WO2022121921A1 - 一种中药抑菌液及其制备方法和应用 - Google Patents

一种中药抑菌液及其制备方法和应用 Download PDF

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WO2022121921A1
WO2022121921A1 PCT/CN2021/136313 CN2021136313W WO2022121921A1 WO 2022121921 A1 WO2022121921 A1 WO 2022121921A1 CN 2021136313 W CN2021136313 W CN 2021136313W WO 2022121921 A1 WO2022121921 A1 WO 2022121921A1
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parts
chinese medicine
water
traditional chinese
hours
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PCT/CN2021/136313
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English (en)
French (fr)
Inventor
唐海涛
马继梅
周立巍
叶灯凤
王涛
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江苏康思尔医药科技有限公司
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Priority to CN202180076477.6A priority Critical patent/CN116782918B/zh
Publication of WO2022121921A1 publication Critical patent/WO2022121921A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/78—Saururaceae (Lizard's-tail family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the invention relates to the field of traditional Chinese medicine compositions, in particular to a bacteriostatic liquid prepared by extracting pure Chinese medicinal materials as raw materials.
  • the invention also relates to the preparation method and application of the traditional Chinese medicine composition.
  • CN107389830B records a preparation method of hemorrhoid fistula fumigation lotion: take 120 g of Houttuynia cordata, add water to distill and extract, collect distillate, set aside for use, collect the distilled Houttuynia cordata aqueous solution, and then distill the distilled Houttuynia cordata slag Combine with 120g of lychee grass, 120g of Polygonum cuspidatum, 60g of rhubarb and 60g of Galla japonica, add water for 2 times, add 7 times the volume of the total medicinal material weight for the first time, decoct for 1.5 hours, add 6 times the volume of the total medicinal material weight for the second time Water, decoct for 1 hour, filter, combine the filtrate, combine the filtrate with the distilled Houttuynia cordata aqueous solution, concentrate under reduced pressure, let it cool, and then add the Houttuynia cordata distillate to obtain
  • the first aspect of the present invention is to provide a traditional Chinese medicine composition extracted and prepared with pure traditional Chinese medicine as a raw material.
  • the traditional Chinese medicine composition of the present invention is mainly made from the following traditional Chinese medicine components in parts by weight: 6-24 parts of Houttuynia cordata, 6-24 parts of Litchi grass, 6-24 parts of Polygonum cuspidatum, 6-24 parts of rhubarb, 0.5-5.8 parts of gall; preferably 6-18 parts of Houttuynia cordata, 6-18 parts of lychee, 6-18 parts of Polygonum cuspidatum, 6-18 parts of rhubarb, 1-4 parts of gall; more preferably 8.4-15.6 parts of Houttuynia cordata parts, 8.4-15.6 parts of lychee grass, 8.4-15.6 parts of Polygonum cuspidatum, 8.4-15.6 parts of rhubarb, 1.4-2.6 parts of gall; more preferably 9.6-14.4 parts of Houttuynia cordata, 9.6-14.4 parts of lychee grass, 9.6-14.4 parts of Houttuynia cordata parts in parts
  • a preferred embodiment of the traditional Chinese medicine composition of the present invention is made from the following components in parts by weight: 12 parts of Houttuynia cordata, 12 parts of Litchi grass, 12 parts of Polygonum cuspidatum, 12 parts of rhubarb, 12 parts of gall 2 servings.
  • the traditional Chinese medicine composition of the present invention further contains antibacterial products, and the antibacterial products are any one or several combinations of sodium benzoate, potassium sorbate and chlorhexidine gluconate, preferably sodium benzoate and /or potassium sorbate; preferably, the weight ratio of the total Chinese medicine components to the antibacterial product is 500:(0.8 ⁇ 3.5), preferably 500:(1 ⁇ 3), preferably 500:(1 ⁇ 2) .
  • the traditional Chinese medicine composition of the present invention further includes pharmaceutically acceptable auxiliary materials, preferably further prepared into solid preparations, solution preparations, such as capsules, tablets, suspensions, solutions and the like.
  • the traditional Chinese medicine composition is prepared by the following method: mixing five medicinal materials of Houttuynia cordata, Litchi grass, Polygonum cuspidatum, rhubarb and Galla japonica, heating and extracting with water, adding ethanol to the obtained water extract for precipitation, filtering, and collecting the filtrate
  • the obtained filtrate is concentrated; further preferably, the obtained filtrate is concentrated to no alcohol taste; even more preferably, the obtained filtrate is concentrated to no alcohol taste, and diluted with water to obtain the composition.
  • the medicinal material may be soaked or not soaked before being heated and extracted with water for extraction of medicinal materials;
  • the soaking time is preferably 0.2 to 1.8 hours, more preferably 0.5 to 1.5 hours, and even more preferably 1 hour;
  • the temperature of the extraction by heating with water is preferably 50°C or higher, more preferably 50-100°C, still more preferably 80-100°C, and even more preferably boiling;
  • the number of times of heating and extraction with water is preferably 1 ⁇ 3 times;
  • the time for the extraction by heating with water is preferably 0.2 to 6 hours, more preferably 0.5 to 4 hours, and even more preferably 1.5 to 3 hours;
  • the weight of the water extracted by heating with water is preferably 5 to 5 of the traditional Chinese medicine prescription.
  • the concentration of the water extract is preferably included, preferably concentrated to a concentration whose relative density is above 1.10, and further It is preferably 1.10-1.30, more preferably 1.12-1.25, and even more preferably 1.15-1.20;
  • the precipitation by adding ethanol is preferably by adding ethanol, stirring, precipitation, or adding ethanol for direct precipitation; the amount of ethanol added
  • the alcohol content of the solution is not less than 40%, more preferably 40-80%, still more preferably 50-70%;
  • the temperature of the precipitation is 0-15°C, more preferably 0-10°C, more preferably It is more preferably 3 to 8°C;
  • the precipitation time is preferably 5 hours or more, more preferably 10 hours or more, still more preferably 30 hours or more, and still more preferably 40 to 60 hours.
  • the traditional Chinese medicine composition of the present invention is preferably prepared by the following method: adding water with 10 to 20 times the total weight of the traditional Chinese medicine components, heating and refluxing for extraction for 1 to 3 hours, filtering, adding the medicinal residues and adding the total weight of the traditional Chinese medicine formula 10 ⁇ 20 times of water, heat and reflux for extraction for 1 ⁇ 3 hours, combine the filtrates obtained twice, the combined filtrate is concentrated to a relative density of 1.15 ⁇ 1.20, add ethanol to the alcohol content of 50% ⁇ 70%, refrigerate for 40 ⁇ 60h , filter, and take the filtrate, and the filtrate can obtain the required traditional Chinese medicine composition after post-processing.
  • the filtrate can be concentrated to have no alcohol smell
  • the composition can be obtained after dilution with water; preferably, the composition obtained after dilution with water contains 0.25-5 g/ml of the total Chinese medicine components, more preferably It is 0.5 to 2.5 g/ml, more preferably 0.5 to 2 g/ml.
  • the second aspect of the present invention provides a preparation method of the traditional Chinese medicine composition.
  • the traditional Chinese medicine composition is mainly made of the following traditional Chinese medicine components in parts by weight: 6-24 parts of Houttuynia cordata, 6-24 parts of Litchi grass, 6-24 parts of Polygonum cuspidatum, 6-24 parts of rhubarb, 0.5 parts of gall ⁇ 5.8 parts; preferably 6-18 parts of Houttuynia cordata, 6-18 parts of Litchi, 6-18 parts of Polygonum cuspidatum, 6-18 parts of rhubarb, 1-4 parts of gall; more preferably 8.4-15.6 parts of Houttuynia cordata, 8.4-15.6 parts of lychee grass, 8.4-15.6 parts of Polygonum cuspidatum, 8.4-15.6 parts of rhubarb, 1.4-2.6 parts of gall; more preferably 9.6-14.4 parts of Houttuynia cordata, 9.6-14.4 parts of lychee grass, 9.6-14.4 parts of Polygonum cuspidatum, 9.6-14.4 parts of
  • the preparation method of the traditional Chinese medicine composition comprises the following steps: mixing five medicinal materials of Houttuynia cordata, Litchi grass, Polygonum cuspidatum, Rhubarb and Galla japonica, heating and extracting with water, adding ethanol to the obtained water extract for precipitation, filtering, collecting filtrate; preferably, the obtained filtrate is concentrated; further preferably, the obtained filtrate is concentrated to no alcohol taste; even more preferably, the obtained filtrate is concentrated to no alcohol taste, and diluted with water to obtain the composition.
  • the medicinal material may be soaked or not soaked before being heated and extracted with water for extraction of medicinal materials;
  • the soaking time is preferably 0.2 to 1.8 hours, more preferably 0.5 to 1.5 hours, and even more preferably 1 hour;
  • the temperature of the extraction by heating with water is preferably 50°C or higher, more preferably 50-100°C, still more preferably 80-100°C, and even more preferably boiling;
  • the number of times of heating and extraction with water is preferably 1 ⁇ 3 times;
  • the time for the extraction by heating with water is preferably 0.2 to 6 hours, more preferably 0.5 to 4 hours, and even more preferably 1.5 to 3 hours;
  • the weight of the water extracted by heating with water is preferably 5 to 5 of the traditional Chinese medicine prescription.
  • the concentration of the water extract is preferably included, preferably concentrated to a concentration whose relative density is above 1.10, and further It is preferably 1.10-1.30, more preferably 1.12-1.25, and even more preferably 1.15-1.20;
  • the precipitation by adding ethanol is preferably by adding ethanol, stirring, precipitation, or adding ethanol for direct precipitation; the amount of ethanol added
  • the alcohol content of the solution is not less than 40%, more preferably 40-80%, still more preferably 50-70%;
  • the temperature of the precipitation is 0-15°C, more preferably 0-10°C, more preferably It is more preferably 3 to 8°C;
  • the precipitation time is preferably 5 hours or more, more preferably 10 hours or more, still more preferably 30 hours or more, and still more preferably 40 to 60 hours.
  • the preparation method of the traditional Chinese medicine composition of the present invention is preferably as follows: adding 10 to 20 times the total weight of the traditional Chinese medicine components, heating and refluxing for extraction for 1 to 3 hours, filtering, adding the medicinal residues and adding 10 times the total weight of the traditional Chinese medicine prescription. ⁇ 20 times of water, heat and reflux for extraction for 1 ⁇ 3 hours, combine the filtrates obtained twice, the combined filtrate is concentrated to a relative density of 1.15 ⁇ 1.20, add ethanol to the alcohol content of 50% ⁇ 70%, refrigerate and stand for 40 ⁇ 60h, Filtration, taking the filtrate, the filtrate can obtain the desired traditional Chinese medicine composition after post-processing.
