阅读说明：本技术 一种乳膏制剂及其制备方法和应用 (Emulsifiable paste preparation and preparation method and application thereof ) 是由 胡成刚 王学军 陈桃香 于 2021-07-14 设计创作，主要内容包括：本发明公开了一种乳膏制剂及其制备方法和应用,乳膏制剂以重量份1000份计包括如下组分：凤仙花提取物20～50份,马桑提取物20～50份,硬脂醇100～400份,白凡士林100～400份,十二烷基硫酸钠5～15份,甘油60～180份,蒸馏水余量。通过醇提等工艺得到提取物,将水相缓缓加入油相中,再加入凤仙花和马桑的提取物制成,本发明首次利用凤仙花和马桑原料制备乳膏制剂,该乳膏制剂在凤仙花和马桑提取物不同稀释倍数的比例下对真菌红色毛癣菌和白色念珠菌均有一定的抑菌作用并无明显刺激性。(The invention discloses a cream preparation and a preparation method and application thereof, wherein the cream preparation comprises the following components in 1000 parts by weight: 20-50 parts of impatiens balsamina extract, 20-50 parts of coriaria sinica extract, 100-400 parts of stearyl alcohol, 100-400 parts of white vaseline, 5-15 parts of sodium dodecyl sulfate, 60-180 parts of glycerol and the balance of distilled water. The preparation method comprises the steps of obtaining an extract by processes of alcohol extraction and the like, slowly adding a water phase into an oil phase, and then adding extracts of impatiens balsamina and coriaria sinica, wherein the impatiens balsamina and coriaria sinica are used as raw materials to prepare a cream preparation for the first time, and the cream preparation has certain bacteriostatic action on fungi trichophyton rubrum and candida albicans and has no obvious irritation under the condition of different dilution times of the impatiens balsamina and coriaria sinica extracts.)

1. The cream preparation is characterized by comprising the following raw and auxiliary materials in parts by weight: 20-50 parts of impatiens balsamina extract, 20-50 parts of coriaria sinica extract, 100-400 parts of stearyl alcohol, 100-400 parts of white vaseline, 5-15 parts of sodium dodecyl sulfate, 60-180 parts of glycerol and the balance of distilled water, and the total weight is 1000 parts.

2. The cream preparation as claimed in claim 1, wherein the preparation consists of the following raw and auxiliary materials in parts by weight: 35 parts of balsamine extract, 35 parts of coriaria sinica extract, 100 parts of stearyl alcohol, 400 parts of white vaseline, 5 parts of sodium dodecyl sulfate, 180 parts of glycerol and the balance of distilled water, and the total weight is 1000 parts.

3. The cream formulation as claimed in any one of claims 1 to 2, wherein the impatiens balsamina extract is extracted by a method comprising: weighing impatiens balsamina medicinal materials, crushing, carrying out reflux extraction for 1-3 times by 55-95% ethanol in an amount which is 5-15 times that of the impatiens balsamina medicinal materials, each time for 1-2 hours, filtering, and concentrating into a thick paste to obtain an impatiens balsamina extract.

4. A cream formulation as claimed in claim 3, wherein the impatiens balsamina extract is extracted by a method comprising: weighing impatiens balsamina medicinal materials, pulverizing, extracting with 10 times of 95% ethanol under reflux for 3 times, each time for 1h, filtering, and concentrating into thick paste to obtain impatiens balsamina extract.

5. The cream formulation as claimed in any one of claims 1 to 2, wherein the coriaria sinica extract is extracted by a method comprising: weighing coriaria sinica diels, crushing, carrying out reflux extraction for 1-3 times by 5-15 times of 55-95% ethanol for 1-2 hours each time, filtering, and concentrating into a thick paste to obtain coriaria sinica diels extract.

6. The cream formulation of claim 5, wherein the coriaria sinica extract is extracted by a method comprising: weighing coriaria sinica diels, crushing, extracting with 10 times of 95% ethanol under reflux for 3 times, each time for 1h, filtering, and concentrating into thick paste to obtain coriaria sinica diels extract.

