External ointment for treating psoriasis and preparation method thereof

Abstract

The invention belongs to the technical field of medicine, and particularly provides external ointment for treating psoriasis and a preparation method thereof.The external ointment is prepared from, by weight, 1.2-2 parts of antifungal agent, 1-1.6 parts of traditional Chinese medicine sustained-release agent, 8-11 parts of glycerin, 8-10 parts of wax stearyl alcohol, 5-7 parts of mineral oil, 2.5-4 parts of propylene glycol, 1-2 parts of emulsifier and 0.2-0.8 part of penetrant. The formula comprises the following components in parts by weight: 0.2 to 0.5 part of preservative, 0.3 to 0.7 part of triethanolamine, 0.5 to 1 part of carbomer, 0.05 to 0.15 part of essence, 0.005 to 0.01 part of pigment, 0.001 to 0.005 part of fluorometholone acetate and 50 to 70 parts of purified water. Wherein the medicinal component in the traditional Chinese medicine slow-release agent is composite plant essential oil. All the components of the external ointment are compatible with one another, and the external ointment is remarkable in curative effect, quick in effect taking, small in toxic and side effects, free of excessive stimulation and low in recurrence rate after curing, has certain calming and itching relieving properties, slow release properties and antibacterial activity and can effectively solve the problem of treatment of psoriasis.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines, and in particular relates to an external ointment for treating psoriasis and a preparation method thereof. Background Art

[0002] Psoriasis, commonly known as "psoriasis", is a long-term and potentially recurrent skin disease. Globally, about 2% of the population is affected by this disease, and its main clinical manifestations are thickening of the skin surface, incomplete keratinization and hyperkeratinization of skin surface cells, formation of epidermal microabscesses, and inflammatory reactions caused by the accumulation of a large number of neutrophils. It is generally believed that the onset of the disease is related to multiple factors such as genetics, infection, metabolism, endocrine, and immunity. There are many types of hormone, chemical, and traditional Chinese medicine drugs on the market for the treatment of skin diseases. Although the formulations are different, there are still problems such as poor healing effect, many side effects, and easy recurrence.

[0003] Chinese patent CN 110151859 A discloses an external Chinese medicine ointment for treating psoriasis and its production process. The formula contains the following raw medicinal materials by weight: 4-6 parts of Baitiao root, 4-6 parts of Beixianpi, 9-11 parts of Lithospermum officinale, 4-6 parts of Cannabis sativa seeds, 4-6 parts of Diaphora scabra, 4-6 parts of Coptis chinensis, 4-6 parts of Phellodendron chinense, 4-6 parts of Rhubarb, 4-6 parts of Yungui, 4-6 parts of Rehmannia glutinosa, 9-11 parts of insect wax, 2-3 parts of borneol, and 190-210 parts of rapeseed oil. This invention has a certain effect on the treatment of psoriasis. However, treatment with pure Chinese medicine ingredients will make the efficacy difficult to control and is prone to relapse after treatment.

[0004] Therefore, there is an urgent need for an external ointment for treating psoriasis, which has significant efficacy, few toxic and side effects, and a low recurrence rate after cure. Summary of the invention

[0005] In view of the existing technical problems, the purpose of the present invention is to provide an external ointment for treating psoriasis and a preparation method thereof. The components of the external ointment of the present invention are compatible with each other, have significant therapeutic effects, and take effect quickly. At the same time, it has small toxic and side effects, does not cause excessive stimulation, and has a low recurrence rate after cure. It also has certain sedative and antipruritic properties, sustained release properties, and antibacterial properties, and can effectively solve the problem of treating psoriasis.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] On one hand, the present invention provides an external ointment for treating psoriasis. The external ointment comprises the following raw materials in parts by weight: 1.2-2 parts of an antifungal agent, 1-1.6 parts of a Chinese medicine sustained-release agent, 8-11 parts of glycerol, 8-10 parts of cerol stearyl alcohol, 5-7 parts of mineral oil, 2.5-4 parts of propylene glycol, 1-2 parts of an emulsifier, 0.2-0.8 parts of a penetrant, 0.2-0.5 parts of a preservative, 0.3-0.7 parts of triethanolamine, 0.5-1 parts of carbomer, 0.05-0.15 parts of a flavor, 0.005-0.01 parts of a pigment, 0.001-0.005 parts of fluorometholone acetate, and 50-70 parts of purified water.

