Traditional chinese medicine gel, and preparation method therefor and use thereof

Abstract

A traditional Chinese medicine gel, and a preparation method therefor and the use thereof. The traditional Chinese medicine gel is prepared from water extracts of Arnebiae radix, Cortex moutan radicis, Sophorae flavescentis radix, Oldenlandia diffusa and Lonicerae japonicae flos compounded with carbomer 940, propylene glycol, triethanolamine, a preservative and water. The traditional Chinese medicine gel has the effects of clearing heat and removing toxicity, cooling blood and promoting eruption, and diminishing inflammation and relieving itching, and can be used for treating conditions such as cutaneous pruritus.

Description

A traditional Chinese medicine gel and its preparation method and application

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on July 4, 2023, with application number CN202310811875.9 and invention name “A Chinese medicine gel, its preparation method and application”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine gel and a preparation method and application thereof. Background Art

[0003] Skin diseases are the most common, most disabling, and most contagious diseases in human history in the 21st century. There are many causes of skin diseases, such as infection, the patient's own physical condition and eating habits, dust, mosquito bites, etc. [Jing Wenxi. Analysis of the causes and preventive measures of skin diseases in spring [J]. Chinese Rural Health, 2021, 13(10):12+14.], which not only affect the patient's physical and mental health, but also endanger their lives and even cause social panic and discrimination. Symptoms such as itching, pain, numbness, and changes in appearance are often associated with skin diseases. The pathogenesis of skin diseases is unknown and they are prone to recurrence. In clinical practice, analgesics, antihistamines, or hormone drugs are often used for treatment. However, these drugs have significant side effects, are difficult to cure, cannot be used for long-term use, are prone to dependence, and are limited to pregnant women, the elderly, and people in special occupations. Commonly used drugs such as Piyanping and hydrocortisone butyrate cream can be used to treat itching, neurodermatitis, chronic eczema, etc., but long-term use can cause skin atrophy, capillary dilation, pigmentation, and secondary infection [Xiao Wei. Summer skin often suffers, be cautious when purchasing medicines yourself [J]. Adolescent Health, 2019(16):52-53.].

[0004] Traditional Chinese medicine has a long history, definite therapeutic effects, fewer adverse reactions, low recurrence rate, and high acceptance. It has great advantages in treating skin diseases. However, traditional topical preparations such as ointments and powders have problems such as poor spreadability, uneven coating, short drug action time, and easy to cause redness and swelling.

[0005] Summary of the Invention

[0006] To solve the above problems, the present invention provides a traditional Chinese medicine gel and its preparation method and application. The traditional Chinese medicine gel provided by the present invention has a uniform and fine texture, is easy to spread, has good anti-inflammatory and antipruritic activities, is non-toxic and has no skin irritation, and has a long drug action time.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] The invention provides a traditional Chinese medicine gel. The traditional Chinese medicine gel comprises the following components in the following concentrations: 3.75wt.% to 5wt.% of a traditional Chinese medicine water extract, 9405wt.% to 7.5wt.% of carbomer, 18.75wt.% to 31.25wt.% of propylene glycol, 1.25 to 2.5mL / kg of triethanolamine, 0.125wt.% of a preservative, and the balance of water. The raw materials for preparing the traditional Chinese medicine water extract include: lithospermum erythrorhizon, moutan bark, sophora flavescens, oldenlandia diffusa herb, and honeysuckle.

[0009] Preferably, the mass ratio of Lithospermum erythrorhizon, Paeonia suffruticosa, Sophora flavescens, Hedyotis diffusa and Lonicera japonica is 1:1:1:1:1:1.

[0010] Preferably, the pH value of the traditional Chinese medicine gel is 6.5-7.5.

[0011] Preferably, the preservative comprises ethylparaben and / or ethylparaben.

