Tibetan medicine bath component with antibacterial effect and preparation method of Tibetan medicine bath component

Abstract

The invention discloses a Tibetan medicine bath component with an antibacterial effect and a preparation method of the Tibetan medicine bath component, and belongs to the field of biological medicine preparations. The component takes 18-25 parts of Wuwei mannan fermented dry powder as a core, is matched with 3-5 parts of modified beta-cyclodextrin and 2-4 parts of modified chitosan, and can further comprise an acid agent, an alkaline agent, a filler, a lubricant, a dispersing aid and a skin protective agent. Wherein the modified beta-cyclodextrin can specifically adsorb harmful components such as methcathinone and cathinone generated in the fermentation process, and meanwhile, adsorption of fat-soluble effective components is reduced; modified chitosan and modified beta-cyclodextrin form a stable ternary complex through hydrophobic interaction and hydrogen bonds, a physical barrier is formed, and absorption of cathinone and cathinone is hindered to a certain extent. According to the preparation method, the stability of the components is ensured through step-by-step granulation and mixed tabletting. The invention effectively reduces the risk of harmful component absorption, and is suitable for skin care and bacteriostasis scenes.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of biological pharmaceutical preparations, in particular to a Tibetan bath component with bacteriostatic efficacy and a preparation method thereof. BACKGROUND

[0002] The fermentation technology of traditional Chinese medicine can be traced back to ancient brewing technology, mainly relying on natural fermentation. With the development of modern technology, the controllability and stability of medicine fermentation have been improved. The effective components of traditional Chinese medicine are mostly in the cell sap and are wrapped by the cell wall. Fermentation is to use various enzymes produced by microorganisms to act on the medicine itself, on the one hand to promote the dissolution of effective components, and on the other hand to promote the decomposition of macromolecular effective substances and improve the bioavailability. However, microorganisms can also produce other enzymes to decompose effective components to produce secondary products, such as the degradation of ephedrine to methcathinone and further to cathinone as described in the paper “Fermentation preparation, dosage form screening and transdermal absorption effect research of Tibetan medicine Wumei Ganlu”. SUMMARY

[0003] In order to solve the above problems, the purpose of the present application is to provide a Tibetan bath component with bacteriostatic efficacy and a preparation method thereof, so as to solve the problem of methcathinone and cathinone contained in the Tibetan bath component prepared by fermenting the medicine.

[0004] The present application provides a Tibetan bath component with bacteriostatic efficacy, comprising the following components in parts by weight: 18-25 parts of fermented dry powder of Wumei Ganlu, 3-5 parts of modified β-cyclodextrin, 2-4 parts of modified chitosan, 16-22 parts of acid agent, 26-36 parts of alkali agent, and 2-5 parts of lubricant.

[0005] The modified β-cyclodextrin is benzoyl-modified modified β-cyclodextrin.

[0006] The modified chitosan is carboxymethyl and octanoyl-modified modified chitosan.

[0007] The acid agent is fumaric acid, the alkali agent is sodium bicarbonate, and the lubricant is polyethylene glycol.

[0008] Further, the Tibetan bath component further comprises the following components in parts by weight: 8-12 parts of filler, 3-5 parts of dispersing aid, and 1-2 parts of skin protectant.

[0009] The dispersing aid is a nano-silica gel carrier, and the filler is microcrystalline cellulose.

[0010] The skin protectant comprises allantoin and panthenol, and the mass ratio of allantoin to panthenol is 1:0.5.

[0011] Further, the modified β-cyclodextrin is prepared by the following method:

[0012] S11, β-cyclodextrin is added to N, N-dimethylformamide at 60°C and magnetically stirred until completely dissolved to obtain solution A;

[0013] S12, benzoyl chloride and triethylamine are added to solution A, and constant temperature reaction is carried out at 60°C for 4h to obtain mixed solution B;

[0014] S13, the mixed solution B is poured into ice water and stirred until precipitation is precipitated, and the precipitate is collected by suction filtration, washed with distilled water for 3 times, and vacuum dried to obtain modified β-cyclodextrin.

