Chinese herbal medicine cream for treating dermatitis and preparation method thereof

Abstract

The invention relates to the technical field of Chinese herbal medicine preparations, and particularly discloses Chinese herbal medicine emulsifiable paste for treating dermatitis and a preparation method thereof.The emulsifiable paste contains core raw materials and matrix auxiliary materials, the core raw materials comprise radix sophorae flavescentis, fructus kochiae, cortex phellodendri, honeysuckle flowers, herba portulacae and licorice roots, and the matrix auxiliary materials comprise an oil phase, a water phase, an emulsifier, a humectant, a pH regulator and a preservative. The preparation method comprises the following steps: preparing a Chinese herbal medicine extracting solution, respectively preparing an oil phase and a water phase, emulsifying, mixing and cooling to obtain a finished product. The cream is prepared from natural Chinese herbal medicines through scientific extraction and preparation, is high in safety, can effectively treat dermatitis, and is uniform in texture, good in stability and comfortable to use.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of Chinese herbal medicine preparation, in particular to a Chinese herbal medicine cream for treating dermatitis and a preparation method thereof. BACKGROUND

[0002] Dermatitis is a kind of inflammatory disease with the main clinical manifestations of skin redness, itching, papules, exudation and scabbing. Its pathogenesis is closely related to skin barrier dysfunction, immune abnormalities, microbial infection and external stimuli (such as chemical substances, ultraviolet rays and mechanical friction). The current clinical treatment methods include external use of glucocorticoid preparations, antihistamine drugs and antibiotic ointments. Although these methods can quickly relieve symptoms, long-term use may cause skin atrophy, capillary dilation, drug resistance and pigmentation, and is particularly unsuitable for infant skin, facial skin and skin in the wrinkle area.

[0003] Chinese herbal medicine has a long history in the treatment of skin diseases. Its advantages include natural ingredients, mild action, multi-target regulation and fewer adverse reactions. Existing external Chinese herbal medicine preparations are mostly in the form of single medicinal material or simple compound decoction or powder, which have poor stability, poor skin permeability, low utilization rate of effective ingredients and inconvenience in use. Some cream preparations cause unstable efficacy or skin irritation due to improper selection of auxiliary materials (such as irritating preservatives and fragrances) or unreasonable compatibility of medicinal materials.

[0004] Therefore, it is an urgent problem to develop a Chinese herbal medicine cream with synergistic ingredients, good permeability, high stability, strong safety and simple preparation process. SUMMARY

[0005] The technical problem to be solved by the present application is to provide a Chinese herbal medicine cream for treating dermatitis and a preparation method thereof. The cream takes natural Chinese herbal medicine as the core active ingredient, realizes the synergistic effect of anti-inflammatory, antibacterial, antipruritic and skin barrier repair through scientific compatibility, and uses a mild auxiliary material system to ensure the stability and skin tolerance of the preparation, which is suitable for people of all ages and sensitive skin areas.

[0006] To solve the above technical problems, the technical solution provided by the present application is as follows: a Chinese herbal medicine cream for treating dermatitis, comprising core raw materials and matrix auxiliary materials.

[0007] The core raw materials include, by weight: Sophora flavescens 3-5 parts, Semen pruni 2-4 parts, Phellodendri chinensis 2-3 parts, honeysuckle 3-5 parts, Herba Portulacae 4-6 parts and Glycyrrhiza 2-3 parts.

[0008] The matrix adjuvant comprises, by weight parts: oil phase ingredients: 15-20 parts, water phase ingredients: 40-50 parts, emulsifiers: 3-5 parts, humectants: 5-8 parts, pH regulators: 0.1-0.3 parts, preservatives: 0.1-0.2 parts.

[0009] Further, the oil phase ingredients include stearic acid 5-7 parts, vaseline 3-5 parts, liquid paraffin 4-6 parts, lanolin 3-4 parts.

[0010] Further, the water phase ingredients use purified water.

[0011] Further, the emulsifier includes glycerol monostearate 2-3 parts, Tween-80 1-2 parts.

[0012] Further, the humectant includes glycerol 4-6 parts, propylene glycol 1-2 parts.

[0013] Further, the pH regulator uses triethanolamine.