[0012] The present invention also provides a method for preparing the traditional Chinese medicine gel described in the above technical solution, comprising the following steps:

[0013] Mixing the Carbomer 940 with a portion of water to obtain a swollen Carbomer 940 matrix;

[0014] Dissolving the Chinese herbal medicine aqueous extract and mixing it with the swollen Carbomer 940 matrix to obtain a drug-containing matrix;

[0015] mixing the drug-containing matrix with propylene glycol, a preservative, triethanolamine and remaining water to obtain the traditional Chinese medicine gel;

[0016] The preparation method of the Chinese medicine water extract is as follows: mixing lithospermum erythrorhizon, peony bark, sophora flavescens, hedyotis diffusa and honeysuckle, decocting with water and filtering to obtain a filtrate;

[0017] The filtrate is dried to obtain the Chinese medicine water extract.

[0018] Preferably, the decoction is performed 1 to 3 times, and the decoction time for each time is 50 to 70 minutes.

[0019] Preferably, the drying temperature is ≤65°C.

[0020] Preferably, the mass ratio of carbomer 940 to part of water in the swollen carbomer 940 matrix is ​​1:5-10.

[0021] Preferably, the mixing of the drug-containing matrix, propylene glycol, preservative, triethanolamine and remaining water comprises: dissolving the preservative in the propylene glycol to obtain an excipient solution; and mixing the drug-containing matrix, the excipient solution, triethanolamine and remaining water.

[0022] The present invention also provides the use of the traditional Chinese medicine gel described in the above technical solution or the traditional Chinese medicine gel prepared by the preparation method described in the above technical solution in the preparation of anti-inflammatory and / or antipruritic products.

[0023] The present invention also provides the use of the traditional Chinese medicine gel described in the above technical solution or the traditional Chinese medicine gel prepared by the preparation method described in the above technical solution in anti-inflammatory and / or antipruritic applications. Beneficial effects:

[0024] The invention provides a traditional Chinese medicine gel. The traditional Chinese medicine gel comprises the following components in the following concentrations: 3.75wt.% to 5wt.% of a traditional Chinese medicine water extract, 9405wt.% to 7.5wt.% of carbomer, 18.75wt.% to 31.25wt.% of propylene glycol, 1.25 to 2.5mL / kg of triethanolamine, 0.125wt.% of a preservative, and the balance of water. The raw materials for preparing the traditional Chinese medicine water extract include: lithospermum erythrorhizon, moutan bark, sophora flavescens, oldenlandia diffusa herb, and honeysuckle. The Chinese medicinal water extract prepared by using lithospermum erythrorhizon, moutan bark, sophora flavescens, oldenlandia diffusa and honeysuckle as raw materials has the effects of clearing away heat and detoxifying, cooling blood and clearing rashes, and anti-inflammatory and antipruritic, and can be used to treat skin itching and the like. The Chinese medicinal gel obtained by compounding appropriate amounts of carbomer 940, propylene glycol, triethanolamine and preservatives has a uniform and fine texture, moderate viscosity and fluidity, is easy to spread and apply evenly, has good anti-inflammatory and antipruritic activities, is non-toxic and non-skin irritating, and has a long drug action time. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG1 is a finished product diagram of the Chinese medicine gel prepared in Example 1. DETAILED DESCRIPTION

[0026] The invention provides a traditional Chinese medicine gel. The traditional Chinese medicine gel comprises the following components in the following concentrations: 3.75wt.% to 5wt.% of a traditional Chinese medicine water extract, 9405wt.% to 7.5wt.% of carbomer, 18.75wt.% to 31.25wt.% of propylene glycol, 1.25 to 2.5mL / kg of triethanolamine, 0.125wt.% of a preservative, and the balance of water. The raw materials for preparing the traditional Chinese medicine water extract include: lithospermum erythrorhizon, moutan bark, sophora flavescens, oldenlandia diffusa herb, and honeysuckle.

[0027] The traditional Chinese medicine gel of the present invention comprises 3.75 to 5 wt.% of a traditional Chinese medicine aqueous extract, preferably 4.375 wt.%. The raw materials for preparing the traditional Chinese medicine aqueous extract preferably include: lithospermum erythrorhizon, moutan bark, sophora flavescens, hedyotis diffusa herb, and honeysuckle. The mass ratio of lithospermum erythrorhizon, moutan bark, sophora flavescens, hedyotis diffusa herb, and honeysuckle is preferably 1:1:1:1:1. The raw materials for preparing the traditional Chinese medicine aqueous extract of the present invention, which are compounded with lithospermum erythrorhizon, moutan bark, sophora flavescens, hedyotis diffusa herb, and honeysuckle, have the effects of clearing heat and detoxifying, cooling blood and clearing rashes, and anti-inflammatory and antipruritic, and can be used to treat itchy skin.