[0015] Further, the modified chitosan is prepared by the following method:

[0016] S21, chitosan is added to an acetic acid solution with a mass fraction of 1%, and stirred at room temperature until completely dissolved to obtain solution C;

[0017] S22, sodium chloroacetate and sodium hydroxide solution are sequentially added to solution C to adjust the pH to 8-9, and carboxymethylation is carried out at 60°C for 4h;

[0018] S23, cooling to room temperature, adding octanoyl chloride, and carrying out hydrophobic modification at room temperature for 2h;

[0019] S24, adjusting the pH to 7 with dilute hydrochloric acid, dialyzing with a dialysis bag with a molecular weight cutoff of 3000Da for 48h, replacing the water every 8h, and freeze-drying to obtain modified chitosan.

[0020] Further, the fermented dry powder of five-flavor ginseng is prepared by the following method:

[0021] S31, five-flavor ginseng medicinal materials and water are mixed according to a dosage ratio of 1:4-5kg / L, soaked at a water temperature of 35-37°C for 8-10h, boiled until the water is evaporated to half of the original water amount, and cooled;

[0022] S32, adding wine starter, the mass ratio of wine starter to five-flavor ginseng medicinal materials being 8-10:1000, and fermenting at 28-33°C for 20-24h;

[0023] S33, adding water with a weight of three times that of the five-flavor ginseng medicinal materials to leach the medicinal liquid, pouring out the medicinal liquid after 3-5h, repeating twice; mixing the two obtained medicinal liquids, concentrating by rotary evaporation under reduced pressure for 68-72h, and drying to obtain fermented dry powder of five-flavor ginseng.

[0024] Further, the raw materials of the fermented dry powder of five-flavor ginseng are juniperus, myricaria, artemisia, rhododendron, and heracleum, and the mass ratio is 1:1:1:1:1.

[0025] A preparation method of a Tibetan bath component with bacteriostatic efficacy, comprising the following steps:

[0026] S1, the five flavors of fermented dry powder, modified β-cyclodextrin, modified chitosan, nano silica gel carrier, polyethylene glycol, fumaric acid, sodium bicarbonate, microcrystalline cellulose 80-100 mesh sieve; mixed with allantoin and panthenol according to the mass ratio 1:0.5, prepared skin protectant premix;

[0027] S2, the five flavors of fermented dry powder, modified β-cyclodextrin, modified chitosan, nano silica gel carrier, polyethylene glycol were mixed with three-dimensional mixer for 15-20 min, and the active mixed powder was obtained;

[0028] S3, the fumaric acid, half of the microcrystalline cellulose and half of the active mixed powder were mixed, 50% ethanol was added to prepare soft material, which was sieved through 16 mesh sieve and vacuum dried to obtain acid phase granules; sodium bicarbonate, the remaining microcrystalline cellulose and the remaining active mixed powder were mixed, and the base phase granules were prepared by the same method;

[0029] S4, the acid phase granules, the base phase granules and the skin protectant premix were mixed for 10-15 min, and the Tibetan medicine bath component was obtained by tabletting with a tablet press.

[0030] It should be noted that the 50% ethanol in step S3 contains water. If the granulation is not separated, the fumaric acid and sodium bicarbonate will react in advance during the mixing process, resulting in insufficient CO2 production during use and affecting the dispersion efficiency. The stability of the granules after separate granulation is improved, and uniform dispersion can be achieved during subsequent mixing, ensuring that the proportions of each component in the final product are consistent.

[0031] The mechanism of the above core components is as follows:

[0032] The modified β-cyclodextrin has specific matching with the molecular structure of methcathinone and cathinone through the hydrophobic structure of benzoyl, and preferentially adsorbs the two harmful ingredients through hydrophobic interaction; at the same time, the steric hindrance effect of this group weakens the adsorption of liposoluble active ingredients (such as quercetin), avoiding the loss of active ingredients due to non-specific binding.

