Toad skin extract, traditional Chinese medicine composition, traditional Chinese medicine gel ointment, preparation method and application

Abstract

The invention provides a toad skin extract, a traditional Chinese medicine composition, a traditional Chinese medicine gel ointment, a preparation method and application, and belongs to the technical field of traditional Chinese medicine extraction and traditional Chinese medicine preparations. The preparation method of the toad skin extract comprises the following steps: mixing dried toad skin with an ethanol solution, performing reflux extraction to obtain a toad skin extracting solution, performing centrifugation to obtain supernate, and performing concentration and drying to obtain the toad skin extract. According to the preparation method, the content of bufalin, cinobufagin, resibufogenin and indole alkaloid extracted from the toad skin is increased, the preparation method is stable and feasible, and the prepared toad skin extract can inhibit bacteria. The traditional Chinese medicine gel ointment is easy to coat, smooth and bright in ointment body, good in skin following performance and uncovering and pasting performance, free of residues in stripping, good in adhesiveness, excellent in overall quality and good in reproducibility, has the effects of diminishing swelling and treating acne, is free of acute toxicity, does not cause the conditions of skin erythema and edema, is free of irritation to skin and is high in safety.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine extraction and traditional Chinese medicine preparation, and in particular relates to a toad skin extract, a traditional Chinese medicine composition, a traditional Chinese medicine gel ointment, and a preparation method and application thereof. Background Art

[0002] Acne is a common skin disease that is prone to recurrence. In recent years, the prevalence of acne has gradually increased, and it has become a major disease that affects people's lives. Acne is common in adolescents whose body perception has not yet been fully established. Acne patients often experience anxiety, depression, anger, weak body perception, loss of self-confidence, and other conditions, which can cause great harm to their physical and mental health. Therefore, acne is a common disease that affects people's daily lives. Finding Chinese medicine that has a good therapeutic effect on acne is also an important issue that Chinese medicine scholars should pay attention to.

[0003] The etiology and pathogenesis of acne involve multiple aspects: (1) Endocrine factors. The fluctuation of hormone levels during adolescence, especially the increase of androgen levels, can promote the proliferation of sebaceous glands and increase sebum secretion, leading to the obstruction of hair follicle opening and the formation of acne. (2) Abnormal keratinization of hair follicles. The abnormal thickening of the stratum corneum at the hair follicle opening leads to the obstruction of sebum excretion at the hair follicle opening and the formation of micro-acne. (3) Propionibacterium acnes. The excessive proliferation of Propionibacterium acnes in the hair follicle sebaceous gland unit causes the decomposition of sebum into free fatty acids and other inflammatory mediators, inducing and aggravating the inflammatory response. (4) Inflammatory response. The local immune response is active and leukocytes infiltrate, leading to inflammatory response and pustule formation around the hair follicles. (5) Other factors. Diet (high-sugar, high-fat foods), lifestyle (staying up late, excessive stress), genetic factors, certain drugs (such as hormone drugs) and improper use of cosmetics may induce or aggravate acne.

[0004] Currently, the western medicines used in clinical treatment of acne include azelaic acid, cimetidine, benzoyl peroxide, adapalene, oral isotretinoin pills and topical retinoic acid drugs. However, some drugs may have drug resistance, side effects (such as liver damage, increased blood lipids, dry and flaky skin, photosensitivity, reproductive damage, etc.), unsatisfactory efficacy and the risk of recurrence after discontinuation of medication. Summary of the invention

[0005] In view of this, the object of the present invention is to provide a toad skin extract, a Chinese medicine composition, a Chinese medicine gel ointment, and a preparation method and application. The toad skin extract and the Chinese medicine composition can effectively inhibit bacteria, and the Chinese medicine composition and the Chinese medicine gel ointment can also achieve the purpose of reducing swelling and treating acne.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The invention provides a method for preparing a toad skin extract, comprising the following steps: mixing dry toad skin with an ethanol solution, refluxing and extracting to obtain a toad skin extract, centrifuging to obtain a supernatant, concentrating and drying to obtain the toad skin extract.

[0008] In the present invention, the dry toad skin is the dried whole skin of Bufo bufo gargarizans Cantor. Before mixing with the ethanol solution, the dry toad skin is further crushed and passed through a 40-80 mesh sieve to obtain a toad skin powder, and then the toad skin powder is mixed with the ethanol solution and refluxed to obtain a toad skin extract. The mass volume ratio of the dry toad skin to the ethanol solution is preferably 1:15-25, more preferably 1:15, 1:20 or 1:25, the volume fraction of the ethanol solution is preferably 70%-90%, more preferably 70%, 80% or 90%; the number of reflux extractions is preferably 1-3 times, such as 1, 2 or 3 times; the time of each reflux extraction is preferably 1.5-2.5h, further 1.5h, 2h or 2.5h. The present invention selects the mass volume ratio of the dry toad skin to the ethanol solution, the number of reflux extractions, the time of reflux extraction and the volume fraction of the ethanol solution to effectively increase the content of indole alkaloids, cinobufogenin, resifobafogenin and bufalin in the extracted toad skin, thereby further exerting the antibacterial function. The present invention has no special restrictions on the methods of centrifugation, concentration and drying, and methods known in the art can be used.

[0009] The invention provides a toad skin extract obtained according to the preparation method.

[0010] The present invention also provides a Chinese medicine composition for inhibiting bacteria, reducing swelling and / or treating acne, comprising the following raw materials:

[0011] 50-70g dried toad skin, 30-40g astragalus, 20-40g frankincense, 20-40g myrrh, 20-40g licorice, 1-2g borneol and 1-2mL peppermint oil.

[0012] In the above-mentioned Chinese medicine composition, the dried toad skin is pungent and cool, enters the heart, lung, spleen, and large intestine meridians, clears away heat and detoxifies, promotes diuresis and relieves swelling, and has the effects of treating carbuncle, swelling, scrofula, tumor, etc. The weight of the dried toad skin is preferably 50, 60, and 70 g. The present invention has no special limitation on the source of the dried toad skin, and any product known in the art or commercially available can be used.

[0013] The astragalus root is sweet and slightly warm, enters the spleen and lung meridians, replenishes qi and strengthens the exterior, promotes diuresis and expel toxins, discharges pus, and heals sores and promotes tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, qi deficiency edema, carbuncle ulcers that are difficult to ulcerate, and long-term ulcers that do not heal. The weight of the astragalus root is preferably 30, 35 and 40g. The present invention has no special restrictions on the source of the astragalus root, and products known in the art or commercially available can be used.

[0014] The frankincense is pungent, bitter, slightly warm, and enters the heart, liver, and spleen meridians, promotes blood circulation, promotes qi circulation, relieves pain, reduces swelling and promotes tissue regeneration, and is used for tendon spasm, traumatic injury, carbuncle, ulcer, etc. The weight of the frankincense is preferably 20, 30, and 40 g. The source of the frankincense is not particularly limited in the present invention, and products known in the art or commercially available can be used.

[0015] The myrrh tastes pungent, bitter and flat, and enters the heart, liver and spleen meridians, dissipates blood stasis and relieves pain, reduces swelling and promotes tissue regeneration, and is used for abdominal pain caused by abdominal masses, rheumatic pain, traumatic injuries, carbuncle swelling and ulcers, etc. The weight of the myrrh is preferably 20, 30 and 40 g. The present invention has no special limitation on the source of the myrrh, and any product known in the art or commercially available can be used.

[0016] The licorice is sweet and flat, and enters the heart, lung, spleen, and stomach meridians, tonifies the spleen and replenishes qi, clears away heat and detoxifies, relieves pain, and harmonizes various medicines. It is used for spleen and stomach weakness, carbuncle, sore, and relieves drug toxicity. The weight of the licorice is preferably 20, 30, and 40 g. The present invention has no particular limitation on the source of the licorice, and any product known in the art or commercially available can be used.

[0017] The borneol is pungent, bitter and cool, and enters the heart, spleen and lung meridians, and can invigorate the mind, clear away heat and relieve pain, and is used for fever, coma, convulsions, red eyes, mouth sores, sore throat, etc. The weight of the borneol is preferably 1g, 1.5g and 2g. The present invention has no special limitation on the source of borneol, and any product known in the art or commercially available can be used.

[0018] The peppermint oil is pungent and cool, enters the lung and liver meridians, dispels wind and clears heat, and is used for exogenous wind-heat, headache, red eyes, sore throat, toothache, and itchy skin. The dosage of the peppermint oil is preferably 1 mL, 1.5 mL, and 2 mL. The present invention has no particular limitation on the source of the peppermint oil, and any product known in the art or commercially available can be used.

[0019] In the present invention, the Chinese medicine composition uses dried toad skin as the main drug, which has an antibacterial effect, astragalus as the assistant drug, frankincense, myrrh and licorice as adjuvants, and borneol and peppermint oil as guiding drugs. The drugs are used together to achieve the effects of antibacterial, swelling reduction and sore astringency.

[0020] The present invention provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0021] (1) preparing a toad skin extract from the dried toad skin according to the above-mentioned method for preparing the toad skin extract;

[0022] (2) mixing the astragalus, frankincense, myrrh, and liquorice with water, decocting, filtering and collecting the supernatant to obtain a mixed extract, and concentrating to obtain a mixed concentrate;

[0023] (3) mixing and dissolving the borneol and peppermint oil, adding the mixed concentrate, and sterilizing to obtain a composite medicinal material extract;

[0024] (4) Mixing the compound medicinal material extract with the toad skin extract to obtain a Chinese medicine composition.