7. A method of preparing a cream formulation as claimed in any one of claims 1 to 2, wherein the method of preparation is as follows: weighing impatiens balsamina medicinal materials, crushing, respectively carrying out reflux extraction for 1-3 times by 55-95% ethanol in an amount which is 5-15 times that of the impatiens balsamina medicinal materials, each time for 1-2 hours, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extract, respectively putting oil-phase stearyl alcohol and white vaseline, water-phase glycerol, sodium dodecyl sulfate and distilled water in a beaker, heating the mixture in a water bath at 75 ℃ for melting, slowly adding the water phase into the oil phase, stirring in the same direction while adding the water phase to emulsify, adding the impatiens balsamina and coriaria extract, and stirring uniformly; adding distilled water to 1000 parts, stirring, and packaging.

8. The preparation method of the cream preparation according to claim 7, wherein the preparation method comprises weighing impatiens balsamina and coriaria sinica, pulverizing, reflux-extracting with 10 times of 95% ethanol for 3 times each time for 1h, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extract, heating oil phase stearyl alcohol and white vaseline and water phase glycerol, sodium lauryl sulfate, and distilled water in a beaker with water bath at 75 deg.C to melt, slowly adding the water phase into the oil phase, stirring in the same direction to emulsify, adding the impatiens balsamina and coriaria sinica extract, and stirring; adding distilled water to 1000 parts, stirring, and packaging.

9. The method of claim 7 or 8, wherein the ratio of oil to water is 1: 2.3.

10. A cream formulation as claimed in any one of claims 1 to 2, wherein the formulation is for use in the manufacture of a medicament for the treatment of fungal infections of trichophyton rubrum and candida albicans.

Technical Field

The invention relates to the field of medicines, and particularly relates to a cream preparation as well as a preparation method and application thereof.

Background

Impatiens balsamina, called "leg protection in acute province" (southeast of Qian), is a whole herb of Impatiens balsamina L. of Balsaminaceae, and has a numb, spicy and hot taste, entering cold, fast and half-edge meridians. Has little toxicity. Has the effects of promoting blood circulation, removing blood stasis, relieving pain, removing toxic substances, dispelling pathogenic wind, removing dampness, and promoting fracture setting. Can be used for treating tonsillitis, lump without digestion, bone sticking, and dysphagia. The stem is used for treating fracture and hyperosteogeny; the flower is used for treating onychomycosis. Impatiens balsamina contains mainly flavonols and naphthoquinone derivatives, such as 2-methoxy-1, 4-naphthoquinone, kaempferol-3-rhamnosyl diglucoside, 2-hydroxy-1, 4-naphthol, etc. The root of impatiens balsamina contains henbane quinone, 2-methoxy-1, 4-naphthoquinone, scopoletin, isofraxidin, etc. Has antifungal, antiallergic, antiinflammatory, analgesic, and skin dialysis promoting effects. Researches report that different extracts of the Balsaminaceae have obvious effects on inhibiting dermatophytes (red bacteria, gypsum bacteria and candida albicans). The antioxidant activity of the extract is measured by a kit method, and the result shows that different extracts have antioxidant effect, and the impatiens balsamina water extract has the strongest antioxidant activity. Impatiens balsamina has a remarkable therapeutic effect on fungal infectious skin diseases, and nowadays, research on the antifungal effect is more and more intensive.

Coriaria sinica, called "Dou Yu" (southeast Qian), is the root and leaf of Coriaria sinica Maxim, a plant of Coriaria sinica, of Coriaria sinica, with astringent taste, cold nature, entering the hot channel. It is toxic. Leaf: has the functions of clearing away heat and toxic material, eliminating swelling, healing sore, relieving pain, killing parasite and promoting granulation. It can be used for treating carbuncle, cellulitis, toxic swelling, eczema, scabies, burn, scald, and impetigo. Root: clearing away heat and toxic material, relieving swelling and pain, dissipating blood stasis and promoting granulation. It can be used for treating rheumatic arthralgia, toothache, phlegm retention, scrofula, acute conjunctivitis, lymphoid tuberculosis, lyssodexis, traumatic injury, burn, and scald. The leaf contains tannin, gallic acid, ursolic acid, kaempferol, corilagin, quercetin Q, and quercetin-3-O-alpha-L-arabinose. The root contains bucilin, norbucilin, coriamyrtin, and dihydrocoriamyrtin. Has effects in inhibiting central nerve and promoting cardiovascular system. The coriaria sinica leaf contains quercetin components with anti-inflammatory and bacteria inhibiting effects, researches report that coriaria sinica extract can promote healing of rat burn wounds and prevent excessive proliferation of wound scars, and coriaria sinica water extract can show good treatment effect on deep II-degree burn through resisting staphylococcus aureus.

