Pharmaceutical composition as well as preparation method and application thereof in preparation of eczema medicine
Through the ratio of traditional Chinese medicine compositions such as Sophora, Fengfeng, and Snake, and other excipients to prepare a pharmaceutical composition, which solves the problems of complex ingredients, slow efficacy and major side effects in the treatment of eczema by existing traditional Chinese medicine preparations, and achieves rapid and effective eczema treatment and skin barrier repair.
Patent Information
- Application Number
- CN202510915044.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-03
- Publication Date
- 2025-08-15
AI Technical Summary
The existing traditional Chinese medicine preparations are used to treat eczema with complex ingredients, slow efficacy, prone to recurrence and side effects.
Traditional Chinese medicine compositions such as Sophora pilosula, Fengfeng, Snake, Baibu, Difuzi, Snake Tonga and Asarum are prepared into pharmaceutical compositions through specific extraction and emulsification methods for the treatment of eczema.
Significantly reduce the level of inflammatory factors, quickly and effectively treat eczema, reduce side effects, repair skin barriers, and relieve stubborn pain and itching.
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Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a pharmaceutical composition, a preparation method thereof, and application thereof in the preparation of eczema medicines. Background Art
[0002] Eczema, also known as atopic dermatitis (AD), is a common inflammatory skin disease. Its chronicity and difficulty in treatment increase the risk of various immune disorders. Common Western medical treatments for eczema include topical moisturizers, glucocorticoids, and oral antihistamines. While these treatments offer short-term efficacy, long-term steroid use carries significant side effects. Both internal and topical Chinese medicines are effective in treating eczema. Traditional Chinese medicine classifies eczema as a condition known as "milk rash," "herbal eczema," or "wet sores," believing it to be caused by spleen dysfunction and the accumulation of dampness. Spleen deficiency leads to imbalanced ascending and descending functions, hindering the distribution of fluids and preventing them from reaching the lungs. Insufficient stomach qi results in poor digestion and digestion, disrupting the transport and transformation of food and water, preventing the nourishment of essence and fine particles in the muscles and skin. Consequently, the body's defenses are weakened, making it susceptible to invasion by external pathogens such as wind, dampness, and heat.
[0003] For example, Chinese patent CN103405718A discloses a Chinese medicine pill for treating psoriasis. It is composed of 25 Chinese herbs: Horn of Buffalo, Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix Adenophorae, Radix Adenophorae, Radix Paeoniae Rubra, Cortex Moutan, Herba Hedyotis Diffusae, Radix Lithospermi, Snake, Herba Scolopendrae, Scolopendra, Caulis Spatholobi, Rhizoma Smilacis Glabrae, Cortex Dictamni, Radix Sophorae Flavescentis, Fructus Cnidii, Fructus Kochiae, Semen Persicae, Carthamus Tinctorius, Rhizoma Trigonellae, Rhizoma Curcumae, Asarum, Radix Astragali, and Radix Codonopsis. It nourishes yin, clears heat, cools blood, and detoxifies; attacks toxic substances, dissipates stagnation, and relieves pain; activates blood circulation, relieves stasis, and relieves pain, and clears away joints; tonifies the middle and replenishes qi, improves physical fitness, regulates immunity, and enhances disease resistance. The combination of these herbs has the effects of clearing away heat and dampness, promoting blood circulation and activating collaterals, clearing heat and cooling blood, promoting blood circulation and removing stasis, and relieving swelling and pain. However, this invention has complex ingredients and corresponding side effects.
