WO2020211189A1 - 治疗脚气和狐臭的中药组合物及其应用 - Google Patents

治疗脚气和狐臭的中药组合物及其应用 Download PDF

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WO2020211189A1
WO2020211189A1 PCT/CN2019/092093 CN2019092093W WO2020211189A1 WO 2020211189 A1 WO2020211189 A1 WO 2020211189A1 CN 2019092093 W CN2019092093 W CN 2019092093W WO 2020211189 A1 WO2020211189 A1 WO 2020211189A1
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matrine
treating
traditional chinese
water
body odor
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PCT/CN2019/092093
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English (en)
French (fr)
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杨洋
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荆楚理工学院
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Priority to US17/919,541 priority Critical patent/US20230120111A1/en
Publication of WO2020211189A1 publication Critical patent/WO2020211189A1/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)
    • A61K36/19—Acanthaceae (Acanthus 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
    • A61P31/10—Antimycotics
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489—Sophora, e.g. necklacepod or mamani
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine

Definitions

  • the invention relates to a traditional Chinese medicine composition with the effects of treating athlete's foot and body odor and its application.
  • Athlete's foot (commonly known as athlete's foot) is caused by a fungal infection, and its skin damage often occurs on one side (ie, one foot) first, and it takes several weeks or months to infect the opposite side.
  • Blisters mainly appear on the belly and side of the toes, most commonly between the third and fourth toes, and can also appear on the soles of the feet. They are small deep blisters that can gradually merge into bullae.
  • the skin damage of tinea pedis has a characteristic, that is, the boundary is clear and can gradually expand outward. Due to the development of the disease or scratching, erosion, exudation, or even bacterial infection, pustules, etc. may appear. It brings great inconvenience to people's daily life.
  • Existing antifungal drugs include azoles (including imidazoles, triazoles) and polyene antifungal drugs, which can effectively treat deep and superficial fungal infections, such as ketoconazole, clotrimazole, and Conazole, etc.; fluconazole, itraconazole and voriconazole in triazoles; amphotericin B in polyenes.
  • azoles including imidazoles, triazoles
  • polyene antifungal drugs which can effectively treat deep and superficial fungal infections, such as ketoconazole, clotrimazole, and Conazole, etc.
  • fluconazole, itraconazole and voriconazole in triazoles such as amphotericin B in polyenes.
  • all existing antifungal drugs can appear resistant strains, and drug resistance has become the main reason for the failure of clinical antifungal treatment.
  • the objective of the present invention is to overcome the shortcomings of the prior art and screen out a traditional Chinese medicine composition with the effects of treating beriberi and body odor through a large number of experiments.
  • the composition of the present invention can be used to prepare anti-fungal, prevent beriberi and treat body odor for external use preparation.
  • a Chinese medicinal composition with the effect of treating beriberi which comprises Sophora flavescens and Nine-head Lion's Grass.
  • the above-mentioned Chinese medicinal composition with the effect of treating athlete's foot is made from 1 to 5 parts of Sophora flavescens and 1 to 5 parts of Lion's grass.
  • the above-mentioned Chinese medicinal composition with the effect of treating athlete's foot is made of matrine alkaloids and water extracts or organic solvent extracts of Lycopersicon esculentum.
  • Organic solvent extracts are methanol, ethanol, acetone, ethyl acetate, chloroform, n-butanol, benzene, ether, petroleum ether, etc.
  • the extraction methods are decoction, reflux extraction, ultrasonic extraction, percolation, continuous reflux extraction and dipping, which can be selected according to actual needs.
  • the matrine alkaloids include matrine, oxymatrine, hydroxymatrine, n-methyl genistein, and anaji Alkaline, Bapfolin and Dehydromatrine.
  • the matrine alkaloids include matrine and oxymatrine.
  • the water extract of the lion grass is prepared by the following preparation method: take the lion grass, add 5 to 20 times the amount of water of the medicinal material, adopt the dipping method and decoction Method, reflux extraction method or continuous reflux extraction method, extract 1 to 5 times, 0.5 to 2 hours each time, filter, combine the extracts, and concentrate.