[0028] The preparation method of the Chinese herbal medicine aqueous extract of the present invention preferably comprises the following steps: mixing lithospermum erythrorhizon, moutan bark, sophora flavescens, hedyotis diffusa and honeysuckle, decocting in water and filtering to obtain a filtrate; and drying the filtrate to obtain the Chinese herbal medicine aqueous extract.

[0029] In the present invention, the number of water decoctions is preferably 1 to 3 times, more preferably 2 times; when the number of water decoctions is 2 or 3 times, the filtrate is preferably the sum of the filtrates filtered after 2 or 3 decoctions; the time for each water decoction is preferably 50 to 70 minutes, more preferably 1 hour; the material-liquid ratio for each water decoction is preferably 1 g:10 to 15 mL, more preferably 1 g:10 mL.

[0030] In the present invention, the filtrate is preferably concentrated before drying; the concentration is preferably to a paste-like state, i.e., a relative density at 65°C of 1.1 to 1.3; the drying temperature is preferably ≤ 65°C, more preferably 65°C. The present invention has no particular requirements for the concentration method, and methods well known to those skilled in the art can be used.

[0031] The traditional Chinese medicine gel of the present invention includes 5 wt.% to 7.5 wt.%, preferably 6.25 wt.%. The carbomer 940 of the present invention, as the matrix material of the traditional Chinese medicine gel, can increase the retention time of the drug in the affected area, improve bioavailability, and solve the solubility and dispersibility problems of the drug in the gel. The carbomer 940 described in the embodiments of the present invention is preferably purchased from Henan Wanbang Chemical Technology Co., Ltd., batch number 20171206.

[0032] The Chinese medicine gel of the present invention comprises 18.75 wt.% to 31.25 wt.% of propylene glycol, preferably 25 wt.%. The propylene glycol of the present invention is a moisturizing agent that can dissolve and disperse other auxiliary materials such as preservatives, making it easier to mix and disperse with the drug-containing matrix.

[0033] The Chinese medicine gel of the present invention comprises 1.25 to 2.5 mL / kg of triethanolamine, preferably 1.875 mL / kg. The triethanolamine of the present invention can keep the Chinese medicine gel at a suitable pH value to avoid irritation to the skin. The purity of the triethanolamine described in the embodiment of the present invention is preferably analytically pure, and is preferably purchased from Shanghai Zhanyun Chemical Technology Co., Ltd., batch number 220112. The triethanolamine of the present invention has the effects of thickening, moisturizing, humidifying, thickening, and pH balance. It is a neutralizer for acidic polymer gels containing carbomer, etc., and forms a stable polymer structure by neutralizing with carboxyl groups such as carbomer, thereby achieving the application effects of thickening and moisturizing.

[0034] The Chinese medicine gel of the present invention includes a preservative of 0.125 wt.%. In the present invention, the preservative preferably includes ethylparaben and / or ethylparaben, more preferably ethylparaben. The purity of the ethylparaben described in the embodiment of the present invention is preferably analytically pure and is preferably purchased from Tianjin Bodi Chemical Co., Ltd., batch number 100106.

[0035] The solvent of the traditional Chinese medicine gel of the present invention is preferably water.

[0036] The pH value of the traditional Chinese medicine gel of the present invention is preferably 6.5 to 7.5, more preferably 7.0.

[0037] The traditional Chinese medicine gel of the present invention is not only beautiful and uniform, easy to clean and stable, but also has anti-inflammatory and antipruritic effects and has no skin irritation effects.

[0038] The present invention also provides a method for preparing the traditional Chinese medicine gel described in the above technical solution, comprising the following steps:

[0039] Mixing the Carbomer 940 with a portion of water to obtain a swollen Carbomer 940 matrix;

[0040] Dissolving the Chinese herbal medicine aqueous extract and mixing it with the swollen Carbomer 940 matrix to obtain a drug-containing matrix;

[0041] The drug-containing matrix is ​​mixed with propylene glycol, a preservative, triethanolamine and the remaining water to obtain the traditional Chinese medicine gel.