[0004] For example, Chinese patent CN104491608A discloses a Chinese medicine lotion for treating eczema, which is made of the following raw materials in parts by weight: 2-6 parts of ephedra, 5-15 parts of siler, 10-30 parts of hyssop, 10-20 parts of schizonepeta, 6-12 parts of black snake, 6-12 parts of whole worm, 4-8 parts of centipede, 10-20 parts of angelica dahurica, 5-10 parts of mint, 5-15 parts of asarum, 20-40 parts of cnidium monnieri, 5-15 parts of ginseng. 1-20 parts of eczema, 5-15 parts of agarwood, 5-15 parts of golden grass, 10-20 parts of Senecio, 10-30 parts of purslane, 10-30 parts of Kochia scoparia, 10-20 parts of Sophora flavescens, 10-30 parts of Smilax glabra, 5-10 parts of Akebia, 5-15 parts of fresh Verbena, 5-15 parts of Plantago, and 10-20 parts of Polyporus; the invention has a short course of treatment for eczema, a high cure rate, is safe and has no toxic side effects, has a significant effect, and the patients who use it basically do not relapse. However, the invention also has the above-mentioned problems.
[0005] Although there are many types of traditional Chinese medicine preparations for treating eczema in the existing technology, most of them have complex ingredients, slow efficacy, easy recurrence, side effects and other problems. Therefore, it is urgent to develop a traditional Chinese medicine composition for treating eczema that has simple ingredients, fast efficacy, safety and no toxic side effects. Summary of the Invention
[0006] Based on the deficiencies of the prior art, the present invention aims to provide a pharmaceutical composition and a preparation method thereof and application in the preparation of eczema drugs.
[0007] To achieve the above object, the present invention adopts the following technical solutions: In one aspect, the present invention provides a pharmaceutical composition comprising a traditional Chinese medicine composition and pharmaceutically acceptable excipients.
[0008] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 30-60 parts of Sophora flavescens, 5-15 parts of Saposhnikovia divaricata, 10-20 parts of Cnidium monnieri, 10-20 parts of Stemona japonica, 10-20 parts of Kochia scoparia, 5-15 parts of Hedyotis diffusa and 1-3 parts of Asarum.
[0009] Preferably, the mass ratio of the siler leaves and the fructus cnidium is 1:1-2, more preferably 1:1.5.
[0010] More preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 40 parts of Sophora flavescens, 10 parts of Saposhnikovia divaricata, 15 parts of Cnidium monnieri, 15 parts of Stemona japonica, 15 parts of Kochia scoparia, 10 parts of Hedyotis diffusa and 2 parts of Asarum.
[0011] Preferably, the pharmaceutically acceptable excipients are composed of the following raw materials in parts by weight: 3-5 parts of hexadecanol, 5-10 parts of liquid paraffin, 15-30 parts of white vaseline, 1-3 parts of dimethyl silicone oil, 1-3 parts of glyceryl monostearate, 0.1-0.3 parts of methyl parahydroxybenzoate, 2-8 parts of sodium lauryl sulfate, 1-5 parts of glycerol and 1-3 parts of propylene glycol.
[0012] More preferably, the pharmaceutically acceptable excipients are composed of the following raw materials in parts by weight: 4 parts of cetyl alcohol, 8 parts of liquid paraffin, 20 parts of white petrolatum, 2 parts of dimethicone, 2 parts of glyceryl monostearate, 0.2 parts of methyl parahydroxybenzoate, 5 parts of sodium lauryl sulfate, 3 parts of glycerol and 2 parts of propylene glycol.
[0013] On the other hand, the present invention also provides a method for preparing the above-mentioned pharmaceutical composition, comprising the following steps: (1) Sophora flavescens, Cnidium monnieri, Stemona tuberosa, Kochia scoparia, Hedyotis diffusa, Saposhnikovia divaricata and Asarum were sieved through 50-80 mesh, added with 75-85% ethanol in a volume fraction of 4-6 times the total weight of the medicinal materials, refluxed at 70-80°C for 1-3h, filtered, and concentrated under reduced pressure to a solid content of 70%-80% to obtain a concentrate; (2) Mixing methyl paraben, sodium lauryl sulfate, glycerin and propylene glycol and stirring uniformly to obtain an aqueous phase; (3) Mix cetyl alcohol, liquid paraffin, white petrolatum, dimethyl silicone oil and glyceryl monostearate, heat to 70-80°C, melt and stir evenly to obtain an oil phase; (4) The aqueous phase obtained in step (2) is heated to 70-80°C, mixed with the oil phase obtained in step (3), and then the concentrate obtained in step (1) is added. The mixture is homogenized and emulsified at 300-600 r / min for 10-20 minutes until coagulation occurs.
