TRADITIONAL CHINESE HERBAL COMPOSITION FOR TREATING ALLERGIC CONJUNCTIVITIS AND/OR ALLERGIC RHINITIS

Abstract

A traditional Chinese herbal composition for treating allergic conjunctivitis and/or allergic rhinitis is prepared from the following raw material herbals in a weight ratio: 3-7 parts of szechuan pepper, 7-13 parts of szechuan lovage rhizome, 7-13 parts of belvedere fruit, 10-15 parts of common anemarrhena rhizome, 7-13 parts of divaricate saposhnikovia root, 4-8 parts of periostracum cicadae, and 7-13 parts of great burdock achene. The traditional Chinese herbal composition has the effects of dispelling wind, clearing heat and relieving itching, and has significant effects on treating allergic conjunctivitis and allergic rhinitis.

Claims

1. A traditional Chinese herbal composition for treating allergic conjunctivitis and/or allergic rhinitis, wherein the traditional Chinese herbal composition is prepared from the following raw material herbals in a weight ratio: 3 parts of szechuan pepper, 10 parts of szechuan lovage rhizome, 10 parts of belvedere fruit, 12 parts of common anemarrhena rhizome, 10 parts of divaricate saposhnikovia root, 6 parts of periostracum cicadae, and 10 parts of great burdock achene.

2. The traditional Chinese herbal composition according to claim 1, wherein the traditional Chinese herbal composition is a formulation prepared by taking herbal powders of the raw material herbals or water or organic solvent extracts of the raw material herbals as active ingredients and adding pharmaceutically acceptable adjuvants.

3. The traditional Chinese herbal composition according to claim 2, wherein the formulation is an oral formulation.

4. The traditional Chinese herbal composition according to claim 3, wherein the oral formulation is a granule, a powder, a pill, or a solution.

5. A preparation method for the traditional Chinese herbal composition according to claim 1, comprising the following steps: (1) weighing the raw material herbals according to the weight ratio in claim 1; and (2) grinding the raw material herbals into powders or preparing an extracting solution of the raw material herbals in water or an organic solvent, and adding pharmaceutically common adjuvants or auxiliary components to obtain the traditional Chinese herbal composition.

6. A use method of the traditional Chinese herbal composition according tom claim 1, comprising: using the traditional Chinese herbal composition in preparing a medicine for treating the allergic conjunctivitis.

7. A use method of the traditional Chinese herbal composition according to claim 1, comprising: using the traditional Chinese herbal composition in preparing a medicine for treating the allergic rhinitis.

8. A use method of the traditional Chinese herbal composition according to claim 1, comprising: using the traditional Chinese herbal composition in preparing a medicine for dispelling wind, clearing heat and relieving itching.

9. The preparation method according to claim 5, wherein the traditional Chinese herbal composition is a formulation prepared by taking herbal powders of the raw material herbals or water or organic solvent extracts of the raw material herbals as active ingredients and adding pharmaceutically acceptable adjuvants.

10. The preparation method according to claim 9, wherein the formulation is an oral formulation.

11. The preparation method according to claim 10, wherein the oral formulation is a granule, a powder, a pill, or a solution.

12. The use method according to claim 6, wherein the traditional Chinese herbal composition is a formulation prepared by taking herbal powders of the raw material herbals or water or organic solvent extracts of the raw material herbals as active ingredients and adding pharmaceutically acceptable adjuvants.

13. The use method according to claim 12, wherein the formulation is an oral formulation.

14. The use method according to claim 13, wherein the oral formulation is a granule, a powder, a pill, or a solution.

15. The use method according to claim 7, wherein the traditional Chinese herbal composition is a formulation prepared by taking herbal powders of the raw material herbals or water or organic solvent extracts of the raw material herbals as active ingredients and adding pharmaceutically acceptable adjuvants.

16. The use method according to claim 15, wherein the formulation is an oral formulation.

17. The use method according to claim 16, wherein the oral formulation is a granule, a powder, a pill, or a solution.

18. The use method according to claim 8, wherein the traditional Chinese herbal composition is a formulation prepared by taking herbal powders of the raw material herbals or water or organic solvent extracts of the raw material herbals as active ingredients and adding pharmaceutically acceptable adjuvants.

19. The use method according to claim 18, wherein the formulation is an oral formulation.

20. The use method according to claim 19, wherein the oral formulation is a granule, a powder, a pill, or a solution.

Description

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0024] The solution, the granule, the powder, and the pill prepared from the composition of the present invention have a mature preparation process, and can be prepared with reference to the conventional methods in the prior art.

