CN115414427A

CN115414427A - Traditional Chinese medicine composition for treating chronic cutaneous pruritus and preparation method and application thereof

Info

Publication number: CN115414427A
Application number: CN202211226410.9A
Authority: CN
Inventors: 唐志铭; 荆梦晴; 单霄
Original assignee: Xuzhou City Hospital Of Tcm
Current assignee: Xuzhou City Hospital Of Tcm
Priority date: 2022-10-09
Filing date: 2022-10-09
Publication date: 2022-12-02
Anticipated expiration: 2042-10-09
Also published as: CN115414427B

Abstract

The invention belongs to the technical field of skin medicines, and particularly discloses a traditional Chinese medicine composition for treating chronic pruritus cutanea, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 to 15 parts of shrubalthea bark, 12 to 20 parts of phellodendron bark, 12 to 20 parts of calcined gypsum, 8 to 15 parts of common cnidium fruit, 8 to 15 parts of pepper, 3 to 8 parts of camphor and 3 to 8 parts of borneol. The traditional Chinese medicine composition provided by the invention can obviously relieve the pruritus and skin damage symptoms of patients with chronic skin pruritus, has no obvious adverse reaction, and can be used as a candidate medicine for treating the chronic skin pruritus.

Description

Traditional Chinese medicine composition for treating chronic cutaneous pruritus and preparation method and application thereof

Technical Field

The invention belongs to the technical field of skin medicines, and particularly discloses a traditional Chinese medicine composition for treating chronic skin pruritus, a preparation method and application thereof.

Background

Skin pruritus is an unpleasant sensation causing the desire to scratch, is one of the most common symptoms of dermatology, and is also the most common reason for patients to see a doctor. Chronic pruritus lasting longer than 6 months can seriously affect the quality of life and the work of patients. The chronic cutaneous pruritus is a disease with high incidence rate mainly comprising cutaneous pruritus, mainly comprising chronic urticaria, chronic eczema, cutaneous pruritus, neurodermatitis and the like, is easy to recur and has a lasting and lasting course of disease.

Common causes of skin pruritus include endocrine dyscrasia and winter pruritus, pruritus can also be caused by liver and kidney diseases, malignant tumors and psychogenic factors, and pruritus can also be caused by dry and degreased skin caused by excessively cleaning the skin. The common symptoms of acute pruritus are paroxysmal and severe itching feeling, which are aggravated at night, and patients often scratch with hands, so that secondary skin damage is caused, and eczema, moss-like change and pigmentation can occur after a long time.

The existing medicines for treating the pruritus cutanea comprise hormone medicines, antihistamine medicines, sedative medicines or antiallergic medicines and the like. The above drugs are often accompanied by serious adverse reactions or poor curative effects. For example, after abuse of hormone drugs, the disease resistance of the skin can be reduced, and the superficial tissues of the skin can be thinned after some drugs are used for a long time, so that the skin can be dry or ichthyoid lesions can occur sometimes; the antiallergic medicine is used for treating skin pruritus, and some side effects such as lethargy can be caused.

Therefore, it is necessary to develop a drug for skin pruritus with high safety, low side effects, and good therapeutic effect.

Disclosure of Invention

In view of the above technical problems, the present invention provides the following technical solutions:

the invention provides a traditional Chinese medicine composition for treating chronic cutaneous pruritus, which is prepared from the following raw materials in parts by weight: 8 to 15 parts of shrubalthea bark, 12 to 20 parts of phellodendron bark, 12 to 20 parts of calcined gypsum, 8 to 15 parts of common cnidium fruit, 8 to 15 parts of pepper, 3 to 8 parts of camphor and 3 to 8 parts of borneol.

Preferably, the feed additive is prepared from the following raw materials in parts by weight: 10 to 12 parts of shrubalthea bark, 12 to 15 parts of phellodendron bark, 12 to 15 parts of calcined gypsum, 10 to 12 parts of common cnidium fruit, 10 to 12 parts of pricklyash peel, 3 to 5 parts of camphor and 3 to 5 parts of borneol.