[0014] Preferably, the mass ratio of the concentrate to the total weight of the water phase and the oil phase is 1:1-3, more preferably 1:2.
[0015] Preferably, the preparation method of the above-mentioned pharmaceutical composition comprises the following steps: (1) Sophora flavescens, Cnidium monnieri, Stemona tuberosa, Kochia scoparia, Hedyotis diffusa, Saposhnikovia divaricata and Asarum were sieved through 70 mesh, added with 80% ethanol in a volume fraction of 5 times the total weight of the medicinal materials, refluxed and extracted at 75°C for 2 hours, filtered, and concentrated under reduced pressure to a solid content of 75% to obtain a concentrate; (2) Mixing methyl paraben, sodium lauryl sulfate, glycerin and propylene glycol and stirring uniformly to obtain an aqueous phase; (3) Mix cetyl alcohol, liquid paraffin, white petrolatum, dimethyl silicone oil and glyceryl monostearate, heat to 75°C, melt and stir evenly to obtain an oil phase; (4) The aqueous phase obtained in step (2) is heated to 80°C, mixed with the oil phase obtained in step (3), and then the concentrate obtained in step (1) is added. The mixture is homogenized and emulsified at 500 r / min for 15 minutes until coagulation occurs.
[0016] On the other hand, the present invention also provides the use of the above-mentioned pharmaceutical composition in the preparation of a drug for treating eczema.
[0017] The present invention is solved as follows: Sophora flavescens: bitter and cold; heart, liver, stomach and large intestine meridians, clears heat and dampness, kills insects and relieves itching, mainly treats redness, swelling and exudation caused by damp-heat, and is the main medicine.
[0018] Saposhnikovia divaricata: pungent, sweet and slightly warm; acts on the bladder, liver and spleen meridians, dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain, disperses wind evil, penetrates the skin surface, and is an assistant medicine.
[0019] Cnidium monnieri: pungent, bitter and warm; acts on the kidney and spleen meridians, dries dampness and dispels wind, kills insects and relieves itching, helps the main medicine to remove dampness and relieve itching, inhibits fungi, and is the minister medicine.
[0020] Stemona: sweet, bitter and slightly warm; Lung meridian, moisturizing and killing insects, inhibiting parasites, relieving epidermal damage caused by scratching, and is an adjuvant.
[0021] Kochia scoparia seeds: pungent and bitter with cold properties; acts on the bladder meridian, clears heat and dampness, dispels wind and relieves itching, is good at clearing damp heat from the skin, and relieves itching caused by urticaria, and is an adjuvant.
[0022] Houttuynia cordata: sweet, mild and cool; acts on the stomach, large intestine and small intestine meridians, clears away heat and detoxifies, promotes dampness and reduces swelling, has anti-inflammatory and antibacterial properties, and prevents secondary infection, serving as an adjuvant.
[0023] Asarum: pungent and warm; acts on the heart, lung and kidney meridians, warms the meridians and dredges the collaterals, relieves pain and kills parasites, helps prevent wind and cold, dredges the collaterals, relieves stubborn pain, and is a guiding drug.
[0024] Compared with the prior art, the present invention has the following beneficial effects: (1) The pharmaceutical composition provided by the present invention mainly clears away heat and dries dampness, dispels wind and relieves itching, and can repair the skin barrier; matrine in Sophora flavescens and osthole in Cnidium monnieri have significant antibacterial activity; Saposhnikovia divaricata can penetrate the body's pathogenic factors and block the "wind-induced itching" link; Asarum spicate can clear the meridians and relieve the stubborn pain of chronic eczema; Stemona radix can moisturize the skin and reduce scratching damage; Kochia scoparia polysaccharide can promote the differentiation of keratinocytes and repair the skin barrier; multiple Chinese medicines work together to effectively treat eczema.
