Traditional Chinese Medicine Composition for Treating Acute Stage of Cerebral Infarction

Abstract

A traditional Chinese medicine composition for treating acute stage of cerebral infarction. The traditional Chinese medicine composition combines buffalo horns, unprocessed rehmannia roots, red paeony roots, cortex moutan, grassleaf sweelflag rhizome and turmeric root-tuber, and exerts the synergistic effects of the medicines through compatibility, thereby being capable of more effectively clearing away heat and toxic materials, cooling the blood, dissipating blood stasis and inducing resuscitation, and achieving the purpose of treating acute stage of cerebral infarction.

Claims

1. A traditional Chinese medicine composition for treating acute stage of cerebral infarction, characterized in that the composition is prepared from the following raw materials in parts by weight: 10-50 parts of buffalo horns, 10-30 parts of unprocessed rehmannia roots, 10-30 parts of red paeony roots, 10-30 parts of cortex moutan, 6-20 parts of grassleaf sweelflag rhizome and 10-30 parts of turmeric root-tuber.

2. The traditional Chinese medicine composition for treating acute stage of cerebral infarction according to claim 1, characterized in that the composition is prepared from the following raw materials in parts by weight: 10-30 parts of buffalo horns, 10-20 parts of unprocessed rehmannia roots, 10-20 parts of red paeony roots, 10-20 parts of cortex moutan, 6-15 parts of grassleaf sweelflag rhizome and 10-20 parts of turmeric root-tuber.

3. The traditional Chinese medicine composition according to claim 1, characterized in that the composition is formulated into a preparation with pharmaceutically acceptable adjuvant materials.

4. The traditional Chinese medicine composition according to claim 3, characterized in that the preparation formulation is decoction, granules, capsules or tablets.

5. A preparation method of the traditional Chinese medicine composition for treating acute stage of cerebral infarction of claim 1, characterized in that the method comprises the following steps: mixing herbal pieces of the buffalo horns, the unprocessed rehmannia roots, the red paeony roots and the cortex moutan and performing water extraction; mixing herbal pieces of the grassleaf sweelflag rhizome and the turmeric root-tuber and performing extraction by hot reflux with 70% ethanol; separately concentrating the water extract and the ethanol extract, and performing combining, spray drying and uniform mixing to prepare the traditional Chinese medicine composition.

6. The method according to claim 5, characterized in that by the water extraction method, water extraction is performed for 2-3 times with 1-3 h each time, and the amount of water is 8-10 times of the total weight of the medicinal materials.

7. The method according to claim 5, characterized in that by the ethanol extraction method, extraction is performed with 70% ethanol for 2-3 times with 1-2 h each time, and the amount of ethanol is 8-10 times of the total weight of the medicinal materials.

8. A process for treating acute stage of cerebral infarction comprising a step of administrating to a subject in need a traditional Chinese medicine composition of claim 1.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0028] The present invention is further illustrated by the following examples. The specific details of the examples are merely illustrative of the present invention and shall not be construed as limitations of the general technical scheme of the present invention. In the following examples, each part by weight is 1 gram.

Example 1

[0029] Preparation of decoction:

[0030] weighing the following crude drugs of the present invention in parts by weight: 30 grams of buffalo horns, 15 grams of unprocessed rehmannia roots, 15 grams of red paeony roots, 10 grams of cortex moutan, 10 grams of grassleaf sweelflag rhizome and 10 grams of turmeric root-tuber;

[0031] weighing herbal pieces of the traditional Chinese medicine components according to the proportions, adding 4 times of water for the first time, performing soaking for 1 h, performing decocting for 2 h, adding 3 times of water for the second time, performing decocting for 1.5 h, adding 3 times of water for the third time, performing decocting for 1.5 h, separately filtering decoctions and combining the decoctions.

[0032] When the traditional Chinese medicine composition of the present invention is used for treating the acute stage of cerebral infarction, one dose of the prepared decoction is administered a day in 2-3 times.

Example 2

[0033] Preparation of granules:

[0034] weighing the following crude drugs of the present invention in parts by weight: 15 grams of buffalo horns, 12 grams of unprocessed rehmannia roots, 10 grams of red paeony roots, 12 grams of cortex moutan, 6 grams of grassleaf sweelflag rhizome and 12 grams of turmeric root-tuber.