  • the matrine is prepared by the following method: taking matrine, adding 5 to 20 times acid water (1 to 5% by volume sulfuric acid, Extract the solution with hydrochloric acid, etc.) for 1 to 2 times, 0.5 to 3 hours each time, combine the acid-water extracts, add alkali (such as sodium hydroxide, sodium carbonate, etc.) to basify, then extract with chloroform for 1 to 3 times, and combine with chloroform for extraction Concentrate to dryness, add water to disperse, pass through a cation exchange resin column, first wash with water, and then eluted with ammonia water to obtain ammonia eluate, which is concentrated.
  • alkali such as sodium hydroxide, sodium carbonate, etc.
  • external preparations include lotions, ointments, tinctures, sprays, aerosols, gels, and the like.
  • the Chinese medicinal composition with the effect of treating athlete's foot of the present invention has significant anti-multiple fungus effects, and the fungi include Candida, Aspergillus and Trichophyton fungi.
  • a Chinese medicinal composition with the effect of treating body odor which comprises Sophora flavescens and Nine-head Lion's Grass.
  • the above-mentioned Chinese medicinal composition with the effect of treating body odor is made from 1 to 5 parts of Sophora flavescens and 1 to 5 parts of Lycopersicon esculentum.
  • the above-mentioned Chinese medicinal composition with the effect of treating body odor is made of Sophora flavescens alkaloids and water extracts or organic solvent extracts of Lycopersicon esculentum.
  • said matrine alkaloids include matrine, oxymatrine, hydroxymatrine, n-methyl genitine, analginine, and Bapp Folicine and dehydromarine.
  • the matrine alkaloids include matrine and oxymatrine.
  • the water extract of Nine-head Lion's Grass is prepared by the following preparation method: Take Nine-head Lion's Grass, add 5 to 20 times the amount of water of the medicinal materials, and adopt the dipping method and the decoction method. , Reflux extraction method or continuous reflux extraction method, extract 1 to 3 times, 0.5 to 2 hours each time, filter, combine the extracts, and concentrate.
  • the matrine is prepared by the following method: take matrine, add 5 to 20 times the acid aqueous solution to extract 1 to 5 times, each time 0.5 to 3 After hours, combine the acid and water extracts, add alkali to alkalize, then extract with chloroform for 1 to 5 times, combine the chloroform extracts, concentrate to dryness, add water to disperse, pass through a cation exchange resin column, first wash with water, then eluted with ammonia water, Obtain the ammonia eluate and concentrate it.
  • External preparations include lotions, ointments, tinctures, sprays, aerosols, gels, etc.
  • concentration of ethanol can be adjusted to 30-99% according to actual needs.
  • the present invention has screened out a composition with Sophora flavescens and Lycopersicon esculenta as the main components.
  • the results of antifungal experiments show that the combination of Sophora flavescens and Lycopersicon elata can play a synergistic antifungal effect.
  • It has better antifungal activity than a single Sophora flavescens or Nine-head Lion's grass at the same dose, and it is not easy to produce durability and has better curative effect. Good technological progress has been made.
  • the extracts of Sophora flavescens and Nine-head Lion's Grass are prepared into external preparations such as lotions, tinctures or ointments, which are convenient to use and have strong practicability.
  • a traditional Chinese medicine composition with the effects of treating beriberi and body odor which comprises 1 g of Sophora flavescens alkaloids and 1 g of cephalothorax extract.
  • the above nine lion grass extract is prepared by the following method: take nine lion grass, add 10 times the amount of water to the medicinal material, use the decoction method, extract 2 times, 1 hour each time, filter, combine the extracts, and concentrate. .
  • the above matrine alkaloids are prepared by the following method: take matrine, add 12 times the 5% volume concentration of sulfuric acid solution to reflux extraction twice, each 1.5 hours, combine the acid and water extracts, and alkalinize with sodium hydroxide To the pH value of 10-11, then extract 3 times with chloroform, combine the chloroform extracts, concentrate to dryness, add water to disperse, pass through 732 strong acid styrene cation exchange resin column, first wash with water until colorless, then wash with ammonia water After removal, the ammonia eluate is obtained, which is concentrated.