Preferably, the feed additive is prepared from the following raw materials in parts by weight: 10 parts of shrubalthea bark, 15 parts of phellodendron bark, 15 parts of calcined gypsum, 10 parts of fructus cnidii, 10 parts of pepper, 5 parts of camphor and 3 parts of borneol.

The invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

weighing the shrubalthea bark, the phellodendron bark, the calcined gypsum, the common cnidium fruit, the pepper, the camphor and the borneol in parts by weight for later use;

mixing the weighed cortex Hibisci, cortex Phellodendri, fructus Cnidii and fructus Zanthoxyli, decocting in water, filtering the decoction, collecting the filtrate, concentrating, adding ground Gypsum Fibrosum Preparatum, camphora and Borneolum Syntheticum, and mixing to obtain the Chinese medicinal composition.

Preferably, the specific operation process of decocting with water is as follows: adding water in an amount which is 6 to 8 times of the amount of the medicinal material mixture, and decocting for 2 to 3 times, 45 to 60min each time.

The invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating chronic skin pruritus caused by internal retention of damp-heat.

Preferably, the chronic cutaneous pruritus is chronic eczema, neurodermatitis, psoriasis or chronic urticaria.

The invention provides a medicinal preparation for treating chronic pruritus cutanea, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials or carriers.

Preferably, the pharmaceutical formulation is an external formulation.

Preferably, the external preparation is an ointment, a patch, a gel or a liniment.

For the pathogenesis of skin pruritus, lingshu & Daizjiejiang records \8230 \ 8230, which is the pulse between the skin and the qi is outside. Open fur and movement of hair. The flow of qi is itching. The opinions of the causes of the pruritus cutanea of each doctor are different, and the opinions roughly include the following points: (1) Skin pruritus is mostly caused by wind, dampness and heat accumulated in the skin, or by blood and qi deficiency, wind dryness and heat, and skin malnutrition. And (2) pruritus caused by invasion of pathogenic qi and deficiency of vital qi. Invasion of exogenous pathogenic factors may cause the accumulation of defensive qi. If the healthy qi is sufficient, the pathogenic qi will disperse and the itching will be stopped. If the vital qi is deficient, pathogenic qi will enter, and wind will flow between the skin and flesh, resulting in itching. (3) Liver and kidney deficiency and qi and blood deficiency are the root cause of senile skin pruritus, and skin pruritus is also related to lung, spleen and kidney. Generally, the pathogenesis of the pruritus cutanea is mainly as follows: damp-heat type, wind-heat type, blood deficiency and wind dryness type, and spleen and kidney yang deficiency type.

Based on the understanding of the prior art on the pathogenesis of skin pruritus, the traditional Chinese medicine composition provided by the invention has the advantages that calcined gypsum has the effects of eliminating dampness, promoting granulation and healing sore, and golden cypress has the effects of clearing heat, eliminating dampness, purging intense heat and detoxifying, and is used as monarch medicine together, so that the effects of clearing heat, eliminating dampness, promoting granulation and healing sore are achieved. The shrubalthea bark, the common cnidium fruit and the Chinese prickly ash are used as ministerial medicines, the shrubalthea bark has the effects of clearing heat and promoting diuresis, and enhancing the effects of clearing heat and promoting diuresis of the amur corktree bark, and the shrubalthea bark also has the effects of killing parasites and relieving itching, and can relieve the pruritus symptom of skin pruritus and avoid the affected part from ulceration due to scratching of a patient so as to avoid wind evil from entering due to the leakage of vital qi; fructus Cnidii has effects of warming kidney and tonifying yang, kidney yang and foot are sufficient for invigorating vital qi, and the vital qi is in conflict with pathogenic qi invading skin surface layer, to dispel pathogenic qi in vitro, and relieve skin pruritus; the pricklyash peel can warm and tonify the spleen and the stomach, ensure the transportation and transformation of the spleen and the stomach, ensure the normal functions of generating qi, blood and essence, ensure the balance of organs of the whole body and the smooth qi movement, and expel pathogenic qi from the body. The camphor is pungent and hot, further enhances the dehumidification effect of monarch and minister drugs, and is used together with the calcined gypsum to relieve the skin ulceration of patients caused by pruritus and difficult scratch resistance, thus being an adjuvant drug. Borneol is a guiding drug for clearing heat and removing toxicity, and relieving the heat of camphor. The medicines are combined to achieve the effects of clearing heat and drying dampness, promoting granulation and astringing sores to relieve itching, warming kidney and supporting yang. Can be used for treating chronic skin pruritus such as damp-heat retention type chronic eczema, neurodermatitis, psoriasis, chronic urticaria, etc., effectively relieving pruritus symptoms of patients, and recovering damaged skin to normal.