[0035] weighing herbal pieces of the traditional Chinese medicine components according to the proportions, mixing herbal pieces of the buffalo horns, the unprocessed rehmannia roots, the red paeony roots and the cortex moutan, and performing water extraction, mixing herbal pieces of the grassleaf sweelflag rhizome and the turmeric root-tuber and performing extraction by hot reflux with 70% ethanol, separately concentrating the water extract and the ethanol extract, performing combining and filtering, taking supernatant liquid, adding dextrin to the supernatant liquid, performing granulating by a wet process, and performing drying and uniform mixing;

[0036] by the water extraction method, water extraction is performed for 3 times with 2 h each time, and the amount of water is 8 times of the total weight of the medicinal materials;

[0037] by the ethanol extraction method, extraction is performed with 70% ethanol for 3 times with 1.5 h each time, and the amount of ethanol is 8 times of the total weight of the medicinal materials;

[0038] combining and filtering the water extract and the ethanol extract, and performing concentration under reduced pressure on the filtrate until the relative density of clear paste is 1.1-1.2 at 75 C., where the rotation speed of a tubular bowl centrifuge is 5000 rpm.

[0039] When the traditional Chinese medicine composition of the present invention is used for treating the acute stage of cerebral infarction, one bag contains 5 g of the composition which is equivalent to 32.5 g of crude medicinal herbs, and 1 bag of the prepared granules is administered each time, 2 times a day.

Example 3

[0040] Preparation of capsules:

[0041] weighing the following crude drugs of the present invention in parts by weight: 20 grams of buffalo horns, 15 grams of unprocessed rehmannia roots, 12 grams of red paeony roots, 12 grams of cortex moutan, 6 grams of grassleaf sweelflag rhizome and 12 grams of turmeric root-tuber;

[0042] weighing herbal pieces of the traditional Chinese medicine components according to the proportions, mixing herbal pieces of the buffalo horns, the unprocessed rehmannia roots, the red paeony roots and the cortex moutan and performing water extraction, mixing herbal pieces of the grassleaf sweelflag rhizome and the turmeric root-tuber and performing extraction by hot reflux with 70% ethanol, separately concentrating the water extract and the ethanol extract, and performing combining, drying under vacuum reduced pressure, pulverizing, uniform mixing, adding of adjuvant materials, granulating, uniform mixing and filling of capsules;

[0043] by the water extraction method, water extraction is performed for 2 times with 2 h each time, and the amount of water is 10 times of the total weight of the medicinal materials;

[0044] by the ethanol extraction method, extraction is performed with 70% ethanol for 2 times with 1.5 h each time, and the amount of ethanol is 10 times of the total weight of the medicinal materials;

[0045] the pharmaceutical adjuvant materials comprise magnesium oxide, calcium hydrogen phosphate, starch and magnesium stearate.

[0046] When the traditional Chinese medicine composition of the present invention is used for treating the acute stage of cerebral infarction, one capsule contains 0.5 g of the composition which is equivalent to 7 g of crude medicinal herbs, and 3-4 of the prepared capsules are administered each time, 2-3 times a day.

Example 4

[0047] Preparation of tablets:

[0048] weighing the following crude drugs of the present invention in parts by weight: 15 grams of buffalo horns, 12 grams of unprocessed rehmannia roots, 12 grams of red paeony roots, 10 grams of cortex moutan, 10 grams of grassleaf sweelflag rhizome and 12 grams of turmeric root-tuber;

[0049] weighing herbal pieces of the traditional Chinese medicine components according to the proportions, mixing herbal pieces of the buffalo horns, the unprocessed rehmannia roots, the red paeony roots and the cortex moutan and performing water extraction, mixing herbal pieces of the grassleaf sweelflag rhizome and the turmeric root-tuber and performing extraction by hot reflux with 70% ethanol, separately concentrating the water extract and the ethanol extract, and performing combining, drying under vacuum reduced pressure, pulverizing, adding of sugar powder, granulating, adding of pharmaceutical adjuvant materials, uniform mixing, tablet pressing, drying and packaging;

[0050] by the water extraction method, water extraction is performed for 3 times with 1.5 h each time, and the amount of water is 9 times of the total weight of the medicinal materials;

[0051] by the ethanol extraction method, extraction is performed with 70% ethanol for 3 times with 1 h each time, and the amount of ethanol is 9 times of the total weight of the medicinal materials;

[0052] the pharmaceutical adjuvant materials comprise microcrystalline cellulose, magnesium stearate and calcium carbonate.