The impatiens balsamina has excellent application value in the aspects of eating, natural pigment, economic value and the like. The flavonoids compounds in the coriaria leaves have good antioxidation effect and certain reference value in pharmacological activity.

The invention firstly utilizes the raw materials of the impatiens balsamina and the coriaria sinica to prepare the cream preparation, and the cream preparation has certain bacteriostatic action on fungi trichophyton rubrum and candida albicans under the condition of different dilution times of the impatiens balsamina and coriaria sinica extracts and has no obvious irritation.

Disclosure of Invention

The invention aims to provide a cream preparation and a preparation method thereof, and in order to realize the aim, the invention adopts the following technical scheme:

the cream preparation provided by the invention comprises the following raw and auxiliary materials in parts by weight: 20-50 parts of impatiens balsamina extract, 20-50 parts of coriaria sinica extract, 100-400 parts of stearyl alcohol, 100-400 parts of white vaseline, 5-15 parts of sodium dodecyl sulfate, 60-180 parts of glycerol and the balance of distilled water, and the total weight is 1000 parts.

Preferably, the cream preparation of the invention consists of the following raw and auxiliary materials in parts by weight: 35 parts of balsamine extract, 35 parts of coriaria sinica extract, 100 parts of stearyl alcohol, 400 parts of white vaseline, 5 parts of sodium dodecyl sulfate, 180 parts of glycerol and the balance of distilled water, and the total weight is 1000 parts.

The extraction method of the impatiens balsamina extract comprises the following steps: weighing impatiens balsamina medicinal materials, crushing, carrying out reflux extraction for 1-3 times by 55-95% ethanol in an amount which is 5-15 times that of the impatiens balsamina medicinal materials, each time for 1-2 hours, filtering, and concentrating into a thick paste to obtain an impatiens balsamina extract.

Preferably, the extraction method of the impatiens balsamina extract comprises the following steps: weighing impatiens balsamina medicinal materials, pulverizing, extracting with 10 times of 95% ethanol under reflux for 3 times, each time for 1h, filtering, and concentrating into thick paste to obtain impatiens balsamina extract.

The extraction method of the coriaria sinica maxim extract comprises the following steps: weighing coriaria sinica diels, crushing, carrying out reflux extraction for 1-3 times by 5-15 times of 55-95% ethanol for 1-2 hours each time, filtering, and concentrating into a thick paste to obtain coriaria sinica diels extract.

Preferably, the method for extracting the coriaria sinica maxim extract comprises the following steps: weighing coriaria sinica diels, crushing, extracting with 10 times of 95% ethanol under reflux for 3 times, each time for 1h, filtering, and concentrating into thick paste to obtain coriaria sinica diels extract.

The preparation method of the cream preparation comprises the following steps: weighing impatiens balsamina medicinal materials, crushing, respectively carrying out reflux extraction for 1-3 times by 55-95% ethanol in an amount which is 5-15 times that of the impatiens balsamina medicinal materials, each time for 1-2 hours, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extract, respectively putting oil-phase stearyl alcohol and white vaseline, water-phase glycerol, sodium dodecyl sulfate and distilled water in a beaker, heating the mixture in a water bath at 75 ℃ for melting, slowly adding the water phase into the oil phase, stirring in the same direction while adding the water phase to emulsify, adding the impatiens balsamina and coriaria extract, and stirring uniformly; adding distilled water to 1000 parts, stirring, and packaging.