The traditional Chinese medicine composition provided by the invention can obviously relieve the pruritus and skin lesion symptoms of patients with chronic skin pruritus, and uses pure natural plant raw materials, so that no obvious adverse reaction occurs in the using process of the patients, and the traditional Chinese medicine composition can be used as a candidate medicine for treating the chronic skin pruritus.

Detailed Description

The present section further details the above-described aspects of the present invention by way of examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

The raw materials of the medicine used by the invention have the following sources, properties and efficacies:

cortex Hibisci: is stem bark or root bark of Hibiscus syriacus L. Sweet, bitter and slightly cold in nature. Clear heat and promote diuresis, kill parasites and relieve itching. Used for treating dysentery and leucorrhea; it is used externally to treat eczema of scrotum, tinea corporis, tinea pedis.

And (3) golden cypress: is dried bark of phellodendron amurense belonging to Rutaceae. Bitter taste and cold nature; it enters kidney, bladder and large intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity, remove bone and steam.

Calcining gypsum: the product is processed product of gypsum. Sweet, pungent, astringent and cold. It has effects in eliminating dampness, promoting granulation, healing wound, and stopping bleeding. It is indicated for unhealing ulcer, eczema, pruritus, scald due to hot water or fire, and traumatic hemorrhage.

Fructus cnidii: is fruit of Cnidium monnieri (L.) Cuss. Pungent and bitter with warm nature. Has the effects of warming kidney, strengthening yang, eliminating dampness, killing parasites, dispelling wind and relieving itching. Mainly treats pudendum wet itch, eczema and mange; cold-dampness with leukorrhagia, damp arthralgia with lumbago; impotence due to kidney deficiency, infertility due to cold womb, etc.

Chinese prickly ash: is dried mature pericarp of green pepper Zanthoxylum schinifolium Sieb. EtZucc. Or Zanthoxylum bungeanum Maxim. Of Zanthoxylum of Rutaceae. Pungent taste and warm nature; it enters spleen, stomach and kidney meridians. Has effects of warming spleen and stomach, relieving pain, killing parasites and relieving itching. It can be used for treating middle-cold abdominal pain, vomiting and diarrhea due to cold-dampness, abdominal pain due to parasitic infestation, eczema, pruritus vulvae, etc.

Camphor: is granular crystal prepared from branches, stems, leaves and roots of presl of Cinnamomum camphora (L.) of Lauraceae. Camphor is pungent in flavor and hot in nature. Has the effects of removing dampness, killing parasite, dispelling heat, relieving pain, inducing resuscitation and removing filth. It can be used for treating abdominal pain due to eruptive disease, emesis, diarrhea, unconsciousness, scabies, tinea, pruritus, pyocutaneous disease, damp rot, tinea pedis due to cold-dampness, toothache, traumatic injury, etc.

Borneol: is natural crystalline compound separated from resin of Borneolum perfume plant, such as Borneolum tree. Pungent, bitter and slightly cold. Unblocking orifices, dissipating stagnated fire, removing nebula and improving eyesight, relieving swelling and pain, clearing heat and removing toxicity, and clearing fire and removing toxicity. It is indicated for mammary gland agglomeration, apoplexy, trismus, coma due to febrile disease, convulsion, phlegm coma, qi block, deafness, throat obstruction, aphtha, otitis media, carbuncle, swelling, hemorrhoid, nebula, and enterobiasis.

The present invention will be described with reference to specific examples.