  • the alkaloids of matrine including matrine, oxymatrine, hydroxymatrine, n-methylgenistein, anajiline, baptiferine, and dehydromarine were determined by high performance liquid chromatography.
  • a Chinese medicinal composition with the effects of treating athlete's foot and body odor which comprises 4 g of Sophora flavescens alkaloids and 1 g of cephalothorax extract.
  • the above nine lion grass extract is prepared by the following method: take nine lion grass, add 12 times the amount of water to the medicinal material, use reflux extraction method, extract 3 times, 1 hour each time, filter, combine the extracts, and concentrate. .
  • the above matrine alkaloids are prepared by the following method: take matrine, add 10 times the 5% volume concentration of hydrochloric acid solution to reflux and extract 3 times, each 1 hour, combine the acid and water extracts, and alkalinize with sodium hydroxide To the pH value of 10-11, then extract 3 times with chloroform, combine the chloroform extracts, concentrate to dryness, add water to disperse, pass through 732 strong acid styrene cation exchange resin column, first wash with water until colorless, then wash with ammonia water After removal, the ammonia eluate is obtained, which is concentrated.
  • the alkaloids of matrine including matrine, oxymatrine, hydroxymatrine, n-methylgenistein, anajiline, baptiferine and dehydromarine were determined by high performance liquid chromatography.
  • a traditional Chinese medicine composition with the effects of treating athlete's foot and body odor which comprises 1 g of Sophora flavescens alkaloids and 4 g of cephalothorax extract.
  • the above nine lion grass extract is prepared by the following method: take nine lion grass, add 8 times the amount of water to the medicinal material, use reflux extraction method, extract 2 times, 1.5 hours each time, filter, combine the extracts, and concentrate. .
  • the above matrine alkaloids are prepared by the following method: take matrine, add 8 times the 5% volume concentration of hydrochloric acid solution to reflux and extract 3 times, each 1 hour, combine the acid and water extracts, and alkalinize with sodium hydroxide To the pH value of 10-11, then extract 3 times with chloroform, combine the chloroform extracts, concentrate to dryness, add water to disperse, pass through 732 strong acid styrene cation exchange resin column, first wash with water until colorless, then wash with ammonia water After removal, the ammonia eluate is obtained, which is concentrated.
  • the alkaloids of matrine including matrine, oxymatrine, hydroxymatrine, n-methylgenistein, anajiline, baptiferine and dehydromarine were determined by high performance liquid chromatography.
  • Aspergillus Aspergillus fumigatus (Aspergillus fumigatus) Bacterial number: CMCCC(F)A1g(ATCC-MYA-3626)
  • Candida genus Candida albicans Bacterial number: CMCCC(F)C.1L(ATCC90028)
  • Trichophyton Trichophyton rubrum. Bacterial number: CMCCC(F)T.1h(ATCC-MYA-4438)
  • Trichophyton mentagrophytes bacteria number CMCCC(F)T.5e(ATCC-MYA-4439)
  • the specific experimental method refers to the standard method of yeast M-27A3 and filamentous fungus M-38P promulgated by the Clinical and Laboratory Standards Institute (US, CLSI).
  • yeasts were cultured on Sandcastle weak agar (SDA) at 30°C for 48 hours; filamentous fungi were cultured on potato dextrose agar (PDA) at 26°C for 7-10 days ; Prepare a suspension with sterile normal saline, count by a hemocytometer, and dilute it to 1.0 ⁇ 10 3 cfu/mL of Candida albicans with a double volume of RMPI-1640 liquid medium containing 2% glucose; Into 2.5 ⁇ 10 4 cfu/mL.
  • SDA Sandcastle weak agar
  • PDA potato dextrose agar
  • Example 5 The effect of treating athlete's foot
  • Example 6 Example of the effect of treating body odor
  • composition extracts of Examples 1 to 3 and the individual Sophora flavescens alkaloids and the individual Nigrass extract prepared in Example 3 are dissolved with 75% ethanol, and an in vitro antifungal test is performed.
