Antibacterial calamine lotion and preparation method thereof

Abstract

The invention provides an antibacterial calamine lotion and a preparation method thereof, and belongs to the technical field of biological medicine manufacturing. The antibacterial calamine lotion is prepared from calamine powder, zinc oxide, vitamin B6, borneol, starch sodium octenylsuccinate, polyvinyl alcohol PVA-2488 and a traditional Chinese medicine extract, the traditional Chinese medicine extract is obtained by performing enzymolysis on golden cypress, honeysuckle and purslane. Wherein the calamine powder and the zinc oxide have the effects of astringing and relieving itching, the vitamin B6 has the effects of enhancing the skin barrier function and relieving inflammatory response, the borneol has the effects of promoting transdermal penetration, cooling, relieving itching and resisting bacteria and diminishing inflammation, the traditional Chinese medicine extract has the effects of clearing away heat and toxic materials, eliminating dampness and resisting bacteria, diminishing inflammation and relieving itching, and the starch sodium octenylsuccinate and the polyvinyl alcohol PVA-2488 can improve the stability of the calamine lotion. All the components have a synergistic effect, antibacterial activity on various microorganisms is achieved, and the skin disease treatment effect is remarkable. Clinical experiment results show that the total effective rate of the calamine lotion for treating the bacterial dermatosis reaches up to 98%.

Description

Technical Field

[0001] The invention relates to the technical field of biological medicine manufacturing, and in particular to an antibacterial calamine lotion and a preparation method thereof. Background Art

[0002] The active ingredient of calamine lotion is calamine, which is a common ore. Its main component is zinc carbonate, and it also contains a small amount of impurities such as calcium oxide, magnesium oxide, and iron oxide. It is a natural mineral medicine, usually in the form of blocks, stalactites, porous shapes, etc., and its colors are white, light red or yellowish brown. The main method of preparing calamine is to use it after calcination and quenching. After calcination, the main component of calamine becomes zinc oxide. In the field of traditional Chinese medicine, calamine has a long history of medicinal use and has good therapeutic effects on surgical, dermatological, ophthalmic, and anorectal diseases.

[0003] However, the function of calamine lotion on the market is single, including convergence, antipruritic, antiallergic, anti-inflammatory, skin protection effect, but poor antibacterial performance for pathogens in the skin, general effect on the skin disease caused by fungal infection, can only play an auxiliary pruritus relief effect, can not be used as main therapeutic drugs. And the effective ingredient calamine powder in traditional calamine lotion can not be evenly distributed in the solution, poor stability, easy to agglomerate, all need to be shaken before use, and medication is inconvenient. Therefore, it is urgent to invent a calamine lotion with high safety, strong stability, antibacterial efficacy, to improve the effect of treating skin diseases. Summary of the invention

[0004] The invention aims to provide an antibacterial calamine lotion, which has the effects of antibacterial and relieving skin itching.

[0005] The present invention also provides a method for preparing an antibacterial calamine lotion, which can improve the stability and efficacy of the lotion.

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

[0007] The invention provides an antibacterial calamine lotion, which comprises the following raw materials in parts by weight: 10-20 parts of calamine powder, 10-20 parts of zinc oxide, 0.5-2 parts of vitamin B6, 0.5-1 parts of borneol, 0.3-0.8 parts of sodium starch octenylsuccinate, 0.5-2 parts of polyvinyl alcohol PVA-2488 and 60-70 parts of traditional Chinese medicine extracts; the traditional Chinese medicine extracts are obtained by enzymolysis of phellodendron chinense, honeysuckle and purslane.

[0008] Preferably, the calamine powder is obtained by washing, calcining and grinding calamine; the calcining preparation method comprises: calcining calamine at a temperature of 300-400° C. for 1-3 hours, mixing and stirring with 8-12 times the weight of acetic acid, decanting the suspension in the upper layer of water, continuing to calcine the residue, combining the suspension, standing overnight to clarify, and discarding the upper clarified liquid.

[0009] More preferably, the mass fraction of the acetic acid is 3%-5%.

[0010] More preferably, the total number of calcinations is 5-8 times.

[0011] Preferably, the particle sizes of the calamine powder and zinc oxide are both 1-10 μm.

[0012] Preferably, the preparation method of the Chinese medicine extract comprises: crushing Phellodendron amurense, honeysuckle and purslane, mixing and soaking them with water, adding a composite enzyme, performing enzymolysis for 30-60 minutes at 40-50°C and pH 6-7, and filtering to obtain the Chinese medicine extract; the composite enzyme is composed of serrapeptase and snail protease in a weight ratio of (1-3): (3-8).