Example 1. Preparation of the Medicine of the Present Invention

[0025] The formula is as follows: 3 g of szechuan pepper, 10 g of szechuan lovage rhizome, 10 g of belvedere fruit, 12 g of common anemarrhena rhizome, 10 g of divaricate saposhnikovia root, 6 g of periostracum cicadae, and 10 g of great burdock achene.

[0026] Preparation Method: [0027] 1) weighing the above raw material herbals according to the ratio; and [0028] 2) mixing the raw material herbals, adding water to decoct twice (the water was added in an amount of about 15 times of the mixture and the mixture was decocted for half an hour each time), mixing, filtering, and concentrating the decoctions to obtain a solution.

Example 2. Preparation of the Medicine of the Present Invention

[0029] The formula is as follows: 3 g of szechuan pepper, 7 g of szechuan lovage rhizome, 7 g of belvedere fruit, 10 g of common anemarrhena rhizome, 7 g of divaricate saposhnikovia root, 4 g of periostracum cicadae, and 7 g of great burdock achene.

[0030] Preparation Method: [0031] 1) weighing the above raw material herbals according to the ratio; and [0032] 2) mixing the raw material herbals, adding water to decoct twice (the water was added in an amount of 10 times of the mixture and the mixture was decocted for half an hour each time), mixing and filtering the decoctions to obtain a filtrate, concentrating the filtrate into a thick paste, mixing well, drying the paste under reduced pressure, pulverizing into fine powders, adding dextrin and mixing well to obtain a granule by wet granulation method.

Example 3. Preparation of the Medicine of the Present Invention

[0033] The formula is as follows: 7 g of szechuan pepper, 13 g of szechuan lovage rhizome, 13 g of belvedere fruit, 15 g of common anemarrhena rhizome, 13 g of divaricate saposhnikovia root, 8 g of periostracum cicadae, and 13 g of great burdock achene.

[0034] Preparation Method: [0035] 1) weighing the above raw material herbals according to the ratio; and [0036] 2) mixing the raw material herbals, adding water to decoct twice (the water was added in an amount of 12 times of the mixture and the mixture was decocted for 1 hour each time), mixing and filtering the decoctions to obtain a filtrate, concentrating the filtrate into a cream extract, and making the cream extract into pills to obtain a pill.

[0037] The beneficial effects of the present invention are illustrated by Test Examples below.

Test Example 1. Clinical Efficacy of the Present Invention

[0038] 1. Data and Method

[0039] 1.1 General Data

[0040] From May 10, 2021 to Aug. 23, 2021, 36 patients diagnosed with allergic conjunctivitis complicated and allergic rhinitis were collected from Eye Hospital, China Academy of Chinese Medical Sciences, and they were divided into 2 groups according to a random number table method with 20 cases in the treatment group and 16 cases in the control group. There was no statistically significant difference in aspects such as age, gender, and disease course between the patients in the two groups before treatment (P>0.05), and therefore the two groups were comparable.

[0041] 1.2 Medicines and Methods of Administration:

[0042] The treatment group was orally administered with the water decoction prepared in Example 1 with one dose a day and for twice a day, and the control group was orally administered with 10 mg of cetirizine capsules once a day.

[0043] 2. Evaluation Indexes: [0044] 1) Ocular and nasal symptoms and signs were standardly divided into 4 grades (0: none, 1: mild: 2: moderate: and 3: severe); [0045] 2) Systemic adverse reactions and local adverse reactions in the eyes and nose were recorded.

[0046] 2.1 Ocular Symptoms

[0047] Eye itching: (1) none; (2) mild: the patient won't notice eye itching when busy at work, but can feel itching when free, or has intermittent eye itching, but it's not severe enough to need to be scratched with hand; (3) moderate: the patient has obvious eye itching, and can still tolerate this symptom, but has the desire to scratch it with hand; and (4) severe: the patient has very obvious and continuous eye itching and stabbing pain, and cannot tolerate these symptoms, and therefore normal life is affected.

[0048] Tearing: (1) none; (2) tears are subjectively perceived in the conjunctival sac but do not flow out of the eyelid margin; (3) tears exist in the conjunctival sac, and occasionally overflow the eyelid margin to the cheek; and (4) tears regularly or continuously overflow to the cheek;

[0049] 2.2 Ocular Signs

[0050] Conjunctival congestion: (1) none; (2) mild: congestion takes place in palpebral conjunctiva and fornix in a reticular form; (3) moderate: congestion takes place in palpebral conjunctiva, fornix and bulbar conjunctiva in a reticular form; and (4) severe: congestion takes place in palpebral conjunctiva in a form of red patches, blood vessels are blurred, and obvious congestion takes place in fornix and bulbar conjunctiva;

[0051] Conjunctival edema: (1) none; (2) bulbar conjunctival edema can be seen under a slit lamp examination; (3) moderate; bulbar conjunctival edema can be directly seen under natural light; and (4) severe: bulbar conjunctival edema with vesicular protuberances;

[0052] Secretions: (1) none; (2) a small amount of mucous secretions, which are filamentous; (3) moderate: a moderate amount of secretions, which are linear; and (4) severe: an excessive amount of secretions, which are flaky or adhesive to eyelid tissues upon awakening in the morning.