  • the filtrate can be concentrated to have no alcohol smell
  • the composition can be obtained after dilution with water; preferably, the composition obtained after dilution with water contains 0.25-5 g/ml of the total Chinese medicine components, more preferably It is 0.5 to 2.5 g/ml, more preferably 0.5 to 2 g/ml.
  • the third aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of medicines for the treatment of cooling blood to stop bleeding, dampness and astringency, anti-inflammatory and bacteriostatic, killing pathogenic microorganisms and hemorrhoids, or in the preparation of disinfectants or
  • the application of the bacteriostatic agent is preferably the application in the preparation of the bacteriostatic agent for inhibiting Escherichia coli, Staphylococcus aureus, Candida albicans, and Pseudomonas aeruginosa, and more preferably the application in the preparation of the bacteriostatic agent for Candida albicans.
  • the traditional Chinese medicine composition is mainly made of the following traditional Chinese medicine components in parts by weight: 6-24 parts of Houttuynia cordata, 6-24 parts of Litchi grass, 6-24 parts of Polygonum cuspidatum, 6-24 parts of rhubarb, gall 0.5 to 5.8 parts; preferably 6 to 18 parts of Houttuynia cordata, 6 to 18 parts of Litchi grass, 6 to 18 parts of Polygonum cuspidatum, 6 to 18 parts of rhubarb, and 1 to 4 parts of gall; more preferably 8.4 to 15.6 parts of Houttuynia cordata , 8.4-15.6 parts of lychee grass, 8.4-15.6 parts of Polygonum cuspidatum, 8.4-15.6 parts of rhubarb, 1.4-2.6 parts of gall; more preferably 9.6-14.4 parts of Houttuynia cordata, 9.6-14.4 parts of lychee grass, 9.6-14.4 parts of Polygonum cuspidatum , 9.6
  • described traditional Chinese medicine composition further contains antibacterial product
  • described antibacterial product is any one or several combinations in sodium benzoate, potassium sorbate and chlorhexidine gluconate, preferably sodium benzoate and/or Potassium sorbate; preferably, the weight ratio of the total Chinese medicine components to the antibacterial product is 500:(0.8-3.5), preferably 500:(1-3), preferably 500:(1-2).
  • the traditional Chinese medicine composition further includes pharmaceutically acceptable auxiliary materials, preferably further prepared into solid preparations, solution preparations, such as capsules, tablets, suspensions, solutions and the like.
  • the traditional Chinese medicine composition is prepared by the following method: mixing five medicinal materials of Houttuynia cordata, Litchi grass, Polygonum cuspidatum, rhubarb and Galla japonica, heating and extracting with water, adding ethanol to the obtained water extract for precipitation, filtering, and collecting the filtrate
  • the obtained filtrate is concentrated; further preferably, the obtained filtrate is concentrated to no alcohol taste; even more preferably, the obtained filtrate is concentrated to no alcohol taste, and diluted with water to obtain the composition.
  • the medicinal material may be soaked or not soaked before being heated and extracted with water for extraction of medicinal materials;
  • the soaking time is preferably 0.2 to 1.8 hours, more preferably 0.5 to 1.5 hours, and even more preferably 1 hour;
  • the temperature of the extraction by heating with water is preferably 50°C or higher, more preferably 50-100°C, still more preferably 80-100°C, and even more preferably boiling;
  • the number of times of heating and extraction with water is preferably 1 ⁇ 3 times;
  • the time for the extraction by heating with water is preferably 0.2 to 6 hours, more preferably 0.5 to 4 hours, and even more preferably 1.5 to 3 hours;
  • the weight of the water extracted by heating with water is preferably 5 to 5 of the traditional Chinese medicine prescription.
  • the concentration of the water extract is preferably included, preferably concentrated to a concentration whose relative density is above 1.10, and further It is preferably 1.10-1.30, more preferably 1.12-1.25, and even more preferably 1.15-1.20;
  • the precipitation by adding ethanol is preferably by adding ethanol, stirring, precipitation, or adding ethanol for direct precipitation; the amount of ethanol added
  • the alcohol content of the solution is not less than 40%, more preferably 40-80%, still more preferably 50-70%;
  • the temperature of the precipitation is 0-15°C, more preferably 0-10°C, more preferably It is more preferably 3 to 8°C;
  • the precipitation time is preferably 5 hours or more, more preferably 10 hours or more, still more preferably 30 hours or more, and still more preferably 40 to 60 hours.
  • the traditional Chinese medicine composition of the present invention is preferably prepared by the following method: adding water with 10 to 20 times the total weight of the traditional Chinese medicine components, heating and refluxing for extraction for 1 to 3 hours, filtering, adding the medicinal residues and adding the total weight of the traditional Chinese medicine formula 10 ⁇ 20 times of water, heat and reflux for extraction for 1 ⁇ 3 hours, combine the filtrates obtained twice, the combined filtrate is concentrated to a relative density of 1.15 ⁇ 1.20, add ethanol to the alcohol content of 50% ⁇ 70%, refrigerate for 40 ⁇ 60h , filter, and take the filtrate, and the filtrate can obtain the required traditional Chinese medicine composition after post-processing.
  • the filtrate can be concentrated to have no alcohol smell
  • the composition can be obtained after dilution with water; preferably, the composition obtained after dilution with water contains 0.25-5 g/ml of the total Chinese medicine components, more preferably It is 0.5 to 2.5 g/ml, more preferably 0.5 to 2 g/ml.
  • the fourth aspect of the present invention is to provide a traditional Chinese medicine antibacterial and antibacterial liquid.
  • the traditional Chinese medicine bacteriostatic liquid is mainly made of the following traditional Chinese medicine components in parts by weight: 6-24 parts of Houttuynia cordata, 6-24 parts of Litchi grass, 6-24 parts of Polygonum cuspidatum, 6-24 parts of rhubarb, 0.5 parts of gallnut ⁇ 5.8 parts; preferably 6 to 18 parts of Houttuynia cordata, 6 to 18 parts of Litchi, 6 to 18 parts of Polygonum cuspidatum, 6 to 18 parts of rhubarb, 1 to 4 parts of gall; more preferably 8.4 to 15.6 parts of Houttuynia cordata, lychee Grass 8.4-15.6 parts, Polygonum 8.4-15.6 parts, Rhubarb 8.4-15.6 parts, Galla japonica 1.4-2.6 parts; more preferably Houttuynia cordata 9.6-14.4 parts, Lychee grass 9.6-14.4 parts, Polygonum cuspidatum 9.6-14.4 parts, Rhubar
  • a preferred embodiment of the traditional Chinese medicine bacteriostatic liquid is made from the following components in parts by weight: 12 parts of Houttuynia cordata, 12 parts of Litchi grass, 12 parts of Polygonum cuspidatum, 12 parts of rhubarb, and 2 parts of gall.
  • the traditional Chinese medicine bacteriostatic liquid of the present invention further contains a bacteriostatic product
  • the bacteriostatic product is any one or a combination of sodium benzoate, potassium sorbate and chlorhexidine gluconate, preferably sodium benzoate Or one or both of potassium sorbate; preferably, the weight ratio of the total Chinese medicine component to the antibacterial product is 500:(0.8 ⁇ 3.5), preferably 500:(1 ⁇ 3), preferably 500 : (1 to 2).
  • the traditional Chinese medicine antibacterial liquid of the present invention further comprises pharmaceutically acceptable auxiliary materials.
  • the preparation method of the traditional Chinese medicine antibacterial liquid of the present invention comprises the following steps: mixing five medicinal materials of Houttuynia cordata, Litchi grass, Polygonum cuspidatum, rhubarb and Galla japonica, heating and extracting with water, adding ethanol to the obtained water extract for precipitation, filtering , collect the filtrate.
  • the medicinal material may be soaked or not soaked before being heated and extracted with water for extraction of medicinal materials;
  • the soaking time is preferably 0.2 to 1.8 hours, more preferably 0.5 to 1.5 hours, and even more preferably 1 hour;
  • the temperature of the extraction by heating with water is preferably 50°C or higher, more preferably 50-100°C, still more preferably 80-100°C, and even more preferably boiling;
  • the number of times of heating and extraction with water is preferably 1 ⁇ 3 times;
  • the time for the extraction by heating with water is preferably 0.2 to 6 hours, more preferably 0.5 to 4 hours, and even more preferably 1.5 to 3 hours;
  • the weight of the water extracted by heating with water is preferably 5 to 5 of the traditional Chinese medicine prescription.
  • the concentration of the water extract preferably to concentrate the concentration to a density of 1.10 or more, more preferably is 1.10-1.30, more preferably 1.12-1.25, still more preferably 1.15-1.20;
  • the adding ethanol for precipitation is preferably adding ethanol, stirring, precipitation, or adding ethanol for direct precipitation;
  • the amount of adding ethanol is preferably In order that the alcohol content of the solution is not less than 40%, more preferably 40-80%, still more preferably 50-70%;
  • the temperature of the precipitation is 0-15 °C, more preferably 0-10 °C, further Preferably, the temperature is 3 to 8°C;
  • the precipitation time is preferably 5 hours or more, more preferably 10 hours or more, still more preferably 30 hours or more, and still more preferably 40 to 60 hours.
  • the preparation method of the traditional Chinese medicine antibacterial liquid according to the present invention is preferably as follows: adding water with 10 to 20 times the total weight of the traditional Chinese medicine components, heating and refluxing for extraction for 1 to 3 hours, filtering, adding the medicinal residues and adding the total weight of the traditional Chinese medicine formula 10 ⁇ 20 times of water, heat and reflux for extraction for 1 ⁇ 3 hours, combine the filtrates obtained twice, the combined filtrate is concentrated to a relative density of 1.15 ⁇ 1.20, add ethanol to the alcohol content of 50% ⁇ 70%, refrigerate for 40 ⁇ 60h , filter, and take the filtrate, and the filtrate can obtain the required traditional Chinese medicine bacteriostatic liquid after post-processing.
  • the filtrate can be concentrated to have no alcohol smell, and diluted with water to obtain the traditional Chinese medicine bacteriostatic liquid; preferably, the composition obtained after dilution with water contains 0.25-5 g/ml of the total traditional Chinese medicine components. , more preferably 0.5 to 2.5 g/ml, still more preferably 0.5 to 2 g/ml, and can also be diluted with water to half the weight of the original medicinal material.