Example 1

A traditional Chinese medicine composition for treating chronic cutaneous pruritus is prepared from the following raw materials: 8g of shrubalthea bark, 12g of phellodendron bark, 12g of calcined gypsum, 8g of fructus cnidii, 8g of pepper, 3g of camphor and 3g of borneol.

Example 2

A traditional Chinese medicine composition for treating chronic cutaneous pruritus is prepared from the following raw materials: 15g of shrubalthea bark, 20g of phellodendron bark, 20g of calcined gypsum, 15g of fructus cnidii, 15g of pepper, 8g of camphor and 8g of borneol.

Example 3

A traditional Chinese medicine composition for treating chronic cutaneous pruritus is prepared from the following raw materials: 10g of shrubalthea bark, 12g of phellodendron bark, 12g of calcined gypsum, 10g of fructus cnidii, 10g of pepper, 3g of camphor and 3g of borneol.

Example 4

A traditional Chinese medicine composition for treating chronic cutaneous pruritus is prepared from the following raw materials: 12g of shrubalthea bark, 15g of phellodendron bark, 15g of calcined gypsum, 12g of fructus cnidii, 12g of pepper, 5g of camphor and 5g of borneol.

Example 5

A traditional Chinese medicine composition for treating chronic cutaneous pruritus is prepared from the following raw materials: 10g of shrubalthea bark, 15g of phellodendron bark, 15g of calcined gypsum, 10g of fructus cnidii, 10g of pepper, 5g of camphor and 3g of borneol.

The traditional Chinese medicine compositions provided by the above embodiments 1 to 5 are all prepared according to the following method:

weighing cortex Hibisci, cortex Phellodendri, gypsum Fibrosum Preparatum, fructus Cnidii, fructus Zanthoxyli, camphora, and Borneolum Syntheticum;

mixing the weighed cortex Hibisci, cortex Phellodendri, fructus Cnidii and fructus Zanthoxyli, adding water in an amount which is 8 times of the weight of the medicinal mixture for the first time, decocting for 45min, filtering the decoction, collecting the first filtrate, adding water in an amount which is 6 times of the total weight of the filter residue for decocting for 45min, filtering the decoction, mixing the filtrate and the first filtrate, concentrating into thick extract, adding calcined gypsum, camphor and borneol which are mixed according to the formula and ground into powder, and uniformly mixing to obtain the traditional Chinese medicine composition.

Example 6

The difference between the traditional Chinese medicine composition for treating chronic cutaneous pruritus and the embodiment 1 is that the preparation method is different, and specifically comprises the following steps:

mixing the weighed medicinal materials, adding water which is 8 times of the total weight of the medicinal materials for the first time, decocting for 60min, filtering decoction, collecting first filtrate, adding water which is 6 times of the total weight of the filter residues for decocting for 60min, filtering the decoction, mixing the filtrate and the first filtrate, concentrating into thick extract, adding calcined gypsum, camphor and borneol which are ground into powder according to the formula amount, and uniformly mixing to obtain the traditional Chinese medicine composition.

The Chinese medicinal composition prepared in the above examples 1 to 6 can be further prepared into an external preparation, such as an ointment, a patch, a gel or a liniment, according to a pharmaceutically acceptable method. The external preparation comprises a traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials or carriers. Such as colorants, preservatives, pH adjusters, antioxidants, skin absorption promoters, matrix or carrier materials, and the like. Alternative colorants include eosin, fuchsin, suavena G, and the like; the antiseptic can be selected from esters of p-hydroxy benzene and acid, parabens, benzoic acid and its salts, sorbic acid and its salts, etc.; the pH regulator can be selected from hydrochloric acid or sodium hydroxide; the antioxidant can be selected from sodium bicarbonate, sodium thiosulfate or thiourea; the matrix can be selected from vaseline, paraffin, lanolin, beeswax, etc.; the carrier material can be selected from cellulose derivatives, polyvidones, polyoxyethylene or polyacrylic resins, etc. It should be noted that these materials are merely examples of the carriers or excipients that can be used in the present invention, and are not intended to limit the technical scope of the present invention.

Since the effects of the Chinese medicinal compositions prepared in examples 1 to 6 on chronic skin pruritus are substantially the same, the effects will be described below by taking the Chinese medicinal composition provided in example 5 as an example.

