A traditional Chinese medicine composition and a pharmaceutical preparation for treating vaginitis in women

Abstract

The present application relates to the technical field of traditional Chinese medicine preparation, and particularly relates to a traditional Chinese medicine composition and a medicine preparation for treating female vaginitis. The traditional Chinese medicine composition comprises Sophora flavescens, Phellodendri chinensis, Isatidis radix, Cnidii fructus, Punica granatum, alum and borneol. The traditional Chinese medicine composition and the medicine preparation provided by the present application have the effects of clearing heat and drying dampness, killing insects and relieving itching, and are particularly suitable for treating female vaginitis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, and in particular to a traditional Chinese medicine composition and pharmaceutical preparation for treating female vaginitis. Background Technology

[0002] Vaginitis is the most common vaginal infection among women of reproductive age. Vaginitis includes bacterial vaginosis, fungal vaginitis, trichomoniasis, and nonspecific vaginitis. It has been reported that the incidence of vaginitis in healthy women is as high as 18.9%. Clinical symptoms of vaginitis mainly include increased thin, frothy vaginal discharge and vulvar itching, which may be accompanied by burning sensation and pain. It can also lead to cervical, uterine, and pelvic inflammatory diseases. Currently, treatment methods for this disease vary, including oral medications and topical washes, but the effects are often incomplete, prone to recurrence, and expensive.

[0003] Therefore, there is a desire to provide a traditional Chinese medicine preparation that can effectively treat vaginitis in women. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition and pharmaceutical preparation for treating female vaginitis. The traditional Chinese medicine composition and pharmaceutical preparation provided by this invention have the effects of clearing heat and drying dampness, killing parasites and relieving itching, and are particularly suitable for the treatment of female vaginitis.

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating female vaginitis, the traditional Chinese medicine composition comprising Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri, pomegranate peel, alum, and borneol.

[0006] The traditional Chinese medicine composition provided by this invention has a simple formulation, definite curative effect and high safety. It is used to treat vaginitis in women and has the effects of clearing heat and drying dampness, killing parasites and relieving itching.

[0007] As a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: Sophora flavescens 280-320 parts by weight, Phellodendron chinense 130-170 parts by weight, Isatis indigotica 130-170 parts by weight, Cnidium monnieri 130-170 parts by weight, Punica granatum peel 130-170 parts by weight, Alum 80-120 parts by weight, Borneol 5-25 parts by weight.

[0008] The amount of Sophora flavescens can be 280 parts by weight, 290 parts by weight, 300 parts by weight, 310 parts by weight, 320 parts by weight, etc.

[0009] The amount of Phellodendron bark can be 130 parts by weight, 140 parts by weight, 150 parts by weight, 160 parts by weight, 170 parts by weight, etc.

[0010] The amount of Daqingye (Isatis indigotica) can be 130 parts by weight, 140 parts by weight, 150 parts by weight, 160 parts by weight, 170 parts by weight, etc.

[0011] The Cnidium monnieri can be in quantities of 130 parts by weight, 140 parts by weight, 150 parts by weight, 160 parts by weight, 170 parts by weight, etc.

[0012] The pomegranate peel can be in quantities of 130 parts by weight, 140 parts by weight, 150 parts by weight, 160 parts by weight, 170 parts by weight, etc.

[0013] The alum can be in quantities of 80 parts by weight, 90 parts by weight, 100 parts by weight, 110 parts by weight, 120 parts by weight, etc.

[0014] The borneol can be in quantities of 5 parts by weight, 10 parts by weight, 15 parts by weight, 20 parts by weight, 25 parts by weight, etc.

[0015] As a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: Sophora flavescens 290-310 parts by weight, Phellodendron chinense 140-160 parts by weight, Isatis indigotica 140-160 parts by weight, Cnidium monnieri 140-160 parts by weight, Punica granatum peel 140-160 parts by weight, Alum 90-110 parts by weight, Borneol 10-20 parts by weight.

[0016] As a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: 300 parts by weight of Sophora flavescens, 150 parts by weight of Phellodendron chinense, 150 parts by weight of Isatis indigotica, 150 parts by weight of Cnidium monnieri, 150 parts by weight of pomegranate peel, 100 parts by weight of alum, and 15 parts by weight of borneol.

