Traditional Chinese medicine composition for treating chronic urticaria

Abstract

The present invention relates to a traditional Chinese medicine composition for treating chronic urticaria. The traditional Chinese medicine composition is prepared from traditional Chinese medicines such as Artemisia capillaris, Patchouli, Silkworm excrement, Cinnamon twig, Periostracum cicada, Poria cocos, Atractylodes macrocephala, Cardamom, and Tangerine peel. The traditional Chinese medicine patch of the present invention is easy to use, highly safe, can quickly and effectively improve skin lesions and itching in patients with chronic urticaria, reduce recurrence of the disease, and has a significant therapeutic effect in treating chronic urticaria.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for chronically treating urticaria. Background Art

[0002] Urticaria is a common clinical allergic disease of the skin, mucous membranes, and blood vessels. Its main clinical manifestations are persistent wheals, erythema, and itching that appear at irregular intervals on the trunk, limbs, and face. It is characterized by recurring attacks and is difficult to cure. Chronic urticaria refers to daily or intermittent attacks of wheals that last for more than 6 weeks. According to relevant research, approximately 20% of the population will have suffered from acute urticaria at least once in their lifetime, and 1.80% will have suffered from chronic urticaria. Existing evidence shows that various forms of urticaria are seriously impairing people's quality of life, affecting their ability to perform daily tasks and their mental health.

[0003] The pathogenesis of chronic urticaria remains unclear. Most researchers believe it to be an allergic reaction. Western medicine, using symptomatic treatments such as antihistamines and hormones, can alleviate symptoms to some extent, but relapses are common after discontinuation. In recent years, traditional Chinese medicine has gained increasing clinical attention, demonstrating unique advantages in the treatment of chronic urticaria through a holistic approach and a differentiated approach to treatment.

[0004] Currently, there are few reports on effective Chinese medicine formulas for the treatment of chronic urticaria. How to find a Chinese medicine from traditional Chinese medicine that can quickly and effectively improve the skin lesions and itching of patients with chronic urticaria, reduce the recurrence of the disease, and has a precise efficacy and is safe to use to meet clinical needs has become a technical problem that needs to be solved urgently. Summary of the Invention

[0005] To solve the above technical problems, the present invention includes the following aspects:

[0006] A first aspect of the present invention provides a traditional Chinese medicine composition for treating chronic urticaria, wherein the traditional Chinese medicine composition is prepared from Artemisia capillaris, Patchouli, Silkworm excrement, Cinnamon twig, Cicada slough, Poria cocos, Raw Atractylodes macrocephala, Cardamom and Tangerine peel.

[0007] Preferably, the traditional Chinese medicine composition is prepared from 10-20 parts of Artemisia capillaris, 40-50 parts of Patchouli, 15-25 parts of silkworm excrement, 25-35 parts of cinnamon twig, 2-8 parts of cicada slough, 5-15 parts of Poria cocos, 5-15 parts of raw Atractylodes macrocephala, 1-5 parts of cardamom, and 2-8 parts of dried tangerine peel.

[0008] More preferably, the traditional Chinese medicine composition is prepared from 12-18 parts of Artemisia capillaris, 42-48 parts of Patchouli, 17-23 parts of silkworm excrement, 27-33 parts of cinnamon twig, 3-7 parts of cicada slough, 8-12 parts of Poria cocos, 8-12 parts of raw Atractylodes macrocephala, 2-4 parts of cardamom, and 4-6 parts of dried tangerine peel.

[0009] Further preferably, the traditional Chinese medicine composition is prepared from 15 parts of Artemisia capillaris, 45 parts of Patchouli, 20 parts of silkworm excrement, 30 parts of cinnamon twig, 5 parts of cicada shell, 10 parts of Poria cocos, 10 parts of raw Atractylodes macrocephala, 3 parts of cardamom, and 5 parts of dried tangerine peel.

[0010] The traditional Chinese medicine composition is prepared from 16 parts of Artemisia capillaris, 46 parts of Patchouli, 21 parts of silkworm excrement, 31 parts of cinnamon twig, 6 parts of cicada slough, 11 parts of Poria cocos, 11 parts of raw Atractylodes macrocephala, 4 parts of cardamom and 6 parts of dried tangerine peel.