[0025] (2) The present invention can significantly reduce the level of inflammatory factors by synergizing the effect of the Chinese medicine composition through the reasonable ratio of excipients. DETAILED DESCRIPTION
[0026] The technical solution of the present invention is described clearly and completely below with specific embodiments. Obviously, the embodiments described are only some embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work are within the scope of protection of the present invention. Unless otherwise specified, the materials and reagents used are commercially available reagents and materials.
[0027] Example 1 A pharmaceutical composition, composed of the following raw materials in parts by weight: 40 parts of Sophora flavescens, 10 parts of Saposhnikovia divaricata, 15 parts of Cnidium monnieri, 15 parts of Stemona officinalis, 15 parts of Kochia scoparia, 10 parts of Hedyotis diffusa and 2 parts of Asarum; 4 parts of cetyl alcohol, 8 parts of liquid paraffin, 20 parts of white vaseline, 2 parts of dimethicone, 2 parts of glyceryl monostearate, 0.2 part of methyl paraben, 5 parts of sodium lauryl sulfate, 3 parts of glycerol and 2 parts of propylene glycol.
[0028] The preparation method of the pharmaceutical composition is as follows: (1) Sophora flavescens, Cnidium monnieri, Stemona tuberosa, Kochia scoparia, Hedyotis diffusa, Saposhnikovia divaricata and Asarum were sieved through 70 mesh, added with 80% ethanol in a volume fraction of 5 times the total weight of the medicinal materials, refluxed and extracted at 75°C for 2 hours, filtered, and concentrated under reduced pressure to a solid content of 75% to obtain a concentrate; (2) Mixing methyl paraben, sodium lauryl sulfate, glycerin and propylene glycol and stirring uniformly to obtain an aqueous phase; (3) Mix cetyl alcohol, liquid paraffin, white petrolatum, dimethyl silicone oil and glyceryl monostearate, heat to 75°C, melt and stir evenly to obtain an oil phase; (4) Take 10 g of the aqueous phase obtained in step (2) and heat it to 80°C, mix it with 10 g of the oil phase obtained in step (3), and then add 10 g of the concentrate obtained in step (1). Homogenize and emulsify at 500 r / min for 15 minutes until it solidifies.
[0029] Example 2 A pharmaceutical composition, composed of the following raw materials in parts by weight: 30 parts of Sophora flavescens, 5 parts of Saposhnikovia divaricata, 10 parts of Cnidium monnieri, 10 parts of Stemona officinalis, 10 parts of Kochia scoparia, 5 parts of Hedyotis diffusa and 1 part of Asarum; 3 parts of cetyl alcohol, 5 parts of liquid paraffin, 15 parts of white vaseline, 1 part of dimethicone, 1 part of glyceryl monostearate, 0.1 part of methyl parahydroxybenzoate, 2 parts of sodium lauryl sulfate, 1 part of glycerol and 1 part of propylene glycol.
[0030] The preparation method of the pharmaceutical composition is as follows: (1) Sophora flavescens, Cnidium monnieri, Stemona tuberosa, Kochia scoparia, Hedyotis diffusa, Saposhnikovia divaricata and Asarum were sieved through 70 mesh, added with 75% ethanol in a volume fraction of 4 times the total weight of the medicinal materials, refluxed at 70°C for 1 hour, filtered, and concentrated under reduced pressure to a solid content of 70% to obtain a concentrate; (2) Mixing methyl paraben, sodium lauryl sulfate, glycerin and propylene glycol and stirring uniformly to obtain an aqueous phase; (3) Mix cetyl alcohol, liquid paraffin, white petrolatum, dimethyl silicone oil and glyceryl monostearate, heat to 75°C, melt and stir evenly to obtain an oil phase; (4) Take 5 g of the aqueous phase obtained in step (2) and heat it to 80°C, mix it with 5 g of the oil phase obtained in step (3), and then add 10 g of the concentrate obtained in step (1). Homogenize and emulsify at 300 r / min for 20 min until it solidifies.