[0053] 2.4 Nasal Symptoms:

[0054] Rhinocnesmus: (1) none; (2) mild and intermittent; (3) moderate: an ant walking sensation that can be tolerated; and (4) severe: an ant walking sensation that cannot be tolerated.

[0055] Sneezing (number of consecutive sneezings): (1) none; (2) mild: 3-9; (3) moderate: 10-14; (4) severe: 15.

[0056] Nose running (number of nose blowings per day): (1) none; (2) mild: =4; (3) moderate: 5-9; (4) severe 10.

[0057] 2.5 Nasal Signs

[0058] Conditions of the nasal mucosa, inferior turbinate, nasal floor and nasal septum are observed with a nasal speculum and divided into the following four grades. [0059] (1) no swelling of the inferior turbinate; (2) mild: mild swelling of the inferior turbinate, and the middle turbinate and nasal septum can still be seen; (3) moderate: the inferior turbinate is tightly close to the nasal septum (nasal floor), and there is still a small gap between the inferior turbinate and the nasal floor (nasal septum); and (4) severe: the inferior turbinate, the nasal floor and the nasal septum are tightly close to one another, and the middle turbinate cannot be seen.

[0060] 3. Evaluation Method

[0061] The effective rate evaluation method is based on standards established in Clinical Development Guidelines for Pharmaceutical Products for Treatment of Allergic Rhinoconjunctivitis published by the European Medicines Agency, Chinese Expert Consensus on Diagnosis and Treatment of Allergic Conjunctivitis by Chinese Journal of Ophthalmology, 2018, and Guidelines for Diagnosis and Treatment of Allergic Rhinitis (Chinese Journal of Otorhinolaryngology Head and Neck Surgery, 2016. Vol. 51), and is divided into 4 grades (0: none; 1: mild; 2: moderate; and 3: severe), and it is considered effective if two symptoms (or signs) are improved by one grade or more, or same symptom (or sign) is improved by two grades or more. ((2) to (1), (3) to (2) or (4) to (3) represents a one-grade improvement, and (3) to (1) represents a two-grade improvement).

[0062] 4. Efficacy Evaluation Results.

[0063] The results are shown in Tables 1 and 2.

TABLE-US-00001 TABLE 1 Comparison of the ocular efficacies of the two groups Effective Groups Effective Ineffective Rate 1-week Treatment 18 3 85.7% Group treatment Control 11 5 68.75% Group

TABLE-US-00002 TABLE 2 Comparison of the nasal efficacies of the two groups Effective Groups Effective Ineffective Rate 1-week Treatment 17 3 85.0% Group treatment Control 12 4 75.0% Group

[0064] As can be seen from Tables 1-2: the effective rate of the herbal composition of the present invention for treating allergic conjunctivitis and allergic rhinitis reaches more than 85%, and compared with the western medicine cetirizine, the effective rate has been improved by 13%-19%, and no adverse reactions have been found.

Test Example 2. Typical Case

[0065] Chen, female, 50 years old, complained of intolerable eye itching, eye reddening, and tearing lasting for one week, accompanied by sneezing, nose running, and rhinocnesmus. This condition took place every autumn. To figure out, she came to visit in Eye Hospital, China Academy of Chinese Medical Sciences. After examination on her, we found congestion in a form of red patches in palpebral conjunctiva, and congestion in a reticular form in fornix and bulbar conjunctiva, and she was diagnosed with allergic conjunctivitis complicated with allergic rhinitis. She was orally administered with the water decoction prepared in Example 1 with one dose a day and for twice a day. After two doses were taken, the symptoms were obviously alleviated, and eye itching and rhinocnesmus were greatly alleviated. After two weeks of treatment, no sneezing or rhinocnesmus was found, eye itching became mild, no congestion in bulbar conjunctiva was found, and congestion in palpebral conjunctive was alleviated. Continuing with 7 doses thereafter, no ocular or nasal symptoms were further found.

[0066] In conclusion, the composition of the present invention solves diseases in two sites of body with one prescription (namely, allergic conjunctivitis and allergic rhinitis which have the same pathogenesis that is type I allergic reaction), achieves significant effects. The composition of the present invention brings greater treatment benefits for patients with allergic conjunctivitis and allergic rhinitis, and meanwhile, the composition avoids adverse reactions possibly caused by chemical medicines, and therefore is worthy of clinical popularization and application.