  • the traditional Chinese medicine antibacterial liquid of the present invention can treat cooling blood to stop bleeding, astringe dampness and sore, anti-inflammatory and bacteriostatic, kill pathogenic microorganisms, hemorrhoids, can be used as a disinfectant, a bacteriostatic agent, and can be applied to inhibit the large intestine Bacillus, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa bacteriostatic agent.
  • the fifth aspect of the present invention is to provide a bacteriostatic method, comprising administering a Chinese medicinal composition to a subject in need, wherein the traditional Chinese medicinal composition is mainly made from the following raw materials in parts by weight: Houttuynia cordata 6 to 24 parts, 6 to 24 parts of lychee grass, 6 to 24 parts of Polygonum cuspidatum, 6 to 24 parts of rhubarb, and 0.5 to 5.8 parts of gall; the bacteria are inhibiting Escherichia coli, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa Monomonas; the bacteria are more preferably Candida albicans; preferably, the composition further includes pharmaceutically acceptable excipients, or preferably is further prepared as a solid preparation or a solution preparation.
  • the antibacterial method of the present invention comprises combining traditional Chinese medicine compositions and other antibacterial products for subjects in need, and the antibacterial products are sodium benzoate, potassium sorbate and chlorhexidine gluconate. Any one or several combinations, preferably sodium benzoate and/or potassium sorbate; the weight ratio of the total Chinese medicine component and the antibacterial product is 500: (0.8 ⁇ 3.5), more preferably 500: (1 ⁇ 3 ), more preferably 500:(1-2). Most preferably, a Chinese medicinal composition is administered to a subject in need thereof in combination with sodium benzoate and potassium sorbate.
  • the traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 6-18 parts of Houttuynia cordata, 6-18 parts of Litchi grass, 6-18 parts of Polygonum cuspidatum, 6-18 parts of rhubarb, and 1-18 parts of gall.
  • the traditional Chinese medicine composition of the present invention further includes pharmaceutically acceptable auxiliary materials, preferably further prepared into solid preparations, solution preparations, such as capsules, tablets, suspensions, solutions and the like.
  • the preparation method of the traditional Chinese medicine composition of the present invention comprises the following steps: taking Houttuynia cordata, Litchi grass, Polygonum cuspidatum, rhubarb and gall, heating and extracting with water, adding ethanol to the obtained water extract for precipitation, filtering, and collecting the filtrate; preferably , the obtained filtrate is concentrated; further preferably, the obtained filtrate is concentrated to have no alcohol taste; further preferably, the obtained filtrate is concentrated to no alcohol taste, and diluted with water to obtain the composition.
  • the soaking time is preferably 0.2 to 1.8 hours, more preferably 0.5 to 1.5 hours, and even more preferably 1 hour
  • the temperature of the described water heating extraction is preferably above 50°C, more preferably 50 ⁇ 100°C, still more preferably 80 ⁇ 100°C, and even more preferably boiling; the number of times of the described water heating extraction is preferably 1 ⁇ 3 time; the time for the extraction by heating with water is preferably 0.2 to 6 hours, more preferably 0.5 to 4 hours, and even more preferably 1.5 to 3 hours; the weight of the water for extraction by heating with water is preferably 5 to 30 of the traditional Chinese medicine formula.
  • the addition of ethanol for precipitation preferably includes concentrating the water extract, preferably to a concentration of 1.10 or more relative density of the concentrate, more preferably 1.10 ⁇ 1.30, more preferably 1.12 ⁇ 1.25, still more preferably 1.15 ⁇ 1.20;
  • the adding ethanol for precipitation is preferably adding ethanol, stirring, precipitation, or adding ethanol for direct precipitation; the amount of adding ethanol is preferably
  • the alcohol content of the solution is not less than 40%, more preferably 40-80%, still more preferably 50-70%;
  • the temperature of the precipitation is 0-15°C, more preferably 0-10°C, even more preferably The temperature is 3-8°C;
  • the precipitation time is preferably 5 hours or more, more preferably 10 hours or more, still more preferably 30 hours or more, and still more preferably 40-60 hours.
  • the preparation method of the traditional Chinese medicine composition of the present invention is preferably as follows: adding 10 to 20 times the total weight of the traditional Chinese medicine components, heating and refluxing for extraction for 1 to 3 hours, filtering, adding the medicinal residues and adding 10 times the total weight of the traditional Chinese medicine prescription. ⁇ 20 times of water, heat and reflux for extraction for 1 ⁇ 3 hours, combine the obtained filtrates twice, the combined filtrate is concentrated to a relative density of 1.15 ⁇ 1.20, add ethanol to the alcohol content of the solution 50% ⁇ 70%, refrigerate and stand for 40 ⁇ 60h, filtering, taking the filtrate, concentrating until there is no alcohol smell, and diluting with water to obtain the composition; 0.5 to 2.5 g/ml, more preferably 0.5 to 2 g/ml.
  • Houttuynia cordata It has the functions of clearing away heat and detoxifying, eliminating carbuncle and discharging pus, and diuretic and dredging stranguria. For heat dysentery, hot stranguria, carbuncle sore. In the in vitro test, Houttuynia cordata has obvious inhibitory effect on Catarella, Influenza Bacillus, Pneumococcus and Staphylococcus aureus.
  • Lychee grass bitter, pungent, cool in nature. It has the effects of clearing away heat and detoxifying, diuretic and swelling, cooling blood and hemostasis. External use can be used to treat carbuncle, hemorrhoid swelling and pain, mastitis, vaginitis, etc. Decoction can inhibit or kill Leptospira in vitro.
  • Rhubarb purging and attacking accumulation, clearing heat and purging fire, cooling blood and detoxifying, removing blood stasis and clearing the meridians, dampness and yellowing. It is used for constipation due to accumulation of heat, blood heat vomiting, epistaxis, red eyes and throat, carbuncle swell and furuncle, intestinal carbuncle and abdominal pain, blood stasis, amenorrhea, postpartum blood stasis, traumatic injury, damp-heat dysentery, jaundice, red urine, stranguria, Edema. Rhubarb has strong antibacterial effect and broad antibacterial spectrum, and its active ingredients rhein, emodin and aloe-emodin have excellent antibacterial effects.
  • Rhein and emodin have obvious bacteriostatic effect on Staphylococcus aureus. In addition, it has antibacterial effects on Shigella, Typhi, Vibrio cholera, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus, Streptococcus, Streptococcus, Diphtheria, Bacillus anthracis and skin fungi.
  • Polygonum cuspidatum slightly bitter in taste, slightly cold in nature. Returns liver, gallbladder, lung meridian. Dispelling dampness and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, relieving cough and resolving phlegm. For damp-heat jaundice, stranguria, leucorrhea, rheumatic arthralgia, carbuncle sore, water-fire scald, amenorrhea, dysmenorrhea, traumatic injury, cough due to lung heat.
  • Polygonum decoction has inhibitory effect on Staphylococcus aureus, Catarella, A or B Streptococcus, Escherichia coli, and Pseudomonas aeruginosa. High concentrations (roots) also have a killing effect on Leptospira.
  • Galla japonica sour, astringent, cold in nature. Returns to the lung, large intestine, and kidney meridians. Astringing the lungs and reducing fire, astringing the intestines and stopping diarrhea, astringing sweat, stopping bleeding, and astringing dampness and sores. It is used for chronic cough due to lung deficiency, phlegm cough due to lung heat, prolonged diarrhea and dysentery, spontaneous sweating and night sweats, diabetes, blood in the stool and hemorrhoids, traumatic hemorrhage, carbuncle and sore, wet and rotten skin.
  • the concentration described in the present invention is a conventional concentration method in the prior art, including but not limited to concentration under reduced pressure.
  • the antibacterial experiment research of the present invention proves that the traditional Chinese medicine disinfectant has strong and extensive antibacterial effect on Escherichia coli, Pseudomonas aeruginosa and the like, and has a certain antibacterial effect on Staphylococcus aureus.
  • the traditional Chinese medicine bacteriostatic liquid of the present invention has a bacteriostatic effect on Candida albicans, and when used in combination with sodium benzoate or potassium sorbate, it shows stronger bacteriostatic effect on Candida albicans.
  • the combination of the present invention with sodium benzoate and potassium sorbate has a synergistic effect.
  • the traditional Chinese medicine antibacterial liquid has good and wide antibacterial activity, and its effect is mild and safe, and the test proves that the present invention has a significant antibacterial effect.
  • the present invention has the following advantages:
  • the traditional Chinese medicine bacteriostatic liquid provided by the invention has the functions of cooling blood to stop bleeding, astringing dampness and astringing sores, anti-inflammatory and bacteriostatic, killing pathogenic microorganisms, etc.
  • the traditional Chinese medicine bacteriostatic agent uses natural Chinese herbal medicines as the main bacteriostatic and disinfecting efficacy components, is convenient and safe to use, is natural and environmentally friendly, and is less irritating.
  • the product provided by the present invention has a good Candida albicans inhibitory effect. The scope of application of the existing technology can be expanded.
  • the relative density refers to the ratio of the density of the substance to the density of water under the same temperature and pressure conditions; unless otherwise specified, the alcohol content refers to the The volume concentration of ethanol contained in the solution; unless otherwise specified, the multiples refer to the multiples of weight.
  • Embodiment 4 Chinese medicine antibacterial effect experiment
  • the antibacterial agent of the traditional Chinese medicine antibacterial liquid of the present invention and the combined use of the traditional Chinese medicine antibacterial liquid of the present invention and sodium benzoate, potassium sorbate or chlorhexidine gluconate is studied on Staphylococcus aureus. , Escherichia coli, Pseudomonas aeruginosa and Candida albicans antibacterial effect.
  • Staphylococcus aureus (ATCC6538), Escherichia coli (8099), Pseudomonas aeruginosa (ATCC9027), Candida albicans (ATCC10231).
  • Chinese herbal antibacterial prescription lychee grass, Houttuynia cordata, rhubarb, Polygonum cuspidatum, gall.