1. General data

84 patients with chronic skin pruritus caused by accumulation of damp-heat in the interior of the skin are selected for clinical diagnosis in Xuzhou traditional Chinese medicine hospital from 12 months in 2019 to 7 months in 2022, and are randomly divided into a control group and an observation group, wherein each group comprises 42 patients. Wherein, 23 male cases and 19 female cases in the control group have the average age of 22 plus or minus 4.2 years and the average course of disease of 7 plus or minus 21 months; the disease types are: 18 cases are chronic eczema, 12 cases are neurodermatitis, 7 cases are psoriasis, and 5 cases are chronic urticaria; the observation group comprises 17 men and 25 women, the average age is 24 + -5.1 years, and the average course is 6 + -19 months; the disease types are: 19 cases are chronic eczema, 14 cases are neurodermatitis, 6 cases are psoriasis and 3 cases are chronic urticaria. The two groups of general data have no significant difference (P > 0.05) and are comparable.

2. Inclusion criteria

Meets the diagnosis standard of chronic pruritic skin diseases.

3. Exclusion criteria

Patients with primary pruritus such as nephropathy, diabetes, lymphoma, etc. are excluded; excluding patients in gestation or lactation; patients who were being treated with western medicines were excluded.

4. Method of producing a composite material

The control group used compound dexamethasone acetate cream, produced by Guangdong Zhongsheng pharmaceutical industry GmbH. For external use, apply a small amount of the composition to the affected part 1-2 times a day, and gently rub the composition for a moment.

The observation group used the concentrated thick paste of the traditional Chinese medicine composition provided in the invention example 5, coated on the affected part, and wrapped with air-permeable medical gauze three times a day.

5. Evaluation of therapeutic Effect

5.1 evaluation of degree of itching

The method described in the reference of ' Yangyuan-compound triamcinolone acetonide acetate solution for treating 64 cases of chronic pruritic skin diseases ' clinical efficacy observation [ J ]. Northern pharmacy 2018,15 (9): 12 ' adopts a visual analogue scoring method (VAS), and scores are carried out before treatment, 2 weeks after treatment and 4 weeks after treatment.

The degree, time, extent of itching and the effect on sleep were scored according to the patient's own experience. The specific scoring criteria are as follows:

0 minute: no itching at all;

1-3 points of: mild itching;

4-6 min: moderate itching;

7-9 parts: severe itching;

10 min: intolerably severe pruritus.

5.2 evaluation of skin Damage

The method recorded in the reference of 64 cases of clinical efficacy observation [ J ] for treating chronic pruritic skin diseases by using the Yangyuan-compound triamcinolone acetonide acetate solution [ 2018,15 (9): 12 ] adopts a visual simulation scoring method, and scores are carried out before treatment, 2 weeks after treatment and 4 weeks after treatment.

Scoring is based on skin lesion area, licheniform lesions, skin color changes, etc. The method specifically comprises the following steps:

0 minute: the skin lesions are all faded;

1-3 points of: slight skin damage;

4-6 min: moderate skin damage;

7-9 min: severe skin lesions;

10 min: skin damage is very severe, with areas exceeding 85% of the total body surface area.

5.3 evaluation of comprehensive therapeutic effects

Basically curing: the skin damage and the pruritus are scored to be 0 points, and the pruritus and skin damage symptoms completely disappear;

the effect is shown: the skin damage and the pruritus are scored to be 1-3 points, and the pruritus and the skin damage symptoms are obviously improved;

the method has the following advantages: the skin damage and the pruritus are scored to be 4 to 6 points, and the pruritus and the skin damage symptoms are relieved;

and (4) invalidation: the skin lesions and the pruritus are scored at 7 points or more.

Total effective rate = basic cure rate + significant efficiency + effective rate.

6. Statistical analysis

Statistical software SPSS 20.0 was used for analysis and processing. The data is checked by the chi-square. P <0.05, indicating a significant difference.

7. As a result, the

7.1 evaluation of degree of itching

The results are shown in tables 1 and 2.