  • Case selection From June 2018 to June 2019, 60 cases of body odor patients, including 30 males and 30 females, were selected and divided into 6 groups with 10 cases in each group.
  • Treatment method Groups 1 to 3, using the same dose of the 75% ethanol solution of the composition extracts of Examples 1 to 3 of the present invention (the weight-volume ratio of the extract and 75% ethanol is 1:5) Scrub; groups 4 to 5 use the same dose of the same dose of the first to 3 groups of the preparation of the single alkaloid of Sophora flavescens and the 75% ethanol solution of a single cephalothorax extract (weight of the extract and 75% ethanol) The volume ratio is 1:5) for scrubbing; the sixth group uses 75% ethanol for scrubbing; the above six groups are used once a day in the morning and evening, and the dosage is 4 mL.
  • Body odor was not smelled nearby (within 1 meter); body odor improved significantly after 1 month of continuous treatment, and there was no body odor after exercise. After 2 months of continuous treatment, body odor under the armpit was completely eliminated.
  • Mr. Zhang, male, driver, age 45 is a patient with moderate body odor, which worsens after exercise.
  • spray twice every day After 2 weeks of continuous treatment, the body odor odor was significantly reduced, and the body odor was not smelled near (within 2 meters); the body odor improved significantly after 1 month of continuous treatment, and the body odor was not smelled near (within 1 meter).
  • Continuous treatment for 2 months After the exercise the body odor did not appear after exercise. After 3 months of continuous treatment, the body odor under the armpit was completely eliminated.

Abstract

一种治疗脚气和狐臭的中药组合物，由苦参和九头狮子草制成，具有协同增效抗真菌的作用，不易产生耐药性；苦参生物碱和九头狮子草提取物配伍后可治疗脚气和狐臭，可制成多种外用制剂。