[0008] The reaction mechanism and effects of the present invention are as follows:

[0009] 1. Plant essential oils have a certain inhibitory effect on a variety of pathogens, and many essential oils have a strong killing effect on fungi. However, most plant essential oils have the characteristics of poor stability, low water solubility, and high volatility, which limits their wide application.

[0010] On the one hand, the present invention uses polyvinyl pyrrolidone of a specific molecular weight to embed the composite plant essential oil, and after adding a surfactant, the plant essential oil is evenly dispersed to prepare a Chinese medicine sustained-release agent, which effectively improves the stability and sustained-release effect of the composite plant essential oil, so that the final external ointment has a long-lasting effect, and further improves the cure rate of psoriasis. On the other hand, the composite plant essential oil of the present invention selects peppermint essential oil and lavender essential oil. The applicant unexpectedly found that by controlling the ratio of peppermint essential oil and lavender essential oil, the medicinal effect of the Chinese medicine sustained-release agent can be coordinated to be good. Peppermint essential oil has anti-inflammatory properties, can improve skin inflammation, and play an antipruritic and analgesic role; lavender essential oil has a more significant effect on the inhibitory effect on fungi, can reduce the biomass and metabolic activity of bacterial biofilms, and at the same time, lavender essential oil has a calming and relaxing effect, relieves stress, and stimulates the brain to release certain neurotransmitters, and stress is a major cause of psoriasis attacks.

[0011] 2. The antifungal agent of the present invention adopts a composition of liranablast and alclomethasone dipropionate in a specific mass ratio. When the ointment is used, liranablast enters the skin surface through the penetrant, and alclomethasone dipropionate has the effect of constricting blood vessels, which can slow down the transdermal absorption rate of liranablast, increase the concentration of liranablast on the local skin surface, reduce the drug penetration into the deep layer of the skin, and improve the cure rate of the external ointment; at the same time, alclomethasone dipropionate has a strong local anti-inflammatory and antipruritic effect, which avoids the patient's scratching and causing secondary infection, improves the patient's compliance during treatment, and reduces the recurrence rate of psoriasis.

[0012] In some embodiments, the composite plant essential oil is a combination of peppermint essential oil and lavender essential oil.

[0013] Preferably, the mass ratio of the peppermint essential oil to the lavender essential oil is 1:(0.5-2).

[0014] In some embodiments, the method for preparing the Chinese medicine sustained-release preparation comprises the following steps:

[0015] Q1. Mix polyvinyl pyrrolidone and distilled water, heat to 80-90°C to obtain a polyvinyl pyrrolidone solution for later use;

[0016] Q2. The surfactant and the composite plant essential oil are mixed, grape seed oil is added, stirred in a water bath at 30-50°C for 30-60 min, the polyvinyl pyrrolidone solution obtained in step Q1 is added dropwise, stirring and emulsifying is continued for 30-60 min, glutaraldehyde is added dropwise, and after stirring at the temperature for 10-15 min, a 0.5-1 mol / L aqueous hydrochloric acid solution is added, and stirring is continued for 1-2 h to obtain an emulsion;

[0017] Q3. Centrifuge the emulsion obtained in step Q2, remove the upper oil, add acetone and centrifuge again to obtain the lower precipitate, dry it, and obtain a Chinese medicine sustained-release agent.

[0018] In some embodiments, the average molecular weight of the polyvinyl pyrrolidone in step Q1 is 10,000-60,000.

[0019] In some embodiments, the mass ratio of the surfactant to the composite plant essential oil in step Q2 is (0.03-0.08):10.

[0020] Preferably, the surfactant is Span 80 and / or Tween 80.