[0014] Further, the preservative uses hydroxyethyl benzoate.

[0015] The application also provides a preparation method of a Chinese herbal medicine cream for treating dermatitis, comprising the following steps:

[0016] (1) Chinese herbal medicine extract preparation

[0017] Kudzu vine, Chinese goldthread, Chinese goldthread, honeysuckle, and licorice are weighed by weight parts, washed and crushed to 10-20 mesh coarse powder, 8-10 times the weight of purified water is added, and soaked for 1-2 hours;

[0018] The soaked medicinal materials and water are placed in a sand pot, heated to boiling with a strong fire, and then kept at a slight boiling state with a weak fire for 2 times, the first time for 2 hours and the second time for 1.5 hours, and the two decoctions are combined;

[0019] The combined decoction is filtered with three layers of gauze, the residue is removed, and the filtrate is concentrated to a clear paste with a relative density of 1.10-1.15 at 60-70℃, and then cooled to room temperature for standby;

[0020] Add ethanol to the clear paste until the alcohol concentration reaches 60%, stir uniformly, stand for 12 hours, filter out the precipitate, and concentrate the filtrate again to remove the alcohol taste to obtain the Chinese herbal medicine extract, which is stored at 4-8℃ for standby;

[0021] (2) Oil phase preparation

[0022] Stearic acid, vaseline, liquid paraffin, and lanolin are weighed by weight parts and added to an oil phase pot, heated to 75-80℃, stirred until completely melted and mixed uniformly, and kept at 75-80℃ for standby;

[0023] (3) Water phase preparation

[0024] The purified water, glycerol, propylene glycol and hydroxyphenyl ethyl ester are weighed by weight parts, added to the water phase pot, heated to 75-80 DEG C, stirred until the hydroxyphenyl ethyl ester is completely dissolved, then slowly add triethanolamine, adjust the pH to 5.5-6.5, and keep the temperature consistent with the oil phase, ready for use;

[0025] (4) Emulsification and mixing

[0026] Under the condition of stirring speed 300-500 r / min, the oil phase is slowly added to the water phase pot, and stirring is continued for 15-20 minutes to form a primary emulsion;

[0027] The stirring speed is reduced to 200-300 r / min, and the refrigerated Chinese herbal extract is slowly added to the primary emulsion, stirring while adding, stirring for 30-40 minutes until mixed evenly;

[0028] Continue to stir and cool to 40-45 DEG C, stop stirring, and naturally cool to room temperature to obtain the Chinese herbal cream for treating dermatitis.

[0029] Compared with the prior art, the advantages of the present application are:

[0030] The selected Sophora, Phellodendron, honeysuckle can synergistically inhibit bacteria and anti-inflammatory, and the Semen Astragali, Herba Portulacae can enhance the effect of relieving itching and anti-allergy, and the Glycyrrhiza can not only anti-inflammatory but also reduce irritation, so that multiple components are matched to realize the multi-target effect of "anti-inflammatory-bacteriostatic-itch relief-repair".

[0031] The core components of the present application are all medicinal and edible or clinically commonly used Chinese herbal medicines, and there is no toxic component; the matrix adjuvant is selected from mild components, and the pH is close to the physiological value of the skin, avoiding the use of sugar corticosteroids, heavy metals and other irritating substances.

[0032] The cream stability is significantly improved by scientific emulsification process and adjuvant ratio, the cream texture is delicate, easy to apply and absorb, no greasy feeling, and the skin moisturizing effect after use is long-lasting, and the patient compliance is high.

[0033] The extraction process of the present application adopts water extraction and alcohol precipitation method, which is simple in operation and low in cost, and does not require special equipment; the emulsification process temperature is easy to control, and is suitable for industrial large-scale production. DETAILED DESCRIPTION

[0034] The various exemplary embodiments of the present application will be described in detail below. It should be noted that the relative arrangement, numerical expression and numerical value of the components and steps set forth in these embodiments do not limit the scope of the present application unless otherwise specifically stated.

[0035] The following description of at least one exemplary embodiment is merely exemplary in nature and is in no way intended to limit the application or its application or uses.

[0036] Techniques, methods, and apparatus known to those of ordinary skill in the relevant art can not be discussed in detail herein. However, where appropriate, such techniques, methods, and apparatus should be considered as being part of the specification.

