding of new rashes; upset and irritable; mouth parched and tongue scorched; yellow urine; red or crimson tongue; slip or rapid pulse.

[0152] (2) Inclusion Criteria

[0153] {circle around (1)} age from 16 to 65, male or female;

[0154] {circle around (2)} meet the diagnostic criteria of psoriasis vulgaris;

[0155] {circle around (3)} diagnosed as blood-heat type psoriasis by traditional Chinese medicine syndrome differentiation; and

[0156] {circle around (4)} the patient agrees and signs the informed consent form.

[0157] (3) Exclusion Criteria

[0158] {circle around (1)} pregnant or lactating women;

[0159] {circle around (2)} allergic to the present medicine, or allergic to a medicinal ingredient;

[0160] {circle around (3)} internally administrated with a steroid drug within recent 2 weeks;

[0161] {circle around (4)} internally administrated with a retinoic acid drug or externally applied with a steroid preparation within 1 week;

[0162] {circle around (5)} being treated with monoclonal antibody or other biological immunotherapy;

[0163] {circle around (6)} combined with serious primary diseases of cardiovascular, cerebrovascular, liver, renal and hematopoietic system, etc., and patients with mental illness.

[0164] {circle around (7)} other cases that do not comply with the inclusion criteria.

[0165] 2. Experimental Method

[0166] (1) Research methods: random open method was used.

[0167] (2) Medicine used for the treatment: 9-ingredient macules-eliminating prescription; medicine prescription: baical skullcap root, Japanese honeysuckle flower, buffalo horn powder, red peony root, tree peony bark, raw garden burnet root, gypsum, charred cape jasmine fruit, and liquorice root (prepared according to the method of Example 1 of the present application).

[0168] (3) Treatment Method:

[0169] Two sachets (14 g for each sachet) were taken orally each time, twice a day, and the treatment period was 2 months to 3 months.

[0170] (4) Observation Indicators

[0171] Safety Indicators:

[0172] {circle around (1)} examination of general physical examination items,

[0173] {circle around (2)} blood and urine routine examinations were performed before and after the treatment,

[0174] {circle around (3)} ECG, liver and kidney functions were examined before and after the treatment,

[0175] {circle around (4)} possible adverse responses, including clinical symptoms, measurement index, severity, elimination methods of adverse responses, and objective evaluation of other safety issues.

[0176] Therapeutic Effect Index:

[0177] Psoriasis lesion area and severity index (PAST) was used to score the improvement of symptoms of patients before and after the treatment: the area size and severity of scales, infiltration and erythema lesions in different parts (head and neck, torso, and upper and lower limbs) of patients were recorded before and after the treatment.

[0178] (5) Criteria of Therapeutic Effect

[0179] The therapeutic effect of patients before and after the treatment was evaluated by PASI score. Therapeutic effect index=(total PASI score before treatment-total PASI score after treatment)/total PASI score before treatment*100%.

[0180] Clinical cured: the therapeutic effect index is greater than 95%

[0181] Notable effect: the therapeutic effect index is 75% to 95%

[0182] Improvement: the therapeutic effect index is 50% to 75%

Effective rate=(number of clinically cured cases in statistics+number of notably effective cases in statistics+number of improvement cases in statistics)/number of cases in statistics×100%.

[0183] Proportion of patients of PASI-75(PASI score decreased by at least 75%). PASI-75 is the leading method to evaluate the efficacy of clinical trials of medicine treatment for psoriasis internationally.

[0184] 3. Results

[0185] (1) General information: A total of 100 cases were observed, including 52 males and 48 females, with an average age of 44 years (ranging from 18 years to 62 years) and an average course of disease of 11.3 years (ranging from 1 year to 40 years). Among them, 17 cases were mild, 35 cases were moderate and 48 cases were severe.

[0186] (2) Therapeutic Effect Results

[0187] Results are shown as Table 11, the total cure rate is 48%, the total effective rate is 96%, and the proportion of PASI-75 patients is 78%. The cure rate is 23.5% and the effective rate is 100% for mild patients; the cure rate is 62.9% and the effective rate is 100% for moderate patients, and the cure rate is 45.8% and the effective rate is 91.7% for severe patients. The medicine of the present application has a high effective rate for psoriasis of different degrees, mild, moderate and severe, and the cure rate of moderate and severe patients is greater than that of mild patients.

TABLE-US-00012 TABLE 11 Therapeutic effect results Proportion Clinically Notable of PASI-75 Effective cured effect Improvement patients rate Number Number Number of Number Number of cases of cases cases of cases of cases % % % % % Mild 4 5 8 9 17 23.5 29.4 47.1 52.9 100 Moderate 22 8 5 30 35 62.9 22.9 14.2 85.7 100 Severe 22 17 5 39 44 45.8 35.4 10.4 81.3 91.7 Total 48 30 18 78 96 48.0 30.0 18.0 78.0 96.0

[0188] (3) Safety Results

[0189] {circle around (1)} there is no abnormal safety index of patients during and after treatment;

[0190] {circle around (2)} 100 cases have no obvious adverse responses.

[0191] {circle around (3)} the 9-ingredient macules-eliminating prescription is generally well tolerated, and there is no serious adverse response of liver and renal functions and blood system.

[0192] {circle around (4)} transaminase of 3 patients was slightly higher than normal value, which has no clinical significance.

[0193] {circle around (5)} the red blood cells and hemoglobin of male patients tend to decrease, which has no clinical significance.

[0194] 4. Conclusion

[0195] The traditional Chinese medicine composition of the present application can be used for condition of psoriasis vulgaris, and the related types include wind-heat and dry-blood condition, wind-heat condition and internal retention of blood-heat condition. The medicine has a good therapeutic effect on psoriasis vulgaris, with a total effective rate of 96% and a total cure rate of 48%. The proportion of patients of PASI-75(PASI score decreased by 75%) is 78%, and the therapeutic effect is comparable to the current monoclonal antibody drugs that antagonize TNF-α and interleukin IL for treating psoriasis.

[0196] The efficacy index of psoriasis treatment medicine counted in the references is PASI-75(PASI score decreased by 75%). At present, the monoclonal antibody drugs for treating psoriasis, such as Adalimumab (Xiumeile), Infiximab (Leike), Ustekinumab, Sucekinumab (Sujin) and so on, achieve a proportion of PASI-75 patients of 70%-80%, comparable to the therapeutic effect of the traditional Chinese medicine composition of the present invention on psoriasis vulgaris (with a proportion of PASI-75 patients of 78%).

[0197] To sum up, the traditional Chinese medicine granules of the present application for treating psoriasis vulgaris are convenient to use, have no obvious side effects, have good therapeutic effect and low cost, and it is a relatively good choice for treating psoriasis vulgaris of blood-heat type. On the basis of the prior art, the traditional Chinese medicine composition of the present application has improved prescription, it does not contain precious medicinal materials or toxic medicinal materials, reduces the cost and toxic and side effects, and does not reduce the curative effect. Compared with monoclonal antibody drugs, the traditional Chinese medicine composition of the present application has low treatment cost, good safety and better pharmacoeconomic value than monoclonal antibody drugs.