Description

[根据细则37.2由ISA制定的发明名称]　治疗脚气和狐臭的中药组合物及其应用 技术领域
本发明涉及具有治疗脚气和狐臭作用的中药组合物及其应用。
背景技术
足癣(俗名脚气)，系真菌感染引起，其皮肤损害往往是先单侧(即单脚)发生，数周或数月后才感染到对侧。水疱主要出现在趾腹和趾侧，最常见于三四趾间，足底亦可出现，为深在性小水疱，可逐渐融合成大疱。足癣的皮肤损害有一特点，即边界清楚，可逐渐向外扩展。因病情发展或搔抓，可出现糜烂、渗液，甚或细菌感染，出现脓疱等。给人们的日常生活带来了很大的不便。
现有的抗真菌药物包括唑类(包括咪唑类、三唑类)及多烯类抗真菌药物，可有效治疗深部及浅表部真菌感染，如咪唑中的酮康唑、克霉唑、益康唑等；三唑类中的氟康唑、伊曲康唑和伏立康唑等；多烯类中的两性霉素B等。但是现有的抗真菌药物都可出现耐药株，耐药性已成为临床抗真菌治疗失败的主要原因。
因此，很有必要在现有技术的基础之上，从天然药物中开发具有防治脚气的物质具有重要的意义。
发明内容
发明目的：本发明的目的是为了克服现有技术的不足，通过大量实验筛选出具有治疗脚气和狐臭作用的中药组合物，本发明的组合物可用于制备抗真菌、防治脚气和治疗狐臭的外用制剂。
技术方案：为了实现以上目的，本发明采取的技术方案为：
一种具有治疗脚气作用的中药组合物，它包括苦参和九头狮子草。
作为优选方案，以上所述的具有治疗脚气作用的中药组合物，它由苦参1～5份和九头狮子草1～5份制成。
作为优选方案，以上所述的具有治疗脚气作用的中药组合物，它由苦参生物碱和九头狮子草水提物或有机溶剂提取物制成。有机溶剂提取物为甲醇、乙醇、丙酮、乙酸乙酯、氯仿、正丁醇、苯、乙醚、石油醚等。提取方法为煎煮法、回流提取法、超声提取法、渗漉法、连续回流提取法和浸渍法，可根据实际需要选择。
作为优选方案，以上所述的具有治疗脚气作用的中药组合物，所述的苦参生物碱包括苦 参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、巴普叶碱和去氢苦参碱。
作为优选方案，以上所述的具有治疗脚气作用的中药组合物，所述的苦参生物碱包括苦参碱和氧化苦参碱。
本发明所述的具有治疗脚气作用的中药组合物，九头狮子草水提物由以下制备方法制备得到：取九头狮子草，加入药材5至20倍量的水，采用浸渍法、煎煮法、回流提取法或连续回流提取法，提取1～5次，每次0.5～2小时，过滤，合并提取液，浓缩既得。
本发明所述的具有治疗脚气作用的中药组合物，所述的苦参碱是通过以下方法制备得到的：取苦参碱，加5至20倍酸水(1～5％体积浓度的硫酸、盐酸等)溶液提取1至2次，每次0.5～3小时，合并酸水提取液，加碱(如氢氧化钠、碳酸钠等)碱化，然后用氯仿萃取1至3次，合并氯仿萃取液，浓缩至干，加水分散，过阳离子交换树脂柱，先采用水洗，然后用氨水洗脱，得氨水洗脱液，浓缩既得。
本发明所述的具有治疗脚气作用的中药组合物在制备防治脚气的外用制剂中的应用。作为优选方案，外用制剂包括洗液、膏剂、酊剂、喷雾剂、气雾剂、凝胶剂等。
本发明所述的具有治疗脚气作用的中药组合物具有显著的抗多种真菌的功效，所述的真菌包括念珠菌属、曲霉属、毛癣菌属真菌。本发明提供的具有治疗脚气作用的中药组合物在制备抗真菌药物中的应用，所述的真菌为白念珠菌、熏烟色曲霉、红色毛癣菌、须癣毛癣菌和絮状表皮癣菌等。
一种具有治疗狐臭作用的中药组合物，它包括苦参和九头狮子草。
以上所述的具有治疗狐臭作用的中药组合物，它由苦参1～5份和九头狮子草1～5份制成。
以上所述的具有治疗狐臭作用的中药组合物，它由苦参生物碱和九头狮子草水提物或有机溶剂提取物制成。
以上所述的具有治疗狐臭作用的中药组合物，所述的苦参生物碱包括苦参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、巴普叶碱和去氢苦参碱。
以上所述的具有治疗狐臭作用的中药组合物，所述的苦参生物碱包括苦参碱和氧化苦参碱。