[0033] The modified chitosan takes octanoyl as the hydrophobic group, and the octyl chain can form a hydrophobic microzone with the benzoyl of the modified β-cyclodextrin through hydrophobic interaction, providing a basis for the combination of the two modified substances; the carboxyl groups on the introduced carboxymethyl and the amino and hydroxyl groups of chitosan itself act as hydrogen bond donors / acceptors, forming multiple hydrogen bonds with the hydroxyl groups of the modified β-cyclodextrin, further stabilizing the combination of the two.

[0034] The modified β-cyclodextrin (after adsorbing methcathinone / cathinone) and the modified chitosan form a ternary complex of "modified β-cyclodextrin-harmful components-modified chitosan" through the above-mentioned hydrophobic interaction and hydrogen bond, and the molecular weight of the ternary complex is significantly increased. The small molecular weight of methcathinone and cathinone itself can be absorbed through the pores of the stratum corneum; and the large molecular weight of the ternary complex is difficult to pass through the physical barrier of the stratum corneum because the volume of the ternary complex is much larger than the pore of the stratum corneum, thereby spatially hindering the transdermal absorption of harmful components.

[0035] Compared with the prior art, the present application has the following beneficial effects:

[0036] 1. The present application reduces the absorption of quercetin active components by adding benzoyl-modified β-cyclodextrin to adsorb methcathinone and cathinone in the bath, overcoming the shortcomings of the prior art that although β-cyclodextrin can adsorb methcathinone and cathinone, it also adsorbs quercetin active components, thereby reducing the efficacy of the components of the Tibetan bath.

[0037] 2. The present application adds carboxymethyl, octanoyl-modified chitosan, the octyl chain forms a hydrophobic microzone with benzoyl, the amino, hydroxyl, and carboxyl groups of the modified chitosan form multiple hydrogen bonds with the hydroxyl groups of the modified β-cyclodextrin, and finally form a stable ternary complex, which combines the small molecular weight of the modified β-cyclodextrin-methcathinone / cathinone into a large molecular weight ternary complex, thereby hindering the absorption of cathinone and cathinone to a certain extent. BRIEF DESCRIPTION OF DRAWINGS

[0038] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings, wherein:

[0039] Figure 1 is a preparation process flow chart of a Tibetan bath component with bacteriostatic efficacy. DETAILED DESCRIPTION

[0040] The technical solutions in the embodiments of the present application will be described below. The described embodiments are only some of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0041] Embodiment 1

[0042] The present embodiment discloses a Tibetan bath component with bacteriostatic efficacy, which comprises the following components in parts by weight:

[0043] 20 parts of five-flavor fermented dry powder, 4 parts of modified β-cyclodextrin, 3 parts of modified chitosan, 17.2 parts of acid agent, 34.4 parts of alkali agent, 10 parts of filler, 4 parts of dispersion aid, 3.5 parts of lubricant, 1.5 parts of skin protective agent;

[0044] The modified β-cyclodextrin is benzoyl-modified modified β-cyclodextrin.

[0045] The modified chitosan is carboxymethyl, octanoyl-modified modified chitosan.

[0046] The acid agent is fumaric acid, the alkali agent is sodium bicarbonate, and the lubricant is polyethylene glycol.

[0047] The dispersion aid is nano silica gel carrier, and the filler is microcrystalline cellulose.

[0048] The skin protective agent includes allantoin and panthenol, and the mass ratio of allantoin to panthenol is 1:0.5.

[0049] The modified β-cyclodextrin is prepared by the following method:

[0050] S11, β-cyclodextrin is added to N,N-dimethylformamide and magnetically stirred at 60°C until completely dissolved to obtain solution A;

[0051] S12, benzoyl chloride and triethylamine are added to solution A, and the reaction is carried out at 60°C for 4h to obtain mixture B;

[0052] S13, mixture B is poured into ice water and stirred until precipitation is precipitated, and the precipitate is collected by suction filtration, washed with distilled water for 3 times, and vacuum dried to obtain modified β-cyclodextrin.