[0013] More preferably, the weight ratio of Phellodendron amurense, honeysuckle and purslane is 1-3:1-3:1-3; the weight ratio of the total weight of Phellodendron amurense, honeysuckle and purslane to water is 1:6-10; and the added amount of the complex enzyme is 0.5%-3% of the total weight of Phellodendron amurense, honeysuckle and purslane.

[0014] The present invention also provides a method for preparing the antibacterial calamine lotion, comprising: firstly using 5-20 parts of traditional Chinese medicine extract to fully swell polyvinyl alcohol PVA-2488, and then mixing with calamine powder, zinc oxide, vitamin B6, borneol, sodium starch octenylsuccinate and the remaining traditional Chinese medicine extract to obtain the antibacterial calamine lotion.

[0015] The present invention also provides the use of the antibacterial calamine lotion in preparing medicines for treating fungal skin diseases.

[0016] Preferably, the calamine lotion has antibacterial and skin itching relieving effects.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The invention provides an antibacterial calamine lotion, comprising: calamine powder, zinc oxide, vitamin B6, borneol, sodium starch octenyl succinate, polyvinyl alcohol PVA-2488 and a Chinese medicine extract; the Chinese medicine extract is obtained by enzymolysis of phellodendron, honeysuckle and purslane. The invention replaces water in the traditional calamine powder preparation process with acetic acid, thereby improving the effect of calamine powder in treating skin diseases. The invention adds zinc oxide with astringent and antipruritic effects, borneol with skin-penetrating, cooling and antipruritic, antibacterial and anti-inflammatory effects, vitamin B6 with enhanced barrier function and reduced inflammation, a Chinese medicine extract with heat-clearing and detoxifying, dampness-drying, antibacterial and anti-inflammatory effects, and sodium starch octenyl succinate and polyvinyl alcohol PVA-2488 with improved stability on the basis of calamine powder. The antibacterial calamine of the invention has a delicate texture and a cool feeling when applied on the skin, and is not easy to fall off after drying, thereby prolonging the action time and improving the medication efficiency.

[0019] The components of the present invention have synergistic effects, have antibacterial properties against a variety of microorganisms, and have significant therapeutic effects on treating skin diseases. Clinical experimental results show that the total effective rate of using the calamine lotion of the present invention to treat bacterial skin diseases is as high as 98%. DETAILED DESCRIPTION

[0020] The invention provides an antibacterial calamine lotion, which comprises the following raw materials in parts by weight: 10-20 parts of calamine powder, 10-20 parts of zinc oxide, 0.5-2 parts of vitamin B6, 0.5-1 parts of borneol, 0.3-0.8 parts of sodium starch octenylsuccinate, 0.5-2 parts of polyvinyl alcohol PVA-2488 and 60-70 parts of traditional Chinese medicine extracts; the traditional Chinese medicine extracts are obtained by enzymolysis of phellodendron chinense, honeysuckle and purslane.

[0021] Drugs prepared by different processing methods have different properties, flavors, and efficacy, and are suitable for different diseases, and have different usage and dosage. For example, during the processing of mineral drugs, the physical or chemical properties will change. Changes in composition and structure will cause changes in the pharmacological characteristics and toxicity of mineral drugs. Different processing methods may affect the valence state and existence form of an element in the mineral drug. Different valence states and existence forms of elements have different effects on the human body. For example, Fe in mineral drugs 3+ It is not easily absorbed by the human body, and Fe 2+ Easily absorbed by the human body; Cr 3+ It is an essential trace element for the human body, and Cr + Therefore, if the efficacy of calamine lotion on skin diseases is to be improved, the raw materials of calamine lotion need to be properly processed.

[0022] The calamine powder of the present invention is preferably obtained by washing, calamine and grinding.

[0023] The present invention does not particularly limit the way of cleaning calamine, and can adopt the conventional cleaning method in the art. As an implementable method, the cleaning is: after soaking calamine in water, washing and removing the dirt and dust impurities attached to the surface of calamine. The cleaning of the present invention can avoid the impurities from affecting the efficacy of calamine lotion.

[0024] The present invention preferably further comprises draining and drying after washing; the drying temperature is preferably 90-110° C., more preferably 100° C. The present invention has no particular limitation on the drying time, as long as the surface of the calamine is dried.