[0017] The compatibility mechanism of the traditional Chinese medicine composition provided by this invention is as follows: Sophora flavescens is the principal ingredient, clearing heat, drying dampness, killing parasites, and relieving itching; Phellodendron chinense and Isatis indigotica clear heat, dry dampness, cool the blood, and detoxify; Cnidium monnieri dries dampness, dispels wind, kills parasites, and relieves itching; pomegranate peel astringes and stops leukorrhea; alum absorbs moisture, relieves itching, detoxifies, and kills parasites; borneol clears heat, relieves pain, and promotes the penetration of medicinal effects. The combined effects of these herbs are to clear heat, dry dampness, kill parasites, relieve itching, astringe, and stop leukorrhea.

[0018] Secondly, the present invention provides the use of the traditional Chinese medicine composition as described in the first aspect in the preparation of a medicament for treating female vaginitis.

[0019] Thirdly, the present invention provides a pharmaceutical preparation for treating female vaginitis, the pharmaceutical preparation comprising the effective components of the traditional Chinese medicine composition described in the first aspect.

[0020] The effective components of the traditional Chinese medicine composition described in this invention can be extracted by the preparation method described in the fourth aspect.

[0021] The pharmaceutical preparation provided by this invention can be used to treat vaginitis in women and has the effects of clearing heat and drying dampness, killing parasites and relieving itching.

[0022] As a preferred embodiment of the present invention, the dosage form of the pharmaceutical preparation includes suppositories, gels, lotions, ointments, or foams.

[0023] Fourthly, the present invention provides a method for preparing a pharmaceutical formulation as described in the third aspect, the method comprising the following steps: (1) Crush alum and borneol to obtain a mixed mineral powder; (2) Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel were extracted with water to obtain an aqueous extract; (3) The aqueous extract and the mixed mineral powder are mixed evenly to prepare the dosage form of the pharmaceutical preparation; In this case, steps (1) and (2) are not in any particular order.

[0024] As a preferred embodiment of the present invention, the particle size of the mixed mineral powder is 10~180 μm, such as 10μm, 20 μm, 50 μm, 80 μm, 100 μm, 120 μm, 150 μm, 180 μm, etc.

[0025] As a preferred technical solution of the present invention, the water extraction method is as follows: Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel are decocted in water at least twice, each time for 1 to 3 hours (e.g., 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, etc.), and the water extract is obtained by filtration.

[0026] As a preferred technical solution of the present invention, the mass of water during water extraction is 8 to 30 times the total mass of the medicinal materials, for example, 8 times, 10 times, 15 times, 20 times, 25 times, 30 times, etc.

[0027] As a preferred embodiment of the present invention, the aqueous extract and the mixed mineral powder are further concentrated under reduced pressure before being mixed. The vacuum degree of the reduced pressure concentration is -0.095 to -0.06 MPa, and the temperature is 45 to 80°C.

[0028] As a preferred embodiment of the present invention, the vacuum degree of the reduced pressure concentration is -0.09 to -0.075 MPa, and the temperature is 55 to 70°C.

[0029] The technical solution provided by the embodiments of the present invention has the following advantages compared with the prior art: The traditional Chinese medicine composition and pharmaceutical preparation provided by this invention have the effects of clearing heat and drying dampness, killing parasites and relieving itching, and are particularly suitable for the treatment of vaginitis in women. Attached Figure Description

[0030] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a growth image of Staphylococcus aureus cultured in a ciprofloxacin gradient dilution culture dish for 18 h in vitro, as shown in the experimental example of this invention. Figure 2 This is a growth image of Staphylococcus aureus in a gradient dilution culture dish of the drug preparation obtained in Example 1 of the present invention after 18 h of in vitro culture; Figure 3 This is a growth image of Candida albicans after 40 h of in vitro culture in a fluconazole gradient dilution culture dish, as an example of the present invention. Figure 4 This is a growth image of Candida albicans after 40 h of in vitro culture in a micafungin gradient dilution culture dish, as an example of the present invention. Figure 5 This is a growth image of Candida albicans after 40 h of in vitro culture in a gradient dilution culture dish of the drug preparation obtained in Example 1 of the present invention. Detailed Implementation

[0033] To better understand the above-mentioned objectives, features, and advantages of the present invention, the solutions of the present invention will be further described below. It should be noted that, unless otherwise specified, the embodiments of the present invention and the features thereof can be combined with each other.

[0034] Many specific details are set forth in the following description in order to provide a full understanding of the invention, but the invention may also be practiced in other ways different from those described herein; obviously, the embodiments in the specification are only some embodiments of the invention, and not all embodiments.

[0035] Example 1 This embodiment provides a traditional Chinese medicine composition for treating female vaginitis, the composition comprising the following components in parts by weight: 300 parts by weight of Sophora flavescens, 150 parts by weight of Phellodendron chinense, 150 parts by weight of Isatis indigotica, 150 parts by weight of Cnidium monnieri, 150 parts by weight of pomegranate peel, 100 parts by weight of alum, and 15 parts by weight of borneol.