  • Experimental group 1 Chinese medicine antibacterial liquid with a concentration equivalent to 2.0g/ml of decoction pieces
  • Experimental group 2 Chinese medicine antibacterial liquid with a concentration equivalent to 1.0g/ml of decoction pieces
  • Experimental group 3 Chinese medicine antibacterial liquid with a concentration equivalent to 0.5g/ml of decoction pieces
  • Experimental group 4 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.1wt%;
  • Experimental group 5 the concentration of Chinese medicine extract is equivalent to 0.5g/ml of decoction pieces, and potassium sorbate is added to the concentration of 0.1wt%;
  • Experimental group 6 the concentration of the traditional Chinese medicine extract is equivalent to 0.5g/ml of decoction pieces, and chlorhexidine gluconate is added to the concentration of 0.5wt%;
  • Experimental group 9 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.15wt%;
  • Experimental group 10 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.20wt%;
  • Experimental group 11 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and potassium sorbate is added to a concentration of 0.15wt%;
  • Experimental group 12 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and potassium sorbate is added to a concentration of 0.20wt%;
  • Experimental group 13 Chinese medicine antibacterial liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.25wt%;
  • Experimental group 14 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.30wt%;
  • Experimental group 15 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 1.0 g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.15 wt%;
  • Experimental group 16 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5 g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.05 wt %, and potassium sorbate to a concentration of 0.05 wt %;
  • Experimental group 17 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5 g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.1 wt %, and potassium sorbate to a concentration of 0.1 wt %;
  • Experimental group 18 Chinese medicine bacteriostatic liquid whose concentration is equivalent to 0.5 g/ml of decoction pieces, and sodium benzoate is added to a concentration of 0.15 wt % potassium sorbate to a concentration of 0.15 wt %.
  • the relative density of 0.5g/ml antibacterial liquid is about 1.04, and the relative density of 1.0g/ml antibacterial liquid is not more than about 1.08.
  • Experimental group 7 Chinese medicine concentrated extract A with a concentration equivalent to 0.5 g/ml of decoction pieces.
  • the experimental group 19 was prepared by the following method:
  • Experimental group 19 Chinese medicine antibacterial liquid whose concentration is equivalent to 0.5 g/ml of decoction pieces.
  • Experimental group 8 control product (equivalent to the concentrated extract of traditional Chinese medicine with a concentration of 0.5 g/ml).
  • the bacteriostatic agent is continuously dissolved through agar diffusion to form different concentration gradients to show its bacteriostatic effect.
  • the size of the antibacterial circle is used to judge whether it has antibacterial ability.
  • Staphylococcus aureus (ATCC6538), Escherichia coli (8099), Pseudomonas aeruginosa (ATCC9027), Candida albicans (ATCC10231) bacterial suspension.
  • Bacteriostatic carrier (Oxford cup, after being sterilized by pressure steam, dried at 120° C. for 2 hours, and stored for later use).
  • Inoculation of test bacteria Use sterile cotton swab to dip the test bacteria suspension with a concentration of 5 ⁇ 10 5 cfu/ml to 5 ⁇ 10 6 cfu/ml, and spread it evenly on the surface of the nutrient agar medium plate 3 times. For each application, the plate should be rotated 60°, and finally apply a cotton swab around the edge of the plate. Cover the plate and let it dry at room temperature for 5 min.
  • a bacteriostatic ring with uniform and complete aseptic growth should be selected.
  • the diameter of the measurement should be bounded by the outer edge of the bacteriostatic ring.
  • the diameter of the antibacterial ring is greater than 7mm, it is judged to have antibacterial effect.
  • the diameter of the antibacterial ring is less than or equal to 7mm, it is judged to have no antibacterial effect.
  • the negative control group (water used for extraction and dilution) should have no antibacterial ring. Otherwise the test is invalid.
  • the negative control group met the requirements, and none of the above strains produced a bacteriostatic ring, and the diameter of the bacteriostatic ring was 0.
  • the traditional Chinese medicine antibacterial liquid of the present invention is effective for bacterial suspensions such as Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, etc., and the diameter of each antibacterial ring is greater than 7 mm, and the product has antibacterial properties for the test bacteria. Bacterial effect.
  • the traditional Chinese medicine bacteriostatic liquid of the present invention is used in combination with sodium benzoate, potassium sorbate, and chlorhexidine gluconate, and each concentration has enhanced bacteriostatic effect on Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, but For Candida albicans, the antibacterial liquid combined with sodium benzoate or potassium sorbate has antibacterial effect, but it is invalid when combined with chlorhexidine gluconate.