[0031] Example 3 A pharmaceutical composition, composed of the following raw materials in parts by weight: 60 parts of Sophora flavescens, 15 parts of Saposhnikovia divaricata, 20 parts of Cnidium monnieri, 20 parts of Stemona officinalis, 20 parts of Kochia scoparia, 15 parts of Hedyotis diffusa and 3 parts of Asarum; 5 parts of cetyl alcohol, 10 parts of liquid paraffin, 30 parts of white vaseline, 3 parts of dimethicone, 0.3 part of methyl paraben, 8 parts of sodium lauryl sulfate, 5 parts of glycerin and 3 parts of propylene glycol.
[0032] The preparation method of the pharmaceutical composition is as follows: (1) Sophora flavescens, Cnidium monnieri, Stemona tuberosa, Kochia scoparia, Hedyotis diffusa, Saposhnikovia divaricata and Asarum were sieved through 70 mesh, added with 85% ethanol in a volume fraction of 6 times the total weight of the medicinal materials, refluxed at 80°C for 3 h, filtered, and concentrated under reduced pressure to a solid content of 80% to obtain a concentrate; (2) Mixing methyl paraben, sodium lauryl sulfate, glycerin and propylene glycol and stirring uniformly to obtain an aqueous phase; (3) Mix cetyl alcohol, liquid paraffin, white petrolatum, dimethyl silicone oil and glyceryl monostearate, heat to 75°C, melt and stir evenly to obtain an oil phase; (4) Take 10 g of the aqueous phase obtained in step (2) and heat it to 80°C, mix it with 20 g of the oil phase obtained in step (3), and then add 10 g of the concentrate obtained in step (1). Homogenize and emulsify at 600 r / min for 10 min until it solidifies.
[0033] Comparative Example 1 The difference from Example 1 is that Asarum is replaced by Herba Cynoglossi, and the rest are the same.
[0034] Comparative Example 2 The difference from Example 1 is that 10 parts of honeysuckle and 10 parts of phellodendron are further added, and the content of sophora flavescens is reduced, that is, the components of the Chinese medicine composition are: 20 parts of sophora flavescens, 10 parts of siler, 15 parts of cnidium monnieri, 15 parts of stemona, 15 parts of kochia scoparia, 10 parts of oldenlandia diffusa, 10 parts of honeysuckle, 10 parts of phellodendron and 2 parts of asarum.
[0035] Comparative Example 3 The difference from Example 1 is that the ratio of the Chinese medicine composition is not within the scope of protection of the present invention, namely: 20 parts of Sophora flavescens, 20 parts of Saposhnikovia divaricata, 5 parts of Cnidium monnieri, 5 parts of Stemona japonica, 25 parts of Kochia scoparia, 20 parts of Hedyotis diffusa and 5 parts of Asarum.
[0036] Comparative Example 4 The difference from Example 1 is that Saposhnikovia divaricata is replaced by Stemona radix, that is, the components of the Chinese medicine composition are: 40 parts of Sophora flavescens, 15 parts of Cnidium monnieri, 25 parts of Stemona radix, 15 parts of Kochia scoparia, 10 parts of Hedyotis diffusa and 2 parts of Asarum.