[0025] The calcined preparation method of the present invention preferably comprises: calcining calamine at 300-400°C for 1-3h, mixing and stirring with 8-12 times the weight of acetic acid, decanting the suspension in the upper water layer, continuing to calcine the residue, combining the suspension, standing overnight to clarify, discarding the upper clarified liquid, and drying the precipitate to a moisture content of less than 2%. The temperature is more preferably 350°C, the time is more preferably 2h, and the weight is more preferably 10 times; the mass fraction of the acetic acid is preferably 3%-5%, more preferably 4%; the total number of calcinations is preferably 5-8 times, more preferably 6 times. The calcination method of the present invention can convert the iron element in calamine into trivalent iron, which is not easily absorbed by the human body, reducing the influence of iron on the efficacy of calamine lotion; some heavy metal impurities (such as mercury, arsenic, etc.) will also partially volatilize if they exist in the form of volatile compounds at high temperatures, reducing the content of harmful components and improving the medicinal safety of calamine.

[0026] The grinding preparation method of the present invention is preferably colloid mill grinding, so that the particle size of the obtained calamine powder is 1-10 μm. The calamine powder with this particle size has a large specific surface area, can more easily penetrate the stratum corneum of the skin, enter the deep layer of the skin to exert its medicinal effect, and can improve the physical stability of the lotion, making the skin feel more delicate when applied.

[0027] The calamine powder obtained by the method of the invention is more easily absorbed by the human body than conventional calamine powder, thereby improving the efficacy of calamine lotion.

[0028] The particle size of the zinc oxide of the present invention is preferably 1-10 μm, which has a convergence effect, soothes the sensory nerve endings in the skin, and can relieve skin itching to a certain extent. In addition, zinc oxide can form a protective film on the skin surface, and its buffering effect can reduce the stimulation of chemicals on the skin, prevent excessive loss of moisture in the skin, maintain the moisture content of the skin, and keep the skin in a relatively stable physiological state, which is conducive to skin repair.

[0029] Borneol of the present invention has the effects of promoting transdermal penetration, cooling and relieving itching, and antibacterial and anti-inflammatory. Borneol has a strong penetrating ability and can promote the penetration of drugs through the skin. In the calamine lotion of the present invention, borneol can make the effective ingredients such as calamine powder and zinc oxide in the calamine lotion better absorbed through the skin, thereby exerting its astringent, antipruritic, anti-inflammatory and other effects. The cooling feeling of borneol can alleviate the discomfort caused by itching, inflammation and the like on the skin to a certain extent, and distract the patient's attention to itching. Borneol is combined with the antipruritic effect of other ingredients (such as calamine powder and zinc oxide) in calamine lotion to produce a synergistic effect. For example, calamine and zinc oxide mainly relieve itching by astringing and protecting the skin, while borneol relieves itching from the perspective of improving sensation. The three work together to more effectively reduce the degree of skin itching, so that the patient's symptoms are better relieved. Borneol has a certain inhibitory effect on a variety of bacteria and fungi. It can destroy the cell membrane structure of bacteria, leak substances inside the bacteria, interfere with the metabolic process of bacteria, thereby achieving the purpose of inhibiting the growth and reproduction of microorganisms. In calamine lotion, the antibacterial and anti-inflammatory effects of borneol can enhance the overall anti-infection ability of the lotion.

[0030] The vitamin B6 of the present invention plays an important role in the metabolism of the skin. It is a coenzyme of multiple enzymes and participates in the metabolism of proteins, fats and carbohydrates. These metabolic processes are essential for the renewal and repair of skin cells. In addition, vitamin B6 can promote the proliferation of fibroblasts, which synthesize extracellular matrix components such as collagen, fill damaged tissues, and promote wound healing. In addition, vitamin B6 can improve the nutritional status of the skin, enhance its barrier function, and reduce inflammation.

[0031] The sodium starch octenyl succinate of the present invention has an emulsifying property, can make various components in the calamine lotion mix better, and prevent solid particles from agglomerating with each other; it has a thickening effect; it can improve the application feeling of the calamine lotion on the skin, and can better adhere to the skin surface when applied, and will not be too thin and flow quickly, nor too thick and difficult to spread; at the same time, the sodium starch octenyl succinate itself is relatively mild to the skin, and will not cause adverse reactions such as skin allergies like some highly irritating thickeners or emulsifiers, and is helpful to improve the comfort of users.

[0032] The polyvinyl alcohol PVA-2488 of the present invention has thickening and suspension stabilizing effects, and its network structure can slowly release the effective ingredients in the calamine lotion to the skin surface, prolong the antibacterial action time, and improve the antibacterial effect.