[0053] The modified chitosan is prepared by the following method:

[0054] S21, chitosan is added to a 1% acetic acid solution and stirred at room temperature until completely dissolved to obtain solution C;

[0055] It should be noted that the molecular weight of the chitosan is 8000-12000 Da.

[0056] S22, sodium chloroacetate and sodium hydroxide solution are added to solution C in sequence to adjust the pH to 8-9, and the carboxymethylation is carried out at 60°C for 4h;

[0057] S23, cool to room temperature, add octanoyl chloride, and react at room temperature for 2h to perform hydrophobic modification;

[0058] S24, adjust the pH to 7 with dilute hydrochloric acid, dialyze with a dialysis bag with a molecular weight cutoff of 3000 Da for 48h with distilled water, and change the water every 8h, and then freeze-dry to obtain modified chitosan.

[0059] The five-flavor Ganlu fermented dry powder is prepared by the following method:

[0060] S31, the five-flavor Ganlu medicinal materials and water are mixed according to the dosage ratio of 1:4-5 kg / L, soaked at water temperature of 35-37℃ for 8-10h, boiled until the water is evaporated to half of the original water volume, and cooled;

[0061] S32, add wine starter, the mass ratio of wine starter to five-flavor Ganlu medicinal materials is 8-10:1000, and ferment at 28-33℃ for 20-24h;

[0062] S33, add water with three times the mass of the five-flavor Ganlu medicinal materials to make the medicinal liquid leach out, pour out the medicinal liquid after 3-5h, repeat twice; mix the two obtained medicinal liquids, concentrate under reduced pressure for 68-72h, and dry to obtain the five-flavor Ganlu fermented dry powder.

[0063] The raw materials of the five-flavor Ganlu fermented dry powder are Thuja sutchuenensis, Myricaria paxiflora, Artemisia sieversiana, Rhododendron anthopogon, and Ephedra przewalskii, and the mass ratio is 1:1:1:1:1.

[0064] A preparation method of a Tibetan bath component with bacteriostatic efficacy, comprising the following steps:

[0065] S1, screen the five-flavor Ganlu fermented dry powder, modified β-cyclodextrin, modified chitosan, nano-silica carrier, polyethylene glycol, fumaric acid, sodium bicarbonate, and microcrystalline cellulose through an 80-100 mesh screen; mix allantoin and panthenol according to the mass ratio of 1:0.5 to prepare a skin protectant premix;

[0066] S2, mix the five-flavor Ganlu fermented dry powder, modified β-cyclodextrin, modified chitosan, nano-silica carrier, and polyethylene glycol in a three-dimensional mixer for 15-20min to obtain an active mixed powder;

[0067] S3, mix half of the microcrystalline cellulose and half of the active mixed powder with fumaric acid, add 50% ethanol to prepare a soft material, pass it through a 16 mesh screen, and vacuum dry to pass through an 18 mesh screen to obtain acid phase granules; mix the remaining microcrystalline cellulose and the remaining active mixed powder with sodium bicarbonate, and prepare base phase granules by the same method;

[0068] S4, mix the acid phase granules, the base phase granules, and the skin protectant premix for 10-15min, and press tablets by a tablet press to obtain the Tibetan bath component.

[0069] Example 2

[0070] The embodiment discloses a Tibetan bath component with bacteriostatic efficacy, which comprises the following components in parts by weight:

[0071] 18 parts of five-flavor fermented dry powder of mannitol, 3 parts of modified β-cyclodextrin, 2 parts of modified chitosan, 16 parts of fumaric acid, 26 parts of sodium bicarbonate, 8 parts of microcrystalline cellulose, 3 parts of nano-silica gel carrier, 2 parts of polyethylene glycol, 0.67 parts of allantoin, and 0.33 parts of panthenol.