[0025] In the preparation method of the above-mentioned traditional Chinese medicine composition, the dry toad skin is prepared into a toad skin extract according to the preparation method of the toad skin extract, which will not be repeated here. The astragalus, frankincense, myrrh, and licorice are mixed with water, decocted, filtered and the supernatant is taken to obtain a mixed extract, concentrated, and a mixed concentrate is obtained. The mass volume ratio of the total mass of the astragalus, frankincense, myrrh, and licorice to water is preferably 1:15-25, and more preferably 1:20; the number of decoctions is preferably 1-3 times, and more preferably 1, 2 or 3 times, and the decoction time is preferably 2-3h, such as 2.5h. The present invention does not specifically limit the concentration method, and a method known in the art can be used. The borneol and peppermint oil are mixed and dissolved, added to the mixed concentrate, sterilized, and a composite medicinal material extract is obtained. The sterilization can be carried out by high temperature sterilization at 120°C for 30min.

[0026] The present invention also provides an application of the toad skin extract, the Chinese medicine composition or the Chinese medicine composition prepared by the preparation method in the preparation of antibacterial drugs.

[0027] The toad skin extract and the traditional Chinese medicine composition of the present invention can effectively inhibit bacteria, and the antibacterial activity of the traditional Chinese medicine composition is better than that of the toad skin extract. The bacteria include one or more of Staphylococcus aureus, Propionibacterium acnes, Staphylococcus epidermidis and Escherichia coli. The specific strains of the bacteria include one or more of Staphylococcus aureus (Staphylococcus aureus CICC10384), Propionibacterium acnes (Propionibacterium acnes ATCC6919), Staphylococcus epidermidis (Staphylococcus epidermidis CICC 10398) and Escherichia coli (Escherichia coli CMCC44829).

[0028] The present invention also provides a Chinese medicine gel paste, comprising auxiliary materials and a Chinese medicine composition, wherein the Chinese medicine composition is the Chinese medicine composition or the Chinese medicine composition prepared by the preparation method;

[0029] The mass volume ratio of the auxiliary material to the traditional Chinese medicine composition is 15-25:6;

[0030] The auxiliary materials include the following ingredients: 0.8-1.2 g of aluminum glycolate, 2-6 g of kaolin, 50-90 g of glycerol, 950-1050 μL of azone, and 8-12 g of sodium polyacrylate.

[0031] In the present invention, the mass volume ratio of the auxiliary material to the Chinese medicine composition is preferably 18 to 23:6, further 20:6. The aluminum glycolate is preferably 0.8, 1 or 1.2 g, the kaolin is preferably 2, 4 and 6 g, the glycerol is preferably 50, 70 or 90 g, and the sodium polyacrylate is preferably 8, 10 or 12 g. The present invention makes the Chinese medicine gel ointment easy to apply, smooth to peel off, smooth and bright, good skin followability and peeling, no residue, good adhesion, excellent overall quality and good reproducibility through the selection of the dosage of sodium polyacrylate, aluminum glycolate, kaolin and glycerol.

[0032] The present invention also provides a method for preparing the above-mentioned Chinese medicine gel ointment, comprising the following steps:

[0033] Dispersing the sodium polyacrylate, kaolin and aluminum glycolate in the glycerol and mixing them evenly to obtain a glycerol phase;

[0034] Adding the azone to water to obtain an aqueous phase;

[0035] The aqueous phase is added to the glycerin phase, mixed evenly, and the traditional Chinese medicine composition is added, mixed evenly, to obtain a traditional Chinese medicine gel ointment.

[0036] The present invention provides use of the above-mentioned Chinese medicine composition, the Chinese medicine composition prepared by the preparation method, the Chinese medicine gel ointment or the Chinese medicine gel ointment obtained by the preparation method in preparing drugs for reducing swelling and / or treating acne.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] The present invention provides a toad skin extract, a Chinese medicine composition, a Chinese medicine gel ointment, and a preparation method and application thereof. The present invention effectively increases the content of bufalin, cinobufogenin, resifobafugin and indole alkaloids extracted from toad skin by selecting the concentration of ethanol solution, the solid-liquid ratio, the extraction time and the number of extractions, and the content of bufalin, cinobufogenin, resifobafugin and indole alkaloids are 0.1622 mg·g -1 , 0.2365mg·g -1 , 0.2977mg·g -1 and 5.18 mg·g -1 The average comprehensive score was 93.24 points, and the RSD value was 0.46%, indicating that the preparation method of the toad skin extract was stable and feasible, and the effective component extraction was relatively complete. In addition, the antibacterial test confirmed that the toad skin extract and the traditional Chinese medicine composition had antibacterial effects on Staphylococcus aureus, Propionibacterium acnes, Staphylococcus epidermidis and Escherichia coli.

[0039] The Chinese medicine gel paste of the present invention is easy to apply, has smooth film peeling, smooth and bright paste, good skin followability and peeling property, no residue after peeling, good adhesion, excellent overall quality and good reproducibility by selecting the dosage of sodium polyacrylate, aluminum glycolate, kaolin and glycerol. The Chinese medicine gel paste has the effects of reducing swelling and treating acne, has no acute toxicity, will not cause skin erythema and edema, has no irritation to the skin, and has high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 The results show the effects of solid-liquid ratio, ethanol solution concentration, reflux time and reflux times on the extraction efficiency of indole alkaloids, cinobufogenin, resifobafugin and bufalin from toad skin.

[0041] Figure 2 The results show the effects of the dosage of sodium polyacrylate, aluminum glycolate, kaolin and glycerol on the performance of the matrix of traditional Chinese medicine gel ointment.

[0042] Figure 3 The properties diagram of the Chinese medicine gel plaster prepared for the Chinese medicine gel plaster of Example 23;

[0043] Figure 4 The paw swelling of rats injected with carrageenan at different time periods after treatment for different groups;

[0044] Figure 5 The inhibition rate of paw swelling in rats injected with carrageenan at different time periods after treatment with different groups;

[0045] Figure 6 The pictures show the swelling results of the paws of rats injected with carrageenan 1.5 hours after modeling after treatment in different groups.

[0046] Figure 7 These are the stained sections of rat foot tissues from different groups;

[0047] Figure 8 The therapeutic effects of different groups on rat auricular acne;

[0048] Fig. 9 The staining sections of rat auricle acne in different groups are shown;

[0049] Fig.10 The therapeutic effects of different groups on rat back acne;

[0050] Fig.11 The stained sections of acne on the back of rats in different groups;

[0051] Fig.12 These are pictures of acute dermal toxicity tests on intact skin rats in different groups;

[0052] Fig.13 These are pictures of acute dermal toxicity test on rats with damaged skin in different groups;

[0053] Fig.14 The results of single-dose irritation experiments for different groups are shown;

[0054] Fig.15 These are the results of multiple-dose irritation experiments in different groups. DETAILED DESCRIPTION

[0055] In the present invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0056] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0057] In the following examples, the dried toad skin was purchased from Shandong Rizhao Kangyu Chinese Medicinal Materials Co., Ltd., and was the dried whole skin of the Chinese giant toad Bufo bufo gargarizans Cantor.

[0058] The SD rats, half male and half female, weighing 180-220 g, were purchased from Jinan Pengyue Experimental Animal Breeding Co., Ltd. They were kept in an environment of 22±2°C, 55±15% relative humidity and 12h light / dark cycle, with free access to water and food. The animal license number is SCXK(Lu)20220006, and the ethics number is SDUTCM20230627001.

[0059] Example 1

[0060] A method for preparing a toad skin extract comprises the following steps:

[0061] The dried toad skin was cut into pieces and crushed with a grinder. The powder was passed through a 60-mesh sieve to obtain toad skin powder. 2 g of toad skin powder was weighed and added with 40 mL of 70% ethanol solution. The mixture was heated under reflux and extracted once for 2 h each time to obtain toad skin extract. The mixture was stirred at 4000 r·min －1 The toad skin extract was centrifuged for 15 minutes, and the supernatant was taken to obtain a toad skin extract solution. The toad skin extract solution was concentrated and freeze-dried to obtain a dry powder, which was the toad skin extract.

[0062] Example 2

[0063] The difference between this embodiment and embodiment 1 is that this embodiment uses 80% ethanol solution by volume, and the remaining steps are the same as those in embodiment 1.

[0064] Example 3

[0065] The difference between this embodiment and embodiment 1 is that this embodiment uses 90% ethanol solution by volume, and the remaining steps are the same as those in embodiment 1.

[0066] Example 4

[0067] The difference between this embodiment and embodiment 1 is that the solid-liquid ratio of the toad skin powder to the 70% ethanol solution by volume in this embodiment is 1:15, that is, 30 mL of 70% ethanol solution by volume is added in this embodiment, and the remaining steps are the same as those in embodiment 1.

[0068] Example 5

[0069] The difference between this embodiment and embodiment 1 is that the solid-liquid ratio of the toad skin powder in this embodiment to the 70% ethanol solution by volume is 1:25, that is, 50 mL of 70% ethanol solution by volume is added in this embodiment, and the remaining steps are the same as those in embodiment 1.