[0033] The sodium starch octenylsuccinate and polyvinyl alcohol PVA-2488 of the present invention have a synergistic thickening effect, can significantly improve the stability of calamine lotion, can allow the active ingredients in the calamine lotion to better adhere to the skin surface, slowly release the active ingredients, prolong the time for the drug to act on the skin, and have a positive effect on treating skin diseases.

[0034] The preparation method of the Chinese herbal medicine extract of the present invention preferably comprises: crushing Phellodendron amurense, honeysuckle and purslane, mixing and soaking them with water, adding a composite enzyme, performing enzymolysis for 30-60 minutes at 40-50°C and pH 6-7, and filtering to obtain the Chinese herbal medicine extract; the composite enzyme is composed of serrapeptase and snail protease in a weight ratio of (1-3): (3-8). The weight ratio of the Phellodendron chinense, honeysuckle and purslane of the present invention is preferably 1-3:1-3:1-3, more preferably 2:2:2; the weight ratio of the total weight of the Phellodendron chinense, honeysuckle and purslane to water is preferably 1:6-10, more preferably 1:8; the amount of the complex enzyme added is preferably 0.5%-3% of the total weight of the Phellodendron chinense, honeysuckle and purslane, more preferably 2%, the soaking time is preferably 20-40min, more preferably 30min; the enzyme activity of the serrapeptase is preferably 10,000-30,000 U / g, more preferably 20,000 U / g; the enzyme activity of the snail protease is preferably 40,000-80,000 U / g, more preferably 50,000 U / g. The phellodendron amurense, honeysuckle and purslane described in the present invention have the effects of clearing away heat and detoxifying, drying dampness, and having antibacterial, anti-inflammatory and antipruritic effects; the use of a composite enzyme to enzymolyze the Chinese medicinal raw materials can enrich the types and increase the content of small molecule peptides, amino acids and compounds with antioxidant, antibacterial and anti-inflammatory biological activities in the extract, promote the change of the chemical structure of the effective ingredients of the extract, and give the extract stronger pharmacological activity.

[0035] The calamine powder in the calamine lotion of the present invention has the effects of astringency and antipruritic, and is more easily absorbed by the human body than conventional calamine powder; zinc oxide has the effects of astringency and antipruritic, can form a protective film on the skin surface, reduce the stimulation of chemical substances to the skin, and is conducive to skin repair; borneol has the effects of promoting skin penetration, cooling and antipruritic, and antibacterial and anti-inflammatory; vitamin B6 can improve the nutritional status of the skin, enhance its barrier function, and reduce inflammation; Chinese medicine extracts have the effects of clearing away heat and detoxification, drying dampness, and antibacterial and anti-inflammatory and antipruritic; sodium octenyl succinate starch and polyvinyl alcohol PVA-2488 can improve the stability of the calamine lotion and prolong the time for the drug to act on the skin, which has a positive effect on the treatment of skin diseases. The components of the present invention have synergistic effects, have antibacterial properties to various microorganisms, and have significant therapeutic effects on the treatment of skin diseases. The antibacterial calamine of the present invention has a fine texture and a cool feeling when applied on the skin, and is not easy to fall off after drying, prolongs the action time, and improves the efficiency of medication.

[0036] The present invention also provides a method for preparing the antibacterial calamine lotion, comprising: firstly fully swelling polyvinyl alcohol PVA-2488 with 5-20 parts of Chinese medicine extract, and then mixing with calamine powder, zinc oxide, vitamin B6, borneol, sodium starch octenyl succinate and the remaining Chinese medicine extract to obtain the antibacterial calamine lotion. The mixing preferably comprises adding calamine powder, zinc oxide, vitamin B6, borneol and sodium starch octenyl succinate in small amounts and multiple times while stirring. The preparation method of the present invention can make calamine powder, zinc oxide, vitamin B6, borneol and sodium starch octenyl succinate uniformly distributed in the swelling system, and is not easy to settle.

[0037] The storage method of the calamine lotion of the present invention is as follows: after use, the calamine lotion should be placed in a place where children cannot easily touch it to prevent children from taking it by mistake. High temperature may affect the stability of the medicine and cause the components to deteriorate, so it should be stored in a cool and dry environment and avoid direct sunlight.

[0038] The present invention also provides the use of the antibacterial calamine lotion in preparing a drug for treating fungal skin diseases. The calamine lotion has the effects of antibacterial and relieving skin itching.

[0039] The method for using the calamine lotion of the present invention is as follows: firstly, wash the affected part of the skin with water, dip a proper amount of the calamine lotion with a clean cotton swab, and gently apply it on the affected part, avoiding rubbing the skin vigorously, and the thickness of the application is preferably enough to cover the skin lesion part, and a thin layer can be applied once a day, and a course of treatment is 7 days.