以上所述的具有治疗狐臭作用的中药组合物，九头狮子草水提物由以下制备方法制备得到：取九头狮子草，加入药材5至20倍量的水，采用浸渍法、煎煮法、回流提取法或连续回流提取法，提取1～3次，每次0.5～2小时，过滤，合并提取液，浓缩既得。
以上所述的具有治疗狐臭作用的中药组合物，所述的苦参碱是通过以下方法制备得到的：取苦参碱，加5至20倍酸水溶液提取1至5次，每次0.5～3小时，合并酸水提取液，加碱碱 化，然后用氯仿萃取1至5次，合并氯仿萃取液，浓缩至干，加水分散，过阳离子交换树脂柱，先采用水洗，然后用氨水洗脱，得氨水洗脱液，浓缩既得。
本发明所述的具有治疗狐臭作用的中药组合物在制备防治狐臭的外用制剂中的应用。
本发明所述的具有治疗脚气作用的中药组合物在制备防治狐臭的外用制剂中的应用。外用制剂包括洗液、膏剂、酊剂、喷雾剂、气雾剂、凝胶剂等。制成酊剂、喷雾剂和气雾剂时，乙醇的浓度可以根据实际需要调整为30～99％。
有益效果：本发明提供的具有治疗脚气作用的中药组合物和现有技术相比具有以下优点：
1、本发明通过大量实验，筛选出以苦参和九头狮子草为主要成分的组合物，抗真菌实验结果表明，该苦参和九头狮子草合用可以起到协同增效抗真菌的作用，比相同剂量的单个苦参或九头狮子草具有更好的抗真菌活性，且不易产生耐用性，疗效更佳。取得了很好的技术进步。
2、并且实验结果表明，经过苦参生物碱和九头狮子草提取物配伍后，可起到明显协同增效的治疗狐臭的作用，有效率100％，相比相同剂量的苦参生物碱和九头狮子草提取物具有更好的抗狐臭的作用，且不易复发，疗效确切。
3、本发明将苦参和九头狮子草提取物制备成洗液、酊剂或膏剂等外用制剂，方便使用，实用性强。
具体实施方式
根据下述实施例，可以更好地理解本发明。然而，本领域的技术人员容易理解，实施例所描述的具体的物料配比、工艺条件及其结果仅用于说明本发明，而不应当也不会限制权利要求书中所详细描述的本发明。
实施例1
1、一种具有治疗脚气和狐臭作用的中药组合物，它包括苦参生物碱1g和九头狮子草提取物1g。
以上九头狮子草提取物是由以下方法制备得到：取九头狮子草，加入药材10倍量的水，采用煎煮法，提取2次，每次1小时，过滤，合并提取液，浓缩既得。
以上苦参生物碱是通过以下方法制备得到的：取苦参碱，加12倍5％体积浓度的硫酸溶液回流提取2次，每次1.5小时，合并酸水提取液，加氢氧化钠碱化至pH值为10～11，然后用氯仿萃取3次，合并氯仿萃取液，浓缩至干，加水分散，过732强酸性苯乙烯系阳离子交换树脂柱，先采用水洗至无色，然后用氨水洗脱，得氨水洗脱液，浓缩既得。通过高效液相色谱仪测定苦参生物碱包括苦参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、 巴普叶碱和去氢苦参碱。
实施例2
1、一种具有治疗脚气和狐臭作用的中药组合物，它包括苦参生物碱4g和九头狮子草提取物1g。
以上九头狮子草提取物是由以下方法制备得到：取九头狮子草，加入药材12倍量的水，采用回流提取法，提取3次，每次1小时，过滤，合并提取液，浓缩既得。
以上苦参生物碱是通过以下方法制备得到的：取苦参碱，加10倍5％体积浓度的盐酸溶液回流提取3次，每次1小时，合并酸水提取液，加氢氧化钠碱化至pH值为10～11，然后用氯仿萃取3次，合并氯仿萃取液，浓缩至干，加水分散，过732强酸性苯乙烯系阳离子交换树脂柱，先采用水洗至无色，然后用氨水洗脱，得氨水洗脱液，浓缩既得。通过高效液相色谱仪测定苦参生物碱包括苦参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、巴普叶碱和去氢苦参碱。
实施例3
1、一种具有治疗脚气和狐臭作用的中药组合物，它包括苦参生物碱1g和九头狮子草提取物4g。
以上九头狮子草提取物是由以下方法制备得到：取九头狮子草，加入药材8倍量的水，采用回流提取法，提取2次，每次1.5小时，过滤，合并提取液，浓缩既得。
以上苦参生物碱是通过以下方法制备得到的：取苦参碱，加8倍5％体积浓度的盐酸溶液回流提取3次，每次1小时，合并酸水提取液，加氢氧化钠碱化至pH值为10～11，然后用氯仿萃取3次，合并氯仿萃取液，浓缩至干，加水分散，过732强酸性苯乙烯系阳离子交换树脂柱，先采用水洗至无色，然后用氨水洗脱，得氨水洗脱液，浓缩既得。通过高效液相色谱仪测定苦参生物碱包括苦参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、巴普叶碱和去氢苦参碱。