[0070] Example 6

[0071] The difference between this embodiment and embodiment 1 is that the extraction in this embodiment is carried out for 1.5 hours each time, and the other steps are the same as those in embodiment 1.

[0072] Example 7

[0073] The difference between this embodiment and embodiment 1 is that the extraction in this embodiment is carried out for 2.5 hours each time, and the other steps are the same as those in embodiment 1.

[0074] Example 8

[0075] The difference between this embodiment and embodiment 1 is that in this embodiment, the heating reflux extraction is performed twice. For the first time, 40 mL of 70% ethanol solution is added and the extraction is performed under heating reflux for 2 h to obtain the first toad skin extract. －1 The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 40 mL of 70% ethanol solution was added for the second time, and the mixture was heated under reflux for 2 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the second supernatant was taken, the first supernatant and the second supernatant were combined to obtain a toad skin extract solution, and the remaining steps were the same as in Example 1.

[0076] Example 9

[0077] The difference between this embodiment and embodiment 1 is that in this embodiment, the heating reflux extraction is performed 3 times. For the first time, 40 mL of 70% ethanol solution is added and the extraction is performed under heating reflux for 2 h to obtain the first toad skin extract. －1The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 40 mL of 70% ethanol solution was added for the second time, and the mixture was heated under reflux for 2 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 min, and the second supernatant was taken; 40 mL of 70% ethanol solution was added for the third time, and the mixture was heated under reflux for 2 h to obtain the third toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the third supernatant was taken, and the first supernatant, the second supernatant and the third supernatant were combined to obtain a toad skin extract solution. The remaining steps were the same as in Example 1.

[0078] Example 10

[0079] A method for preparing a toad skin extract comprises the following steps:

[0080] The dried toad skin was cut into pieces and crushed with a grinder. The powder was passed through a 60-mesh sieve to obtain toad skin powder. 2 g of toad skin powder was weighed and added with 40 mL of 80% ethanol solution by volume. The mixture was heated under reflux and extracted twice. The first time, 40 mL of 80% ethanol solution by volume was added and the mixture was heated under reflux and extracted for 2.5 h to obtain the first toad skin extract. The mixture was heated under reflux and extracted at 4000 r·min －1 The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 40 mL of 80% ethanol solution was added for the second time, and the mixture was heated under reflux for 2.5 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the second supernatant was taken, and the first supernatant and the second supernatant were combined to obtain a toad skin extract solution. The toad skin extract solution was concentrated and freeze-dried to obtain a dry powder, which was the toad skin extract.

[0081] Comparative Example 1

[0082] The difference between this comparative example and Example 1 is that this comparative example uses 50% ethanol solution by volume, and the remaining steps are the same as those in Example 1.

[0083] Comparative Example 2

[0084] The difference between this comparative example and Example 1 is that this comparative example uses 60% ethanol solution by volume, and the remaining steps are the same as those in Example 1.

[0085] Comparative Example 3

[0086] The difference between this comparative example and Example 1 is that the solid-liquid ratio of the toad skin powder to the 70% ethanol solution by volume in this comparative example is 1:8, that is, 16 mL of 70% ethanol solution by volume is added in this comparative example, and the remaining steps are the same as in Example 1.

[0087] Comparative Example 4

[0088] The difference between this comparative example and Example 1 is that the solid-liquid ratio of the toad skin powder to the 70% ethanol solution by volume in this comparative example is 1:10, that is, 20 mL of 70% ethanol solution by volume is added in this comparative example, and the remaining steps are the same as in Example 1.

[0089] Comparative Example 5

[0090] The difference between this comparative example and Example 1 is that the extraction in this comparative example is 0.5 h each time, and the other steps are the same as those in Example 1.

[0091] Comparative Example 6

[0092] The difference between this comparative example and Example 1 is that the extraction in this comparative example is for 1 hour each time, and the other steps are the same as those in Example 1.

[0093] Comparative Example 7

[0094] The difference between this comparative example and Example 1 is that in this comparative example, the heating reflux extraction is performed 4 times. For the first time, 40 mL of 70% ethanol solution is added and the extraction is performed under heating reflux for 2 h to obtain the first toad skin extract. The first toad skin extract is obtained by heating at 4000 r·min －1 The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 40 mL of 70% ethanol solution was added for the second time, and the mixture was heated under reflux for 2 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 min, and the second supernatant was taken; 40 mL of 70% ethanol solution was added for the third time, and the mixture was heated under reflux for 2 h to obtain the third toad skin extract. －1 The toad skin extract was centrifuged for 15 min, and the third supernatant was taken; 40 mL of 70% ethanol solution was added for the fourth time, and the mixture was heated under reflux for 2 h to obtain the fourth toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the fourth supernatant was taken, and the first supernatant, the second supernatant, the third supernatant and the fourth supernatant were combined to obtain a toad skin extract solution. The remaining steps were the same as in Example 1.

[0095] Test Example 1

[0096] (1) Effects of solid-liquid ratio, ethanol solution concentration, reflux time and reflux times on the extraction efficiency of indole alkaloids, cinobufogenin, resifolinin and bufalin from toad skin

[0097] The contents of toad venom lactone components (i.e., cinobucoid toxin base, resibufogenin and bufalin) and the indole alkaloids in the toad skin extract solutions prepared in Examples 1 to 9 and Comparative Examples 1 to 7 were determined, and the effects of the solid-liquid ratio, ethanol solution concentration, reflux time and reflux times on the extraction efficiency of indole alkaloids, cinobucoid toxin base, resibufogenin and bufalin in toad skin were studied by comprehensive scoring.

[0098] Among them, the content determination method of toad venom lactone components:

[0099] Chromatographic conditions: Agilent InfinityLab Poroshell 120EC-C 18 (150 mm × 3 mm, 2.7 μm) chromatographic column; mobile phase A was 0.1% phosphoric acid water, mobile phase B was acetonitrile, gradient elution (0-5 min, 80% → 75% A; 5-20 min, 75% → 71% A; 20-30 min, 71% → 65% A; 30-50 min, 65% → 60% A), column temperature 30 ° C, detection wavelength 296 nm, flow rate 0.5 mL min －1 , injection volume 5μL, automatic injection.

[0100] Preparation of reference solution: Accurately weigh appropriate amounts of cinobucoid venom base, resibufogenin, and bufalin reference substances, and dissolve them in anhydrous ethanol to a concentration of 1 mg mL －1 , shake well.

[0101] Determination of indole alkaloids:

[0102] Preparation of reference solution: Accurately weigh an appropriate amount of 5-HT reference and dissolve it in anhydrous ethanol to a concentration of 1 mg mL －1 , shake well.

[0103] Determination of indole alkaloids:

[0104] With 5-hydroxytryptamine as the reference substance, the content was determined by ultraviolet spectrophotometry. The determination method was based on Li Wei, Wang Yuanqing, Yan Jianye, et al. Uniform design optimization of water extraction process of indole alkaloids in dried toad [J]. Modern Distance Education of Chinese Traditional Medicine, 2014, 12(4): 144-146. Accurately measure 0.5 mL of sample solution, put it in a 5 mL volumetric flask, add 1 mL of 15% p-dimethylaminobenzaldehyde solution, dilute the extraction solvent to the scale line, shake well, and obtain.

[0105] The calculation method of the comprehensive score is as follows:

[0106] In this example, indole alkaloids, cinobucini, resifugin, and bufalin are used as index components, and the weights of various index components are determined according to the analytic hierarchy process. In the 2020 edition of the Chinese Pharmacopoeia, cinobucoid venom toxin base, resintoxin genin, and bufalin are used as the content determination components of toad venom medicinal materials. The content of cinobucoid venom toxin base in toad skin is higher than that of resintoxin genin and bufalin in toad skin. Therefore, cinobucoid venom toxin base and indole alkaloids are ranked first, resintoxin genin is ranked second, and bufalin is ranked third. The judgment priority matrix for pairwise comparison is constructed, as shown in Table 1. The weight coefficients of indole alkaloids, cinobucoid venom toxin base, resintoxin genin, and bufalin are 0.3507, 0.3507, 0.1892, and 0.1093, respectively. The consistency test of each weight coefficient obtained shows that the consistency index CI = 0.0034≠0, and the random consistency ratio CR = CI / RI = 0.0037 < 0.1 (RI, CR, and CI are the average random consistency index, random consistency ratio, and consistency index, respectively), indicating that the judgment matrix has good consistency and the weight coefficients are reasonable and effective. Comprehensive score Y = (0.3507 × indole alkaloid content / maximum indole alkaloid content + 0.3507 × cinobucini content / maximum cinobucini content + 0.1892 × resibufogenin content / maximum resibufogenin content + 0.1093 × bufalin content / maximum bufalin content) × 100. Among them, the indole alkaloid content, cinobucini content, resibufogenin content and bufalin content in the comprehensive score Y formula are all average contents.