[0011] Chronic urticaria is mostly caused by dampness and turbidity on the surface, and the treatment focuses on strengthening the spleen and waking up the spleen, removing dampness and turbidity. A healthy spleen will enable the production of qi and blood, and dampness and heat will not be generated internally, so the evil cannot interfere.

[0012] In the Chinese medicine composition, Artemisia capillaris is the monarch drug, clearing away dampness and heat, while Patchouli is aromatic and clearing turbidity, dispelling exterior pathogens and removing dampness. The two drugs serve as monarch drugs together, strengthening the efficacy of removing dampness and removing dampness. Silkworm excrement, an assistant drug, dispels wind and removes dampness, warms and dries, and helps warm and remove dampness in the body. Combined with cinnamon twig, it warms and unblocks the meridians, warming the middle and removing dampness. Cicada slough dispels wind and dissipates heat, clears rashes and relieves itching, helping the monarch drug to strengthen the effect of removing wind and relieving itching. Poria cocos and raw Atractylodes macrocephala strengthen the spleen and remove dampness, while cardamom warms the middle and removes dampness. Together, they strengthen the spleen, warm the middle and remove dampness, and tangerine peel strengthens the spleen, regulates qi and removes dampness, allowing the medicinal properties to reach the five internal organs and limbs. The combination of all the drugs has the effects of strengthening the spleen, invigorating the spleen, removing dampness and eliminating spots.

[0013] The second aspect of the present invention provides a traditional Chinese medicine compound preparation for treating chronic urticaria, which is prepared from Artemisia capillaris, Patchouli, Silkworm excrement, Cinnamon twig, Cicada slough, Poria cocos, Raw Atractylodes macrocephala, Cardamom, Tangerine peel and pharmaceutically acceptable excipients.

[0014] The formulation of each medicinal ingredient in the traditional Chinese medicine compound preparation is as described in the first aspect of the present invention.

[0015] Preferably, the Chinese medicine compound preparation is an oral preparation.

[0016] Preferably, the dosage form of the Chinese medicine compound preparation is decoction, tablet, granule, capsule, powder or pill.

[0017] More preferably, the dosage form of the Chinese medicine compound preparation is decoction or granules.

[0018] The pharmaceutically acceptable excipients include, but are not limited to, one or more of: excipients, lubricants, binders, disintegrants and flavoring agents.

[0019] The excipient is selected from one or more of lactose, sucrose, glucose, mannitol, sorbitol, starch, dextrin, crystalline cellulose, gum arabic and dextran.

[0020] The lubricant is selected from one or more of magnesium stearate, calcium stearate, talc, micro-powder silica gel, boric acid and sodium lauryl sulfate.

[0021] The binder is selected from one or more of hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl pyrrolidone and polyethylene glycol.

[0022] The disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl starch and cross-linked polyvinyl pyrrolidone.

[0023] The flavoring agent is selected from one or more of sucrose, spices, aspartame and cyclodextrin.

[0024] The third aspect of the present invention provides a method for preparing a traditional Chinese medicine compound preparation for treating chronic urticaria, the preparation method mainly comprising: extracting the traditional Chinese medicine by water decoction, alcohol extraction, etc., and concentrating the extract; optionally: drying, and adding pharmaceutically acceptable excipients to prepare the preparation.

[0025] The preparation method of the decoction comprises: taking prescribed amounts of Artemisia capillaris, Patchouli, silkworm excrement, cinnamon twig, cicada slough, Poria cocos, raw Atractylodes macrocephala, cardamom and tangerine peel, adding distilled water 3-6 times the total weight of the Chinese medicinal materials, soaking for 1-2 hours, decocting over high heat until boiling, then decocting over low heat, extracting for 1-3 hours, extracting 1-2 times, filtering the medicinal residue, and heating and concentrating the filtrate to obtain the decoction.

[0026] Preferably, soak for 2 hours, extract for 2 hours, and extract twice.