[0021] Further preferably, the surfactants are Span 80 and Tween 80, and the mass ratio of the two is 1:1.

[0022] In some embodiments, the mass ratio of polyvinyl pyrrolidone to the composite plant essential oil in the polyvinyl pyrrolidone solution in step Q2 is (0.3-0.65):10.

[0023] In some embodiments, the antifungal agent is a combination of liranabate and alclomethasone dipropionate.

[0024] Preferably, the mass ratio of liranabate to alclomethasone dipropionate is 10:(0.5-1.2).

[0025] In some embodiments, the penetrant is any one or more of isopropyl myristate, dimethyl isosorbide, azone and thiothione.

[0026] In some embodiments, the preservative is any one or more of methylparaben, propylparaben and ethylparaben.

[0027] In some embodiments, the emulsifier is a combination of glyceryl stearate and sodium lauryl sulfate.

[0028] Preferably, the mass ratio of glyceryl stearate to sodium lauryl sulfate is 1:1.

[0029] Another aspect of the present invention provides a method for preparing an external ointment for treating psoriasis, comprising the following steps:

[0030] S1. Mix the whale wax stearyl alcohol, mineral oil, penetrant, preservative, flavor, and fluorometholone acetate, heat to 60-80°C, melt, add the antifungal agent and the Chinese medicine sustained-release agent in sequence, stir, and obtain a mixture 1, which is kept warm for standby use;

[0031] S2. Mix glycerin, propylene glycol, emulsifier, carbomer, pigment and purified water, heat to 60-80 ° C, stir to obtain mixture 2, and keep warm for later use;

[0032] S3. Pour the mixture 1 obtained in step S1 into a reactor, heat to 60-80°C, stir, add the mixture 2 obtained in step S2, homogenize, then add triethanolamine, stir, vacuum degas, cool while stirring until the temperature drops to 20-25°C, and obtain an external ointment.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] 1. The components of the external ointment of the present invention are compatible with each other, and the curative effect is remarkable. At the same time, the toxic and side effects are small, there is no excessive stimulation, the recurrence rate is low after cure, and it has certain calming and antipruritic properties, sustained release and antibacterial properties, which can effectively solve the treatment problem of psoriasis. When the ointment is correctly applied daily, obvious effects can be seen in three days, and the symptoms of dry skin and itching can be effectively alleviated, and erythema and scaling phenomena can be reduced.

[0035] 2. The present invention uses polyvinyl pyrrolidone and surfactant to modify the composite plant essential oil to form a Chinese medicine sustained-release agent, which effectively improves the stability and sustained-release effect of the composite plant essential oil; on the other hand, the applicant controls the ratio of peppermint essential oil and lavender essential oil to synergistically enable the external ointment to exert anti-inflammatory, antipruritic, analgesic and sedative effects.

[0036] 3. The antifungal agent of the present invention adopts a composition of liranablast and alclomethasone dipropionate in a specific mass ratio, which effectively increases the concentration of liranablast on the local skin surface and synergistically improves the cure rate of the ointment; at the same time, alclomethasone dipropionate has a strong local anti-inflammatory and antipruritic effect, which prevents patients from scratching and causing secondary infection, improves the compliance of patients during treatment, and indirectly reduces the recurrence rate of psoriasis. DETAILED DESCRIPTION

[0037] The present invention will be described below in conjunction with specific embodiments. It should be noted that the following embodiments are examples of the present invention and are only used to illustrate the present invention, rather than to limit the present invention. Other combinations and various modifications within the concept of the present invention may be performed without departing from the spirit or scope of the present invention.

[0038] According to the ratios and preparation methods of the raw materials specified in the following examples and comparative examples, various external ointments were prepared.