[0072] The preparation method of the modified β-cyclodextrin and the modified chitosan of the present embodiment is consistent with that of Embodiment 1. The preparation method of the Tibetan medicine bath component with bacteriostatic efficacy of the present embodiment is consistent with that of Embodiment 1.

[0073] Embodiment 3

[0074] The present embodiment discloses a Tibetan medicine bath component with bacteriostatic efficacy, which comprises the following components in parts by weight:

[0075] 25 parts of five-flavor fermented dry powder of mannitol, 5 parts of modified β-cyclodextrin, 4 parts of modified chitosan, 22 parts of fumaric acid, 36 parts of sodium bicarbonate, 12 parts of microcrystalline cellulose, 5 parts of nano-silica gel carrier, 5 parts of polyethylene glycol, 1.33 parts of allantoin, and 0.67 parts of panthenol.

[0076] The preparation method of the modified β-cyclodextrin and the modified chitosan of the present embodiment is consistent with that of Embodiment 1. The preparation method of the Tibetan medicine bath component with bacteriostatic efficacy of the present embodiment is consistent with that of Embodiment 1.

[0077] Embodiment 4

[0078] The present embodiment discloses a Tibetan medicine bath component with bacteriostatic efficacy, which comprises the following components in parts by weight:

[0079] 21.5 parts of five-flavor fermented dry powder of mannitol, 4 parts of modified β-cyclodextrin, 3 parts of modified chitosan, 19 parts of fumaric acid, 31 parts of sodium bicarbonate, 10 parts of microcrystalline cellulose, 4 parts of nano-silica gel carrier, 3.5 parts of polyethylene glycol, 1 part of allantoin, and 0.5 part of panthenol.

[0080] The preparation method of the modified β-cyclodextrin and the modified chitosan of the present embodiment is consistent with that of Embodiment 1. The preparation method of the Tibetan medicine bath component with bacteriostatic efficacy of the present embodiment is consistent with that of Embodiment 1.

[0081] Comparative Example 1

[0082] Based on Embodiment 1, the difference between the present comparative example and Embodiment 1 is that the present comparative example does not add modified β-cyclodextrin.

[0083] Comparative Example 2

[0084] Based on Embodiment 1, the difference between the present comparative example and Embodiment 1 is that the present comparative example does not add modified chitosan.

[0085] Comparative Example 3

[0086] Based on Example 1, different from Example 1, this comparative example uses 4 parts of β-cyclodextrin instead of modified β-cyclodextrin.

[0087] Comparative Example 4

[0088] Based on Example 1, different from Example 1, this comparative example uses 3 parts of chitosan instead of modified chitosan.

[0089] Comparative Example 5

[0090] Based on Example 1, different from Example 1, this comparative example uses 4 parts of β-cyclodextrin instead of modified β-cyclodextrin and 3 parts of chitosan instead of modified chitosan.

[0091] Test Example 1

[0092] According to the weight fraction ratio of the two modified substances or unmodified substitute substances in Examples 1-4 and Comparative Examples 1-5, nine kinds of adsorption compositions were prepared. 3 mg of adsorption composition of different groups was taken, 3 mL of quercetin standard solution with an initial concentration of 20 μg / L and 3 mL of cathinone standard solution with an initial concentration of 20 μg / L were added, and the mixture was fully oscillated at 40°C and 180 rpm for 30 min. The above steps were repeated by replacing cathinone with methcathinone. In the control, no sample of the adsorbent to be tested was added, and the other operations were the same. Then, solid-liquid separation was carried out by an external magnetic field, and the supernatant was filtered through a 0.22 μm filter membrane. The filter membrane was used to analyze the residual amount of methcathinone, and LC-MS / MS was used to detect the content of methcathinone, cathinone and quercetin in the solution. The adsorption rates of methcathinone, cathinone and quercetin of each group were calculated and recorded, and the results are shown in Table 1.