[0027] The preparation method of the granules comprises: taking prescribed amounts of Artemisia capillaris, Patchouli, silkworm excrement, cinnamon twig, cicada slough, Poria cocos, raw Atractylodes macrocephala, cardamom and tangerine peel, adding 40-60% ethanol water which is 3-6 times the total weight of the Chinese medicinal materials, soaking for 1-2 hours, extracting for 1-3 hours, extracting 1-2 times, filtering the medicinal residue, heating and concentrating the filtrate, drying, and adding one or more pharmaceutically acceptable excipients to prepare the granules.

[0028] Preferably, soak for 1 hour; extract for 2 hours, and extract once.

[0029] The third aspect of the present invention provides use of the above-mentioned Chinese medicine composition or the Chinese medicine compound preparation in the preparation of a medicament for treating chronic urticaria.

[0030] The present invention has positive and beneficial effects:

[0031] 1. The Chinese medicine composition of the present invention has been clinically used for many years, and has a precise efficacy in treating chronic urticaria and is safe to use. It can quickly and effectively improve the skin lesions and itching of patients with chronic urticaria and reduce the recurrence of the disease.

[0032] 2. The Chinese medicine composition of the present invention has a definite therapeutic effect on improving the scope, severity and itching of chronic urticaria lesions. DETAILED DESCRIPTION

[0033] The present invention will be further described below with reference to the examples, but the embodiments of the present invention are not limited thereto. The experimental methods used in the following examples are conventional methods unless otherwise specified.

[0034] Example 1

[0035] Take 15g of Artemisia capillaris, 45g of Patchouli, 20g of silkworm excrement, 30g of cinnamon twig, 5g of cicada slough, 10g of Poria cocos, 10g of raw Atractylodes macrocephala, 3g of cardamom, and 5g of dried tangerine peel, add distilled water 5 times the total weight of the Chinese medicinal materials, soak for 1.5 hours, then boil over high heat until boiling, then simmer over low heat for 2 hours, extract twice, filter the residue, and take the filtrate, heat and concentrate to 140g to obtain the Chinese medicinal decoction 1 of the present invention.

[0036] Example 2

[0037] Take 16g of Artemisia capillaris, 46g of Patchouli, 21g of silkworm excrement, 31g of cinnamon twig, 6g of cicada slough, 11g of Poria cocos, 11g of raw Atractylodes macrocephala, 4g of cardamom, and 6g of dried tangerine peel, add distilled water 6 times the total weight of the Chinese medicinal materials, soak for 2 hours, boil over high heat until boiling, then simmer over low heat for 1 hour, extract twice, filter the residue, and heat the filtrate to concentrate to 140g to obtain the Chinese medicinal decoction 2 of the present invention.

[0038] Example 3

[0039] Take 15g of Artemisia capillaris, 45g of Patchouli, 20g of silkworm excrement, 30g of cinnamon twig, 5g of cicada slough, 10g of Poria, 10g of raw Atractylodes macrocephala, 3g of cardamom, and 5g of dried tangerine peel, add 40-60% ethanol water (6 times the total weight of the Chinese medicinal materials), soak for 1 hour, extract for 2 hours, extract once, filter the medicinal residues, take the filtrate, heat and concentrate, dry, add sucrose and hydroxypropyl cellulose to granulate, granulate, and sieve to obtain the Chinese medicinal granules of the present invention.

[0040] Comparative Example 1

[0041] Take 5g of Artemisia capillaris, 35g of Patchouli, 20g of silkworm excrement, 30g of cinnamon twig, 5g of cicada slough, 20g of Poria, 20g of raw Atractylodes macrocephala, 13g of cardamom, and 10g of dried tangerine peel, add distilled water 5 times the total weight of the Chinese medicinal materials, soak for 1.5 hours, then boil over high heat until boiling, then simmer over low heat for 2 hours, extract twice, filter the residue, and take the filtrate, heat and concentrate to 140g to obtain the Chinese medicinal decoction 3 of the present invention.

[0042] Comparative Example 2

[0043] Take 15g of Herba Lysimachiae, 45g of Patchouli, 10g of Poria, 5g of Periostracum Cicadae, 10g of Atractylodes Macrocephalae, 5g of Citrus Reticulatae, 20g of Silkworm Excrement, 3g of Cardamom, and 30g of Cinnamon Twig, add 5 times the total weight of the Chinese medicinal materials in distilled water, soak for 1.5 hours, boil over high heat until boiling, then simmer over low heat for 2 hours, extract twice, filter the residue, and heat the filtrate to concentrate to 140g to obtain Chinese medicine decoction 4 of the present invention.