[0039] In order to facilitate those skilled in the art to implement the present invention, some raw material manufacturers of the embodiments and comparative examples are described as follows:

[0040] Polyvinylpyrrolidone K30: purchased from Hebei Tuohai Biotechnology Co., Ltd.;

[0041] Polyvinyl pyrrolidone K90: purchased from Huzhou Shenhua Polymer Materials Co., Ltd.;

[0042] Grape seed oil: purchased from Ji'an Zhongda Natural Plant Spice Co., Ltd.;

[0043] Peppermint essential oil and lavender essential oil: purchased from Xi'an Jinxiang Pharmaceutical Excipients Co., Ltd.;

[0044] Mineral oil 10#: purchased from Shanghai Hongshen Industry and Trade Co., Ltd.;

[0045] Carbomer 940: purchased from Guangzhou Huayu Biotechnology Co., Ltd.;

[0046] Other raw materials are not specially specified and can be purchased from the market.

[0047] Preparation Example 1

[0048] The preparation method of Chinese medicine sustained-release agent A comprises the following steps:

[0049] Q1. Mix 10 g of polyvinyl pyrrolidone K30 and 200 mL of distilled water, heat to 85 ° C to obtain a polyvinyl pyrrolidone solution for later use;

[0050] Q2. 0.5 g of Span 80, 0.5 g of Tween 80 and 200 g of composite plant essential oil were mixed, 100 mL of grape seed oil was added, the mixture was stirred in a water bath at 45 ° C for 45 min, all the polyvinyl pyrrolidone solution obtained in step Q1 was added dropwise, and stirring and emulsification was continued for 45 min. Then 0.7 mL of glutaraldehyde was added dropwise, and 2 mL of 1 mol / L aqueous hydrochloric acid solution was added after stirring for 15 min. The mixture was stirred for 1.5 h to obtain an emulsion; wherein the composite plant essential oil was a composition of 80 g of peppermint essential oil and 120 g of lavender essential oil;

[0051] Q3. Centrifuge the emulsion obtained in step Q2, remove the upper oil, add acetone 2.5 times the volume of the remaining substance and centrifuge again to obtain the lower precipitate, dry it naturally at room temperature, and obtain Chinese medicine sustained-release agent A.

[0052] Preparation Example 2

[0053] The preparation method of Chinese medicine sustained-release agent B is the same as that of Preparation Example 1, except that the polyvinyl pyrrolidone K30 in step Q1 is replaced by polyvinyl pyrrolidone K90 in equal amounts.

[0054] Preparation Example 3

[0055] The preparation method of Chinese medicine sustained-release agent C is the same as that of Preparation Example 1, except that the added amounts of Span 80 and Tween 80 in step Q2 are both 0.2 g.

[0056] Preparation Example 4

[0057] The preparation method of Chinese medicine sustained-release agent D is the same as that of Preparation Example 1, except that in step Q1, 16 g of polyvinyl pyrrolidone K30 and 250 mL of distilled water are mixed and heated to 85° C. to obtain a polyvinyl pyrrolidone solution.

[0058] Preparation Example 5

[0059] The preparation method of Chinese medicine sustained-release agent E is the same as that of Preparation Example 1, except that an equal amount of peppermint essential oil is used instead of the composite plant essential oil in step Q2.

[0060] Example 1

[0061] A topical ointment for treating psoriasis, comprising the following raw materials by weight: 1.6 parts of antifungal agent, 1.3 parts of Chinese medicine sustained-release agent A, 9.5 parts of glycerol, 9 parts of cetearyl alcohol, 6 parts of mineral oil, 3.2 parts of propylene glycol, 1.5 parts of emulsifier, 0.5 parts of penetrant, 0.35 parts of preservative, 0.5 parts of triethanolamine, 0.75 parts of carbomer, 0.1 parts of flavor, 0.008 parts of pigment, 0.003 parts of fluorometholone acetate, and 60 parts of purified water; wherein,

[0062] The antifungal agent is a combination of liranabate and alclomethasone dipropionate, with a mass ratio of 10:0.8;

[0063] The emulsifier is a combination of glyceryl stearate and sodium lauryl sulfate, and the mass ratio of the two is 1:1;

[0064] The preservatives are methylparaben and propylparaben, and the mass ratio of the two is 1:1;

[0065] The penetrant is azone; the flavor is jasmine powder flavor; and the pigment is lemon yellow pigment.