[0037] In all of the compositions and methods shown and discussed herein, any specific numerical value should be interpreted as merely an example, and not as a limitation. Other examples of the exemplary embodiments can have different values.

[0038] A Chinese herbal cream for treating dermatitis and a preparation method thereof are described in detail below.

[0039] A Chinese herbal cream for treating dermatitis, by weight, comprises the following raw materials:

[0040] 1. Core active ingredients (20-35 parts)

[0041] Sophora flavescens: 3-5 parts (containing matrine, with anti-inflammatory and antibacterial effects);

[0042] Fructus Kochiae: 2-4 parts (containing kochiae saponin, with heat-clearing, dampness-removing, and itching-relieving effects);

[0043] Phellodendri Chinensis: 2-3 parts (containing berberine, with antibacterial and anti-inflammatory effects, and skin mucosa repairing effects);

[0044] Honeysuckle: 3-5 parts (containing chlorogenic acid, with heat-clearing and detoxifying effects, and skin pathogenic bacteria inhibiting effects);

[0045] Portulaca oleracea: 4-6 parts (containing portulaca oleracea glycoside, with anti-inflammatory, anti-allergic, and skin repair promoting effects);

[0046] Glycyrrhiza: 2-3 parts (containing glycyrrhizin, with anti-inflammatory effects enhancing and other component irritation reducing effects);

[0047] 2. Matrix adjuvant (65-80 parts)

[0048] Oil phase ingredients: 15-20 parts (stearic acid 5-7 parts, vaseline 3-5 parts, liquid paraffin 4-6 parts, and lanolin 3-4 parts, which can form a stable oil film and reduce skin water loss);

[0049] Water phase ingredients: 40-50 parts (purified water as a solvent and dispersion medium);

[0050] Emulsifiers: 3-5 parts (glyceryl monostearate 2-3 parts and Tween-80 1-2 parts, which can uniformly disperse the oil phase and water phase and improve the stability of the cream);

[0051] Moisturizer: 5-8 parts (glycerin 4-6 parts, propylene glycol 1-2 parts, enhance skin moisture capacity, improve skin barrier function);

[0052] pH regulator: 0.1-0.3 parts (triethanolamine, adjust the pH of the cream to 5.5-6.5, close to the physiological pH of the skin, reduce irritation);

[0053] Preservative: 0.1-0.2 parts (ethyl hydroxybenzoate, in line with national pharmaceutical standards, to ensure that the preparation is free of microbial contamination within the shelf life).

[0054] The present application also provides a preparation method of the above-mentioned Chinese herbal medicine cream for treating dermatitis, comprising the following steps:

[0055] 1. Preparation of Chinese herbal medicine extract

[0056] Weigh the Sophora flavescens, Fructus Kochiae, Phellodendri, Honeysuckle, Portulaca oleracea, and liquorice by weight, wash and crush to 10-20 mesh coarse powder, add 8-10 times the weight of purified water, soak for 1-2 hours;

[0057] Put the soaked medicinal materials and water together in a sand pot, heat to boiling with strong fire, then keep it slightly boiling with medium heat for 2 times, the first time for 2 hours, the second time for 1.5 hours, combine the two decoctions;

[0058] Filter the combined decoction with three layers of gauze, remove the residue and collect the juice, concentrate the filtrate to a clear paste with a relative density of 1.10-1.15 at 60-70℃, cool to room temperature, and reserve for use;

[0059] Add ethanol to the clear paste to a concentration of 60% (v / v), stir evenly, then stand for 12 hours, filter to remove the precipitate, and concentrate the filtrate to be alcohol-free at 60-70℃, to obtain the Chinese herbal medicine extract, which is stored at 4-8℃.

[0060] 2. Preparation of oil phase

[0061] Weigh stearic acid, vaseline, liquid paraffin, and lanolin by weight, add them to an oil phase pot, heat to 75-80℃, stir until completely melted and mixed evenly, and reserve for use, maintaining the temperature at 75-80℃ to avoid oxidation of the ingredients.