[0037] Effect Experiment Eight-week-old healthy male Balb / c mice, weighing 17-25g, were fed an adaptive diet for 7 days and divided into a normal control group, a model group, a positive control group (compound dexamethasone acetate cream purchased from China Resources Sanjiu Pharmaceutical Co., Ltd.), Example 1-3 groups, and Comparative Example 1-3 groups, with 5 mice in each group. One day before the experiment, the hair on the backs and ears of the mice was shaved, and the dorsal lesion area, approximately 3.0 cm × 3.0 cm, was identified. The normal control group received no treatment. The mice in the model, positive control, Example 1-3, and Comparative Example 1-3 groups were used to establish the model.
[0038] Prepare the sensitizer first: acetone and olive oil are used as the matrix in a ratio of 4:1, mixed with dinitrochlorobenzene (DNCB) to prepare a DNCB solution with a volume concentration of 1%.
[0039] Sensitization stage: Apply 100 μL of 1% DNCB solution evenly on the back of the mouse once a day for three consecutive days.
[0040] Provocation stage: On the fifth day, 20 μL of 1% DNCB solution was applied to the inner and outer sides of the right ear of the mice to induce dermatitis. Obvious inflammation appeared within 2 hours, indicating that the model was successfully established.
[0041] Maintenance stage: After successful modeling, apply 100 μL of 1% DNCB solution to the back every other day starting from the 9th day, and apply 20 μL of 1% DNCB solution to the inner and outer sides of the right ear to maintain the skin lesions (apply at 9 am every day) until the 21st day.
[0042] Dosing: Starting on day 9, the normal control group and the model group received no treatment. The positive control group received an even application of 1 g of compound dexamethasone acetate cream on the lesioned area. The Example 1-3 and Comparative Example 1-3 groups received an even application of 1 g of the corresponding pharmaceutical composition on the lesioned area. Dosing was performed once daily for 14 consecutive days (at 8:00 PM each day). On day 23, the severity of the back lesions was scored, the number of scratches, and the degree of ear swelling were recorded. Blood was collected from the eyeballs, and the mice were then sacrificed.
[0043] 1. Skin lesion severity score Skin lesions on the backs and ears of mice were visually observed and recorded. Lesion severity was assessed using a lesion severity score, which evaluates erythema, edema, and scratches, with a final total score. No erythema was assigned a score of 0, mild 1, moderate 2, moderate to severe 3, and severe 4. No redness or swelling was assigned a score of 0, mild 1, moderate 2, moderate to severe 3, and severe 4. No scratches were assigned a score of 0, and the presence of scratches was assigned a score of 1. The combined score is the sum of these three scores, as shown in Table 1 below.
[0044] Table 1
[0045] Note: Compared with Example 1, *p<0.05.
[0046] 2. Number of scratches The number of times each mouse scratched its ears and back within 10 minutes was recorded, with continuous scratching counted as one time. The results are shown in Table 2 below.
[0047] Table 2
[0048] Note: Compared with Example 1, *p<0.05.
[0049] 3. Ear swelling The degree of ear swelling was assessed by the increase in ear thickness. The ear thickness of both mice was measured using a vernier caliper. The increase in ear thickness (mm) = right ear thickness (mm) - left ear thickness (mm). Three measurements were performed at the same site by the same operator, and the average value was calculated. The results are shown in Table 3 below.
[0050] Table 3
[0051] Note: Compared with the model group, *p < 0.05; compared with Example 1, # p<0.05.
[0052] 4. Serum IgE level detection Mouse blood was centrifuged at 3000 rpm / min and 4°C for 10 minutes to obtain mouse serum, which was stored at -20°C and tested strictly according to the ELISA test kit. The results are shown in Table 4.
[0053] Table 4
[0054] Note: Compared with the model group, *p < 0.05; compared with Example 1, # p<0.05.
[0055] It can be seen from the above data that the pharmaceutical composition prepared by the present invention has a good improvement effect on the mouse eczema model by rationally controlling the ratio between the Chinese medicines and the ratio between the excipients.
[0056] The above detailed description is a specific description of one feasible embodiment of the present invention. This embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not depart from the present invention should be included in the scope of the technical solution of the present invention.