Preferably, the cream formulation of the present invention is prepared as follows: weighing impatiens balsamina and coriaria sinica medicinal materials, crushing, respectively carrying out reflux extraction for 3 times by 10 times of 95% ethanol, each time for 1 hour, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extracts, respectively putting oil phase stearyl alcohol and white vaseline, water phase glycerol, sodium dodecyl sulfate and distilled water in a beaker, heating in a water bath at 75 ℃ for melting, slowly adding the water phase into the oil phase, stirring along the same direction for emulsification while adding, then adding the impatiens balsamina and coriaria sinica extracts, and stirring uniformly; adding distilled water to 1000 parts, stirring, and packaging.

The ratio of oil to water is 1: 2.3.

The cream preparation of the invention is applied to the infection of trichophyton rubrum and candida albicans.

The weight parts in the invention can be g, mg, kg and other units which are conventional in the field.

Has the advantages that:

1. the invention prepares the cream preparation by using the raw materials of the impatiens balsamina and the coriaria sinica for the first time.

2. The cream preparation has certain bacteriostatic effect on fungi such as trichophyton rubrum and candida albicans under different dilution ratio of flos Impatientis extract and coriaria sinica extract, and has no obvious irritation.

3. According to the evaluation of the content determination result index of the 2-methoxy-1, 4-naphthoquinone, the visual analysis shows that the influence sequence of all factors on the extraction efficiency of the 2-methoxy-1, 4-naphthoquinone is A>B>C>D, analysis of variance results show that factor A, B, C has a significant effect on the results. Combining with visual analysis, the optimal process is preferably selected as A₃B₃C₁D₂The extraction solvent is 95% ethanol, and the extraction time is 1h and the material-liquid ratio is 1:10, and the extraction is carried out for 3 times.

4. According to the invention, 3 parts of balsam extract and coriaria sinica extract are prepared in parallel by an extraction method of extracting solvent of 95% ethanol for 3 times, 1 hour each time and the material-liquid ratio of 1:10, and the content of 2-methoxy-1, 4-naphthoquinone is respectively determined, and the verification experiment result shows that the percentage content of the 2-methoxy-1, 4-naphthoquinone is respectively 1.79, 1.84 and 1.82, which are all larger than the orthogonal design test value, and the RSD is 0.18%, which shows that the extraction process is stable and feasible.

5. In the four test processes of high-temperature test, low-temperature test, centrifugation test and long-term sample retention observation, the result shows that the cream has qualified stability and unchanged appearance color and uniformity. Particularly, after the sample is kept at the high temperature of 55 ℃ for a long time and observed for 4 months, the oil-water stratification does not occur. The stability of the Junkening cream is good.

Drawings

FIG. 1 cream before high temperature

FIG. 2 cream after high temperature

FIG. 3 cream before hypothermia

FIG. 4 cream after hypothermia

FIG. 5 cream before centrifugation (batch number 2020122901 ~ 2020122910 from left to right)

FIG. 6 cream after centrifugation (batch number: 2020122901 ~ 2020122910 from left to right)

FIG. 7 original cream

FIG. 8 cream for 1 month of storage

FIG. 9 cream for 2 months

FIG. 10 cream for 3 months

FIG. 11 cream for 4 months

FIG. 12 is a diagram showing the results of experiments on the inhibitory effect of different concentrations of drugs on Trichophyton rubrum;

FIG. 13 is a graph showing the results of experiments on the bacteriostatic effect of Candida albicans by different concentrations of drugs;

FIG. 14 is a light microscope picture of pathological tissue pathological section of Miao ethnomedicine Junkening cream.

Detailed Description

The present invention will be further described with reference to the accompanying drawings, and it should be noted that the present embodiment is based on the technical solution, and the detailed implementation and the specific operation process are provided, but the protection scope of the present invention is not limited to the present embodiment.

Example 1

The formula is as follows: 35 parts of balsamine extract, 35 parts of coriaria sinica extract, 100 parts of stearyl alcohol, 400 parts of white vaseline, 5 parts of sodium dodecyl sulfate, 180 parts of glycerol and the balance of distilled water, and the total weight is 1000 parts.