[0107] Table 1 Comparison and judgment priority matrix of index components in toad skin extract

[0108] Indicator ingredients Total alkaloids Cinotophaga Resifugin Bufalin Weight coefficient Indole alkaloids 1 1 2 3 0.3507 Cinotophaga 1 1 2 3 0.3507 Resifugin 1 / 2 1 / 2 1 2 0.1892 Bufalin 1 / 3 1 / 3 1 / 2 1 0.1093

[0109] Figure 1 The results show that, in terms of ethanol solution concentration, compared with comparative examples 1 to 2, the comprehensive scores of Examples 1 to 3 are high, that is, the extraction efficiency of indole alkaloids, cinobucoid venom toxin base, resibufogenin, and bufalin in the toad skin extract solutions of Examples 1 to 3 is high. In terms of solid-liquid ratio, compared with comparative examples 3 to 4, the comprehensive scores of Examples 1, 4 and 5 are high, that is, the extraction efficiency of indole alkaloids, cinobucoid venom toxin base, resibufogenin, and bufalin in the toad skin extract solutions of Examples 1, 4 and 5 is high. In terms of reflux time, compared with comparative examples 5 to 6, the comprehensive scores of Examples 1, 6 and 7 are high, that is, the extraction efficiency of indole alkaloids, cinobucoid venom toxin base, resibufogenin, and bufalin in the toad skin extract solutions of Examples 1, 6 and 7 is high. In terms of the number of reflux times, compared with Comparative Example 7, Examples 1, 8 and 9 have higher comprehensive scores, that is, the extraction efficiency of indole alkaloids, cinobufogenin, resifolin and bufalotoxin in the toad skin extract solutions of Examples 1, 8 and 9 is high.

[0110] (2) Orthogonal test

[0111] Based on the results of part “(1)”, the concentration of ethanol solution (A), solid-liquid ratio (B), reflux time (C), and reflux times (D) were selected as influencing factors, and L9 (3 4 ) orthogonal table was used to conduct toad skin extraction optimization experiment, and a 4-factor 3-level orthogonal experiment of toad skin extraction process was designed, as shown in Table 2. The contents of toad venom lactone components (i.e., cinobucini, resifobacillus and bufalotoxin) and indole alkaloids in the toad skin extract solutions prepared in each experiment were determined by “(1)”, and the comprehensive scores were calculated. The results are shown in Table 3, and the variance analysis results are shown in Table 4.

[0112] Table 2 Orthogonal test of toad skin extraction process

[0113] Factor Levels Ethanol solution concentration (A) Material-liquid ratio (B) Reflow time (C) Reflow times (D) 1 70％ 1:15g / mL 1.5h 1 time 2 80％ 1:20g / mL 2h 2 times 3 90％ 1:25g / mL 2.5h 3 times

[0114] Table 3 Results of orthogonal experiment of toad skin extraction process

[0115]

[0116] Table 4 Analysis results of comprehensive scoring method for toad skin extraction process

[0117] Sources of variance Type III Sum of Squares <![CDATA[d f ]]> variance F-number P-value Significance A 803.20 2 401.60 20.33 0.047 * B 39.54 2 19.77 1.07 0.889 C 280.91 2 140.45 7.11 0.123 D 369.97 2 184.98 9.365 0.096 error 39.51 2 19.75

[0118] The results in Table 3 show that the four factors have an influence on the extraction efficiency of the toad skin index components in the order of solid-liquid ratio (B) < reflux time (C) < reflux times (D) < ethanol concentration (A). The optimal extraction process of toad skin is A2B3C3D3, that is, adding 80% ethanol solution by volume, the solid-liquid ratio of toad skin powder to 80% ethanol solution by volume is 1:25g / mL, heating reflux extraction 3 times, each reflux extraction 2.5h. The results in Table 4 show that factor A has a significant effect on the results of the toad skin extraction process (P < 0.05), while factors C and D have no significant effect (P > 0.05). The effects of B2 and B3, D2 and D3 on the toad skin extraction efficiency are not much different. Combined with the comprehensive score of toad skin extraction and actual factors, the optimal process is adjusted to add 80% ethanol solution by volume, the solid-liquid ratio of toad skin powder to 80% ethanol solution by volume is 1:20 g / mL, and heating reflux extraction is performed twice, each reflux extraction is 2.5 hours, that is, the preparation method of the toad skin extract of Example 10.

[0119] Based on the optimal extraction process of toad skin, i.e., the preparation method of toad skin extract of Example 10, three verification tests were conducted, and the content of toad venom lactone components (i.e., cinobucini, resifobacillus and bufalotoxin) and the content of indole alkaloids in the toad skin extract solution prepared in Example 10 were determined using part "(1)", and the comprehensive score was calculated. The verification test results are shown in Table 5.

[0120] Table 5 Verification test results

[0121]

[0122] The results in Table 5 show that the average comprehensive score of the toad skin index components is Y=93.24, and the RSD is 0.46%<3%. The extraction was performed 10 times under the preparation method of Example 10 and repeated 3 times. The results show that the average contents of bufalin, cinobufogenin, resifugine and indole alkaloids are 0.1622 mg·g -1 , 0.2365mg·g -1 , 0.2977mg·g -1 and 5.18 mg·g -1 , RSD were 0.69%, 0.33%, 0.99% and 1.8%, respectively, indicating that the preparation method has good repeatability and stability.

[0123] Embodiment 11

[0124] A Chinese medicinal composition for inhibiting bacteria, reducing swelling and / or treating acne, comprising the following raw materials in amounts by weight:

[0125] 50g dried toad skin, 30g astragalus, 20g frankincense, 20g myrrh, 20g liquorice, 1g borneol and 1mL peppermint oil;

[0126] The preparation method of the Chinese medicine composition comprises the following steps:

[0127] (1) After the dried toad skin is cut into pieces, it is crushed by a grinder, and the powder is passed through a 60-mesh sieve to obtain toad skin powder. 50 g of the toad skin powder is weighed, and 1000 mL of 80% ethanol solution is added, and the mixture is heated under reflux for extraction twice. For the first time, 1000 mL of 80% ethanol solution is added, and the mixture is heated under reflux for extraction for 2.5 h to obtain the first toad skin extract, which is then heated under reflux for extraction at 4000 r / min. －1 The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 1000 mL of 80% ethanol solution was added for the second time, and the mixture was heated under reflux for 2.5 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the second supernatant was taken, and the first supernatant and the second supernatant were combined to obtain a toad skin extract solution. The toad skin extract solution was concentrated and freeze-dried to obtain a dry powder, which was the toad skin extract.

[0128] (2) Add 1800 mL of distilled water to 30 g of Astragalus, 20 g of Frankincense, 20 g of Myrrh, and 20 g of Licorice, and decoct twice. For the first time, add 1800 mL of distilled water, decoct and extract for 2.5 h to obtain a first extract, filter and take supernatant 1, add 1800 mL of distilled water for the second time, decoct and extract for 2.5 h to obtain a second extract, filter and take supernatant 2, combine supernatant 1 and supernatant 2 to obtain a mixed extract, and concentrate under reduced pressure to a crude drug amount of 8 g / mL to obtain a mixed concentrate;

[0129] (3) Add 1 g of borneol to 1 mL of peppermint oil and grind to dissolve, add the mixed concentrate, and sterilize at 120° C. to obtain a composite medicinal material extract. The composite medicinal material extract is mixed with the toad skin extract to obtain a traditional Chinese medicine composition (referred to as traditional Chinese medicine compound extract A), which is stored in a 4° C. refrigerator for later use.

[0130] Example 12

[0131] A Chinese medicinal composition for inhibiting bacteria, reducing swelling and / or treating acne, comprising the following raw materials in amounts by weight:

[0132] 60g dried toad skin, 35g astragalus, 30g frankincense, 30g myrrh, 30g liquorice, 1.5g borneol and 1.5mL peppermint oil;

[0133] The preparation method of the Chinese medicine composition comprises the following steps:

[0134] (1) After the dried toad skin is cut into pieces, it is crushed by a grinder, and the powder is passed through a 60-mesh sieve to obtain toad skin powder. 60 g of toad skin powder is weighed, 1200 mL of 80% ethanol solution is added, and the mixture is heated under reflux for extraction twice. For the first time, 1200 mL of 80% ethanol solution is added, and the mixture is heated under reflux for extraction for 2.5 h to obtain the first toad skin extract. The mixture is heated under reflux for extraction at 4000 r / min. －1 The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 1200 mL of 80% ethanol solution was added for the second time, and the mixture was heated under reflux for 2.5 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the second supernatant was taken, and the first supernatant and the second supernatant were combined to obtain a toad skin extract solution. The toad skin extract solution was concentrated and freeze-dried to obtain a dry powder, which was the toad skin extract.

[0135] (2) Add 2500 mL of distilled water to 35 g of Astragalus, 30 g of Frankincense, 30 g of Myrrh, and 30 g of Licorice, and decoct twice. For the first time, add 2500 mL of distilled water, decoct and extract for 2.5 h to obtain a first extract, filter and take supernatant 1, add 2500 mL of distilled water for the second time, decoct and extract for 2.5 h to obtain a second extract, filter and take supernatant 2, combine supernatant 1 and supernatant 2 to obtain a mixed extract, and concentrate under reduced pressure to a crude drug amount of 9 g / mL to obtain a mixed concentrate;

[0136] (3) 1.5 g of borneol was added to 1.5 mL of peppermint oil and ground to dissolve, and the mixed concentrate was added, and then sterilized at 120° C. to obtain a composite medicinal material extract, which was mixed with the toad skin extract to obtain a traditional Chinese medicine composition (referred to as traditional Chinese medicine compound extract B), which was stored in a 4° C. refrigerator for later use.