[0042] In the present invention, the carbomer 940 is mixed with a portion of water to obtain a swollen carbomer 940 matrix. In the present invention, the mass ratio of carbomer 940 to the portion of water in the swollen carbomer 940 matrix is ​​preferably 1:5-10, more preferably 1:10. After the carbomer 940 and the portion of water are mixed, the mixture is preferably left to stand overnight and / or heated at 60°C. This overnight standing and / or heating at 60°C allows the carbomer 940 to fully absorb and swell. Preliminary swelling of the carbomer 940 avoids clumping that occurs with direct mixing, thereby facilitating material dispersion.

[0043] After obtaining the swollen Carbomer 940 matrix, the present invention dissolves the traditional Chinese medicine water extract and mixes it with the swollen Carbomer 940 matrix to obtain a drug-containing matrix.

[0044] In the present invention, the preservative is preferably dissolved in the propylene glycol to obtain an auxiliary material solution. The present invention utilizes propylene glycol to fully dissolve the preservative and other auxiliary materials in the propylene glycol.

[0045] After obtaining the drug-containing matrix and the excipient solution, the present invention preferably mixes the drug-containing matrix, the excipient solution, triethanolamine and the remaining water to obtain the traditional Chinese medicine gel.

[0046] The present invention also provides the use of the traditional Chinese medicine gel described in the above technical solution, or the traditional Chinese medicine gel prepared using the preparation method described in the above technical solution, in the preparation of anti-inflammatory and / or antipruritic products. The traditional Chinese medicine gel of the present invention has excellent anti-inflammatory and antipruritic activity, is non-toxic and non-skin irritating, and has a long duration of drug action, and can be used to prepare anti-inflammatory and / or antipruritic products.

[0047] The present invention also provides the use of the traditional Chinese medicine gel described in the above technical solution or the traditional Chinese medicine gel prepared by the preparation method described in the above technical solution in anti-inflammatory and / or antipruritic applications.

[0048] Example 1

[0049] A traditional Chinese medicine aqueous extract is prepared by the following steps: taking 50 g each of lithospermum erythrorhizon, moutan bark, sophora flavescens, hedyotis diffusa herb, and honeysuckle crude powder, adding water and decocting twice, adding 500 mL of water each time, each time for 60 minutes, combining the filtrates after the two decoctions, concentrating to a thick paste, and drying at 65°C to obtain the traditional Chinese medicine aqueous extract; the lithospermum erythrorhizon, moutan bark, sophora flavescens, hedyotis diffusa herb, and honeysuckle are all purchased from Beijing Huaishuntang Pharmaceutical Co., Ltd., batch number 20220115.

[0050] Example 2

[0051] A traditional Chinese medicine gel with anti-inflammatory and / or antipruritic effects, comprising the following components in the following concentrations: 4.375 wt.% of the aqueous extract of the traditional Chinese medicine prepared in Example 1, 9406.25 wt.% of carbomer, 2.5 wt.% of propylene glycol, 1.875 mL / kg of triethanolamine, 0.125 wt.% of ethylparaben, and the balance of water;

[0052] The Chinese medicine gel is prepared by the following steps:

[0053] 0.5 g of Carbomer 940 was added to 5 mL of water (i.e., the mass ratio of Carbomer 940 to water was 1:10) and soaked overnight to obtain a swollen Carbomer 940 matrix;

[0054] Dissolve 0.35 g of the Chinese herbal medicine aqueous extract and mix with the swollen Carbomer 940 matrix, stirring evenly to obtain a drug-containing matrix;

[0055] 0.01 g of ethyl hydroxybenzoate was dissolved in 2 g of propylene glycol, and the mixture was evenly mixed with the drug-containing matrix. Then, 15 μL of triethanolamine was added and stirred evenly. Finally, water was added to make up to 8 g to obtain the traditional Chinese medicine gel.