  • the diameters of the antibacterial rings of each experimental group of the present invention were greater than 7 mm for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Streptococcus albicans, the same as before storage. There was no significant difference in the bacteriostatic effect of the two groups, indicating that the bacteriostatic effect against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Streptococcus albicans was stable.
  • Bacteria Staphylococcus aureus (ATCC6538), Escherichia coli (8099), Pseudomonas aeruginosa (ATCC9027).
  • Yeast Candida albicans (ATCC10231).
  • Bacterial liquid preparation Take the fresh culture (18h-24h) of the nutrient agar medium slant of the 3rd to 14th generations of the strain, wash the bacterial lawn with 5mL of 0.03mol/L phosphate buffer (hereinafter referred to as PBS) to suspend the bacteria After homogenization, dilute to the desired concentration with the above PBS.
  • PBS 0.03mol/L phosphate buffer
  • the 24h slant culture of the test bacteria was washed with PBS to make a bacterial suspension (the required concentration is: drop 100 ⁇ l on the control sample or in 5ml of the sample solution, and the number of recovered bacteria is 1 ⁇ 104cfu/piece ⁇ 9 ⁇ 104cfu/ tablet or ml).
  • A The average number of colonies in the control sample
  • the traditional Chinese medicine bacteriostatic liquid stock solution of the present invention acts on Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa for 2min, 5min, 10min, and 20min, and the antibacterial rates of each time are all >50%, and the product is for The bacteriostatic rates of Escherichia coli are all >90%, and the traditional Chinese medicine bacteriostatic liquid of the present invention has bacteriostatic effect on Staphylococcus aureus and Pseudomonas aeruginosa, and has strong bacteriostatic effect on Escherichia coli.
  • the traditional Chinese medicine bacteriostatic liquid of the present invention is used in combination with sodium benzoate and potassium sorbate. Under a certain concentration, the antibacterial effect of the product of the present invention on Candida albicans can be improved. According to the above test results, the product of the present invention is combined with 0.1% sodium benzoate. (Experimental group 4), 0.2% potassium sorbate (experimental group 12) or 0.1% sodium benzoate combined with potassium sorbate (experimental group 16), the effect on Candida albicans is greater than or equal to use. ⁇ secondary inhibition%, the above combination products have good bacteriostatic effect on Candida albicans.
  • the present invention selects natural traditional Chinese medicine with sterilization and bacteriostatic effect as raw material, extracts effective components to prepare traditional Chinese medicine antibacterial liquid, is convenient to use, and does not have any poison to human body after use, and can be used for treating hemorrhoids, hemorrhoid leakage, hemorrhoid swelling and pain, Inflammatory infections, etc.

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Abstract

一种中药抑菌液及其制备方法和应用，所述中药抑菌液含有主要由以下重量份数的中药组分制成的中药组合物：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份。所述的中药抑菌液具有良好、广泛的抑菌活性，其作用温和、安全，经试验证明具有显著抑菌效果。

Description

一种中药抑菌液及其制备方法和应用 技术领域
本发明涉及中药组合物领域，特别是涉及一种以纯中药材为原料提取配制而成的抑菌液。本发明还涉及该中药组合物的制备方法和应用。
背景技术
我国从20世纪40年代开始进行传统中药的体外抑菌试验，证明了多种中药对各种细菌有抑制作用，但单味中药灭菌范围小，效果不显著。中草药之间的配伍可达到单味中药无法满足的效果，有利于提高药效，中药配伍后的协同作用也为开发新的中药抑菌剂提供了重要依据。但以往用于灭菌的中药配伍大多依赖于传统经验或古方，无法满足当前依靠科学实验依据对复方中药进行配方优化的需求。
CN107389830B记载了一种痔瘘薰洗剂的制备方法为：取鱼腥草120g，加水蒸馏提取，收取蒸馏液，备用，并收集蒸馏后的鱼腥草水溶液，然后将蒸馏后的鱼腥草药渣与荔枝草120g，虎杖120g，大黄60g和五倍子60g合并，加水煎煮2次，第一次加总药材重量7倍体积量水，煎煮1.5小时，第二次加总药材重量6倍体积量水，煎煮1小时，滤过，合并滤液，滤液与蒸馏后的鱼腥草水溶液合并，减压浓缩，放冷，然后再加入鱼腥草蒸馏液，即得。文献“中华中医药学刊，2015，33(8)”记载了该痔瘘熏洗剂抑菌实验研究结果，其中对金黄色葡萄球菌、大肠埃希菌、肺炎克雷伯菌、变形杆菌利用平皿法测试抑菌效果约为10.5～12.3mm，具有一定的抑菌效果。但是现有技术没有记载该痔瘘薰洗剂对白色念珠菌的抑菌作用。
因此，需要开发一种抑菌活性比现有的痔瘘薰洗剂抑菌效果更好的药物，特别是对白色念珠菌具有良好抑制作用的中药抑菌液或药物。
发明内容
本发明的第一个方面是提供一种以纯中药为原料提取配制的中药组合物。
其中，本发明所述的中药组合物主要由以下重量份数的中药组分制成：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份；优选为鱼腥草6～18份、荔枝草6～18份、虎杖6～18份、大黄6～18份、五倍子1～4份；进一步优选为鱼腥草8.4～15.6份、荔枝草8.4～15.6份、虎杖8.4～15.6份、大黄8.4～15.6份、五倍子1.4～2.6份；更进一步优选为鱼腥草9.6～14.4份、荔枝草9.6～14.4份、虎杖9.6～14.4份、大黄9.6～14.4份、五倍子1.6～2.4份；再更进一步优选为鱼腥草10.8～13.2份、荔枝草10.8～13.2份、虎杖10.8～13.2份、大黄10.8～13.2份、五倍子1.8～2.2份。
其中，本发明所述的中药组合物，优选的一种实施例方式为由以下重量份数的组分制成：鱼腥草12份、荔枝草12份、虎杖12份、大黄12份、五倍子2份。
其中，本发明所述的中药组合物进一步含有抑菌产品，所述抑菌产品为苯甲酸钠、山梨酸钾和中葡萄糖酸氯己定中的任意一种或几种组合，优选为苯甲酸钠和/或山梨酸钾；优选地，所述总中药组分与抑菌产品的重量比为500:(0.8～3.5)，优选为500:(1～3)，优选为500:(1～2)。
其中，本发明所述的中药组合物，进一步包括药学上可接受的辅料，优选进一步制备为固体制剂、溶液制剂，例如胶囊剂、片剂、混悬液、溶液剂等。
其中，所述的中药组合物由以下方法制备得到：取鱼腥草、荔枝草、虎杖、大黄和五倍子五种药材混合，用水加热提取，向所得水提取液加入乙醇进行沉淀，过滤，收集滤液；优选地，所得滤液浓缩；进一步优选地，所得滤液浓缩至无醇味；更进一步优选地，所得滤液浓缩至无醇味，用水稀释，得到所述组合物。
其中，在该制成方法中，药材提取用水加热提取前，可以浸泡，也可以是未经浸泡；所述浸泡的时间优选为0.2～1.8小时，进一步优选为0.5～1.5小时，更进一步优选为1小时；所述用水加热提取的温度优选为50℃以上，进一步优选为50～100℃，更进一步优选为80～100℃，再更进一步优选为沸腾；所述用水加热提取的次数优选为1～3次；所述用水加热提取的时间优选为0.2～6小时，进一步优选为0.5～4小时，更进一步优选为1.5～3小时；所述水加热提取的水重量优选为中药组方的5～30倍，进一步优选为10～25倍，更进一步优选为15～20倍；所述加入乙醇进行沉淀前优选为包括对水提取液浓缩，优选为浓缩至浓缩液相对密度为1.10以上，进一步优选为1.10～1.30，更进一步优选为1.12～1.25，再更进一步优选为1.15～1.20；所述加入乙醇进行沉淀优选为加入乙醇，搅拌，沉淀，或加入乙醇直接沉淀；所述加入乙醇的用量优选为至溶液含醇量不低于40％，进一步优选为40～80％，更进一步优选为50～70％；所述沉淀的温度为0～15℃，进一步优选为0～10℃，更进一步优选为3～8℃；所述沉淀的时间优选为5小时以上，进一步优选为10小时以上，更进一步优选为30小时以上，再更进一步优选为40～60小时。