[0062] 3. Preparation of water phase

[0063] Weigh purified water, glycerin, propylene glycol, and hydroxybenzoic acid by weight, add them to a water phase pot, heat to 75-80℃, stir until the hydroxybenzoic acid is completely dissolved, then slowly add triethanolamine, stir to adjust the pH to 5.5-6.5, and reserve for use, maintaining the same temperature as the oil phase to avoid temperature differences causing separation during emulsification.

[0064] 4. Emulsification and mixing

[0065] Under the stirring condition of 300-500 r / min, the oil phase is slowly added into the water phase pot, and stirring is continued for 15-20 minutes to form a primary emulsion;

[0066] The stirring speed is reduced to 200-300 r / min, and the refrigerated Chinese herbal extract is slowly added into the primary emulsion while stirring, and stirring is continued for 30-40 minutes until the mixture is uniform;

[0067] Stirring is continued and cooling is performed to 40-45℃, and then stirring is stopped, and natural cooling is performed to room temperature, thereby obtaining the Chinese herbal cream for treating dermatitis.

[0068] 5. Quality control

[0069] Appearance: The cream should be uniform and fine light yellow ointment without visible particles or foreign matters;

[0070] Stability: Under the condition of 40℃±2℃ and relative humidity of 75%±5%, the cream is placed for 6 months, and no delamination, discoloration or odor is observed;

[0071] Active ingredient content: The content of matrine is ≥0.15 g and the content of chlorogenic acid is ≥0.10 g per 100 g of the cream;

[0072] Microbial limit: The microbial limit meets the microbial limit standard of Chinese Pharmacopoeia for external preparations (bacterial count ≤100 CFU / g, mold and yeast count ≤10 CFU / g, and Staphylococcus aureus, Pseudomonas aeruginosa are not detected).

[0073] The specific implementation process of the Chinese herbal cream for treating dermatitis and the preparation method thereof is as follows:

[0074] 1. Raw material composition (by weight)

[0075] Core active ingredients: Sophora flavescens 4 parts, Fructus Kochiae 3 parts, Phellodendri Cortex 2.5 parts, Lonicera japonica 4 parts, Herba Portulacae 5 parts and Glycyrrhiza 2.5 parts (total 21 parts);

[0076] 2. Matrix adjuvant: Stearic acid 6 parts, vaseline 4 parts, liquid paraffin 5 parts, lanolin 3.5 parts (oil phase 18.5 parts), purified water 45 parts (water phase), glyceryl monostearate 2.5 parts, Tween-80 1.5 parts (emulsifier 4 parts), glycerol 5 parts, propylene glycol 1.5 parts (humectant 6.5 parts), triethanolamine 0.2 parts (pH adjuster), hydroxyphenyl ethyl ester 0.15 parts (preservative) (total 75.35 parts).

[0077] 3. Preparation steps

[0078] Preparation of Chinese herbal extract: The above 6 kinds of medicinal materials were crushed to 15 mesh, and then soaked in 9 times of purified water for 1.5 hours. After boiling, the extract was obtained by extracting for 2 hours and 1.5 hours, respectively. The extract was filtered, concentrated to a clear extract with a relative density of 1.12 (measured at 60°C), and then added with ethanol to a concentration of 60%. After standing for 12 hours, the extract was filtered, concentrated to no alcohol taste, and then stored in a refrigerator for standby;

[0079] Preparation of oil phase: the oil phase ingredients were heated to 78°C, melted and mixed uniformly, and then kept at the temperature;

[0080] Preparation of water phase: the water phase ingredients were heated to 78°C, and then dissolved with hydroxyphenyl ethyl ester. After adjusting the pH to 6.0 with triethanolamine, the mixture was kept at the temperature;

[0081] Emulsification and mixing: the oil phase was added to the water phase (stirring at 350 r / min), and then the extract was added after 18 minutes (stirring at 250 r / min). After 35 minutes, the mixture was cooled to 42°C, and then naturally cooled to room temperature to obtain the cream.

[0082] 4. Performance detection

[0083] Appearance: light yellow, uniform and fine cream without particles;

[0084] Stability: no stratification and discoloration after being placed at 40°C and 75% RH for 6 months;

[0085] Effective components: matrine 0.18 g / 100 g, chlorogenic acid 0.12 g / 100 g;

[0086] Microbial limit: in line with the standard of pharmacopoeia.