Claims
1. A pharmaceutical composition, characterized in that The pharmaceutical composition is composed of a traditional Chinese medicine composition and pharmaceutically acceptable excipients; the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30-60 parts of Sophora flavescens, 5-15 parts of Saposhnikovia divaricata, 10-20 parts of Cnidium monnieri, 10-20 parts of Stemona japonica, 10-20 parts of Kochia scoparia, 5-15 parts of Hedyotis diffusa and 1-3 parts of Asarum.
2. The pharmaceutical composition according to claim 1, characterized in that The mass ratio of the fangfeng and cnidium monnieri in the traditional Chinese medicine composition is 1:1-2.
3. The pharmaceutical composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 40 parts of Sophora flavescens, 15 parts of Cnidium monnieri, 15 parts of Stemona radix, 15 parts of Kochia scoparia, 10 parts of Hedyotis diffusa, 10 parts of Saposhnikovia divaricata and 10 parts of Asarum.
4. The pharmaceutical composition according to claim 1, characterized in that The pharmaceutically acceptable excipients are composed of the following raw materials in parts by weight: 3-5 parts of hexadecanol, 5-10 parts of liquid paraffin, 15-30 parts of white vaseline, 1-3 parts of dimethyl silicone oil, 1-3 parts of glyceryl monostearate, 0.1-0.3 parts of methyl parahydroxybenzoate, 2-8 parts of sodium lauryl sulfate, 1-5 parts of glycerol, 1-3 parts of propylene glycol and 10-20 parts of water.
5. The pharmaceutical composition according to claim 4, characterized in that The pharmaceutically acceptable excipients are composed of the following raw materials in parts by weight: 4 parts of hexadecanol, 8 parts of liquid paraffin, 20 parts of white vaseline, 2 parts of dimethyl silicone oil, 0.2 parts of methyl parahydroxybenzoate, 5 parts of sodium lauryl sulfate, 3 parts of glycerol and 2 parts of propylene glycol.
6. The method for preparing the pharmaceutical composition according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) Sophora flavescens, Cnidium monnieri, Stemona tuberosa, Kochia scoparia, Hedyotis diffusa, Saposhnikovia divaricata and Asarum were sieved, added with ethanol, refluxed for extraction, filtered and concentrated to obtain a concentrate; (2) Mixing methyl paraben, sodium lauryl sulfate, glycerin and propylene glycol and stirring uniformly to obtain an aqueous phase; (3) Mix cetyl alcohol, liquid paraffin, white petrolatum, dimethyl silicone oil and glyceryl monostearate, heat and melt, and stir evenly to obtain an oil phase; (4) The aqueous phase obtained in step (2) is heated, mixed with the oil phase obtained in step (3), and then the concentrate obtained in step (1) is added, homogenized and emulsified to obtain the product.
7. The preparation method according to claim 6, characterized in that The mesh size of the sieving in step (1) is 50-80 mesh; the volume of the added ethanol is 4-6 times the total weight of the medicinal materials, and the volume fraction of the ethanol is 75-85%; the time of the reflux extraction is 1-3 hours; and the concentration is vacuum concentration, concentrated to a solid content of 70%-80%.
8. The preparation method according to claim 6, characterized in that The heating temperature in step (3) and step (4) is 70-80°C; the speed of the homogenization and emulsification is 300-600 r / min, and the time is 10-20 min.
9. The preparation method according to claim 6, characterized in that The mass ratio of the concentrate of step (1) to the total weight of the aqueous phase of step (2) and the oil phase of step (3) is 1:1-3.
10. Use of the pharmaceutical composition according to any one of claims 1 to 5 or the pharmaceutical composition prepared by the preparation method according to any one of claims 6 to 9 in the preparation of a drug for treating eczema.
Citation Information
Patent Citations
TCM pill for treating psoriasis
CN103405718A
Traditional Chinese medicine lotion for treating eczema
CN104491608A