TABLE 1 comparison of itch degree scores for two groups of patients

Grouping	Number of examples	Before treatment	Treatment week 2	Treatment week 4
					Control group	42	9	7	5
Observation group	42	9	6	2

TABLE 2 evaluation of the relief Effect of itching symptom in both patients

Grouping	Number of examples	Basic cure	Show effect	Is effective	Nullification	Total effective rate (%)
							Control group	42	3	16	10	13	69.05
Observation group	42	8	20	11	3	92.86 ^*

Note: compared with the control group, the compound of the formula, ^* P<0.05。

7.2 evaluation of skin Damage

The results are shown in tables 3 and 4.

TABLE 3 comparison of skin lesion score for two groups of patients

Grouping	Number of examples	Before treatment	Treatment week 2	Treatment week 4
					Control group	42	8	6	4
Observation group	42	8	4	2

TABLE 4 evaluation of the skin lesion symptom relieving Effect of both patients

Grouping	Number of examples	Basic cure	Show effect	Is effective	Invalidation	Total effective rate (%)
							Control group	42	6	17	14	5	88.10
Observation group	42	10	22	9	1	97.62

7.3 evaluation of comprehensive curative effects

The results are shown in Table 5.

TABLE 5 comparison of the combined therapeutic effects of the two patients

in conclusion, the observation group has obvious relieving effect on skin damage and pruritus symptoms of the chronic skin pruritus patients, and shows that the traditional Chinese medicine composition provided by the invention can be used for treating chronic skin pruritus.

8. Evaluation of safety

During the medication period, the patients in the group 3 are observed to have slight red and swollen symptoms initially and then disappear automatically without other adverse reactions.

While embodiments of the invention have been shown and described, it will be understood by those of ordinary skill in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. The traditional Chinese medicine composition for treating chronic cutaneous pruritus is characterized by being prepared from the following raw materials in parts by weight: 8 to 15 parts of shrubalthea bark, 12 to 20 parts of phellodendron bark, 12 to 20 parts of calcined gypsum, 8 to 15 parts of common cnidium fruit, 8 to 15 parts of pricklyash peel, 3 to 8 parts of camphor and 3 to 8 parts of borneol.

2. The traditional Chinese medicine composition for treating chronic cutaneous pruritus according to claim 1, which is prepared from the following raw materials in parts by weight: 10 to 12 parts of shrubalthea bark, 12 to 15 parts of phellodendron bark, 12 to 15 parts of calcined gypsum, 10 to 12 parts of common cnidium fruit, 10 to 12 parts of pricklyash peel, 3 to 5 parts of camphor and 3 to 5 parts of borneol.

3. The traditional Chinese medicine composition for treating chronic cutaneous pruritus according to claim 1, which is prepared from the following raw materials in parts by weight: 10 parts of shrubalthea bark, 15 parts of phellodendron bark, 15 parts of calcined gypsum, 10 parts of fructus cnidii, 10 parts of pepper, 5 parts of camphor and 3 parts of borneol.

4. A method for preparing the traditional Chinese medicine composition of any one of claims 1 to 3, which is characterized by comprising the following steps:

5. The preparation method of the traditional Chinese medicine composition according to claim 4, wherein the specific operation process of decocting with water is as follows: adding water in an amount which is 6 to 8 times of the amount of the medicinal material mixture, and decocting for 2 to 3 times, 45 to 60min each time.

6. Use of the Chinese medicinal composition of any one of claims 1 to 3 in the preparation of a medicament for treating chronic pruritus cutanea due to internal accumulation of damp-heat.

7. Use according to claim 6, wherein the chronic cutaneous pruritus is chronic eczema, neurodermatitis, psoriasis or chronic urticaria.

8. A pharmaceutical preparation for treating chronic skin pruritus, which is characterized in that the pharmaceutical preparation comprises the traditional Chinese medicine composition of any one of claims 1 to 3 and pharmaceutically acceptable auxiliary materials or carriers.

9. The pharmaceutical preparation according to claim 8, wherein the pharmaceutical preparation is an external preparation.

10. The pharmaceutical formulation of claim 9, wherein the external preparation is an ointment, a patch, a gel, or a liniment.