[0066] The method for preparing the external ointment of this embodiment comprises the following steps:

[0067] S1. Mix whale wax stearyl alcohol, mineral oil, penetrant, preservative, essence and fluorometholone acetate, heat to 70°C, melt into liquid, add antifungal agent and Chinese medicine sustained-release agent A in sequence, stir at a speed of 30r / min for 1h to obtain mixture 1, keep warm for standby use; wherein, the antifungal agent needs to be firstly subjected to airflow ultrafine grinding by airflow mill to make its average particle size less than 100μm;

[0068] S2. Glycerin, propylene glycol, emulsifier, carbomer, pigment, purified water were mixed, heated to 70 ° C, stirred evenly, to obtain a mixture 2, and kept warm for later use;

[0069] S3. The mixed material 1 obtained in step S1 is pumped into an emulsifying homogenizer, the temperature is controlled at 70°C, and the mixture is stirred at a speed of 30 r / min for 30 min. Then, the mixed material 2 obtained in step S2 is added, and the mixture is homogenized at a speed of 50 r / min for 30 min, and then at a speed of 4000 r / min for 10 min. Triethanolamine is added, and the mixture is stirred at a speed of 50 r / min for 1 h. Vacuum degassing is performed, and the mixture is cooled while stirring until the temperature drops to 25°C to obtain an external ointment.

[0070] Example 2

[0071] A topical ointment for treating psoriasis, comprising the following raw materials by weight: 1.2 parts of antifungal agent, 1 part of Chinese medicine sustained-release agent A, 8 parts of glycerol, 8 parts of cetearyl alcohol, 5 parts of mineral oil, 2.5 parts of propylene glycol, 1 part of emulsifier, 0.2 parts of penetrant, 0.2 parts of preservative, 0.3 parts of triethanolamine, 0.5 parts of carbomer, 0.05 parts of flavor, 0.005 parts of pigment, 0.001 parts of fluorometholone acetate, and 50 parts of purified water; wherein,

[0072] The antifungal agent is a combination of liranabate and alclomethasone dipropionate, with a mass ratio of 10:0.5;

[0073] The emulsifier is a combination of glyceryl stearate and sodium lauryl sulfate, and the mass ratio of the two is 1:1;

[0074] The preservatives are methylparaben and propylparaben, and the mass ratio of the two is 1:1;

[0075] The penetrant is azone; the flavor is jasmine powder flavor; and the pigment is lemon yellow pigment.

[0076] The method for preparing the external ointment of this embodiment comprises the following steps:

[0077] S1. Mix whale wax stearyl alcohol, mineral oil, penetrant, preservative, essence and fluorometholone acetate, heat to 60°C, melt into liquid, add antifungal agent and Chinese medicine sustained-release agent A in sequence, stir at a speed of 30r / min for 1h to obtain mixture 1, keep warm for standby use; wherein, the antifungal agent needs to be firstly subjected to airflow ultrafine grinding by airflow mill to make its average particle size less than 100μm;

[0078] S2. Glycerin, propylene glycol, emulsifier, carbomer, pigment, purified water were mixed, heated to 60 ° C, stirred evenly, to obtain a mixture 2, and kept warm for later use;

[0079] S3. The mixed material 1 obtained in step S1 is pumped into an emulsifying homogenizer, the temperature is controlled at 60°C, and the mixture is stirred at a speed of 30 r / min for 30 min. Then, the mixed material 2 obtained in step S2 is added, and the mixture is homogenized at a speed of 50 r / min for 30 min, and then at a speed of 4000 r / min for 10 min. Triethanolamine is added, and the mixture is stirred at a speed of 50 r / min for 1 h. Vacuum degassing is performed, and the mixture is cooled while stirring until the temperature drops to 25°C to obtain an external ointment.