[0093] Adsorption rate (%) = (initial concentration - residual mass concentration) / initial concentration x 100%

[0094] Wherein the initial concentration is the concentration of methcathinone, cathinone or quercetin in the initial solution, and the residual mass concentration is the concentration of residual methcathinone, cathinone or quercetin in the supernatant after adsorption actually detected by high performance liquid chromatography.

[0095] Table 1 Adsorption effect detection of methcathinone, cathinone and quercetin

[0096]

[0097]

[0098] Table 1 is the results of the adsorption test of the examples and the comparative examples. The adsorption rate of methcathinone in examples 1-4 is 74.9%-77.3%, and the adsorption rate of cathinone is 72.4%-75.6%, both of which maintain a high level; while the adsorption rate of quercetin is only 11.9%-13.1%, which is significantly lower than the adsorption of the two harmful ingredients. The results show that the adsorption composition in the examples can efficiently and specifically adsorb harmful ingredients while minimizing the adsorption of the effective ingredient quercetin. The adsorption rate of comparative example 1 is the lowest, indicating that modified β-cyclodextrin is the basic core of adsorbing harmful ingredients, and even if other components (such as modified chitosan) are present, the effective adsorption cannot be achieved. The adsorption rate of comparative example 2 is higher than that of comparative example 1, but still lower than that of the examples, indicating that modified chitosan is not the basic adsorbent, but enhances the adsorption effect through synergistic action with modified β-cyclodextrin, and the absence of it will lead to a decrease in adsorption capacity. The adsorption rate of methcathinone and cathinone in comparative examples 3-5 (30.1%-62.4%) is significantly lower than that in examples (72.4%-77.3%), among which the adsorption rate of comparative example 5 (none of which is modified) is the lowest (30.1%-32.4%), which is only about 40% of the examples; the adsorption rate of quercetin in comparative examples 3 and 5 (26.7%-27.1%) is more than twice that of examples (11.9%-13.1%), indicating that unmodified substances will non-specifically adsorb effective ingredients, destroying the efficacy retention. The data of the above comparative examples 1-5 prove that the benzoyl modification of β-cyclodextrin and the carboxymethyl / octanoyl modification of chitosan are the core. Unmodified substances not only cannot specifically target adsorb harmful ingredients, but also will lead to a decrease in adsorption efficiency due to low structural matching or lack of synergistic action sites, while increasing non-specific adsorption of effective ingredients.

[0099] Test Example 2

[0100] The artificial skin membrane (Strat-M membrane) was used as the permeation membrane, and the bath components of examples 1-4 and comparative examples 1-5 were prepared into standard concentration bath solution at a mass-volume ratio of 1:4000 g / mL, placed in the supply chamber of Franz cell, the receiving chamber was filled with PBS buffer with pH 7.4 and placed on a constant temperature magnetic stirrer with stirring speed of 500 r / min to maintain water temperature at 37±0.5℃, the donor chamber was added with bath solution containing each component, 4mL samples were taken at 0.5, 1, 2, 4, 6, 8, 12 hours, and at the same time, an equal amount of fresh PBS buffer was supplemented, the cumulative penetration of methcathinone and cathinone was detected by LC-MS / MS and recorded, and the corresponding penetration barrier rate was calculated, and a control group without components was set up for comparison. The results are shown in Table 2.

[0101] Penetration barrier rate (%) = (cumulative penetration of control group-cumulative penetration of experimental group) / cumulative penetration of control group x 100%

[0102] Wherein, the cumulative permeation amount of methcathinone and cathinone through Strat-M membrane (ng / cm2) in the control group is without the medicated bath components, and the cumulative permeation amount of methcathinone and cathinone through Strat-M membrane (ng / cm 2 ) in the experimental group is with the medicated bath components.