[0036] This embodiment also provides a pharmaceutical preparation for treating female vaginitis and a method for preparing the same, the preparation method comprising the following steps: (1) Weigh alum and borneol according to the proportion of the traditional Chinese medicine composition provided in this embodiment, pulverize them and pass them through a 100-mesh sieve to obtain mixed mineral powder; (2) Weigh out Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel according to the proportion of the Chinese herbal composition provided in this embodiment, place them in a decoction container, add water equal to 8 times the total mass of the herbs and decoct for 1 hour, filter to obtain the first filtrate; continue to add water equal to 8 times the total mass of the herbs to the decoction container, decoct for 2 hours, filter to obtain the second filtrate, and combine the filtrates; (3) The combined filtrate was concentrated under vacuum (vacuum degree -0.09 to -0.075 MPa, temperature 60~65℃) to a crude drug concentration of 2.06 g / mL to obtain a concentrated solution; (4) Mix the concentrated liquid and the mixed mineral powder to obtain an extract, each g of extract is equivalent to 1.633 g of crude drug.

[0037] Example 2 This embodiment provides a traditional Chinese medicine composition for treating female vaginitis, the composition comprising the following components in parts by weight: Sophora flavescens 290 parts by weight, Phellodendron chinense 160 parts by weight, Isatis indigotica 140 parts by weight, Cnidium monnieri 160 parts by weight, Punica granatum peel 140 parts by weight, Alum 110 parts by weight, Borneol 10 parts by weight.

[0038] This embodiment also provides a pharmaceutical preparation for treating female vaginitis and a method for preparing the same, the preparation method comprising the following steps: (1) Weigh alum and borneol according to the proportion of the traditional Chinese medicine composition provided in this embodiment, pulverize them and pass them through a 100-mesh sieve to obtain mixed mineral powder; (2) Weigh out Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel according to the proportion of the Chinese herbal composition provided in this embodiment, place them in a decoction container, add water in a volume 15 times the total mass of the herbs and decoct for 2 hours, filter to obtain the first filtrate; continue to add water in a volume 30 times the total mass of the herbs to the decoction container, decoct for 3 hours, filter to obtain the second filtrate, and combine the filtrates; (3) The combined filtrate was concentrated under vacuum (vacuum degree -0.09 to -0.075 MPa, temperature 60~65℃) to a crude drug concentration of 2.06 g / mL to obtain a concentrated solution; (4) Mix the concentrated liquid and the mixed mineral powder to obtain an extract, each g of extract is equivalent to 1.633 g of crude drug.

[0039] Example 3 This embodiment provides a traditional Chinese medicine composition for treating female vaginitis, the composition comprising the following components in parts by weight: Sophora flavescens 310 parts by weight, Phellodendron chinense 140 parts by weight, Isatis indigotica 160 parts by weight, Cnidium monnieri 140 parts by weight, Punica granatum peel 160 parts by weight, Alum 90 parts by weight, Borneol 20 parts by weight.

[0040] This embodiment also provides a pharmaceutical preparation for treating female vaginitis and a method for preparing the same, the preparation method comprising the following steps: (1) Weigh alum and borneol according to the proportion of the traditional Chinese medicine composition provided in this embodiment, pulverize them and pass them through a 100-mesh sieve to obtain mixed mineral powder; (2) Weigh out Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel according to the proportion of the Chinese herbal composition provided in this embodiment, place them in a decoction container, add water with a total mass of 20 times the total mass of the herbs and decoct for 2 hours, filter to obtain the first filtrate; continue to add water with a total mass of 10 times the total mass of the herbs to the decoction container, decoct for 1 hour, filter to obtain the second filtrate, and combine the filtrates; (3) The combined filtrate was concentrated under vacuum (vacuum degree -0.09 to -0.075 MPa, temperature 60~65℃) to a crude drug concentration of 2.06 g / mL to obtain a concentrated solution; (4) Mix the concentrated liquid and the mixed mineral powder to obtain an extract, each g of extract is equivalent to 1.633 g of crude drug.

[0041] Example 4 This embodiment provides a traditional Chinese medicine composition for treating female vaginitis, the composition comprising the following components in parts by weight: Sophora flavescens 280 parts by weight, Phellodendron chinense 170 parts by weight, Isatis indigotica 130 parts by weight, Cnidium monnieri 170 parts by weight, Punica granatum peel 130 parts by weight, Alum 120 parts by weight, Borneol 5 parts by weight.