[0137] Embodiment 13

[0138] A Chinese medicinal composition for inhibiting bacteria, reducing swelling and / or treating acne, comprising the following raw materials in amounts by weight:

[0139] 70g dried toad skin, 40g astragalus, 40g frankincense, 40g myrrh, 40g liquorice, 2g borneol and 2mL peppermint oil;

[0140] The preparation method of the Chinese medicine composition comprises the following steps:

[0141] (1) After the dried toad skin is cut into pieces, it is crushed by a grinder, and the powder is passed through a 60-mesh sieve to obtain toad skin powder. 70 g of the toad skin powder is weighed, and 1400 mL of 80% ethanol solution is added, and the mixture is heated under reflux for extraction twice. For the first time, 1400 mL of 80% ethanol solution is added, and the mixture is heated under reflux for extraction for 2.5 h to obtain the first toad skin extract, which is then heated under reflux for extraction at 4000 r / min. －1 The toad skin extract was centrifuged for 15 min, and the first supernatant was taken; 1400 mL of 80% ethanol solution was added for the second time, and the mixture was heated under reflux for 2.5 h to obtain the second toad skin extract. －1 The toad skin extract was centrifuged for 15 minutes, the second supernatant was taken, and the first supernatant and the second supernatant were combined to obtain a toad skin extract solution. The toad skin extract solution was concentrated and freeze-dried to obtain a dry powder, which was the toad skin extract.

[0142] (2) Add 3200 mL of distilled water to 40 g of Astragalus, 40 g of Frankincense, 40 g of Myrrh, and 40 g of Licorice, and decoct twice. For the first time, add 3200 mL of distilled water, decoct and extract for 2.5 h to obtain a first extract, filter and take supernatant 1, add 3200 mL of distilled water for the second time, decoct and extract for 2.5 h to obtain a second extract, filter and take supernatant 2, combine supernatant 1 and supernatant 2 to obtain a mixed extract, and concentrate under reduced pressure to a crude drug amount of 10 g / mL to obtain a mixed concentrate;

[0143] (3) Add 2 g of borneol to 2 mL of peppermint oil and grind to dissolve, add the mixed concentrate, and then sterilize at 120° C. for 30 min to obtain a composite medicinal material extract. The composite medicinal material extract is mixed with the toad skin extract to obtain a traditional Chinese medicine composition (referred to as traditional Chinese medicine compound extract C), which is stored in a 4° C. refrigerator for later use.

[0144] Test Example 2

[0145] Antibacterial test

[0146] The minimum inhibitory concentration (MIC) of toad skin and the Chinese medicine compound extract B prepared in Example 12 was detected by two-fold dilution method. First, the toad skin extract prepared in Example 10 was dissolved in distilled water to obtain a toad skin extract with a crude drug amount of 4000 mg / mL, and the crude drug amount of toad skin in the Chinese medicine compound extract B was 2000 mg / mL.

[0147] Pick a loop of Staphylococcus aureus CICC10384, Propionibacterium acnes ATCC6919, Staphylococcus epidermidis CICC 10398, and Escherichia coli CMCC44829 stored at -80°C, activate them on solid culture medium, and culture them at 37°C overnight. Pick a loop of bacteria on solid culture medium, activate them once in different shaking tubes containing different liquid culture media (LB medium and FT medium), and culture them at 37°C in a shaking incubator. Take 500 μL of the activated bacterial solution and place it in a conical flask containing 50 mL of different liquid culture media for a second activation, and culture them at 37°C in a shaking incubator. When the bacterial solution OD 600nm When the range is 0.6-0.8, the strain is preserved for future use.

[0148] A 96-well microplate was used. 100 μL of culture medium and 100 μL of Chinese herbal compound extract B were added to the first well, and two-fold dilution was performed in sequence. The dilution concentrations of toad skin extract were 2000, 1000, 500, 250, 125, 62.50, 31.25, 15.63, 7.82, and 3.91 mg / mL, respectively, and the dilution concentrations of Chinese herbal compound extract B were 1000, 500, 250, 125, 62.5, 31.25, 15.63, 7.82, 3.91, and 1.96 mg / mL, respectively. The 11th well was a negative control without any drug treatment, and each group was repeated 3 times. The culture plate was incubated at 37°C for 24 hours. Add 20 μL of TTC dye and observe the results. If the liquid in wells 1 to 10 does not change color when the negative control well turns red, the concentration of the toad skin extract or the Chinese medicine compound extract B in the well is the MIC of the drug against the bacteria. The results are shown in Table 6.

[0149] Table 6 Minimum inhibitory concentration of different drugs (mg / mL)

[0150] drug Propionibacterium acnes Staphylococcus aureus Staphylococcus epidermidis Escherichia coli Toad Skin Extract 500 500 250 125 Chinese herbal compound extract B 250 250 125 125

[0151] The results in Table 6 show that the toad skin extract and the Chinese medicine compound extract B prepared by the present invention can effectively inhibit Propionibacterium acnes, Staphylococcus aureus, Staphylococcus epidermidis and Escherichia coli, and the antibacterial ability of the Chinese medicine compound extract B is stronger than that of the toad skin extract.

[0152] Embodiment 14

[0153] A Chinese medicine gel ointment is composed of the following raw materials: 200g of auxiliary materials and 60mL of the Chinese medicine compound extract B prepared in Example 12; the auxiliary materials are 1g of aluminum glycolate (i.e., accounting for 0.5% of the auxiliary materials), 4g of kaolin (i.e., accounting for 2% of the auxiliary materials), 70g of glycerol (i.e., accounting for 35% of the auxiliary materials), 1000μL of azone, and 8g of sodium polyacrylate (i.e., accounting for 4% of the auxiliary materials), and the amount is supplemented to 200g with water.

[0154] The preparation method of the traditional Chinese medicine gel ointment comprises the following steps:

[0155] (1) Weigh the sodium polyacrylate, kaolin, and aluminum glycolate mentioned above respectively, disperse them in the glycerol mentioned above, and stir them evenly at 60° C. to form the glycerol phase;

[0156] (2) taking the above-mentioned azone and adding it into the above-mentioned water as the aqueous phase;

[0157] (3) Add the aqueous phase to the glycerin phase and stir thoroughly. After the mixture is evenly mixed, add the Chinese herbal compound extract B, stir evenly, and place in an oven at 37° C. for 24 hours.

[0158] Embodiment 15

[0159] The difference between this embodiment and Example 14 is that the amount of sodium polyacrylate used in the raw material composition and preparation method of the traditional Chinese medicine gel ointment in this embodiment is 10 g (i.e., 5% of the excipients), and the rest of the raw material composition and preparation method of the traditional Chinese medicine gel ointment are the same as those in Example 14.

[0160] Example 16

[0161] The difference between this embodiment and Example 14 is that the amount of sodium polyacrylate used in the raw material composition and preparation method of the traditional Chinese medicine gel ointment in this embodiment is 12g (i.e., 6% of the auxiliary materials), and the rest of the raw material composition and preparation method of the traditional Chinese medicine gel ointment are the same as those in Example 14.

[0162] Embodiment 17

[0163] The difference between this embodiment and Embodiment 14 is that the amount of aluminum glycolate used in the raw material composition and preparation method of the traditional Chinese medicine gel ointment in this embodiment is 0.8 g (i.e., 0.4% of the auxiliary materials), and the rest of the raw material composition and preparation method of the traditional Chinese medicine gel ointment are the same as those in Embodiment 14.

[0164] Embodiment 18

[0165] The difference between this embodiment and Example 14 is that the amount of aluminum glycolate used in the raw material composition and preparation method of the traditional Chinese medicine gel ointment in this embodiment is 1.2 g (i.e., 0.6% of the auxiliary materials), and the rest of the raw material composition and preparation method of the traditional Chinese medicine gel ointment are the same as those in Example 14.

[0166] Embodiment 19

[0167] The difference between this embodiment and Example 14 is that the amount of kaolin in the raw material composition and preparation method of the traditional Chinese medicine gel ointment in this embodiment is 2 g (i.e., 1% of the excipients), and the rest of the raw material composition and preparation method of the traditional Chinese medicine gel ointment are the same as those in Example 14.

[0168] Embodiment 20

[0169] The difference between this embodiment and Example 14 is that the amount of kaolin in the raw material composition and preparation method of the traditional Chinese medicine gel ointment in this embodiment is 6 g (i.e., 3% of the auxiliary materials), and the rest of the raw material composition and preparation method of the traditional Chinese medicine gel ointment are the same as those in Example 14.