[0040] The water used in the present invention is preferably distilled water.

[0041] In the present invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0042] The technical solutions in the present invention will be described clearly and completely below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] Example 1

[0044] Preparation method of calamine lotion

[0045] (1) Preparation method of calamine powder

[0046] After soaking calamine in water, washing to remove dirt and dust impurities attached to the surface of calamine, draining, drying at 100° C., calcining 100 g of the washed calamine at 350° C. for 2 h, mixing with 1 L of 4% acetic acid solution by mass, and stirring, taking the suspension in the upper water, and continuing to calcine the residue 5 times according to the above method, combining the suspension, standing overnight to clarify, discarding the upper clarified liquid, drying the precipitate to a moisture content of less than 2%, grinding with a colloid mill and taking a powder with a particle size of 1-10 μm to obtain calamine powder;

[0047] (2) Preparation of Chinese herbal medicine extracts

[0048] 20g of Phellodendron amurense, 20g of honeysuckle and 20g of purslane were crushed and passed through a 50-mesh sieve, mixed with 480g of water and soaked for 30min, 1.2g of complex enzyme was added, and enzymolysis was performed at 45℃ and pH 6.5 for 45min, the temperature was raised to 85℃ for 15min to inactivate the enzyme, and the temperature was lowered to room temperature, and the filtrate was filtered to obtain the Chinese medicine extract;

[0049] The complex enzyme is composed of serrapeptase and snail protease in a weight ratio of 2:5;

[0050] The enzyme activity of serrapeptase is 20,000 U / g, and the enzyme activity of snail protease is 50,000 U / g;

[0051] (3) Preparation of Calamine Lotion

[0052] First, 10 g of the Chinese herbal extract was used to dissolve 1 g of polyvinyl alcohol PVA-2488, and then 15 g of calamine powder, 15 g of zinc oxide, 1.2 g of vitamin B6, 0.8 g of borneol, 2 g of sodium starch glycolate octenylsuccinate and 55 g of the Chinese herbal extract were added, and stirred at 200 rpm for 30 min to obtain the calamine lotion.

[0053] Example 2

[0054] Preparation method of calamine lotion

[0055] (1) Preparation method of calamine powder

[0056] After soaking calamine in water, washing to remove dirt and dust impurities attached to the surface of calamine, draining, drying at 90° C., calcining 100 g of the washed calamine at 400° C. for 1 h, stirring with 800 mL of 5% acetic acid solution by mass, taking the suspension in the upper water, and continuing to calcine the residue 4 times according to the above method, combining the suspension, standing overnight to clarify, discarding the upper clarified liquid, drying the precipitate to a moisture content of less than 2%, grinding with a colloid mill and taking a powder with a particle size of 1-10 μm to obtain calamine powder;

[0057] (2) Preparation of Chinese herbal medicine extracts

[0058] 10g of Phellodendron amurense, 10g of honeysuckle and 30g of purslane were crushed and passed through a 50-mesh sieve, mixed with 250g of water and soaked for 20min, 1.5g of complex enzyme was added, and enzymolysis was performed at 40℃ and pH 6.0 for 60min, the temperature was raised to 85℃ for 15min to inactivate the enzyme, and then the temperature was lowered to room temperature, and the filtrate was filtered to obtain the Chinese medicine extract;

[0059] The complex enzyme is composed of serrapeptase and snail protease in a weight ratio of 1:3;

[0060] The enzyme activity of serrapeptase is 10,000 U / g, and the enzyme activity of snail protease is 40,000 U / g;

[0061] (3) Preparation of Calamine Lotion

[0062] First, 0.5 g of polyvinyl alcohol PVA-2488 was dissolved with 5 g of the Chinese herbal extract, and then 14 g of calamine powder, 20 g of zinc oxide, 2 g of vitamin B6, 0.5 g of borneol, 3 g of sodium starch octenylsuccinate and 55 g of the Chinese herbal extract were added, and the mixture was stirred at 150 rpm for 40 min to obtain the calamine lotion.