其中，本发明所述的中药组合物优选为由以下方法制备得到：加入中药组分总重量10～20倍的水，加热回流提取1～3小时，过滤，药渣再加中药组方总重量10～20倍的水，加热回流提取1～3小时，合并两次所得滤液，合并后的滤液浓缩相对密度1.15～1.20，加入乙醇至含醇量50％～70％，冷藏静置40～60h，过滤，取滤液，所述滤液经后处理即可获得需要的中药组合物。特别的，可以将所述滤液浓缩至无醇味，用水稀释后，得到所述组合物；优选地，用水稀释后得到的组合物含有相当于含总中药组分0.25～5g/ml，进一步优选为0.5～2.5g/ml，更进一步优选为0.5～2g/ml。
本发明的第二个方面，提供所述中药组合物的制成方法。
其中，所述中药组合物，主要由以下重量份数的中药组分制成：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份；优选为鱼腥草6～18份、荔枝草6～18份、虎杖6～18份、大黄6～18份、五倍子1～4份；进一步优选为鱼腥草8.4～15.6份、荔枝草8.4～15.6份、虎杖8.4～15.6份、大黄8.4～15.6份、五倍子1.4～2.6份；更进一步优选为鱼腥草9.6～14.4份、荔枝草9.6～14.4份、虎杖9.6～14.4份、大黄9.6～14.4份、五倍子1.6～2.4份；再更进一步优选为鱼腥草10.8～13.2份、荔枝草10.8～13.2份、虎杖10.8～13.2份、大黄10.8～13.2份、五倍子1.8～2.2份；再更进一步优选为，鱼腥草12份、荔枝草12份、虎杖12份、大黄12份、五倍子2份。
其中，所述中药组合物的制成方法包括如下步骤：取鱼腥草、荔枝草、虎杖、大黄和五倍子五种药材混合，用水加热提取，向所得水提取液加入乙醇进行沉淀，过滤，收集滤液；优选地，所得滤液浓缩；进一步优选地，所得滤液浓缩至无醇味；更进一步优选地，所得滤液浓缩至无醇味，用水稀释，得到所述组合物。
其中，在该制成方法中，药材提取用水加热提取前，可以浸泡，也可以是未经浸泡；所述浸泡的时间优选为0.2～1.8小时，进一步优选为0.5～1.5小时，更进一步优选为1小时；所述用水加热提取的温度优选为50℃以上，进一步优选为50～100℃，更进一步优选为80～100℃，再更进一步优选为沸腾；所述用水加热提取的次数优选为1～3次；所述用水加热提取的时间优选为0.2～6小时，进一步优选为0.5～4小时，更进一步优选为1.5～3小时；所述水加热提取的水重量优选为中药组方的5～30倍，进一步优选为10～25倍，更进一步优选为15～20倍；所述加入乙醇进行沉淀前优选为包括对水提取液浓缩，优选为浓缩至浓缩液相对密度为1.10以上，进一步优选为1.10～1.30，更进一步优选为1.12～1.25，再更进一步优选为1.15～1.20；所述加入乙醇进行沉淀优选为加入乙醇，搅拌，沉淀，或加入乙醇直接沉淀；所述加入乙醇的用量优选为至溶液含醇量不低于40％，进一步优选为40～80％，更进一步优选为50～70％；所述沉淀的温度为0～15℃，进一步优选为0～10℃，更进一步优选为3～8℃；所述沉淀的时间优选为5小时以上，进一步优选为10小时以上，更进一步优选为30小时以上，再更进一步优选为40～60小时。
其中，本发明所述的中药组合物的制成方法优选如下：加入中药组分总重量10～20倍的水，加热回流提取1～3小时，过滤，药渣再加中药组方总重量10～20倍的水，加热回流提取1～3小时，合并两次所得滤液，合并后的滤液浓缩相对密度1.15～1.20，加入乙醇至含醇量50％～70％，冷藏静置40～60h，过滤，取滤液，所述滤液经后处理即可获得需要的中药组合物。特别的，可以将所述滤液浓缩至无醇味，用水稀释后，得到所述组合物；优选地，用水稀释 后得到的组合物含有相当于含总中药组分0.25～5g/ml，进一步优选为0.5～2.5g/ml，更进一步优选为0.5～2g/ml。
本发明的第三个方面，是提供上述中药组合物在制备治疗凉血止血、收湿敛疮、抗炎抑菌、杀灭病原微生物、痔疮的药物中的应用，或者是在制备消毒剂或抑菌剂中的应用，优选在制备抑制大肠杆菌、金黄色葡萄菌、白色念珠菌、铜绿假单胞菌抑菌剂中的应用，更优选在制备白色念珠菌抑菌剂中的应用。
其中，所述的中药组合物，主要由以下重量份数的中药组分制成：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份；优选为鱼腥草6～18份、荔枝草6～18份、虎杖6～18份、大黄6～18份、五倍子1～4份；进一步优选为鱼腥草8.4～15.6份、荔枝草8.4～15.6份、虎杖8.4～15.6份、大黄8.4～15.6份、五倍子1.4～2.6份；更进一步优选为鱼腥草9.6～14.4份、荔枝草9.6～14.4份、虎杖9.6～14.4份、大黄9.6～14.4份、五倍子1.6～2.4份；再更进一步优选为鱼腥草10.8～13.2份、荔枝草10.8～13.2份、虎杖10.8～13.2份、大黄10.8～13.2份、五倍子1.8～2.2份；再更进一步优选为鱼腥草12份、荔枝草12份、虎杖12份、大黄12份、五倍子2份。
其中，所述的中药组合物进一步含有抑菌产品，所述抑菌产品为苯甲酸钠、山梨酸钾和中葡萄糖酸氯己定中的任意一种或几种组合，优选为苯甲酸钠和/或山梨酸钾；优选地，所述总中药组分与抑菌产品的重量比为500:(0.8～3.5)，优选为500:(1～3)，优选为500:(1～2)。
其中，所述的中药组合物进一步包括药学上可接受的辅料，优选进一步制备为固体制剂、溶液制剂，例如胶囊剂、片剂、混悬液、溶液剂等。
其中，所述的中药组合物由以下方法制备得到：取鱼腥草、荔枝草、虎杖、大黄和五倍子五种药材混合，用水加热提取，向所得水提取液加入乙醇进行沉淀，过滤，收集滤液；优选地，所得滤液浓缩；进一步优选地，所得滤液浓缩至无醇味；更进一步优选地，所得滤液浓缩至无醇味，用水稀释，得到所述组合物。
其中，在该制成方法中，药材提取用水加热提取前，可以浸泡，也可以是未经浸泡；所述浸泡的时间优选为0.2～1.8小时，进一步优选为0.5～1.5小时，更进一步优选为1小时；所述用水加热提取的温度优选为50℃以上，进一步优选为50～100℃，更进一步优选为80～100℃，再更进一步优选为沸腾；所述用水加热提取的次数优选为1～3次；所述用水加热提取的时间优选为0.2～6小时，进一步优选为0.5～4小时，更进一步优选为1.5～3小时；所述水加热提取的水重量优选为中药组方的5～30倍，进一步优选为10～25倍，更进一步优选为15～20倍；所述加入乙醇进行沉淀前优选为包括对水提取液浓缩，优选为浓缩至浓缩液相对密度为1.10以上，进一步优选为1.10～1.30，更进一步优选为1.12～1.25，再更进一步优选为1.15～1.20；所 述加入乙醇进行沉淀优选为加入乙醇，搅拌，沉淀，或加入乙醇直接沉淀；所述加入乙醇的用量优选为至溶液含醇量不低于40％，进一步优选为40～80％，更进一步优选为50～70％；所述沉淀的温度为0～15℃，进一步优选为0～10℃，更进一步优选为3～8℃；所述沉淀的时间优选为5小时以上，进一步优选为10小时以上，更进一步优选为30小时以上，再更进一步优选为40～60小时。
其中，本发明所述的中药组合物优选为由以下方法制备得到：加入中药组分总重量10～20倍的水，加热回流提取1～3小时，过滤，药渣再加中药组方总重量10～20倍的水，加热回流提取1～3小时，合并两次所得滤液，合并后的滤液浓缩相对密度1.15～1.20，加入乙醇至含醇量50％～70％，冷藏静置40～60h，过滤，取滤液，所述滤液经后处理即可获得需要的中药组合物。特别的，可以将所述滤液浓缩至无醇味，用水稀释后，得到所述组合物；优选地，用水稀释后得到的组合物含有相当于含总中药组分0.25～5g/ml，进一步优选为0.5～2.5g/ml，更进一步优选为0.5～2g/ml。
本发明的第四个方面，是提供一种中药抑菌抑菌液。
其中，所述中药抑菌液主要由以下重量份数的中药组分制成：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份；优选鱼腥草6～18份、荔枝草6～18份、虎杖6～18份、大黄6～18份、五倍子1～4份；进一步优选为鱼腥草8.4～15.6份、荔枝草8.4～15.6份、虎杖8.4～15.6份、大黄8.4～15.6份、五倍子1.4～2.6份；更进一步优选为鱼腥草9.6～14.4份、荔枝草9.6～14.4份、虎杖9.6～14.4份、大黄9.6～14.4份、五倍子1.6～2.4份；再更进一步优选为鱼腥草10.8～13.2份、荔枝草10.8～13.2份、虎杖10.8～13.2份、大黄10.8～13.2份、五倍子1.8～2.2份。
其中，所述中药抑菌液优选的一种实施例方式为由以下重量份数的组分制成：鱼腥草12份、荔枝草12份、虎杖12份、大黄12份、五倍子2份。
其中，本发明所述的中药抑菌液进一步含有抑菌产品，所述抑菌产品为苯甲酸钠、山梨酸钾和中葡萄糖酸氯己定中的任意一种或几种组合，优选为苯甲酸钠或山梨酸钾中的一种或两种；优选地，所述总中药组分与抑菌产品的重量比为500:(0.8～3.5)，优选为500:(1～3)，优选为500:(1～2)。
其中，本发明所述的中药抑菌液，进一步包括药学上可接受的辅料。
其中，本发明所述中药抑菌液的制成方法包括如下步骤：取鱼腥草、荔枝草、虎杖、大黄和五倍子五种药材混合，用水加热提取，所得水提取液加入乙醇进行沉淀，过滤，收集滤液。
其中，在该制成方法中，药材提取用水加热提取前，可以浸泡，也可以是未经浸泡；所 述浸泡的时间优选为0.2～1.8小时，进一步优选为0.5～1.5小时，更进一步优选为1小时；所述用水加热提取的温度优选为50℃以上，进一步优选为50～100℃，更进一步优选为80～100℃，再更进一步优选为沸腾；所述用水加热提取的次数优选为1～3次；所述用水加热提取的时间优选为0.2～6小时，进一步优选为0.5～4小时，更进一步优选为1.5～3小时；所述水加热提取的水重量优选为中药组方的5～30倍，进一步优选为10～25倍，更进一步优选为15～20倍；所述加入乙醇进行沉淀前优选为包括对水提取液浓缩，优选为浓缩至浓缩液密度为1.10以上，进一步优选为1.10～1.30，更进一步优选为1.12～1.25，再更进一步优选为1.15～1.20；所述加入乙醇进行沉淀优选为加入乙醇，搅拌，沉淀，或加入乙醇直接沉淀；所述加入乙醇的用量优选为至溶液含醇量不低于40％，进一步优选为40～80％，更进一步优选为50～70％；所述沉淀的温度为0～15℃，进一步优选为0～10℃，更进一步优选为3～8℃；所述沉淀的时间为优选5小时以上，进一步优选为10小时以上，更进一步优选为30小时以上，再更进一步优选为40～60小时。
其中，本发明所述的中药抑菌液的制成方法优选如下：加入中药组分总重量10～20倍的水，加热回流提取1～3小时，过滤，药渣再加中药组方总重量10～20倍的水，加热回流提取1～3小时，合并两次所得滤液，合并后的滤液浓缩相对密度1.15～1.20，加入乙醇至含醇量50％～70％，冷藏静置40～60h，过滤，取滤液，所述滤液经后处理即可获得需要的中药抑菌液。特别的，可以将所述滤液浓缩至无醇味，用水稀释后，得到所述中药抑菌液；优选地，用水稀释后得到的组合物含有相当于含总中药组分的0.25～5g/ml，进一步优选为0.5～2.5g/ml，更进一步优选为0.5～2g/ml，也可以选择加水稀释至原药材重量的一半。
其中，本发明所述的中药抑菌液可以治疗凉血止血、收湿敛疮、抗炎抑菌、杀灭病原微生物、痔疮，可以用作消毒剂、抑菌剂中，可以应用于抑制大肠杆菌、金黄色葡萄菌、白色念珠菌、铜绿假单胞菌抑菌剂。