Example 2

20 parts of balsamine extract, 20 parts of coriaria sinica extract, 400 parts of stearyl alcohol, 100 parts of white vaseline, 5 parts of sodium dodecyl sulfate, 60 parts of glycerol and the balance of distilled water, and the total weight is 1000 parts.

Example 3

50 parts of impatiens balsamina extract, 50 parts of coriaria sinica extract, 100 parts of stearyl alcohol, 400 parts of white vaseline, 15 parts of sodium dodecyl sulfate, 180 parts of glycerol and the balance of distilled water, and the total is 1000 parts.

Examples 1-3 were prepared according to any of the following preparative methods:

example 4

The preparation method comprises the following steps: weighing impatiens balsamina and coriaria sinica linn medicinal materials, crushing, respectively carrying out reflux extraction for 3 times by 10 times of 95% ethanol, each time for 1 hour, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica linn extracts, respectively putting oil-phase stearyl alcohol and white vaseline, and water-phase glycerol, sodium dodecyl sulfate and distilled water (oil: water: 1:2.3) in a beaker according to the formula amount into a water bath, heating to 75 ℃ for melting, slowly adding the water phase into the oil phase, stirring in the same direction while adding until emulsification is carried out, then adding the impatiens balsamina linn and coriaria sinica linn extracts, and stirring uniformly; adding distilled water to 1000 parts, stirring, and packaging.

Example 5

The preparation method comprises the following steps: weighing impatiens balsamina medicinal materials, crushing, respectively extracting with 5 times of 55% ethanol under reflux for 2 times, each time for 1h, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extract, respectively placing the oil phase of stearyl alcohol and white vaseline, and water phase of glycerol, sodium dodecyl sulfate and distilled water (oil: water 1:2.3) in a beaker, heating in a water bath at 75 ℃ for melting, slowly adding the water phase into the oil phase, stirring in the same direction while adding until emulsification is carried out, adding the impatiens balsamina and coriaria sinica extract, and stirring uniformly; adding distilled water to 1000 parts, stirring, and packaging.

Example 6

The preparation method comprises the following steps: weighing impatiens balsamina medicinal materials, crushing, respectively carrying out reflux extraction for 1 time by 15 times of 95% ethanol, extracting for 3 hours, filtering, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extract, respectively putting oil phase stearyl alcohol and white vaseline, and water phase glycerol, sodium dodecyl sulfate and distilled water (oil: water: 1:2.3) in a beaker, heating in a water bath at 75 ℃ for melting, slowly adding the water phase into the oil phase, stirring in the same direction while adding until emulsification is carried out, then adding the impatiens balsamina and coriaria sinica extract, and stirring uniformly; adding distilled water to 1000 parts, stirring, and packaging.

The application comprises the following steps: can be used for treating fungal infection of Trichophyton rubrum and Candida albicans.

To further verify the feasibility of the present invention, the inventors conducted the following tests:

1. the invention relates to a research on the extraction process of the medicine composition Junkening

By 4 factors, 3 levels per factor are preferred. Weighing 9 parts of flos Impatientis and coriaria sinica (1: 1) in total, and making into oral liquid according to orthogonal table L9 (3)⁴) Orthogonal experiments were performed. Experiments were performed according to the factor levels of table 1, the experimental design of table 2, visual analysis and analysis of variance.

TABLE 1 JUNKENING EXTRACTION TECHNOLOGY FACTOR LEVEL TABLE L9 (3)⁴)

TABLE 2 JUNKENING EXTRACTION TECHNOLOGY ORTHOGONAL TEST DEMANTLET

According to the evaluation of the content determination result index of the 2-methoxy-1, 4-naphthoquinone, the visual analysis shows that the influence sequence of all factors on the extraction efficiency of the 2-methoxy-1, 4-naphthoquinone is A>B>C>D, analysis of variance results show that factor A, B, C has a significant effect on the results. Combining with visual analysis, the optimal process is preferably selected as A₃B₃C₁D₂The extraction solvent is 95% ethanol, and the extraction time is 1h and the material-liquid ratio is 1:10, and the extraction is carried out for 3 times.