[0063] Example 3

[0064] Preparation method of calamine lotion

[0065] (1) Preparation method of calamine powder

[0066] After soaking calamine in water, washing to remove dirt and dust impurities attached to the surface of calamine, draining, drying at 110° C., calcining 100 g of the washed calamine at 300° C. for 3 h, mixing with 1.2 L of 3% acetic acid solution, stirring, taking the suspension in the upper water, and continuing to calcine the residue 7 times according to the above method, combining the suspension, standing overnight to clarify, discarding the upper clarified liquid, drying the precipitate to a moisture content of less than 2%, grinding with a colloid mill and taking a powder with a particle size of 1-10 μm to obtain calamine powder;

[0067] (2) Preparation of Chinese herbal medicine extracts

[0068] 30g of Phellodendron amurense, 30g of honeysuckle and 10g of purslane were crushed and passed through a 50-mesh sieve, mixed with 560g of water and soaked for 40min, then 0.35g of complex enzyme was added, and enzymolysis was performed at 50℃ and pH 7 for 30min, and the temperature was raised to 85℃ to inactivate the enzyme for 15min and then cooled to room temperature, and the filtrate after filtration was the Chinese medicine extract;

[0069] The complex enzyme is composed of serrapeptase and snail protease in a weight ratio of 3:8;

[0070] The enzyme activity of serrapeptase is 30,000 U / g, and the enzyme activity of snail protease is 80,000 U / g;

[0071] (3) Preparation of Calamine Lotion

[0072] First, 20 g of the Chinese herbal extract was used to dissolve 2 g of polyvinyl alcohol PVA-2488, and then 20 g of calamine powder, 10.5 g of zinc oxide, 0.5 g of vitamin B6, 1 g of borneol, 1 g of sodium starch glycolate octenylsuccinate and 45 g of the Chinese herbal extract were stirred at 200 rpm for 20 min to obtain the calamine lotion.

[0073] Comparative Example 1

[0074] The specific implementation method is the same as Example 1, except that the acetic acid in the preparation method of calamine powder is replaced by distilled water.

[0075] Comparative Example 2

[0076] The specific implementation is the same as that of Example 1, except that zinc oxide is not added.

[0077] Comparative Example 3

[0078] The specific implementation is the same as that of Example 1, except that vitamin B6 is not added.

[0079] Comparative Example 4

[0080] The specific implementation is the same as that of Example 1, except that borneol is not added.

[0081] Comparative Example 5

[0082] The specific implementation method is the same as that of Example 1, except that the composite enzyme in step (2) is replaced by bromelain and neutral protease, wherein the weight ratio of bromelain to neutral protease is 2:5, the enzymatic activity of bromelain is 20,000 U / g, and the enzymatic activity of neutral protease is 50,000 U / g.

[0083] Comparative Example 6

[0084] The specific implementation method is the same as Example 1, except that sodium starch octenyl succinate is not added, and the addition amount of polyvinyl alcohol PVA-2488 is modified to 3g.

[0085] Comparative Example 7

[0086] The specific implementation method is the same as Example 1, except that polyvinyl alcohol PVA-2488 is not added, and the addition amount of sodium starch octenyl succinate is modified to 3g.

[0087] Experimental Example 1

[0088] Stability determination

[0089] Sedimentation volume ratio is one of the important indicators to measure its stability. The calculation formula of sedimentation volume ratio (F) is F = Hu / H0, where Hu is the height of non-sedimentation and H0 is the initial height of suspension. The higher the F value, the stronger the stability of calamine lotion.

[0090] The calamine lotion sedimentation volume ratios of Examples 1-3 and Comparative Examples 1-7 were measured at 12h and 7d, respectively. The specific results are shown in Table 1.

[0091] Table 1 Sedimentation volume ratio of different embodiments and comparative examples of calamine lotion

[0092]

[0093]

[0094] It can be seen from the data in Table 1 that the calamine lotion prepared by the methods of Examples 1-3 and Comparative Examples 1-5 of the present invention has good stability. According to the sedimentation volume ratio data of Example 1 and Comparative Examples 6-7, it can be seen that polyvinyl alcohol PVA-2488 and sodium starch octenyl succinate have the effect of promoting each other and synergistically improving the stability of calamine lotion.

[0095] Experimental Example 2

[0096] In vitro antibacterial test (plate method)

[0097] The inhibitory effects of the calamine lotions of Examples 1-3 and Comparative Examples 1-5 on Escherichia coli (CMCC(B)44102), Staphylococcus aureus (CMCC(B)26003), Bacillus subtilis (CMCC(B)63501) and Candida albicans (CMCC(F)98001) were tested by the plate method.

[0098] Escherichia coli, Staphylococcus aureus, and Bacillus subtilis were inoculated on nutrient agar, activated at 37°C for 24 h, and suitable single colonies were selected and inoculated into nutrient broth. The culture was incubated at 37°C in a constant temperature shaker until the bacterial solution concentration reached 10 6 CFU / mL, and the activated bacterial solution was obtained.