[0080] Example 3

[0081] A topical ointment for treating psoriasis, comprising the following raw materials by weight: 2 parts of antifungal agent, 1.6 parts of Chinese medicine sustained-release agent A, 11 parts of glycerol, 10 parts of cetearyl alcohol, 7 parts of mineral oil, 4 parts of propylene glycol, 2 parts of emulsifier, 0.8 parts of penetrant, 0.5 parts of preservative, 0.7 parts of triethanolamine, 1 part of carbomer, 0.15 parts of flavor, 0.01 parts of pigment, 0.005 parts of fluorometholone acetate, and 70 parts of purified water; wherein,

[0082] The antifungal agent is a combination of liranabate and alclomethasone dipropionate, with a mass ratio of 10:1.2;

[0083] The emulsifier is a combination of glyceryl stearate and sodium lauryl sulfate, and the mass ratio of the two is 1:1;

[0084] The preservatives are methylparaben and propylparaben, and the mass ratio of the two is 1:1;

[0085] The penetrant is azone; the flavor is jasmine powder flavor; and the pigment is lemon yellow pigment.

[0086] The method for preparing the external ointment of this embodiment comprises the following steps:

[0087] S1. Mix whale wax stearyl alcohol, mineral oil, penetrant, preservative, essence and fluorometholone acetate, heat to 80°C, melt into liquid, add antifungal agent and Chinese medicine sustained-release agent A in sequence, stir at a speed of 30r / min for 1h to obtain mixture 1, and keep warm for later use; wherein, the antifungal agent needs to be firstly subjected to airflow ultrafine grinding by airflow mill to make its average particle size less than 100μm;

[0088] S2. Glycerin, propylene glycol, emulsifier, carbomer, pigment, purified water were mixed, heated to 80 ° C, stirred evenly, to obtain a mixture 2, and kept warm for later use;

[0089] S3. The mixed material 1 obtained in step S1 is pumped into an emulsifying homogenizer, the temperature is controlled at 80°C, and the mixture is stirred at a speed of 30 r / min for 30 min. Then, the mixed material 2 obtained in step S2 is added, and the mixture is homogenized at a speed of 50 r / min for 30 min, and then at a speed of 4000 r / min for 10 min. Triethanolamine is added, and the mixture is stirred at a speed of 50 r / min for 1 h. Vacuum degassing is performed, and the mixture is cooled while stirring until the temperature drops to 25°C to obtain an external ointment.

[0090] Example 4

[0091] An external ointment for treating psoriasis and a preparation method thereof, wherein the specific implementation manner is the same as that of Example 1, except that an equal amount of a Chinese medicine sustained-release agent B is used to replace a Chinese medicine sustained-release agent A.

[0092] Example 5

[0093] An external ointment for treating psoriasis and a preparation method thereof, wherein the specific implementation manner is the same as that of Example 1, except that an equal amount of a Chinese medicine sustained-release agent C is used to replace a Chinese medicine sustained-release agent A.

[0094] Example 6

[0095] An external ointment for treating psoriasis and a preparation method thereof, wherein the specific implementation manner is the same as that of Example 1, except that an equal amount of a Chinese medicine sustained-release agent D is used to replace a Chinese medicine sustained-release agent A.

[0096] Example 7

[0097] An external ointment for treating psoriasis and a preparation method thereof, wherein the specific implementation manner is the same as that of Example 1, except that an equal amount of a Chinese medicine sustained-release agent E is used instead of a Chinese medicine sustained-release agent A.

[0098] Example 8

[0099] An external ointment for treating psoriasis and a preparation method thereof, the specific implementation manner is the same as that of Example 1, except that the antifungal agent is only liranabate.

[0100] Comparative Example 1

[0101] An external ointment for treating psoriasis and a preparation method thereof, wherein the specific implementation manner is the same as that of Example 1, except that an equal amount of peppermint essential oil is used to replace the traditional Chinese medicine sustained-release agent A.

[0102] Effect evaluation:

[0103] The external ointments prepared in the above Examples 1-8 and Comparative Example 1 were tested and analyzed, and the specific results are shown in Table 1.