本发明的第五个方面，是提供一种抑菌方法，包括给有需要的受试者施用中药组合物，其中所述的中药组合物主要由以下重量份数的原料制成：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份；所述的菌为抑制大肠杆菌、金黄色葡萄菌、白色念珠菌、铜绿假单胞菌；所述的菌更优选为白色念珠菌；优选地，所述组合物进一步包括药学上可接受的辅料，或者优选为进一步制备为固体制剂或溶液制剂。
其中，本发明所述的抑菌方法，包括给有需要的受试者联用中药组合物和其他抑菌产品，所述抑菌产品为苯甲酸钠、山梨酸钾和葡萄糖酸氯己定中的任意一种或几种组合，优选为苯甲酸钠和/或山梨酸钾；所述总中药组分与抑菌产品的重量比为500:(0.8～3.5)，进一步优选为500:(1～3)，更进一步优选为500:(1～2)。最优选的是给有需要的受试者联用中药组合物与苯甲 酸钠和山梨酸钾。
优选地，所述的中药组合物主要由以下重量份数的原料制成：鱼腥草6～18份、荔枝草6～18份、虎杖6～18份、大黄6～18份、五倍子1～4份；优选为鱼腥草8.4～15.6份、荔枝草8.4～15.6份、虎杖8.4～15.6份、大黄8.4～15.6份、五倍子1.4～2.6份；进一步优选为鱼腥草9.6～14.4份、荔枝草9.6～14.4份、虎杖9.6～14.4份、大黄9.6～14.4份、五倍子1.6～2.4份；再更进一步优选为鱼腥草10.8～13.2份、荔枝草10.8～13.2份、虎杖10.8～13.2份、大黄10.8～13.2份、五倍子1.8～2.2份；再更进一步优选为鱼腥草12份、荔枝草12份、虎杖12份、大黄12份、五倍子2份。
本发明所述的中药组合物，进一步包括药学上可接受的辅料，优选进一步制备为固体制剂、溶液制剂，例如胶囊剂、片剂、混悬液、溶液剂等。
本发明所述中药组合物的制成方法包括如下步骤：取鱼腥草、荔枝草、虎杖、大黄和五倍子，用水加热提取，向所得水提取液加入乙醇进行沉淀，过滤，收集滤液；优选地，所得滤液浓缩；进一步优选地，所得滤液浓缩至无醇味；更进一步优选地，所得滤液浓缩至无醇味，用水稀释，得到所述组合物。
其中，在该制成方法中，所述用水加热提取前优选为先加水浸泡再加热提取；所述浸泡的时间优选为0.2～1.8小时，进一步优选为0.5～1.5小时，更进一步优选为1小时；所述用水加热提取的温度为优选50℃以上，进一步优选为50～100℃，更进一步优选为80～100℃，再更进一步优选为沸腾；所述用水加热提取的次数优选为1～3次；所述用水加热提取的时间优选为0.2～6小时，进一步优选为0.5～4小时，更进一步优选为1.5～3小时；所述水加热提取的水重量优选为中药组方的5～30倍，进一步优选为10～25倍，更进一步优选为15～20倍；所述加入乙醇进行沉淀前优选为包括对水提取液浓缩，优选为浓缩至浓缩液相对密度为1.10以上，进一步优选为1.10～1.30，更进一步优选为1.12～1.25，再更进一步优选为1.15～1.20；所述加入乙醇进行沉淀优选为加入乙醇，搅拌，沉淀，或加入乙醇直接沉淀；所述加入乙醇的用量优选为至溶液含醇量不低于40％，进一步优选为40～80％，更进一步优选为50～70％；所述沉淀的温度为0～15℃，进一步优选为0～10℃，更进一步优选为3～8℃；所述沉淀的时间优选为5小时以上，进一步优选为10小时以上，更进一步优选为30小时以上，再更进一步优选为40～60小时。
其中，本发明所述的中药组合物的制成方法优选如下：加入中药组分总重量10～20倍的水，加热回流提取1～3小时，过滤，药渣再加中药组方总重量10～20倍的水，加热回流提取1～3小时，合并两次所得滤液，合并后的滤液浓缩相对密度1.15～1.20，加入乙醇至溶液的含醇量50％～70％，冷藏静置40～60h，过滤，取滤液，浓缩至无醇味，用水稀释后，得到所述 组合物；优选地，用水稀释后得到的组合物含有相当于含总中药组分0.25～5g/ml，进一步优选为0.5～2.5g/ml，更进一步优选为0.5～2g/ml。
本发明各中药的药用功能如下：
鱼腥草：具有清热解毒，消痈排脓，利尿通淋的功效。用于热痢，热淋，痈肿疮毒。在体外试验中，鱼腥草提取物对卡他球菌、流感杆菌、肺炎球菌、金黄色葡萄球菌有明显抑制作用。
荔枝草：味苦、辛，性凉。具有清热解毒，利尿消肿，凉血止血的功效。外用可用于治疗痈肿，痔疮肿痛，乳腺炎，阴道炎等。煎剂体外可抑制或杀死钩端螺旋体。
大黄：泻下攻积，清热泻火，凉血解毒，逐瘀通经，利湿退黄。用于实热积滞便秘，血热吐衄，目赤咽肿，痈肿疔疮，肠痈腹痛，瘀血经闭，产后瘀阻，跌打损伤，湿热痢疾，黄疸尿赤，淋证，水肿。大黄的抗菌作用强，抗菌谱广，其有效成分大黄酸、大黄素和芦荟大黄素的抗菌作用极好。大黄酸和大黄素对金黄色葡萄球菌有明显抑菌作用。此外对痢疾杆菌、伤寒杆菌、霍乱弧菌、大肠杆菌、绿脓杆菌、葡萄球菌、链球菌、肺炎双球菌、白喉杆菌、炭疽杆菌及皮肤真菌等均有抗菌作用。
虎杖：味微苦，性微寒。归肝、胆、肺经。利湿退黄，清热解毒，散瘀止痛，止咳化痰。用于湿热黄疸，淋浊，带下，风湿痹痛，痈肿疮毒，水火烫伤，经闭，癥瘕，跌打损伤，肺热咳嗽。虎杖煎液对金黄色葡萄球菌、卡他球菌、甲型或乙型链球菌、大肠杆菌、绿脓杆菌有抑制作用。高浓度(根)对钩端螺旋体也有杀灭作用。
五倍子：味酸、涩，性寒。归肺、大肠、肾经。敛肺降火，涩肠止泻，敛汗，止血，收湿敛疮。用于肺虚久咳，肺热痰嗽，久泻久痢，自汗盗汗，消渴，便血痔血，外伤出血，痈肿疮毒，皮肤湿烂。
本发明中所述的浓缩，为现有技术中常规的浓缩方法，包括但不限于减压浓缩。
本发明抑菌实验研究证明，该中药消毒剂对大肠杆菌、铜绿假单胞菌等具有较强的广泛的抑菌作用，对金黄色葡萄球菌具有一定的抑菌作用。同时，本发明的中药抑菌液对白色念珠菌有抑菌作用，与苯甲酸钠或山梨酸钾联用，对白色念珠菌显示出更强的抑菌作用。本发明与苯甲酸钠、山梨酸钾的联用，具有协同增效的作用。所述的中药抑菌液具有良好、广泛的抑菌活性，其作用温和、安全，经试验证明本发明具有显著抑菌效果。
有益效果：与现有技术相比，本发明具有如下优势：
本发明所提供的中药抑菌液具有凉血止血、收湿敛疮、抗炎抑菌、杀灭病原微生物等功效，作用于人体肛门，有消炎止痛和杀菌清洁作用。该中药抑菌剂以天然中草药为主要抑菌消毒功效性成分，使用方便安全，天然环保，刺激性小。特别的，本发明提供的产品，具有 良好的白色念珠菌抑制作用。可以扩大现有技术的应用范围。
具体实施方式
以下结合实施例用于进一步描述本发明，但这些实施例并非限制着本发明的范围。
下述实施例中，若无特殊说明，所述相对密度，是指相同的温度、压力条件下，该物质的密度与水的密度之比；若无特殊说明，所述含醇量是指该溶液所含乙醇的体积浓度；若无特殊说明，所述倍量指的是重量的倍数。
实施例1 中药抑菌液的制备
按下述重量准备中药原料(中药组分)：荔枝草12kg、鱼腥草12kg、大黄12kg、虎杖12kg、五倍子2kg。将上述药材混合在一起，加入1000kg饮用水，浸泡1小时，加热煮沸2小时，过滤，滤渣中加入750kg饮用水，煮沸2小时，过滤，合并两次滤液，加热浓缩至相对密度为1.15，加入乙醇至含醇量为60％，搅拌均匀，4℃下，冷藏静置48小时，过滤，滤液浓缩至无醇味，加水稀释至25L即得浓度为相当于饮片(中药组分)2.0g/ml的样品，稀释至100L即得浓度为相当于饮片0.5g/ml的样品。所得样品为澄清溶液。
实施例2 中药抑菌液的制备
按下述重量准备中药原料：荔枝草10kg、鱼腥草10kg、大黄10kg、虎杖10kg、五倍子5kg。将上述药材混合在一起，加入10倍量饮用水，煮沸1.5小时，过滤，滤渣中加入10倍量饮用水，煮沸1.5小时，过滤，合并两次滤液，加热浓缩至相对密度至1.18，加入乙醇至含醇量为50％，搅拌均匀，8℃下，冷藏静置50小时，过滤，滤液浓缩至无醇味，加水稀释至22.5L即得浓度为相当于饮片(中药组分)2.0g/ml的样品，稀释至90L即得浓度为相当于饮片0.5g/ml的样品。所得样品为澄清溶液。
实施例3 中药抑菌液的制备
按下述重量准备中药原料：荔枝草14kg、鱼腥草14kg、大黄6kg、虎杖6kg、五倍子5kg。将上述药材混合在一起，加入20倍量饮用水，浸泡1小时，煮沸1小时，过滤，滤渣中加入20倍量饮用水，煮沸1小时，过滤，合并两次滤液，加热浓缩至相对密度至1.20，加入乙醇至含醇量为70％，搅拌均匀，5℃下，冷藏静置48小时，过滤，滤液浓缩至无醇味，加水稀释至22.5L即得浓度为相当于饮片(中药组分)2.0g/ml的样品，稀释至90L即得浓度为相当于饮片0.5g/ml的样品。所得样品为澄清溶液。
实施例4 中药抑菌效果实验
1.实验目的
依据《消毒技术规范》(2002年版)检验，研究本发明中药抑菌液及本发明中药抑菌液与苯甲酸钠、山梨酸钾或葡萄糖酸氯己定联用的抑菌剂对金黄色葡萄球菌、大肠杆菌、铜绿假单胞菌和白色念珠菌的抑菌效果。
2.实验材料
2.1实验菌株
金黄色葡萄球菌(ATCC6538)，大肠杆菌(8099)，铜绿假单胞菌(ATCC9027)、白色念珠菌(ATCC10231)。
2.2实验药材
中药抑菌剂处方：荔枝草、鱼腥草、大黄、虎杖、五倍子。
3.实验方法
3.1中药抑菌剂制备工艺
取中药材荔枝草12g、鱼腥草12g、大黄12g、虎杖12g、五倍子2g，加20倍量水，加热回流提取2h，过滤，药渣再加15倍量水加热回流提取2h，合并滤液，滤液浓缩至相当于饮片0.5g/ml，即得中药浓缩提取液A。
将中药浓缩提取液A继续浓缩至相对密度1.15，加乙醇至含醇量为60％，4℃下冷藏48h，过滤，取滤液，浓缩至无醇味，稀释至25ml即得浓度为相当于饮片2.0g/ml的中药抑菌液。用水对所得中药抑菌液进行稀释，分别得到浓度为相当于饮片2.0g/ml的中药抑菌液、浓度为相当于饮片1.0g/ml的中药抑菌液和浓度为相当于饮片0.5g/ml的中药抑菌液。
同时准备以下实验组样品进行实验：
实验组1：浓度为相当于饮片2.0g/ml的中药抑菌液；
实验组2：浓度为相当于饮片1.0g/ml的中药抑菌液；
实验组3：浓度为相当于饮片0.5g/ml的中药抑菌液；
实验组4：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.1wt％；
实验组5：浓度为相当于饮片0.5g/ml的中药提取液，并添加山梨酸钾至浓度为0.1wt％；
实验组6：浓度为相当于饮片0.5g/ml的中药提取液，并添加葡萄糖酸氯己定至浓度为0.5wt％；
实验组9：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.15wt％；
实验组10：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.20wt％；
实验组11：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加山梨酸钾至浓度为0.15wt％；
实验组12：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加山梨酸钾至浓度为0.20wt％；
实验组13：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.25wt％；
实验组14：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.30wt％；
实验组15：浓度为相当于饮片1.0g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.15wt％；
实验组16：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.05wt％，山梨酸钾至浓度为0.05wt％；
实验组17：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.1wt％，山梨酸钾至浓度为0.1wt％；
实验组18：浓度为相当于饮片0.5g/ml的中药抑菌液，并添加苯甲酸钠至浓度为0.15wt％山梨酸钾至浓度为0.15wt％。
其中，0.5g/ml的抑菌液相对密度为1.04左右，1.0g/ml的抑菌液相对密度为不超过1.08左右。
另外，使用中药浓缩提取液A配置实验组7：
实验组7：浓度为相当于饮片0.5g/ml的中药浓缩提取液A。
利用如下方法制备实验组19：