[0099] Candida albicans was inoculated on a red bengal culture medium, activated at 28°C for 48 hours, suitable single colonies were selected, and inoculated into a liquid mold culture medium; activated in a constant temperature shaker at 28°C until the bacterial solution concentration reached 10 5 CFU / mL, and the activated bacterial solution was obtained.

[0100] 0.1 mL of activated bacterial solution of Escherichia coli, Staphylococcus aureus, Bacillus subtilis and Candida albicans were respectively evenly coated on broth agar plates, and after drying for several minutes, 4 holes were punched with a sterile steel pipe, and 0.1 mL of calamine lotion of Examples 1-3 and Comparative Examples 1-5 were respectively injected. Broth agar plates of Escherichia coli, Staphylococcus aureus and Bacillus subtilis were cultured at 37°C, and broth agar plates of Candida albicans were cultured at 28°C. After 24 hours, the diameter of the inhibition zone was measured with a ruler, and 0.1 mL of distilled water was used as a negative control. The specific results are shown in Table 2.

[0101] Table 2 Diameter of inhibition zone of microorganisms by calamine lotion in different embodiments and comparative examples (mm)

[0102] Group Escherichia coli Staphylococcus aureus Bacillus subtilis Candida albicans Example 1 20.2 25.6 19.5 22.6 Example 2 19.5 23.4 19.3 21.3 Example 3 19.7 24.7 18.9 22.1 Comparative Example 1 17.5 21.8 16.5 18.4 Comparative Example 2 10.2 13.2 7.3 8.7 Comparative Example 3 17.9 19.6 15.4 18.8 Comparative Example 4 17.0 19.1 14.8 18.2 Comparative Example 5 16.4 18.3 13.9 17.5 Negative control 0 0 0 0

[0103] It can be seen from the experimental data of Table 2 that the calamine lotion prepared by using Examples 1-3 has a strong antibacterial effect. According to the data of Example 1 and Comparative Examples 1-5, the calamine powder, zinc oxide, vitamin B6, borneol and Chinese medicine extract in the calamine lotion of the present invention have a positive antibacterial effect, which also illustrates that calamine powder, zinc oxide, vitamin B6, borneol and Chinese medicine extract have a synergistic effect in antibacterial. The data comparison of Example 1 and Comparative Example 5 shows that the calamine lotion prepared by using the composite enzyme of serrapeptase and snail protease for enzymolysis has a stronger antibacterial effect than other enzymes.

[0104] Experimental Example 3

[0105] Clinical trials

[0106] (1) Case selection

[0107] Diagnostic criteria: The skin of the groin, perineum, and perianal area presents with redness and erosion, accompanied by small blisters, desquamation, and itching; local skin secretions, Gram staining of smears, and three microscopic examinations reveal pathogenic fungi.

[0108] Inclusion criteria: All patients met the diagnostic criteria for fungal skin infection, had clear symptoms, gave informed consent for the study, followed the doctor's instructions for medication, and came to the hospital for regular follow-up visits.

[0109] Exclusion criteria: patients who have used other antifungal drugs recently; patients with cognitive or communication disorders; patients with liver, kidney and other systemic diseases; women who are pregnant or lactating; and patients with a history of clinical drug allergy.

[0110] According to the case selection criteria, 100 volunteers with skin fungal infections that met the diagnostic criteria and inclusion criteria were selected and divided into an embodiment group and a control group according to the average, with 50 cases in each group.

[0111] In the embodiment group, there were 25 males and 25 females, aged 18-55 years old, with an average age of 38.1 years old. The fungal infection sites were perineum in 22 cases, perianal area in 15 cases, and groin in 13 cases.

[0112] There were 23 males and 27 females in the control group, aged 20-46 years old with an average age of 37.8 years old. The sites of fungal infection were perineum in 23 cases, perianal area in 14 cases, and groin in 13 cases.

[0113] There was no significant difference in the basic information (gender, age, and fungal infection site) between the two groups of patients (P>0.05), and they were comparable.

[0114] (2) Treatment methods

[0115] Example group: First wash the affected area with water, dip a clean cotton swab in an appropriate amount of Example 1 calamine lotion, and gently apply it to the affected area, avoiding rubbing the skin. The thickness of the application should be enough to cover the skin lesion, and a thin layer can be applied once a day.

[0116] Control group: First clean the affected area with water, then use a clean cotton swab to take an appropriate amount of Pervisone ointment and gently apply it to the affected area to allow the Pervisone ointment to fully penetrate the skin, twice a day.