[0170] Embodiment 21

[0171] The difference between this embodiment and Example 14 is that the amount of glycerol used in the raw material composition and preparation method of the Chinese medicine gel ointment in this embodiment is 50g (i.e., accounting for 25% of the auxiliary materials), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0172] Embodiment 22

[0173] The difference between this embodiment and Example 14 is that the amount of glycerol used in the raw material composition and preparation method of the Chinese medicine gel ointment in this embodiment is 90g (i.e., accounting for 45% of the auxiliary materials), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0174] Comparative Example 8

[0175] The difference between this comparative example and Example 14 is that the amount of sodium polyacrylate used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 2 g (i.e., 1% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0176] Comparative Example 9

[0177] The difference between this comparative example and Example 14 is that the amount of sodium polyacrylate used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 4 g (i.e., 2% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0178] Comparative Example 10

[0179] The difference between this comparative example and Example 14 is that the amount of sodium polyacrylate used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 6 g (i.e., 3% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0180] Comparative Example 11

[0181] The difference between this comparative example and Example 14 is that the amount of aluminum glycolate used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 0.2 g (i.e., 0.1% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0182] Comparative Example 12

[0183] The difference between this comparative example and Example 14 is that the amount of aluminum glycolate used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 0.4 g (i.e., 0.2% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0184] Comparative Example 13

[0185] The difference between this comparative example and Example 14 is that the amount of aluminum glycolate used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 0.6 g (i.e., 0.3% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0186] Comparative Example 14

[0187] The difference between this comparative example and Example 14 is that the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example do not contain kaolin (i.e., accounting for 0% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as Example 14.

[0188] Comparative Example 15

[0189] The difference between this comparative example and Example 14 is that the amount of kaolin in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 8 g (i.e., 4% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as Example 14.

[0190] Comparative Example 16

[0191] The difference between this comparative example and Example 14 is that the amount of kaolin in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 10g (i.e., 5% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as Example 14.

[0192] Comparative Example 17

[0193] The difference between this comparative example and Example 14 is that the raw material composition of the Chinese medicine gel ointment in this comparative example does not contain glycerin (i.e., it accounts for 0% of the excipients), and the rest of the raw material composition of the Chinese medicine gel ointment is the same as that of Example 14.

[0194] The preparation method of the traditional Chinese medicine gel ointment comprises the following steps:

[0195] (1) Weigh the above sodium polyacrylate, kaolin, and aluminum glycolate respectively, and stir them evenly at 60° C. to form a mixed phase;

[0196] (2) taking the above-mentioned azone and adding it into the above-mentioned water as the aqueous phase;

[0197] (3) Add the aqueous phase to the mixed phase and stir thoroughly. After the mixture is evenly mixed, add the Chinese herbal compound extract B, stir evenly, apply, and place in an oven at 37° C. for 24 hours.

[0198] Comparative Example 18

[0199] The difference between this comparative example and Example 14 is that the amount of glycerol used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 10g (i.e., 5% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0200] Comparative Example 19

[0201] The difference between this comparative example and Example 14 is that the amount of glycerol used in the raw material composition and preparation method of the Chinese medicine gel ointment in this comparative example is 30g (i.e., 15% of the excipients), and the rest of the raw material composition and preparation method of the Chinese medicine gel ointment are the same as those in Example 14.

[0202] Test Example 3

[0203] (1) This test example studies the effect of the dosage of sodium polyacrylate, aluminum glycolate, kaolin and glycerol on the performance of the traditional Chinese medicine gel ointment matrix. Taking the comprehensive sensory evaluation as an indicator, the higher the score, the better the performance of the traditional Chinese medicine gel ointment. The specific comprehensive scoring standard is shown in Table 7. The traditional Chinese medicine gel ointment prepared in Examples 14 to 22 and Comparative Examples 8 to 19 is applied to a non-woven fabric to obtain a traditional Chinese medicine gel patch, and the performance of the traditional Chinese medicine gel patch is studied through comprehensive sensory evaluation. After recording the data, the comprehensive score is calculated and a chart is drawn. The results are shown in Figure 2 .

[0204] Table 7 Comprehensive scoring criteria for traditional Chinese medicine gel ointment

[0205]

[0206] Figure 2 The results show that, in terms of the amount of sodium polyacrylate, compared with comparative examples 8 to 9, the comprehensive scores of the Chinese medicine gel ointments of Examples 14 to 16 are high, that is, compared with comparative examples 8 to 9, the Chinese medicine gel ointments of Examples 14 to 16 have good spreadability, uniformity, permeability, skin membrane residual and skin follow-up. In terms of the amount of aluminum glycolate, compared with comparative examples 11 to 13, the comprehensive scores of the Chinese medicine gel ointments of Examples 14, 17 and 18 are high, that is, compared with comparative examples 11 to 13, the Chinese medicine gel ointments of Examples 14, 17 and 18 have good spreadability, uniformity, permeability, skin membrane residual and skin follow-up. As for the amount of kaolin used, kaolin has little effect on the comprehensive score of the plaster, so the subsequent orthogonal test does not select kaolin as an investigation factor, but compared with comparative examples 14, 15 and 16, the comprehensive scores of the Chinese medicine gel ointments of Examples 14, 19 and 20 are high, that is, compared with comparative examples 14, 15 and 16, the Chinese medicine gel ointments of Examples 14, 19 and 20 have good spreadability, uniformity, permeability, skin membrane residual and skin follow-up. As for the amount of glycerol used, compared with comparative examples 17 to 19, the comprehensive scores of the Chinese medicine gel ointments of Examples 14, 21 and 22 are high, that is, compared with comparative examples 17 to 19, the Chinese medicine gel ointments of Examples 14, 21 and 22 have good spreadability, uniformity, permeability, skin membrane residual and skin follow-up.

[0207] (2) Orthogonal test

[0208] Based on the results of part (1) above, three factors that have the greatest impact on the quality of traditional Chinese medicine gel ointment, sodium polyacrylate (A), aluminum glycolate (B), glycerol (C) and error (D), were selected for orthogonal test. 4 ) orthogonal table was used to conduct optimization test on the dosage of raw materials of Chinese medicine gel ointment, and 4 factors and 3 levels of orthogonal test on the dosage of raw materials of Chinese medicine gel ointment were designed, as shown in Table 8. The comprehensive sensory evaluation was used as an indicator. The higher the score, the better the performance of the Chinese medicine gel ointment. The specific comprehensive scoring standards are shown in Table 7. The orthogonal test results of the dosage of raw materials of Chinese medicine gel ointment are shown in Table 9, and the variance analysis is shown in Table 10.

[0209] Table 8 Orthogonal test of raw material dosage of Chinese medicine gel ointment

[0210] Factor Levels Sodium polyacrylate dosage (A) Aluminum glycolate dosage (B) Glycerol dosage (C) 1 4％ 0.4％ 25％ 2 5％ 0.5％ 35％ 2 6％ 0.6％ 45％

[0211] Table 9 Results of orthogonal test on the dosage of raw materials of Chinese medicine gel ointment

[0212] serial number A B C D Overall Rating 1 1 1 1 1 35 2 1 2 3 2 37 3 1 3 2 3 41 4 2 1 3 3 38 5 2 2 2 1 45 6 2 3 1 2 39 7 3 1 2 2 35 8 3 2 1 3 34 9 3 3 3 1 35 K1 113 108 108 115 K2 122 116 121 111 K3 104 115 110 113 k1 37.66 36.00 36.00 38.33 k2 40.66 38.66 40.33 37.00 k3 34.66 38.33 36.66 37.66 R 6.00 2.66 4.33 0.66

[0213] Table 10 Orthogonal test variance analysis table of raw material dosage of Chinese medicine gel ointment

[0214]

[0215]

[0216] According to the range of the range in Table 9, the influence of each factor on the total score is A>C>B, and A2>A1>A3, B2>B3>B1, C2>C3>C1. In order to verify the reliability of the results, the experimental data were subjected to variance analysis. The results of variance analysis are shown in Table 10. The results show that factor A has a significant effect on the optimization results of the matrix of the traditional Chinese medicine gel patch (P<0.05). Comprehensive analysis of the results and actual production conditions show that A2B2C2 is the best process. At the same time, when the dosage of kaolin is 2%, the comprehensive score is the highest, that is, the best process for the dosage of raw materials of traditional Chinese medicine gel paste is the mass ratio of sodium polyacrylate: aluminum glycolate: kaolin: glycerol = 1:0.1:0.4:7.

[0217] Embodiment 23

[0218] A Chinese medicine gel ointment is composed of the following raw materials: 200g of auxiliary materials and 60mL of the Chinese medicine compound extract B prepared in Example 12; the auxiliary materials are 1g of aluminum glycolate (i.e., accounting for 0.5% of the auxiliary materials), 4g of kaolin (i.e., accounting for 2% of the auxiliary materials), 70g of glycerol (i.e., accounting for 35% of the auxiliary materials), 1000μL of azone, and 10g of sodium polyacrylate (i.e., accounting for 5% of the auxiliary materials), and the amount is supplemented to 200g with water.

[0219] The preparation method of the traditional Chinese medicine gel ointment comprises the following steps:

[0220] (1) Weigh the sodium polyacrylate, kaolin, and aluminum glycolate mentioned above respectively, disperse them in the glycerol mentioned above, and stir them evenly at 60° C. to form the glycerol phase;

[0221] (2) taking the above-mentioned azone and adding it into the above-mentioned water as the aqueous phase;

[0222] (3) Add the aqueous phase to the glycerin phase and stir thoroughly. After the mixture is evenly mixed, add the Chinese herbal compound extract B, stir evenly, apply, and place in an oven at 37° C. for 24 hours.

[0223] Based on the above optimal extraction process, i.e., the Chinese medicine gel ointment and its preparation method of Example 23, three verification tests were carried out to prepare three batches of Chinese medicine gel ointments and apply them on non-woven fabrics to prepare Chinese medicine gel patches (such as Figure 3 ), and evaluated by comprehensive sensory score. The scoring criteria are shown in Table 8, and the comprehensive sensory score results are shown in Table 11.