TABLE 3 extraction Process conditions of Junkening L9 (3)⁴) Results of orthogonal experiments

3 parts of balsamine and coriaria sinica extractive solution are prepared in parallel according to the extraction method that the extraction solvent is 95% ethanol, the extraction is carried out for 3 times, the material-liquid ratio is 1h every time, and the content of 2-methoxyl-1, 4-naphthoquinone is respectively determined, the verification experiment result shows that the percentage content of the 2-methoxyl-1, 4-naphthoquinone is respectively 1.79, 1.84 and 1.82 which are respectively larger than the orthogonal design test value, and the RSD is 0.18 percent, which shows that the extraction process is stable and feasible.

2. Research on forming process of Junkening cream preparation

The influence of the test results of 4 factors of the dosage of the sodium dodecyl sulfate, the glycerol, the stearyl alcohol and the white vaseline on the preparation forming process is examined through an orthogonal test to determine the optimal process parameters, and the orthogonal test level and the factor design are shown in table 4.

TABLE 4 orthogonal test levels and factor design L9 (3)⁴)

The appearance, the centrifugation, the cold resistance, the heat resistance and the spreadability are evaluation indexes, and the visual analysis shows that the influence sequence of the factors on the appearance, the centrifugation, the cold resistance, the heat resistance and the spreadability is A according to the extremely poor knowledge>D>B>C, combining the total and 5 evaluation items, and preferably selecting the optimal process as A₁B₃C₁D₃The dosage of the factors is 1.0g of stearyl alcohol, 4.0g of white vaseline, 0.05g of sodium dodecyl sulfate and 1.8g of glycerol.

TABLE 5 results and analysis of orthogonal experiments

3. Stability study of Junkening cream preparation

3.1 high temperature test

Randomly taking 10 batches of prepared emulsifiable paste, respectively placing one bottle of the emulsifiable paste in a forced air drying oven at 55 ℃ for 6 hours, taking out the emulsifiable paste, placing the emulsifiable paste to room temperature, and observing whether oil and water are layered or not and demulsifying. As shown in table 6 and fig. 1 and 2.

TABLE 6 stability results of cream high temperature test

3.2 Low temperature test

One bottle of each of the 10 batches of prepared creams was randomly placed in a low-temperature storage tank at-15 ℃ for 24 hours, and oil-free water layering and demulsification were observed. As shown in table 7 and fig. 3 and 4.

TABLE 7 stability results of cream Low temperature test

3.3 centrifugal test

And respectively putting the 10 batches of creams in centrifugal tubes into a centrifuge, centrifuging for 30min at the speed of 2500r/min, and observing whether oil-free water stratification occurs. As shown in table 8 and fig. 5 and 6.

TABLE 8 stability results of the cream centrifuge test

3.4 Long term sample Observation

Sampling 1 bottle of cream in different batches in a glass bottle, placing at room temperature for 4 months, sampling once at the end of 0, 1, 2, 3 and 4 months, and inspecting the appearance and properties of the cream according to the requirement of cream stability inspection. See tables 9-12 and FIGS. 7-11.

TABLE 9 stability test results with sample retention in the first month

TABLE 10 second month sample retention observation stability test results

TABLE 11 stability test results on third month sample

TABLE 12 stability test results on the fourth month sample

In the four test processes of high-temperature test, low-temperature test, centrifugation test and long-term sample retention observation, the result shows that the cream has qualified stability and unchanged appearance color and uniformity. Particularly, after the sample is kept at the high temperature of 55 ℃ for a long time and observed for 4 months, the oil-water stratification does not occur. The stability of the Junkening cream is good.

Fourth, preliminary pharmacodynamic study data

Test results show that the impatiens balsamina and coriaria sinica extracts have certain bacteriostatic action on fungi trichophyton rubrum and candida albicans in different dilution ratio; the Junkening cream preparation has no obvious irritation on the application part of the skin of an experimental guinea pig.