[0117] (3) Criteria for determining treatment efficacy

[0118] Significantly effective: symptoms disappeared, skin lesions healed, and fungal tests repeated 3 times showed negative results;

[0119] Effective: Compared with before treatment, symptoms and signs were relieved, the skin lesions were reduced, and the fungal microscopic examination was negative after three times.

[0120] Ineffective: Compared with before treatment, the patient's skin symptoms and signs did not improve, the skin lesions did not recover, and the fungal microscopic examination results were positive after three repeated tests.

[0121] Total effective rate (%) = (markedly effective + effective) ÷ total number of cases × 100%.

[0122] Average time to significant effect (d) = total time for significant effect in patients with significant effect ÷ number of significant effect cases.

[0123] (4) Results

[0124] The patients in the embodiment group and the control group were treated for 7 days, and the efficacy was evaluated according to the treatment effect judgment criteria, and the significant effect was statistically analyzed.

[0125] The specific results are shown in Table 3.

[0126] Table 3 Results of efficacy evaluation of the embodiment group and the control group

[0127]

[0128] As shown in Table 3, the effective rate of using the calamine lotion of Example 1 of the present invention to treat fungal skin diseases is as high as 98%, which has excellent therapeutic effect compared with the conventional fungal skin disease treatment drug pevisone ointment. In addition, the calamine lotion of the present invention can significantly shorten the time to show effect compared with pevisone ointment.

[0129] 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. An antibacterial calamine lotion, characterized in that, The invention comprises the following raw materials in parts by weight: 10-20 parts of calamine powder, 10-20 parts of zinc oxide, 0.5-2 parts of vitamin B6, 0.5-1 parts of borneol, 0.3-0.8 parts of sodium starch octenylsuccinate, 0.5-2 parts of polyvinyl alcohol PVA-2488 and 60-70 parts of traditional Chinese medicine extract; the traditional Chinese medicine extract is obtained by enzymolysis of phellodendron amurense, honeysuckle and purslane.

2. The antibacterial calamine lotion according to claim 1, characterized in that The calamine powder is obtained by washing, calcining and grinding calamine; the preparation method of the calcined calamine comprises: calcining calamine at a temperature of 300-400°C for 1-3h, mixing and stirring with 8-12 times the weight of acetic acid, decanting the upper layer of water suspension, continuing to calcine the residue, combining the suspension, standing overnight to clarify, and discarding the upper layer of clarified liquid.

3. The antibacterial calamine lotion according to claim 2, characterized in that The mass fraction of the acetic acid is 3%-5%.

4. The antibacterial calamine lotion according to claim 2, characterized in that: The total number of calcinations is 5-8 times.

5. The antibacterial calamine lotion according to claim 1, characterized in that: The particle sizes of the calamine powder and zinc oxide are both 1-10 μm.

6. The antibacterial calamine lotion according to claim 1, characterized in that: The preparation method of the Chinese medicine extract comprises: crushing Phellodendron amurense, honeysuckle and purslane, mixing and soaking them with water, adding a composite enzyme, performing enzymolysis for 30-60 minutes at 40-50° C. and pH 6-7, and filtering to obtain the Chinese medicine extract; the composite enzyme is composed of serrapeptase and snail protease in a weight ratio of (1-3):(3-8).

7. The antibacterial calamine lotion according to claim 6, characterized in that: The weight ratio of the phellodendron, honeysuckle and purslane is 1-3:1-3:1-3; the weight ratio of the total weight of the phellodendron, honeysuckle and purslane to water is 1:6-10; and the added amount of the complex enzyme is 0.5%-3% of the total weight of the phellodendron, honeysuckle and purslane.

8. The method for preparing the antibacterial calamine lotion according to any one of claims 1 to 7, characterized in that: include: Firstly, 5-20 parts of the traditional Chinese medicine extract are used to fully swell the polyvinyl alcohol PVA-2488, and then the polyvinyl alcohol PVA-2488 is mixed with calamine powder, zinc oxide, vitamin B6, borneol, sodium starch octenylsuccinate and the remaining traditional Chinese medicine extract to obtain the antibacterial calamine lotion.

9. Use of the antibacterial calamine lotion according to any one of claims 1 to 7 or the antibacterial calamine lotion prepared by the method according to claim 8 in preparing a drug for treating fungal skin diseases.

10. The use according to claim 9, characterized in that: The calamine lotion has the effects of antibacterial and relieving skin itching.

Images