[0087] The above describes the present application and its embodiments, which are not limited. If a person skilled in the art is inspired by the above description, without departing from the purpose of the present application, similar structural modes and embodiments can be designed without creative design, which should belong to the protection scope of the present application.

Claims

1. A Chinese herbal cream for treating dermatitis, characterized by comprising: The core raw material and matrix auxiliary material are included; ​ The core raw material includes Sophora flavescens 3-5 parts, Semen pruni 2-4 parts, Phellodendri chinensis 2-3 parts, honeysuckle 3-5 parts, Portulaca oleracea 4-6 parts, and licorice 2-3 parts by weight; The matrix auxiliary material includes oil phase ingredients 15-20 parts, water phase ingredients 40-50 parts, emulsifier 3-5 parts, humectant 5-8 parts, pH regulator 0.1-0.3 parts, and preservative 0.1-0.2 parts by weight.

2. The Chinese herbal cream for treating dermatitis according to claim 1, characterized in that: The oil phase ingredients include stearic acid 5-7 parts, vaseline 3-5 parts, liquid paraffin 4-6 parts, and lanolin 3-4 parts.

3. The Chinese herbal cream for treating dermatitis according to claim 2, characterized in that: The water phase ingredients use purified water.

4. The Chinese herbal cream for treating dermatitis according to claim 3, characterized in that: The emulsifier includes glycerol monostearate 2-3 parts and Tween-80 1-2 parts.

5. The Chinese herbal cream for treating dermatitis according to claim 4, characterized in that: The humectant includes glycerol 4-6 parts and propylene glycol 1-2 parts.

6. The Chinese herbal cream for treating dermatitis according to claim 5, characterized in that: The pH regulator uses triethanolamine.

7. The Chinese herbal cream for treating dermatitis according to claim 6, characterized in that: The preservative uses hydroxyethyl benzoate.

8. A method for preparing the Chinese herbal cream for treating dermatitis according to any one of claims 1 to 7, characterized by, The method includes the following steps: (1) Preparation of Chinese herbal medicine extract Sophora flavescens, Semen pruni, Phellodendri chinensis, honeysuckle, Portulaca oleracea, and licorice are weighed by weight parts, washed, and crushed into 10-20 mesh coarse powder, then 8-10 times weight of purified water is added and soaked for 1-2 hours; The soaked medicinal materials and water are placed in a sand pot, heated to boiling with strong fire, then kept in a state of slight boiling with a weak fire for 2 times, the first time for 2 hours and the second time for 1.5 hours, and the two times of decoction are combined; The combined decoction is filtered through three layers of gauze, the residue is removed, and the filtrate is concentrated to a clear paste with a relative density of 1.10-1.15 at 60-70℃, then cooled to room temperature, and used as needed; Ethanol is added to the clear paste until the alcohol concentration reaches 60%, stirred uniformly, then placed for 12 hours, the precipitate is removed by filtration, the filtrate is concentrated again until there is no alcohol taste, and the Chinese herbal medicine extract is obtained, which is stored at 4-8℃ for later use; (2) Preparation of oil phase Stearic acid, vaseline, liquid paraffin, and lanolin are weighed by weight parts, added to an oil phase pot, heated to 75-80℃, stirred until completely melted and mixed uniformly, and kept at 75-80℃ for standby; (3) Preparation of water phase Purified water, glycerol, propylene glycol, and hydroxyethyl benzoate are weighed by weight parts, added to a water phase pot, heated to 75-80℃, stirred until the hydroxyethyl benzoate is completely dissolved, then slowly add triethanolamine, and adjust the pH to 5.5-6.5, and keep at the same temperature as the oil phase for standby; (4) Emulsification and mixing The oil phase is slowly added to the water phase pot at a stirring speed of 300-500 r / min, continue to stir for 15-20 minutes to form a primary emulsion; The stirring speed is reduced to 200-300 r / min, and the refrigerated Chinese herbal medicine extract is slowly added to the primary emulsion while stirring, and stirred for 30-40 minutes until mixed uniformly; Continue to stir and cool to 40-45℃, stop stirring, and naturally cool to room temperature to obtain the Chinese herbal medicine cream for treating dermatitis.