1. Inspecting antibacterial effect of impatiens balsamina and coriaria sinica extract by Pieris canaliculata method

Weighing 10g of each of impatiens balsamina herb powder and coriaria sinica powder, adding 200ml of 95% ethanol, performing reflux extraction for 3 times, each time for 1 hour, combining filtrates obtained in three times, concentrating into thick paste to obtain impatiens balsamina and coriaria sinica extractive solution with the concentration of 1g/ml, and diluting the impatiens balsamina and coriaria sinica extractive solution by 5 times by using 95% ethanol, namely, 1:100, 1:400, 1:700, 1:1000 and 1: 1200, and using a blank control as a 95% ethanol solution for later use. On a sterile operating table, a cotton swab is respectively used for dipping candida albicans and trichophyton rubrum, and the candida albicans and the trichophyton rubrum are inoculated on a PDA culture medium. Culturing Candida albicans in 37 deg.C incubator for 3 days; trichophyton rubrum was cultured in an incubator at 28 ℃ for 5 days to activate it.

Dipping each strain with a cotton swab on a sterile operating platform, uniformly coating the strain on a plate made of nutrient agar, marking the strain and the concentration of a medicament on the plate by using a pen after inoculation is finished, clamping a sterilized small steel tube by using sterile forceps, placing the small steel tube in a corresponding area on the surface of a double-layer plate, standing for 2min, adding 300 mu l of the small steel tube into liquid medicaments with different concentrations by using a pipettor, placing candida albicans in a 37 ℃ constant-temperature incubator, and observing the result of inhibiting fungi of each group after culturing for three days; putting the trichophyton rubrum into a constant-temperature incubator at 28 ℃, observing the result of fungus inhibition of each group of medicines after five days of culture, recording the diameter of an inhibition zone, calculating the mean value of the diameters of the inhibition zones of each group of medicines, and judging the inhibition effect. The results are shown in table 6, fig. 12, and fig. 13.

TABLE 6 bacteriostatic results of the balsamine and coriaria sinica extract by Pieris sinensis

Note: 0 is blank control, and 1, 2, 3, 4 and 5 are extracts of impatiens balsamina and coriaria sinica at different dilution ratio. The diameter of the zone is above 20mm for hypersensitiveness, 15-20mm for hypersensitiveness, 10-14mm for moderate allergy, and below 10mm for hyposensitization. The above samples were assayed in parallel 3 times.

The result of bacteriostatic test by Pieris rapae shows that the extracts of impatiens balsamina and coriaria sinica have good bacteriostatic action on candida albicans and trichophyton rubrum.

2. Skin irritation test of Guinea pig by administering Junkening cream preparation

18 common-grade experimental guinea pigs were selected and purchased from changsha daily biotechnology limited, and the production license numbers of the animals were: SCXK (Xiang) 20114-. The weight is between 180-220g, the male and female parts are respectively, the experimental guinea pig is respectively arranged in 12 mouse cages, each group is divided into two parts, and the male and female parts are separately raised. The same food and water were fed daily. Prior to the experiment, 18 experimental guinea pigs were placed in the animal house in the experiment and fed for 3 days to acclimatize, while the same quality of food and water was given.

The guinea pig was depilated 24h before the experiment, the depilating range was controlled at 2.5cm × 2.5cm, the application area was 2.5cm × 2.5cm, the blank control group was left without intervention, and the depilating area of intact skin group and skin-broken group was dipped with 0.5g of Junkening ointment with a cotton swab and applied evenly in the designated area. Applying Junkening ointment for 4h, washing off residual Junkening ointment with warm water, observing whether there is swelling, edema, pimple, etc. at 1h, 24h, 48h, and 72h after removing Junkening ointment, and comparing the observation results with blank control unhairing area skin to determine whether there is skin irritation.

According to the "methodology of pharmacological experiments on Chinese herbs", erythema, edema, etc. were used as evaluation indexes, and the results are shown in Table 7 and FIG. 14.

TABLE 7 experimental results of skin irritation in guinea pigs administered with Junkening cream

The results of animal experiments of skin administration of the Junkening cream preparation show that the application part has no obvious irritation such as red swelling, erythema, edema and the like compared with a blank control, and the average value of skin irritation is less than 0.25.

Various changes and modifications can be made by those skilled in the art based on the above technical solutions and concepts, and all such changes and modifications should be included in the scope of the present invention.