[0104] Performance Test:

[0105] (1) Safety test: 27 volunteers aged 20-60 were selected and divided into 9 groups, with 3 people in each group. The external ointments prepared in Examples 1-8 and Comparative Example 1 were respectively applied at a coating amount of 1 g per square decimeter, twice a day. During the test, ointments other than the test samples were not allowed to be used on the test site. The skin was observed after the second application of the ointment. If the skin had no symptoms such as itching, redness, and swelling, it was "no allergic symptoms"; if the skin had itching, slight redness, and swelling, but no obvious redness, swelling, erythema, edema, etc., it was "mild allergic symptoms"; if the skin had obvious symptoms such as erythema, edema, papules, large (small) blisters, etc., it was "allergic symptoms".

[0106] It was found through experiments that the external-use ointments prepared in Examples 1-8 and Comparative Example 1 of the present invention all showed “no allergic symptoms” after testing.

[0107] (2) 135 volunteers aged 20-60 years old suffering from psoriasis were selected and divided into 9 groups, each with 15 people. The external ointments prepared in Examples 1-8 and Comparative Example 1 were respectively applied at a coating amount of 2 g per square decimeter, once a day, before going to bed every day, and the lesion site was covered with food-grade plastic wrap for 10 hours. The course of treatment was 18 days. During the test, ointments other than the test samples were not allowed to be used on the test site. A follow-up visit was conducted 3 months after the cure to see if there was any recurrence. The treatment evaluation criteria were as follows:

[0108] Cure: Fungal microscopy is negative, ringworm and itching completely disappear, and the skin area of ​​lesions is reduced by more than 85%;

[0109] Significantly effective: fungal microscopic examination is negative, ringworm basically disappears, there is no itching, and the skin area of ​​lesions is reduced by 60%-85%;

[0110] Ineffective: Fungal microscopy is positive, tinea and itching are not completely relieved, and the lesion skin area is reduced by less than 60%.

[0111] Table 1

[0112] Serial number Cured / person Significant effect / person Invalid / person Relapse after 3 months / person Example 1 14 1 0 0 Example 2 13 2 0 1 Example 3 14 1 0 0 Example 4 12 2 1 2 Example 5 12 1 2 2 Example 6 11 2 2 3 Example 7 10 2 3 3 Example 8 11 2 2 4 Comparative Example 1 9 3 3 3

[0113] As can be seen from the above table, the external ointments prepared in Examples 1-3 have good effects, no abnormal phenomena during use, good cure rates, and low recurrence rates. The recurrence in Example 2 was found to be most likely caused by not paying attention to his diet.

[0114] Compared with Example 1, when preparing the Chinese medicine sustained-release agent, Example 4 selects polyvinyl pyrrolidone with a molecular weight exceeding this range, so that the embedding rate of the composite plant essential oil decreases, and Example 5 changes the mass ratio of the surfactant and the composite plant essential oil, resulting in insufficient interfacial film strength, which is easy to destroy the stability of the system, and Example 6 changes the mass ratio of polyvinyl pyrrolidone and the composite plant essential oil, and the solution viscosity is too large, which leads to the final Chinese medicine sustained-release agent being difficult to disperse evenly, and Example 7 replaces the composite plant essential oil with an equal amount of peppermint essential oil, which may lose the synergistic effect and reduce the antibacterial effect, and Comparative Example 1 replaces the Chinese medicine sustained-release agent A with an equal amount of peppermint essential oil, which loses the sustained-release effect, all of which will affect the cure rate of psoriasis to varying degrees.

[0115] Compared with Example 1, the antifungal agent added in Example 8 is only liranablast, the concentration of liranablast on the skin surface decreases, the synergistic effect is lost, and the antibacterial effect is reduced, thereby affecting the cure rate of psoriasis.

[0116] The above is only a preferred embodiment of the present invention and does not constitute any form of limitation to the present application. Although the present application is disclosed as above in the preferred embodiment, it is not intended to limit the present application. Any technician familiar with the profession, without departing from the scope of the technical solution of the present application, using the technical content disclosed above to make slight changes or modifications are equivalent to equivalent implementation cases. However, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution.