[0042] This embodiment also provides a pharmaceutical preparation for treating female vaginitis and its preparation method, the preparation method being the same as in Example 1.

[0043] Example 5 This embodiment provides a traditional Chinese medicine composition for treating female vaginitis, the composition comprising the following components in parts by weight: Sophora flavescens 320 parts by weight, Phellodendron chinense 130 parts by weight, Isatis indigotica 170 parts by weight, Cnidium monnieri 130 parts by weight, Punica granatum peel 170 parts by weight, Alum 80 parts by weight, Borneol 25 parts by weight.

[0044] This embodiment also provides a pharmaceutical preparation for treating female vaginitis and its preparation method, the preparation method being the same as in Example 1.

[0045] Test case This experimental example is used to investigate the inhibitory effect of the drug preparation provided by the present invention on Staphylococcus aureus and Candida albicans, with the minimum inhibitory concentration (MIC) of the antibacterial drug on the test strain as the indicator.

[0046] 1. Test materials 1.1 Test strains Staphylococcus aureus strain 1: ATCC 29213 (CLSI recommended quality control strain); Two strains of Candida albicans: ATCC MYA-2876 and ATCC MYA-574; One strain of Candida glabrata: ATCC 22019 (CLSI recommended quality control strain).

[0047] 1.2 Test Reagents Ciprofloxacin: Purity ≥ 98%; Fluconazole: Purity ≥ 98%; Micafenidine: Purity ≥ 98%; The pharmaceutical preparation prepared in Example 1.

[0048] 2. Test methods The MIC of the tested antimicrobial drugs (ciprofloxacin and the drug preparation prepared in Example 1) against Staphylococcus aureus was tested using the microdilution method in CLSI-M7, and the MIC of the tested antimicrobial drugs (fluconazole, micafungin and the drug preparation prepared in Example 1) against Candida albicans was tested using the microdilution method in CLSI-M27.

[0049] The test drugs were serially diluted 2-fold in 96-well plates, and the growth inhibitory effect of each dilution on the test strains was tested. Each compound was serially diluted 2-fold in 96-well plates, for a total of 11 dilutions. The specific dilution concentrations of each compound are shown in the appendix. Figures 1-5 The 12th row of wells was set as a control well for the growth of the test strain without any added drugs.

[0050] For Staphylococcus aureus: Inoculum size 2.76 × 10⁻⁶ 4 CFU / spot, after inoculation with bacterial culture, incubate at 35±2℃ for 16~20 h, and the lowest drug concentration at which no obvious growth is observed with the naked eye is taken as the MIC value; For Candida albicans: ATCC MYA-2876 inoculation dose was 48 CFU / spot, ATCC MYA-574 inoculation dose was 34 CFU / spot, and ATCC 22019 inoculation dose was 57 CFU / spot. After inoculation, the bacterial suspension was incubated at 35±2℃ for 24~48h. The lowest drug concentration at which bacterial growth was significantly inhibited (50%) relative to the growth control well was taken as the MIC value. During the test, CLSI recommended control compounds and control strains were set up simultaneously. The MIC value of the control compound for the control strain in each round of testing should be within the range reported by CLSI.

[0051] 3. Test Results 3.1. Growth images of Staphylococcus aureus cultured in serially diluted ciprofloxacin culture dishes after 18 hours in vitro. Figure 1 As shown, the growth images of Staphylococcus aureus in the graded dilution culture dishes of the drug preparation obtained in Example 1 after 18 h of in vitro culture are as follows. Figure 2 As shown.

[0052] Depend on Figure 1 It can be found that the minimum inhibitory concentration (MIC) of ciprofloxacin against Staphylococcus aureus in vitro is 0.25 μg / mL, while the quality control range is 0.12~0.5 μg / mL, indicating that the results of this experiment are accurate and reliable.

[0053] Depend on Figure 2 It can be observed that the minimum inhibitory concentration (MIC) of the pharmaceutical preparation prepared in Example 1 of the present invention against Staphylococcus aureus is 1 / 64 of the original extract, indicating that the original extract still has antibacterial effect after being diluted 64 times.

[0054] 3.2 Images of Candida albicans cultured in serially diluted fluconazole petri dishes for 40 hours in vitro. Figure 3 As shown in the image, the growth of Candida albicans in serially diluted micafungin culture dishes after 40 hours of in vitro culture is as follows. Figure 4 As shown, the growth images of Candida albicans in the graded dilution culture dishes of the drug preparation obtained in Example 1 after 40 h of in vitro culture are as follows. Figure 5 As shown; in each petri dish, the upper left plaque is Candida albicans ATCC MYA-2876, the upper right plaque is Candida albicans ATCCMYA-574, and the lower left plaque is Candida parapsilosis ATCC 22019.