取中药材荔枝草10g、鱼腥草10g、大黄12g、虎杖10g、五倍子4g，加10倍量水，加热回流提取1.5h，过滤，药渣再加10倍量水加热回流提取1.5h，合并滤液，滤液浓缩至相当于饮片0.5g/ml，即得中药浓缩提取液B。
将中药浓缩提取液B继续浓缩至相对密度1.15，加乙醇至含醇量为60％，4℃下冷藏48h，过滤，取滤液，浓缩至无醇味，稀释至46ml即得浓度为相当于饮片1g/ml的中药抑菌液。用水对所得中药抑菌液进行稀释，得到浓度为相当于饮片0.5g/ml的中药抑菌液。同时准备以下实验组样品进行实验：
实验组19：浓度为相当于饮片0.5g/ml的中药抑菌液。
3.2对照产品的制备
取鱼腥草120g，加水蒸馏提取，收取蒸馏液，备用，并收集蒸馏后的鱼腥草水溶液，然后将蒸馏后的鱼腥草药渣与荔枝草120g，虎杖120g，大黄60g和五倍子60g合并，加水煎煮2次，第一次加总药材重量7倍体积量水，煎煮1.5小时，第二次加总药材重量6倍体积量水，煎煮1小时，滤过，合并滤液，滤液与蒸馏后的鱼腥草水溶液合并，减压浓缩，放冷，然后再加入鱼腥草蒸馏液，制备得到同于浓度为0.5g/ml的中药浓缩提取液B。溶液不澄清。同时以其准备以下实验组样品进行实验：
实验组8：对照产品(等同于浓度为0.5g/ml的中药浓缩提取液)。
3.3抑菌能力测试方法
依据《消毒技术规范》(2002年版)2.1.7项抗(抑)菌试验检测本发明中药抑菌液的抑菌性能，具体方法和检测结果如下：
3.3.1原理
利用抑菌剂不断溶解经琼脂扩散形成不同浓度梯度，以显示其抑菌作用。试验通过抑菌环大小以判断其是否具有抑菌能力。
3.3.2试验器材
(1)金黄色葡萄球菌(ATCC6538)、大肠杆菌(8099)、铜绿假单胞菌(ATCC9027)、白色念珠菌(ATCC10231)菌悬液。
(2)抑菌剂载体(牛津杯，经压力蒸汽灭菌处理后，置120℃烤干2h，保存备用)。
(3)活菌培养计数所需器材、无菌蒸馏水作为阴性对照备用。
(4)微量移液器(5μl～50μl，可调式)。
(5)游标卡尺。
(6)营养琼脂培养基、胰酪大豆胨琼脂培养基与沙氏葡萄糖琼脂培养基。
3.3.3操作程序
(1)试验菌的接种：用无菌棉拭子蘸取浓度为5×10 5cfu/ml～5×10 6cfu/ml试验菌悬液，在营养琼脂培养基平板表面均匀涂抹3次。每涂抹1次，平板应转动60°，最后将棉拭子绕平板边缘涂抹一周。盖好平皿，置室温干燥5min。
(2)抑菌剂的添加：每次牛津杯放1个染菌平板，每个平板放4个牛津杯作为试样，1个牛津杯作为阴性对照样，共5个。用无菌镊子取牛津杯贴放于平板表面。各牛津杯中心之间相距25mm以上，与平板的周缘相距15mm以上。贴放好后，用无菌习轻压牛津杯，使其紧贴于平板表面。用无菌吸管添加试样与对照样至牛津杯中加满，盖好平皿，置37℃温箱，培养16h～18h观察结果。用游标卡尺测量抑菌环的直径并记录。试验重复3次。
测量抑菌环时，应选均匀而完全无菌生长的抑菌环进行。测量其直径应以抑菌环外沿为界。
3.3.4评价规定
(1)抑菌作用的判断：
抑菌环直径大于7mm者，判为有抑菌作用。
抑菌环直径小于或等于7mm者，判为无抑菌作用。
(2)3次重复试验均有抑菌作用结果者，判为合格。
(3)阴性对照组(为提取稀释所用水)应无抑菌环产生。否则试验无效。
3.3.5试验结果
Figure PCTCN2021136313-appb-000001
阴性对照组符合要求，以上菌种均未产生抑菌环，抑菌环直径为0。
根据以上实验结果，得出以下结论：
A、本发明的中药抑菌液对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌等试验用菌悬液，各次抑菌环直径＞7mm，产品对于试验用菌有抑菌作用。
B、本发明的中药抑菌液与苯甲酸钠、山梨酸钾、葡萄糖酸氯己定联用，各浓度对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌的抑菌作用均有增强，但对白色念珠菌，抑菌液与苯甲酸钠或山梨酸钾联用有抑菌作用，与葡萄糖酸氯己定联用无效。
另外，实验样品继续经37℃保温90天后，本发明的各实验组液对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌和白色链球菌，各次抑菌环直径＞7mm，与存放前的抑菌效果没有显著差异，表明对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌和白色链球菌的抑菌效果稳定。
3.4抑菌率测试方法
依据《消毒技术规范》(2002年版)溶出性抗(抑)菌产品抑菌性能测试方法检测本发明中药抑菌液的抑菌性能，具体方法和检测结果如下：
3.4.1检验方法
(1)试验菌与菌液制备
试验菌：
细菌：金黄色葡萄球菌(ATCC6538)，大肠杆菌(8099)、铜绿假单胞菌(ATCC9027)。
酵母菌：白色念珠菌(ATCC10231)。
菌液制备：取菌株第3代～14代的营养琼脂培养基斜面新鲜培养物(18h～24h)，用5mL0.03mol/L磷酸盐缓冲液(以下简称PBS)洗下菌苔，使菌悬浮均匀后用上述PBS稀释至所需浓度。
(2)操作步骤
将试验菌24h斜面培养物用PBS洗下，制成菌悬液(要求的浓度为：用100μl滴于对照样片上或5ml样液内，回收菌数为1×104cfu/片～9×104cfu/片或ml)。
取被试样液(5ml)和对照样液(无菌蒸馏水)各4管。
取上述菌悬液，分别在每个被试样液和对照样液内滴加100μl，均匀混合，开始计时，作用2min、5min、10min、20min，用无菌吸管分别将样液(0.5ml)投入含5mLPBS的试管内，充分混匀，作适当稀释，然后取其中2-3个稀释度，分别吸取0.5ml，置于两个平皿，用凉至40℃～45℃的营养琼脂培养基(细菌)或沙氏葡萄糖琼脂培养基(酵母菌)15ml作倾注，转动平皿，使其充分均匀，琼脂凝固后翻转平板，35℃±2℃培养48h(细菌)或72h(酵母菌)，作活菌菌落计数。
试验重复3次，按下式计算抑菌率:
X4＝(A-B)/A×100％
式中：
X4：抑菌率，％；
A：对照样品平均菌落数；
B：被试样品平均菌落数。
3.4.2抑菌率检测结果(％)
Figure PCTCN2021136313-appb-000002
Figure PCTCN2021136313-appb-000003
Figure PCTCN2021136313-appb-000004
根据以上实验结果，得出以下结论：
A、本发明中药抑菌液原液(实验组1)对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌作用2min、5min、10min、20min，各次抑菌率均>50％，且产品对于大肠杆菌的抑菌率均>90％，本发明中药抑菌液对于金黄色葡萄球菌、铜绿假单胞菌均有抑菌作用，对于大肠杆菌有较强的抑菌作用。
B、本发明中药抑菌液与苯甲酸钠和山梨酸钾联用，在一定浓度下，可提高本发明产品对于白色念珠菌的抑菌作用，根据以上检验结果，本发明产品与0.1％苯甲酸钠(实验组4)、0.2％的山梨酸钾(实验组12)或0.1％苯甲酸钠与山梨酸钾(实验组16)联用，对白色念珠菌作用≥用，对白，各次抑菌率均≥次抑％，以上联用产品对于白色念珠菌有良好的抑菌作用。
本发明选用有灭菌抑菌效果的天然中药为原料，提取有效成分制成中药抑菌液，使用方便，而且使用后对人体无任何毒害，可以用于治疗痔疮、痔漏，痔核肿胀疼痛，炎性感染等。

Claims (11)

  1. 一种中药组合物，其特征在于，主要由以下重量份数的中药组分制成：鱼腥草6～24份、荔枝草6～24份、虎杖6～24份、大黄6～24份、五倍子0.5～5.8份。
  2. 如权利要求1所述的组合物，其特征在于，主要由以下重量份数的组分制成：鱼腥草6～18份、荔枝草6～18份、虎杖6～18份、大黄6～18份、五倍子1～4份；优选为鱼腥草8.4～15.6份、荔枝草8.4～15.6份、虎杖8.4～15.6份、大黄8.4～15.6份、五倍子1.4～2.6份；进一步优选为鱼腥草9.6～14.4份、荔枝草9.6～14.4份、虎杖9.6～14.4份、大黄9.6～14.4份、五倍子1.6～2.4份；更进一步优选为鱼腥草10.8～13.2份、荔枝草10.8～13.2份、虎杖10.8～13.2份、大黄10.8～13.2份、五倍子1.8～2.2份；再更进一步优选为鱼腥草12份、荔枝草12份、虎杖12份、大黄12份、五倍子2份。
  3. 如权利要求1或2所述的组合物，其特征在于，由以下方法制备得到：取鱼腥草、荔枝草、虎杖、大黄和五倍子，用水加热提取，向所得水提取液中加入乙醇进行沉淀，过滤，收集滤液；优选地，所得滤液浓缩；进一步优选地，所得滤液浓缩至无醇味；更进一步优选地，所得滤液浓缩至无醇味，用水稀释，得到所述组合物。
  4. 权利要求1或2所述组合物的制备方法，其特征在于，包括如下步骤：取鱼腥草、荔枝草、虎杖、大黄和五倍子，用水加热提取，向所得水提取液中加入乙醇进行沉淀，过滤，收集滤液；优选地，所得滤液浓缩；进一步优选地，所得滤液浓缩至无醇味；更进一步优选地，所得滤液浓缩至无醇味，用水稀释，得到所述组合物。
  5. 如权利要求3所述组合物或权利要求4所述制备方法，其特征在于，所述用水加热提取前先加水浸泡再加热提取；所述浸泡的时间优选为0.2～1.8小时，进一步优选为0.5～1.5小时，更进一步优选为1小时；
    所述用水加热提取的温度优选为50℃以上，进一步优选为50～100℃，更进一步优选为80～100℃，再更进一步优选为沸腾；
    所述用水加热提取的次数优选为1～3次；
    所述用水加热提取的时间优选为0.2～6小时，进一步优选为0.5～4小时，更进一步优选为1.5～3小时；
    所述用水加热提取的水重量优选为中药组方重量的5～30倍，进一步优选为10～25倍，更进一步优选为15～20倍；
    所述加入乙醇进行沉淀前优选为包括对水提取液浓缩，优选为浓缩至浓缩液相对密度为1.10以上，进一步优选为1.10～1.30，更进一步优选为1.12～1.25，再更进一步优选为1.15～1.20；
    所述加入乙醇进行沉淀优选为加入乙醇，搅拌，沉淀，或加入乙醇直接沉淀；
    所述加入乙醇的用量优选为至溶液含醇量不低于40％，进一步优选为40～80％，更进一步优选为50～70％；
    所述沉淀的温度优选为0～15℃，进一步优选为0～10℃，更进一步优选为3～8℃；
    所述沉淀的时间优选为5小时以上，进一步优选为10小时以上，更进一步优选为30小时以上，再更进一步优选为40～60小时。
  6. 如权利要求1或2所述组合物，其特征在于，其制成方法如下：加入中药组分总重量10～20倍的水，加热回流提取1～3小时，过滤，药渣再加中药组方总重量10～20倍的水，加热回流提取1～3小时，合并两次所得滤液，合并后的滤液浓缩相对密度1.15～1.20，加入乙醇至溶液的含醇量50％～70％，冷藏静置40～60小时，过滤，取滤液，浓缩至无醇味，用水稀释后，得到所述组合物；优选地，用水稀释后得到的组合物含有相当于总中药组分0.25～5.0g/ml，进一步优选为0.5～2.5g/ml，更进一步优选为0.5～2g/ml。
  7. 如权利要求1至6任一所述组合物，其特征在于，所述组合物进一步含有抑菌产品；所述抑菌产品为苯甲酸钠、山梨酸钾和葡萄糖酸氯己定中的任意一种或几种组合，优选为苯甲酸钠和/或山梨酸钾；所述总中药组分与抑菌产品的重量比为500:(0.8～3.5)，优选为500:(1～3)，优选为500:(1～2)。
  8. 如权利要求1至7任一所述组合物，其特征在于，所述组合物进一步包括药学上可接受的辅料，或者优选为进一步制备为固体制剂或溶液制剂。
  9. 如权利要求1至8任一所述组合物在制备治疗凉血止血、收湿敛疮、抗炎抑菌、杀灭病原微生物或痔疮的药物中的应用。
  10. 如权利要求1至8任一所述组合物在制备消毒剂或抑菌剂中的应用，优选在制备抑制大肠杆菌、金黄色葡萄菌、白色念珠菌、铜绿假单胞菌抑菌剂中的应用，更优选在制备抑制白色念珠菌抑菌剂中的应用。
  11. 一种中药抑菌抑菌液，其特征在于，含有如权利要求1至8任一所述组合物。
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