Claims

1. An external ointment for treating psoriasis, characterized in that: The external ointment contains the following raw materials by weight: 1.2-2 parts of antifungal agent, 1-1.6 parts of traditional Chinese medicine sustained-release agent, 8-11 parts of glycerin, 8-10 parts of cereth-23 alcohol, 5-7 parts of mineral oil, 2.5-4 parts of propylene glycol, 1-2 parts of emulsifier, 0.2-0.8 parts of penetrant, 0.2-0.5 parts of preservative, 0.3-0.7 parts of triethanolamine, 0.5-1 parts of carbomer, 0.05-0.15 parts of flavor, 0.005-0.01 parts of pigment, 0.001-0.005 parts of fluorometholone acetate, and 50-70 parts of purified water; wherein the medicinal ingredient in the traditional Chinese medicine sustained-release agent is a composite plant essential oil.

2. The external ointment for treating psoriasis according to claim 1, characterized in that: The composite plant essential oil is a composition of peppermint essential oil and lavender essential oil.

3. The external ointment for treating psoriasis according to claim 1, characterized in that: The preparation method of the Chinese medicine sustained-release preparation comprises the following steps: Q1. Mix polyvinyl pyrrolidone and distilled water, heat to 80-90°C to obtain a polyvinyl pyrrolidone solution for later use; Q2. The surfactant and the composite plant essential oil are mixed, grape seed oil is added, stirred in a water bath at 30-50°C for 30-60 min, the polyvinyl pyrrolidone solution obtained in step Q1 is added dropwise, stirring and emulsifying is continued for 30-60 min, glutaraldehyde is added dropwise, and after stirring at the temperature for 10-15 min, a 0.5-1 mol / L aqueous hydrochloric acid solution is added, and stirring is continued for 1-2 h to obtain an emulsion; Q3. Centrifuge the emulsion obtained in step Q2, remove the upper oil, add acetone and centrifuge again to obtain the lower precipitate, dry it, and obtain a Chinese medicine sustained-release agent.

4. The external ointment for treating psoriasis according to claim 3, characterized in that: The average molecular weight of the polyvinyl pyrrolidone in step Q1 is 10,000-60,000.

5. The external ointment for treating psoriasis according to claim 3, characterized in that: The mass ratio of the surfactant to the composite plant essential oil in step Q2 is (0.03-0.08):

10.

6. The external ointment for treating psoriasis according to claim 3, characterized in that: The mass ratio of polyvinyl pyrrolidone to composite plant essential oil in the polyvinyl pyrrolidone solution in step Q2 is (0.3-0.65):

10.

7. The external ointment for treating psoriasis according to claim 1, characterized in that: The antifungal agent is a combination of liranabate and alclomethasone dipropionate.

8. The external ointment for treating psoriasis according to claim 1, characterized in that: The penetrant is any one or more of isopropyl myristate, dimethyl isosorbide, azone and thiazone.

9. The external ointment for treating psoriasis according to claim 1, characterized in that: The preservative is any one or more of methylparaben, propylparaben and ethylparaben.

10. A method for preparing the external ointment for treating psoriasis according to any one of claims 1 to 9, characterized in that: The following steps are included: S1. Mix the whale wax stearyl alcohol, mineral oil, penetrant, preservative, flavor, and fluorometholone acetate, heat to 60-80°C, melt, add the antifungal agent and the Chinese medicine sustained-release agent in sequence, stir, and obtain a mixture 1, which is kept warm for standby use; S2. Mix glycerin, propylene glycol, emulsifier, carbomer, pigment and purified water, heat to 60-80 ° C, stir to obtain mixture 2, and keep warm for later use; S3. Pour the mixture 1 obtained in step S1 into a reactor, heat to 60-80°C, stir, add the mixture 2 obtained in step S2, homogenize, then add triethanolamine, stir, vacuum degas, cool while stirring until the temperature drops to 20-25°C, and obtain an external ointment.