[0044] Test Example 1 Clinical trial for the treatment of chronic urticaria

[0045] 40 patients with chronic urticaria were randomly selected, and the diagnostic criteria were as follows:

[0046] The diagnostic criteria for chronic urticaria are formulated with reference to the "Chinese Journal of Clinical Dermatology": a rash that rises and falls suddenly all over the body, accompanied by varying degrees of itching; the rash occurs at least twice a week, and the course of the disease lasts for more than 6 weeks.

[0047] Inclusion criteria:

[0048] (1) Meet the clinical diagnostic criteria;

[0049] (2) Aged over 16 years;

[0050] (3) Voluntarily participate in this study, provide informed consent and sign the informed consent form.

[0051] Exclusion criteria:

[0052] (1) Those who are prone to allergies and are informed of their allergies to the test drugs;

[0053] (2) People who are addicted to drugs or alcohol; people with mental illness;

[0054] (3) Malignant tumors, serious heart diseases, blood system diseases, cerebrovascular accidents, severe trauma or major surgery;

[0055] (4) Participating in another clinical trial within three months;

[0056] (5) Women who are pregnant or trying to get pregnant, and women who are breastfeeding;

[0057] (6) Those who are judged by the researcher to be unsuitable for participation in this study.

[0058] Basic intervention: All enrolled patients will receive basic intervention, including patient education: ensuring that patients have a full understanding of their condition and the correct care methods at home. Avoid eating foods to which they are allergic to prevent triggering or aggravating the condition. Necessary and permitted combined medication treatment when the condition changes: For patients with unbearable itching, temporary addition of second-generation antihistamines (such as cetirizine, loratadine, etc.) is allowed, and combined medication must be recorded in detail. For patients who need medication for other diseases, the combined medication must be recorded.

[0059] The 40 patients were randomly divided into four groups: a baseline control group, a Chinese herbal decoction group 1, a Chinese herbal decoction group 3, and a Chinese herbal decoction group 4. The baseline control group received a baseline intervention, while the Chinese herbal decoction group received a combination of the baseline intervention and oral administration of the Chinese herbal decoction. The decoction was taken once daily, half an hour after breakfast and dinner. A course of treatment consisted of four weeks. After each course of treatment, each patient's treatment outcome was assessed using the following scoring criteria. The results are shown in Table 1.

[0060] Scoring criteria:

[0061] Ineffective: The itching cannot be relieved after treatment, and the skin lesions are more severe.

[0062] Relief: After treatment, itching is relieved and the degree of skin lesions is reduced by 20%, but itching begins again 1-2 days after stopping the drug;

[0063] Effective: After treatment, itching is relieved, the degree of skin lesions is reduced by 60%, and there is no itching within 1 week after stopping the drug.

[0064] Table 1 Statistics of treatment with Chinese medicine combination

[0065] Group invalid ease efficient Efficiency Basic control group 7 3 0 0 1 set of Chinese herbal decoction 1 2 7 70％ 3 groups of Chinese herbal decoctions 3 4 3 30％ 4 groups of Chinese herbal decoctions 4 4 2 20％

[0066] As can be seen from Table 1 above, compared with the Chinese herbal decoction groups 3-4, after using the drugs in the Chinese herbal decoction group 1, the number of effective cases was 7, the effective rate was 70%, the treatment effect was good, and the symptoms could be effectively relieved.

[0067] Test Example 2:

[0068] A total of 40 valid cases were selected, using the same diagnostic criteria, inclusion criteria, exclusion criteria, and administration method as in Experimental Example 1. Group 1 was treated with a traditional Chinese medicine decoction. Lesion extent, pruritus intensity, and severity scores were compared before and after 4 weeks of treatment. Patients were scored using the Patient Disease Activity Score (DAS) to obtain scores for lesion extent, pruritus intensity, and severity.