[0103] Table 2: Results of skin permeation rate detection of methcathinone and cathinone

[0104]

[0105]

[0106] Table 2 is the results of skin permeability determination test of examples and comparative examples. The cumulative permeation amount of methcathinone in examples 1-4 is 2.8-4.8 ng / cm 2 , and the penetration barrier rate is 83.3%-90.2%; the cumulative permeation amount of cathinone is 3.1-5.3 ng / cm 2 , and the barrier rate is 83.0%-90.1%. The high barrier rate indicates that the ternary complex formed by the hydrophobic interaction and hydrogen bond between the modified β-cyclodextrin and the modified chitosan can significantly reduce the transdermal absorption of harmful ingredients through the physical barrier effect (large molecular structure difficult to penetrate the skin membrane). The low barrier rate of comparative examples 3, 4 and 5 proves that the unmodified β-cyclodextrin and chitosan cannot achieve high-efficiency barrier, which indicates that benzoyl and carboxymethyl / octanoyl are the key to form stable ternary complex. The barrier rates of comparative example 1 and comparative example 2 are much lower than those of the example group, which indicates that the two modified substances need to work together to achieve the best barrier effect, and a single component cannot be replaced.

[0107] Test Example 3

[0108] The medicated bath component particles prepared in examples 1-4 and comparative examples 1-5 were added to 40℃ water at a mass-volume ratio of 1:4000 g / mL and reacted for 30 min. Referring to 2.1.7.2 of the Technical Specifications for Disinfection (2017 edition), the bacteriostatic ring test was carried out to investigate the bacteriostatic ability of the medicated bath component particles on pathogenic bacteria such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans, with the bacteriostatic ring diameter as the index. The results are shown in Table 3.

[0109] Table 3: Results of bacteriostatic ring diameter determination

[0110]

[0111]

[0112] Table 3 is the results of the antibacterial test of the examples and the comparative examples, examples 1-4 all show good antibacterial effect, the inhibition zone diameter is generally in the range of 15-19mm; example 3 is the best, which is related to the highest concentration of five kinds of sweet fermented dry powder and modified components; the antibacterial effect on gram-positive bacteria (staphylococcus aureus) is the strongest, and the antibacterial effect on fungi (candida albicans) is relatively weak; the antibacterial effect of comparative example 1 (without modified β-cyclodextrin) is the worst, which shows that the modified β-cyclodextrin has important contribution to the antibacterial effect; the antibacterial effect of comparative example 2 (without modified chitosan) and comparative example 4 (unmodified chitosan) is moderate, but still lower than the example group; the effect of comparative example 3 (unmodified β-cyclodextrin) and comparative example 5 (two unmodified components) is poor.

[0113] The test results show that the Tibetan medicine bath component containing modified β-cyclodextrin and modified chitosan has good antibacterial effect on common pathogenic bacteria, and the antibacterial mechanism is mainly realized by reducing the interference of harmful components, maintaining the activity of effective components and the antibacterial effect of chitosan itself.

[0114] The above only describes the preferred embodiments of the present application and is not intended to limit the protection scope of the present application. Any modification, equivalent replacement and improvement made by any person skilled in the art within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A Tibetan bath component having antibacterial efficacy, characterized in that, The components include the following components by weight: 18-25 parts of five-flavor Ganlu fermented dry powder, 3-5 parts of modified β-cyclodextrin, 2-4 parts of modified chitosan, 16-22 parts of acid agent, 26-36 parts of alkali agent, 2-5 parts of lubricant; The modified β-cyclodextrin is benzoyl-modified modified β-cyclodextrin; The modified chitosan is carboxymethyl, octanoyl-modified modified chitosan; The acid agent is fumaric acid, the alkali agent is sodium bicarbonate, and the lubricant is polyethylene glycol.

2. The Tibetan bath component having bacteriostatic efficacy according to claim 1, characterized in that, It also includes the following components by weight: 8-12 parts of filler, 3-5 parts of dispersion aid, and 1-2 parts of skin protectant; The dispersion aid is a nano-silica gel carrier, and the filler is microcrystalline cellulose; The skin protectant includes allantoin and panthenol, and the mass ratio of allantoin to panthenol is 1:0.