[0224] Table 11 Comprehensive sensory evaluation of the Chinese medicine gel ointment of Example 23 (points)

[0225] Gel patch Spreadability Uniformity Permeability Skin following Skin Residue Overall Rating 1 10 10 10 9 10 49 2 10 9 10 10 10 49 3 10 10 10 10 10 50

[0226] The results of Table 11 show that the comprehensive score of the Chinese medicine gel ointment of the present invention is 49.3, and the RSD value is 1.17%. The Chinese medicine ointment is easy to apply, the film is peeled off smoothly, the paste is smooth and bright, the skin followability and peeling property are good, there is no residue when peeled off, the adhesion is good, the overall quality is excellent and the reproducibility is good.

[0227] Test Example 4

[0228] Animal model establishment

[0229] Preparation of Chinese medicine gel patch: The Chinese medicine gel patch prepared in Example 23 was applied on non-woven fabric at 0.5 g, 1 g, and 1.5 g per square centimeter, respectively, and the patch was cut into a size of 1×3 cm to prepare Chinese medicine gel patches 1 to 3, which were respectively recorded as patch group A, patch group B, and patch group C.

[0230] (1) Rat foot swelling model

[0231] Thirty SD rats were randomly divided into five groups: model control group, positive drug group (erythromycin ointment), plaster A, B, and C groups, with 6 rats in each group, half male and half female. The model group was smeared with normal saline on the right foot, the positive drug group was smeared with erythromycin ointment on the right foot, and the plaster A, B, and C groups were applied to the right foot of the mice, twice a day for 7 consecutive days. One hour after the last administration, 0.1 mL / rat of 1% carrageenan suspension was injected into the sole of the right hind foot of each group of rats. The basal foot volume of the right hind foot of the rats was measured before swelling modeling. 0.5, 1.5, and 3 hours after modeling, the foot volume of the right hind foot of the rats was measured and photographed, and the foot swelling degree and foot swelling inhibition rate were calculated.

[0232] Swelling rate = [(right hind foot volume after inflammation - right hind foot volume before inflammation) / right hind foot volume before inflammation] × 100%.

[0233] Figures 4 to 6 The results showed that compared with the model group, there were significant differences in the degree of foot swelling and foot swelling inhibition rate between the positive drug group and plaster groups A, B, and C (P<0.01, P<0.05). Compared with the model group, the redness and swelling of the right hind foot in the positive drug group and plaster groups A, B, and C were significantly reduced, and the plaster had a relieving effect on rat foot swelling.

[0234] At the same time, rats without any treatment were used as the blank group, the model control group 3 hours after modeling, the positive drug group (erythromycin ointment), and the plaster A, B, and C groups. The foot tissue sections of the rats were fixed in 4% formaldehyde solution for 24 hours and then HE stained. The tissue samples fixed in 4% paraformaldehyde were taken for dehydration, embedding, sectioning, and staining (HE staining). The pathological changes of the tissue sections were observed using an inverted fluorescence microscope.

[0235] like Figure 7 The results showed that compared with the blank group, the subcutaneous tissue of the foot of the rats in the model group was accompanied by a large number of neutrophil infiltration, slight edema, and increased intercellular space; a very small number of neutrophil infiltration was observed in the subcutaneous tissue of the foot of the rats in the positive drug group, the subcutaneous structure was intact, and the swelling of the subcutaneous tissue was not obvious; a small number of neutrophil infiltration was observed in the subcutaneous tissue of the foot of the rats in the plaster A and B groups, the subcutaneous structure was relatively intact, and the swelling of the subcutaneous tissue was reduced; mild neutrophil infiltration was observed in the subcutaneous tissue of the foot of the rats in the plaster C group. The results showed that plaster A, B, C groups and the positive drug group could improve the pathological changes of the foot of rats caused by carrageenan.

[0236] (2) Rat auricle complex acne model

[0237] 60 SD rats, half male and half female, were randomly divided into a blank control group and an experimental group, including 10 in the blank group (without any drug treatment) and 50 in the experimental group. The 50 rats in the experimental group were smeared with 50% oleic acid solution at the opening of the ear tube on the inner side of the right ear every day, 0.5mL / d, and Propionibacterium acnes ATCC6919 was injected intradermally into the auricle of the rats every other day for 3 consecutive weeks, and the left ear was not treated with any treatment. On the 22nd day, the morphology of the auricle lesions of the rats was observed, and 5 rats were randomly selected for pathological section observation. After the pathological results showed that the model was successfully established, the remaining 45 rats were randomly divided into a model group, plaster A, B, C groups and a positive drug group (retinoic acid cream). The model group applied normal saline to the right ear, plaster A, B, C groups applied 1 to 3 Chinese medicine gel plasters to the right ear, and the positive drug group applied erythromycin ointment to the right ear. After 14 consecutive days of administration, the recovery of the auricle of the rats was observed.

[0238] Figure 8 The results showed that the rat auricle complex acne model was successfully established. The ears of the mice in the model group showed severe skin damage, rough skin lesions, dilated capillaries, desquamation cysts, and a significant thickening of the stratum corneum. Compared with the model group, the ears of the mice in the positive drug group and plaster groups A, B, and C were significantly improved, with reduced skin damage, reduced desquamation cysts, and significantly improved stratum corneum thickening.

[0239] At the same time, HE staining was performed on the right ear tissue sections of the rats in the blank group, model control group, positive drug group, plaster A, B, and C groups after 14 days of administration. The staining results are shown in Fig. 9 .

[0240] Fig. 9 The results showed that there was no obvious abnormality in the auricle of the rats in the blank control group, the boundaries between the dermis, epidermis and subcutaneous tissue were clear, and no inflammatory cell infiltration was observed; the epidermis in the model group was significantly thickened, the boundaries between the dermis, epidermis and subcutaneous tissue became blurred, the capillaries were significantly dilated, and a large number of inflammatory cells infiltrated; the epidermal thickness of the rats in the positive drug group and plaster group A was significantly reduced, the boundaries between the dermis, epidermis and subcutaneous tissue were basically clearly visible, and there was a small amount of inflammatory cell infiltration; the epidermal thickness of the auricle of the rats in plaster group B was reduced, and the number of inflammatory cells decreased; the epidermal thickness of the auricle in plaster group C was slightly reduced, the boundaries between the dermis, epidermis and subcutaneous tissue became slightly clearer, and there was inflammatory cell infiltration.

[0241] (3) Rat back acne model

[0242] Thirty-six SD rats, half male and half female, were randomly divided into a blank group and an experimental group, with 6 rats in the blank control group and 30 rats in the experimental group. The backs of the rats were depilated 24 hours before modeling, and the depilated area was about 4×4 cm 2, take 0.5mL of 100% oleic acid and apply it evenly on the back of the rats, once a day for 7 consecutive days. After the model was successfully established, the acne model rats were randomly divided into a model control group, a positive group, and plaster groups A, B, and C, with 6 rats in each group. The model group applied normal saline to the back, the plaster groups A, B, and C applied Chinese medicine gel plasters 1 to 3 on the back, and the positive drug group applied retinoic acid cream on the back. After 7 consecutive days of administration, the condition of the rats' back skin was observed.

[0243] Depend on Fig.10 It can be seen that the rat back acne model was successfully established, and severe skin damage, papular inflammation and pus cells appeared on the back of the rats in the model group; compared with the model group, the back conditions of the rats in the positive drug group and gel patch groups A, B, and C were significantly improved, the skin damage was alleviated, and the papular inflammation and pus cells disappeared.

[0244] At the same time, HE staining was performed on the back skin tissue sections of the rats in the blank group, model control group, positive drug group, plaster A, B, and C groups 7 days after administration. The staining results are shown in Fig.11 .

[0245] Fig.11 The results showed that the skin structure of the rats in the blank group was normal, the skin tissue and collagen fibers were evenly distributed, and there was no inflammatory cell infiltration. The skin tissue of the rats in the model group was significantly thickened, capillary hyperplasia, a large number of inflammatory cells infiltrated, and deep connective tissue damage was visible in some parts. Compared with the model group, the skin thickening phenomenon of the positive drug group and plaster groups A and B was alleviated, the inflammatory exudation and inflammatory cell infiltration were reduced, and the capillary hyperplasia was significantly improved; the inflammatory cell infiltration of plaster group C was also alleviated, and the skin thickening was improved, but the improvement effect was not as obvious as that of the positive drug group and plaster groups A and B.

[0246] Test Example 5

[0247] Safety Test

[0248] Acute dermal toxicity test

[0249] The Chinese medicine gel plaster prepared in Example 23 was applied to the non-woven fabric at 0.5, 1 and 1.5 g, respectively, and the plaster was cut into a size of 2×2 cm to prepare low, medium and high concentration Chinese medicine gel plasters, respectively, which were recorded as plaster group A, plaster group B and plaster group C. The blank matrix refers to a non-woven fabric that does not contain any drug.