[0055] Depend on Figure 3 It was found that the in vitro minimum inhibitory concentration (MIC) of fluconazole against Candida albicans ATCC MYA-2876 was 0.25 μg / mL; the in vitro minimum inhibitory concentration (MIC) of fluconazole against Candida albicans ATCC MYA-574 was 64 μg / mL; and the in vitro minimum inhibitory concentration (MIC) of fluconazole against Candida parapsilosis ATCC22019 was 1 μg / mL, while the quality control range was 0.5~4 μg / mL, indicating that the results of this experiment were accurate and reliable.

[0056] Depend on Figure 4It was found that the in vitro minimum inhibitory concentration (MIC) of micafungin against Candida albicans ATCC MYA-2876 was less than or equal to 0.008 μg / mL, the in vitro minimum inhibitory concentration (MIC) against Candida albicans ATCC MYA-574 was less than or equal to 0.008 μg / mL, and the in vitro minimum inhibitory concentration (MIC) against Candida parapsilosis ATCC22019 was 0.5 μg / mL.

[0057] Depend on Figure 5 It can be observed that the minimum inhibitory concentration (MIC) of the pharmaceutical preparation prepared in Example 1 against Candida albicans ATCC MYA-2876 is 1 / 64 of the original extract, against Candida albicans ATCC MYA-574 is 1 / 128 of the original extract, and against Candida parapsilosis ATCC22019 is 1 / 512 of the original extract. This indicates that the original extract prepared in this invention, even after dilution by 64 times, 128 times, and 512 times, still exhibits inhibitory activity against the corresponding Candida albicans.

[0058] In summary, the pharmaceutical preparation provided by this invention can effectively inhibit the growth of both Staphylococcus aureus and Candida albicans, and has the effects of clearing heat and drying dampness, killing parasites and relieving itching, making it particularly suitable for the treatment of vaginitis in women.

[0059] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0060] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition for treating female vaginitis, characterized in that, The herbal composition includes Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri, pomegranate peel, alum, and borneol.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Sophora flavescens 280-320 parts by weight, Phellodendron chinense 130-170 parts by weight, Isatis indigotica 130-170 parts by weight, Cnidium monnieri 130-170 parts by weight, Punica granatum peel 130-170 parts by weight, Alum 80-120 parts by weight, Borneol 5-25 parts by weight.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Sophora flavescens 290-310 parts by weight, Phellodendron chinense 140-160 parts by weight, Isatis indigotica 140-160 parts by weight, Cnidium monnieri 140-160 parts by weight, Punica granatum peel 140-160 parts by weight, Alum 90-110 parts by weight, Borneol 10-20 parts by weight.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 300 parts by weight of Sophora flavescens, 150 parts by weight of Phellodendron chinense, 150 parts by weight of Isatis indigotica, 150 parts by weight of Cnidium monnieri, 150 parts by weight of pomegranate peel, 100 parts by weight of alum, and 15 parts by weight of borneol.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating female vaginitis.

6. A pharmaceutical preparation for treating vaginitis in women, characterized in that, The pharmaceutical preparation comprises the active ingredients of the traditional Chinese medicine composition according to any one of claims 1 to 4.

7. The pharmaceutical preparation according to claim 6, characterized in that, The dosage forms of the pharmaceutical preparations include suppositories, gels, lotions, ointments, or foams.

8. A method for preparing a pharmaceutical formulation as described in claim 6 or 7, characterized in that, The preparation method includes the following steps: (1) Crush alum and borneol to obtain a mixed mineral powder; (2) Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel were extracted with water to obtain an aqueous extract; (3) The aqueous extract and the mixed mineral powder are mixed evenly to prepare the dosage form of the pharmaceutical preparation; In this case, steps (1) and (2) are not in any particular order.

9. The preparation method according to claim 8, characterized in that, The particle size of the mixed mineral powder is 10~180 μm; And / or, the water extraction method is as follows: Sophora flavescens, Phellodendron chinense, Isatis indigotica, Cnidium monnieri and pomegranate peel are decocted in water at least twice, each time for 1 to 3 hours, and the water extract is obtained by filtration; And / or, the mass of water used in the water extraction is 8 to 30 times the total mass of the medicinal materials.

10. The preparation method according to claim 8 or 9, characterized in that, Before the aqueous extract and the mixed mineral powder are mixed, they are further concentrated under reduced pressure. The vacuum degree of the reduced pressure concentration is -0.095 to -0.06 MPa, and the temperature is 45 to 80°C.

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