[0056] Example 3

[0057] A traditional Chinese medicine gel having anti-inflammatory and / or antipruritic effects, comprising the following components in the following concentrations: 3.75 wt.% of the traditional Chinese medicine aqueous extract prepared in Example 1, 9407.5 wt.% of carbomer, 18.75 wt.% of propylene glycol, 1.875 mL / kg of triethanolamine, 0.125 wt.% of ethylparaben, and the remainder being water. The preparation method of the traditional Chinese medicine gel is similar to that of Example 2, except that the amount of each component is adaptively adjusted according to the concentration, wherein the amount of the traditional Chinese medicine aqueous extract is 0.3 g.

[0058] Example 4

[0059] A Chinese medicine gel similar to Example 3, except that the concentration of the Chinese medicine aqueous extract prepared in Example 1 is 4.375 wt.%, and the amount of the Chinese medicine aqueous extract used in preparing the Chinese medicine gel is 0.35 g.

[0060] Example 5

[0061] A Chinese medicine gel similar to Example 3, except that the concentration of the Chinese medicine aqueous extract prepared in Example 1 is 5 wt.%, and the amount of the Chinese medicine aqueous extract used in preparing the Chinese medicine gel is 0.4 g.

Claims

1. A Chinese medicine gel, characterized in that: The Chinese medicine gel comprises the following components in concentrations: 3.75wt.% to 5wt.% of Chinese medicine water extract, 5wt.% to 7.5wt.% of Carbomer 940, 18.75wt.% to 31.25wt.% of propylene glycol, 1.25 to 2.5mL / kg of triethanolamine, 0.125wt.% of preservative and the balance of water; The raw materials for preparing the Chinese medicine water extract include: lithospermum officinale, peony bark, sophora flavescens, oldenlandia diffusa and honeysuckle.

2. The Chinese medicine gel according to claim 1, characterized in that: The mass ratio of the lithospermum officinale, moutan bark, sophora flavescens, oldenlandia diffusa and honeysuckle is 1:1:1:1:1:

1.

3. The Chinese medicine gel according to claim 1 or 2, characterized in that: The pH value of the traditional Chinese medicine gel is 6.5-7.

5.

4. The Chinese medicine gel according to claim 1 or 2, characterized in that: The preservatives include ethylparaben and / or ethylparaben.

5. The method for preparing the traditional Chinese medicine gel according to any one of claims 1 to 4, characterized in that: The following steps are involved: Mixing the Carbomer 940 with a portion of water to obtain a swollen Carbomer 940 matrix; Dissolving the Chinese medicine water extract and mixing it with the swollen Carbomer 940 matrix to obtain a drug-containing matrix; Mixing the drug-containing matrix with propylene glycol, a preservative, triethanolamine and remaining water to obtain the traditional Chinese medicine gel; The preparation method of the Chinese medicine water extract is as follows: mixing lithospermum officinale, peony bark, sophora flavescens, oldenlandia diffusa and honeysuckle, decocting in water and filtering to obtain a filtrate; The filtrate is dried to obtain the Chinese medicine water extract.

6. The preparation method according to claim 5, characterized in that: The decoction is performed 1 to 3 times, and the decoction time for each time is 50 to 70 minutes.

7. The preparation method according to claim 5, characterized in that: The drying temperature is ≤65°C.

8. The preparation method according to claim 5, characterized in that: The mass ratio of Carbomer 940 to part of water in the swollen Carbomer 940 matrix is ​​1:5-10.

9. The preparation method according to claim 5, characterized in that: The mixing of the drug-containing matrix, propylene glycol, preservative, triethanolamine and remaining water comprises: dissolving the preservative in the propylene glycol to obtain an auxiliary material solution; and mixing the drug-containing matrix, the auxiliary material solution, triethanolamine and remaining water.

10. Use of the traditional Chinese medicine gel according to any one of claims 1 to 4 or the traditional Chinese medicine gel prepared by the preparation method according to any one of claims 5 to 9 in the preparation of anti-inflammatory and / or antipruritic products.

11. Use of the traditional Chinese medicine gel according to any one of claims 1 to 4 or the traditional Chinese medicine gel prepared by the preparation method according to any one of claims 5 to 9 in anti-inflammatory and / or antipruritic applications.

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