[0053] When the traditional Chinese medicine composition of the present invention is used for treating the acute stage of cerebral infarction, one tablet contains 0.4 g of the composition which is equivalent to 6 g of crude medicinal herbs, and 3-4 of the prepared tablets are administered each time, 2-3 times a day.

Example 5

[0054] The medicine composition prepared by the method of the example of the present invention is used for clinical trials:

[0055] 1. Case selection: A total of 115 patients in the acute stage of cerebral infarction in a neurology department of a hospital are selected, including 61 males and 54 females; the oldest is 81 years old, the youngest is 66 years old, and the average age is 78.0787.215 years old. The diagnostic criteria refer to the 2013 American Academy of Neurology (AAN) guidelines for the application of antithrombotic drugs for ischemic cerebrovascular disease, and the Chinese guidelines for the diagnosis and treatment of cerebral infarction with integrated Chinese and Western medicine (2017). All patients are scored according to the National Institutes of Health Stroke Scale (NIHSS) at admission. The above cases are randomly divided into 2 groups. There are no significant differences (P>0.05) in age, gender and condition between the two groups, which are comparable.

[0056] 2. Treatment methods: The two groups of patients are divided into a control group and a treatment group. The control group received routine treatment, including regulation of the patients' blood pressure according to conditions, treatment with anti-platelet, fiber-reducing and intravenous thrombolytic drugs, observation of complications and expectant treatment on the disease, and combination with neurological function rehabilitation training. In the treatment group, in addition to the above-mentioned therapy, the decoction of the Example 1 is orally administered, the single prescription amount/day is administered in two times, the course of treatment is 14 days, and the course of treatment is continued for 2 courses.

[0057] 3. Curative effect evaluation criteria: According to the changes of NIHSS scores before and after treatment, the curative effects of each group and the comparison between groups are evaluated. Curative effect evaluation criteria:

[0058] basic cure: NIHSS reduces by 90%;

[0059] significant improvement: NIHSS reduces by 46% to 89%;

[0060] improvement: NIHSS reduces by 18% to 45%;

[0061] no change: NIHSS reduces or increases by <18%;

[0062] deterioration: NIHSS increases by 8%.

Marked effective rate=basic cure rate+significant improvement rate; total effective rate=basic cure rate+significant improvement rate+improvement rate.

[0063] Statistical treatment is performed by using the t test and the Fisher test.

[0064] 4. Comparison of clinical effects between the two groups is shown in Table 1:

TABLE-US-00001 TABLE 1 Comparison of the curative effects of two groups of patients in acute stage of cerebral infarction (example) Number Significant of Basic improve- Improve- No Groups patients cure ment ment change Deterioration Control 57 8 22 16 9 2 group Treat- 58 13 32 11 1 1 ment group

[0065] From the above results, it can be seen that the improvement degree of NIHSS index in patients treated with additional use of the decoction of the present invention is significantly better than the control group, indicating that the use of conventional treatment with addition of the decoction can effectively improve restoration of neurological functions of patients in the acute stage of cerebral infarction, and can effectively reduce the incidence of sequelae.

[0066] The comparison of clinical curative effects of the two groups of patients is shown in Table 2:

TABLE-US-00002 TABLE 2 Comparison of clinical curative effects of two groups of patients Marked No Marked effective Effective Groups effective Effective effect rate (%) rate (%) Control 30 46 11 52.63 80.70 group Treatment 45 56 2 77.59 96.55 group
The comparison of NIHSS scores between the two groups is shown in Table 3:

TABLE-US-00003 TABLE 3 Comparison of NIHSS scores between 2 groups of patients Number of Before treatment After treatment Groups patients (x s) (x s) Control group 57 15.65 4.12 6.61 2.24 Treatment group 58 15.16 4.35 4.75 1.87
As shown in the above table, the effective rate of the treatment group is 96.55%, the effective rate of the control group is 73.68%, and there is a significant difference between the two groups (P<0.05, the treatment group is significantly better than the control group). The marked effective rate of the treatment group is 77.59%, the marked effective rate is 52.63%, and there is significant difference between the two groups (P<0.05, the treatment group is significantly better than the control group). The above curative results show that the traditional Chinese medicine composition of the present invention has a good auxiliary effect on the restoration of neurological functions of patients in the acute stage of cerebral infarction and can be used together with clinical treatment to improve the clinical symptoms and physical signs of patients in the acute stage of cerebral infarction, demonstrating that the traditional Chinese medicine composition of the present invention has good curative effects on patients in the acute stage of cerebral infarction and has potential clinical application value.