5.

3. The Tibetan bath composition having bacteriostatic efficacy as claimed in claim 1, wherein, The modified β-cyclodextrin is prepared by the following method: S11, β-cyclodextrin is added to N,N-dimethylformamide and stirred magnetically at 60°C until completely dissolved to obtain solution A; S12, benzoyl chloride and triethylamine are added to solution A, and constant temperature reaction is carried out at 60°C for 4h to obtain mixed solution B; S13, pour mixed solution B into ice water and stir until precipitation is precipitated, collect the precipitate by suction filtration, wash with distilled water for 3 times, and vacuum dry to obtain modified β-cyclodextrin.

4. The Tibetan bath composition having bacteriostatic efficacy as claimed in claim 1, wherein, The modified chitosan is prepared by the following method: S21, chitosan is added to a 1% acetic acid solution, stirred at room temperature until completely dissolved to obtain solution C; S22, sodium chloroacetate and sodium hydroxide solution are added to solution C in sequence to adjust pH to 8-9, and carboxymethylation is carried out at 60°C for 4h; S23, cool to room temperature, add octanoyl chloride, and carry out hydrophobic modification at room temperature for 2h; S24, adjust pH to 7 with dilute hydrochloric acid, dialyze with a dialysis bag with a molecular weight cutoff of 3000 Da using distilled water for 48h, replace the water every 8h, and freeze-dry to obtain modified chitosan.

5. The Tibetan bath composition having bacteriostatic efficacy as claimed in claim 1, wherein, The five-flavor Ganlu fermented dry powder is prepared by the following method: S31, mix five-flavor Ganlu medicinal materials and water according to a dosage ratio of 1:4-5 kg / L, soak at water temperature of 35-37°C for 8-10h, boil until the water is evaporated to half of the original water volume, and cool; S32, add wine starter, and the mass ratio of wine starter to five-flavor Ganlu medicinal materials is 8-10:1000, ferment at 28-33°C for 20-24h; S33, add water with a volume of three times the mass of the five-flavor Ganlu medicinal materials to leach the medicinal liquid, pour out the medicinal liquid after 3-5h, repeat twice, mix the obtained medicinal liquids, concentrate under reduced pressure by rotary evaporation for 68-72h, and dry to obtain five-flavor Ganlu fermented dry powder.

6. The Tibetan bath composition having bacteriostatic efficacy as claimed in claim 5, wherein, The five-flavor Ganlu medicinal materials are Thuja sutchuenensis, Myricaria paxiflora, Artemisia sieversiana, Rhododendron anthopogon, and Ephedra przewalskii, and the mass ratio is 1:1:1:1:

1.

7. A process for the preparation of the Tibetan bath component having bacteriostatic efficacy as claimed in any one of claims 1 to 6, wherein, The steps include: S1, pass five-flavor Ganlu fermented dry powder, modified β-cyclodextrin, modified chitosan, nano-silica gel carrier, polyethylene glycol, fumaric acid, sodium bicarbonate, microcrystalline cellulose through an 80-100 mesh sieve; mix allantoin and panthenol according to a mass ratio of 1:0.5 to prepare a skin protectant premix; S2, mix the five flavors of fermented dry powder, modified β-cyclodextrin, modified chitosan, nano-silica gel carrier and polyethylene glycol with a three-dimensional mixer for 15-20 min to obtain an active mixed powder; S3, mix half of the microcrystalline cellulose and half of the active mixed powder with fumaric acid, add 50% ethanol to make a soft material, pass through a 16-mesh sieve, vacuum dry and pass through an 18-mesh sieve to obtain acid-phase granules; mix the remaining microcrystalline cellulose and the remaining active mixed powder with sodium bicarbonate, and prepare base-phase granules in the same way; S4, mix the acid-phase granules, base-phase granules and skin protectant premix for 10-15 min, and press tablets with a tablet press to obtain the Tibetan medicine bath component.

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