[0069] Skin lesion score = wheal diameter score + wheal number score

[0070] Itching degree score = wheal attack frequency score + wheal duration score + itching score

[0071] Severity score = (frequency score of wheal attacks + wheal diameter score + number score of wheals + wheal duration score) * itching score

[0072] Patient disease activity score sheet:

[0073]

[0074] The paired t-test showed that the differences in scores between the groups before and after treatment were statistically significant (P < 0.05), indicating that the Chinese medicine composition of the present invention has a significant effect on improving the range, severity and itching of chronic urticaria lesions, as shown in Table 2:

[0075] Table 2 Scores before and after treatment of chronic urticaria patients with Chinese medicine composition

[0076]

[0077] Although specific embodiments of the present invention have been described, it will be appreciated by those skilled in the art that various changes and modifications may be made to the present invention without departing from the scope or spirit of the present invention. Therefore, the present invention is intended to cover all such changes and modifications that fall within the scope of the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating chronic urticaria, characterized in that: The traditional Chinese medicine composition is prepared from 10-20 parts of Artemisia capillaris, 40-50 parts of patchouli, 15-25 parts of silkworm excrement, 25-35 parts of cassia twig, 2-8 parts of cicada slough, 5-15 parts of Poria cocos, 5-15 parts of raw Atractylodes macrocephala, 1-5 parts of cardamom and 2-8 parts of dried tangerine peel.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from 12-18 parts of Artemisia capillaris, 42-48 parts of Patchouli, 17-23 parts of silkworm excrement, 27-33 parts of cassia twig, 3-7 parts of cicada slough, 8-12 parts of Poria cocos, 8-12 parts of raw Atractylodes macrocephala, 2-4 parts of cardamom and 4-6 parts of dried tangerine peel.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from 15 parts of Artemisia capillaris, 45 parts of Patchouli, 20 parts of silkworm excrement, 30 parts of cinnamon twig, 5 parts of cicada slough, 10 parts of Poria cocos, 10 parts of raw Atractylodes macrocephala, 3 parts of cardamom and 5 parts of dried tangerine peel.

4. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from 16 parts of Artemisia capillaris, 46 parts of Patchouli, 21 parts of silkworm excrement, 31 parts of cinnamon twig, 6 parts of cicada slough, 11 parts of Poria cocos, 11 parts of raw Atractylodes macrocephala, 4 parts of cardamom and 6 parts of dried tangerine peel.

5. A Chinese medicinal compound preparation for treating chronic urticaria, characterized in that: The Chinese medicine compound preparation is prepared from the Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients, and the Chinese medicine compound preparation is an oral preparation.

6. The Chinese medicinal compound preparation according to claim 5, characterized in that: The dosage form of the Chinese medicine compound preparation is decoction, tablet, granule, capsule, powder or pill.

7. The method for preparing the Chinese medicinal compound preparation according to claim 6, wherein: The traditional Chinese medicine composition according to any one of claims 1 to 4 is extracted by water decoction or alcohol extraction.

8. The preparation method according to claim 7, characterized in that The preparation method of the decoction comprises: taking prescribed amounts of Artemisia capillaris, Patchouli, silkworm excrement, cinnamon twig, cicada slough, Poria cocos, raw Atractylodes macrocephala, cardamom and tangerine peel, adding distilled water 3-6 times the total weight of the Chinese medicinal materials, soaking for 1-2 hours, decocting over high heat until boiling, then decocting over low heat, extracting for 1-3 hours, extracting 1-2 times, filtering the medicinal residue, and heating and concentrating the filtrate to obtain the decoction; The preparation method of the granules comprises: taking prescribed amounts of Artemisia capillaris, Patchouli, silkworm excrement, cinnamon twig, cicada slough, Poria cocos, raw Atractylodes macrocephala, cardamom and tangerine peel, adding 40-60% ethanol water which is 3-6 times the total weight of the Chinese medicinal materials, soaking for 1-2 hours, extracting for 1-3 hours, extracting 1-2 times, filtering the medicinal residue, heating and concentrating the filtrate, drying, and adding one or more pharmaceutically acceptable excipients to prepare the granules.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine compound preparation according to any one of claims 5 to 6 in the preparation of a medicament for treating chronic urticaria.

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