[0250] 1.1 Model establishment

[0251] Two methods were used for testing, namely intact skin and damaged skin. For each method, 24 SD rats were taken, half male and half female, and randomly divided into 4 groups, 6 rats in each group, namely the matrix group, high, medium and low dose groups. 24 hours before the start of the experiment, the hair on the back of the animal's trunk, which accounts for about 10% of the animal's body surface area, was shaved. The skin should not be damaged during hair removal to avoid affecting the permeability of the skin. The damaged skin method used a needle to draw a tic-tac-toe pattern on the back of the skin. After 24 hours, the depilatory area was plastered (i.e., the matrix group, the high, medium and low dose groups were respectively plastered with blank matrix, low, medium and high concentrations of Chinese medicine gel plasters), and then covered with a layer of thin film and fixed with non-irritating tape to prevent animals from licking. The animals were raised in separate cages. After 24 hours of applying the medicine, the residual medicine was gently washed off with warm water, and the medicine was observed 1, 3, and 5 days after the removal of the medicine. The experimental animals were observed regularly for signs of poisoning and death, and then carefully examined once a day for changes in their coat, skin, eyes, mucous membranes, as well as their respiratory, circulatory, autonomic and central nervous systems, limb movements, and behavioral activities, and photographs were taken.

[0252] 2 Skin irritation test

[0253] 2.1 Single skin irritation test

[0254] 2.1.1 Complete skin

[0255] After 1 week of adaptive feeding, 24 healthy SD rats were randomly divided into high-dose, medium-dose, and low-dose groups and a saline control group, with 6 rats in each group, half male and half female. The hair on the back of the rats was removed 24 hours before the experiment, and the shaved area was 3cm×3cm. The skin should not be damaged. After 24 hours, blank matrix, low-, medium-, and high-concentration Chinese medicine gel patches were applied to the two sites on the left side of the hair removal area, respectively, and fixed with non-irritating adhesive tape, and washed with warm water after 24 hours. The erythema and edema of the hair removal site were observed and recorded at 1, 24, 48, and 72 hours after the tape was removed. Erythema score: no erythema is scored as 0 points, barely visible is scored as 1 point, obviously visible is scored as 2 points, moderate to severe erythema is scored as 3 points, and purple erythema with eschar formation is scored as 4 points; edema score: no edema is scored as 0 points, barely visible is scored as 1 point, visible edge is higher than the surrounding skin is scored as 2 points, skin bulge of about 1mm with clear outline is scored as 3 points, edema bulge of more than 1mm and expansion is scored as 4 points. After scoring separately, the total score of erythema and edema is calculated, 0-0.49 points for no irritation, 0.5-2.99 points for mild irritation, 3.0-5.99 points for moderate irritation, and 6.0-8.0 points for severe irritation.

[0256] 2.1.2 Damaged skin

[0257] After cleaning and disinfecting the exposed skin with ethanol, a sterile needle was used to make a "well"-shaped cut on the skin to create a wound, with the exudation of small blood beads as the standard. After 24 hours, a blank matrix, low, medium and high concentrations of Chinese medicine gel plaster were applied to the two sites on the left side of the hair removal area, and fixed with non-irritating adhesive tape. After 24 hours, it was washed with warm water, and the erythema and edema of the hair removal site were observed and recorded at 1, 24, 48 and 72 hours after removing the adhesive tape.

[0258] 2.2 Multiple skin irritation tests

[0259] After one week of adaptive feeding, healthy SD rats were randomly divided into low, medium and high concentrations of Chinese medicine gel plaster groups and a normal saline control group, with 6 rats in each group, half male and half female. The hair on the back of the rats was removed 24 hours before the experiment, and the shaved area was 3cm×3cm. The skin should not be damaged. Each group was given the drug twice a day for 7 consecutive days. After 6 hours of each drug administration, the drug administration site was washed with warm water. After 1 hour, the drug administration site was observed for erythema and edema. The skin after drug administration was scored and the skin irritation intensity was determined based on the average score.

[0260] Skin irritation scoring criteria: no erythema, mild erythema, moderate erythema, severe erythema and edema erythema were scored as 0, 1, 2, 3, and 4 points respectively; Skin irritation scoring criteria: no erythema, mild erythema, moderate erythema, severe erythema and edema erythema were scored as 0, 1, 2, 3, and 4 points respectively; Irritation score = (erythema score + edema score) / number of animals. Irritation score P < 0.50 is no irritation, 0.50-2.99 is mild irritation, 3.00-5.99 is moderate irritation, and 6.00-8.00 is strong irritation.

[0261] 3 Results and analysis

[0262] 3.1 Acute skin toxicity test

[0263] Acute skin toxicity test was conducted on four groups of rats. The skin condition of the rats was observed and recorded every day. The results are as follows: Figure 12-13 .

[0264] Figure 12-13 The results showed that through continuous observation of four groups of rats for many days, it was found that the matrix group and plaster groups A, B, and C had no acute skin toxicity to rats. The rats in the intact skin and damaged skin groups did not show poisoning or death, and the skin did not show symptoms such as redness, swelling, and ulcers. The rats' fur, skin, eyes, and mucous membranes, as well as their respiratory, circulatory, autonomic and central nervous systems, limb movements, and behavioral activities did not change. The toad skin gel patch has no acute toxicity.

[0265] 3.2 Skin irritation test

[0266] Four groups of rats were subjected to skin irritation experiments. The skin conditions of the rats were observed and recorded every day. The results are as follows: Fig.14 , Fig.15 , Tables 12-13.

[0267] Table 12 Evaluation of skin irritation after single administration

[0268]

[0269]

[0270] Table 13 Evaluation of skin irritation after repeated administration

[0271]

[0272] Figures 14-15 The results in Tables 12 to 13 show that through continuous observation of four groups of rats for many days, it was found that the matrix group and the gel patches A, B, and C groups had no skin irritation to rats, and the rats in the intact skin and damaged skin groups did not develop erythema and edema after single and multiple administrations, and the behavioral activities of the rats did not change. The gel patch had no skin irritation.

[0273] The acute skin toxicity experiment and the skin irritation experiment confirmed that the Chinese medicine gel ointment of the present invention has no skin toxicity and irritation after long-term administration. It can be considered that the preparation safety of the gel ointment is good, which lays a solid foundation for the practical application of the gel ointment.

[0274] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A method for preparing a toad skin extract, characterized in that: The following steps are involved: The dried toad skin is mixed with the ethanol solution, and refluxed for extraction to obtain a toad skin extract, and the supernatant is collected by centrifugation, concentrated, and dried to obtain a toad skin extract.

2. The preparation method according to claim 1, characterized in that: The mass volume ratio of the dry toad skin to the ethanol solution is 1:15-25; the volume fraction of the ethanol solution is 70%-90%; the number of reflux extractions is 1-3 times; and the time of each reflux extraction is 1.5-2.5 hours.

3. A toad skin extract obtained according to the preparation method of claim 1 or 2.

4. A Chinese medicine composition for inhibiting bacteria, reducing swelling and / or treating acne, characterized in that: Including the following raw materials: 50-70g dried toad skin, 30-40g astragalus, 20-40g frankincense, 20-40g myrrh, 20-40g licorice, 1-2g borneol and 1-2mL peppermint oil.

5. A method for preparing the Chinese medicine composition according to claim 4, characterized in that: The following steps are involved: (1) preparing a toad skin extract from the dried toad skin according to the preparation method of claim 1 or 2; (2) mixing the astragalus, frankincense, myrrh, and liquorice with water, decocting, filtering and collecting the supernatant to obtain a mixed extract, and concentrating to obtain a mixed concentrate; (3) mixing and dissolving the borneol and peppermint oil, adding the mixed concentrate, sterilizing, and obtaining a composite medicinal material extract; (4) mixing the composite medicinal material extract with the toad skin extract to obtain a traditional Chinese medicine composition.

6. The preparation method according to claim 5, characterized in that: The mass volume ratio of the total mass of the astragalus, frankincense, myrrh and liquorice to water is 1:15-25; the number of decoctions is 1-3 times, and the decoction time is 2-3 hours.

7. Use of the toad skin extract according to claim 3, the Chinese medicine composition according to claim 4, or the Chinese medicine composition prepared by the preparation method according to claim 5 or 6 in the preparation of antibacterial drugs.

8. A Chinese medicine gel ointment, characterized in that: The method comprises auxiliary materials and a Chinese medicine composition, wherein the Chinese medicine composition is the Chinese medicine composition according to claim 4 or the Chinese medicine composition prepared by the preparation method according to claim 5 or 6; The mass volume ratio of the auxiliary material to the traditional Chinese medicine composition is 15-25:6; The auxiliary materials include the following ingredients: 0.8-1.2 g of aluminum glycolate, 2-6 g of kaolin, 50-90 g of glycerol, 950-1050 μL of azone, and 8-12 g of sodium polyacrylate.

9. A method for preparing the Chinese medicine gel ointment according to claim 8, characterized in that: The following steps are involved: Dispersing the sodium polyacrylate, kaolin and aluminum glycolate in the glycerol and mixing them evenly to obtain a glycerol phase; Adding the azone to water to obtain an aqueous phase; The aqueous phase is added to the glycerin phase, mixed evenly, and the traditional Chinese medicine composition is added, mixed evenly, to obtain a traditional Chinese medicine gel ointment.

10. Use of the Chinese medicine composition according to claim 4, the Chinese medicine composition prepared by the preparation method according to claim 5 or 6, the Chinese medicine gel ointment according to claim 8 or the Chinese medicine gel ointment obtained by the preparation method according to claim 9 in preparing drugs for reducing swelling and / or treating acne.

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