实施例4抗真菌活性实验
1、本发明对实施例1至3的组合物提取物和实施例3制备得到的单个苦参生物碱和单个九头狮子草提取物进行体外抗真菌试验。试验所用细胞株均为卫生部医学微生物菌(毒)种保藏管理中心真菌中心提供ATCC标准菌株，其中包括：
曲霉属：熏烟色曲霉(Aspergillus fumigatus)菌号：CMCCC(F)A1g(ATCC-MYA-3626)
念珠菌属：白念珠菌(Candida albicans)菌号：CMCCC(F)C.1L(ATCC90028)
毛癣菌属：红色毛癣菌(Trichophyton rubrum)菌号：CMCCC(F)T.1h(ATCC-MYA-4438)
须癣毛癣菌(Trichophyton mentagrophytes)菌号：CMCCC(F)T.5e(ATCC-MYA-4439)
2、具体实验方法参照美国临床和实验室标准化研究所(Clinical and Laboratory Standards Institute,US,CLSI)颁布的酵母菌M-27A3和丝状真菌M-38P的标准方法进行实验。
3、实验方法：
菌液制备
实验前，将实验菌活化后，酵母菌在沙堡弱琼脂培养基(SDA)上，30℃培养48小时；丝状真菌在马铃薯葡萄糖琼脂(PDA)培养基上，26℃培养7-10天；用无菌生理盐水配成悬液，经血球计数板计数，用倍量含2％葡萄糖RMPI-1640液体培养基稀释成白念珠菌1.0×10 3cfu/mL；其它三株丝状真菌配成2.5×10 4cfu/mL。分别取菌液0.1mL，加入含有实施例1至3制备得到组合物和相同剂量的实施例3制备得到的苦参生物碱和九头狮子草提取物的培养基到各孔中，11孔为溶媒对照，12孔为培养基对照。溶媒对照孔中加入0.1mL的稀释后的溶媒，对照孔中加入0.1mL的蒸馏水。加样完毕后，放在摇板机上，转速为100r/min×10min，使药物和菌液充分接触。以不含任何抗生素的含2％葡萄糖RMPI-1640液体培养基作为基础培养基。阳性对照药为伊曲康唑。
4、实验结果判定方法
80％最低抑菌浓度(80％MIC)：以空白对照和溶媒对照孔菌已生长为参照，药基孔中菌仅生长80％表示有抑菌作用，菌已生长表示无抑菌作用。实验结果如下表1所示：
表1组合物对真菌80％MIC测定结果
Figure PCTCN2019092093-appb-000001
由以上表1实验结果表明，本发明提供组合物对多种真菌显示很好的抑菌效果，特别是苦参生物碱和九头狮子草提取物配伍后，可起到明显协同增效的作用，相比相同剂量的苦参生物碱和九头狮子草提取物具有更好的抑菌作用。特别是苦参生物碱和九头狮子草提取物重量比为1:4时抗菌效果更加。
实施例5治脚气效果实施例
选取脚气患者30例，男性20例，女性10例，年龄12至60岁，平均年龄38岁；每日用本发明实施例3制备得到的组合物20g，每天用热水溶解泡脚30分钟，连续泡脚7天，患者异味、瘙痒症状消失，皮肤破裂处炎症消失，总有效率100％；连续泡脚14天，治愈率86％，随访2个月未复发。
实施例6治狐臭效果实施例
1、本发明对实施例1至3的组合物提取物和实施例3制备得到的单个苦参生物碱和单个九头狮子草提取物用75％乙醇进行溶解，进行体外抗真菌试验。
2、病例选择：2018年6月到2019年6月选取狐臭患者60例，男性30例，女性30例，分成6组，每组10例。
3、治疗方法：第1至3组，采用相同剂量的本发明的实施例1至3的组合物提取物的75％乙醇溶液(提取物和75％乙醇的重量体积比为1:5)进行擦洗；第4至5组采用与第1至3组相同剂量的实施例3制备得到的单个苦参生物碱和单个九头狮子草提取物的75％乙醇溶液(提取物和75％乙醇的重量体积比为1:5)进行擦洗；第6组采用75％乙醇液进行擦洗；以上6组均每天早晚各1次，用量4mL。
1个月为一个疗程。
4、判断标准：一个疗程后腋下狐臭气味完全消除，二月内不再复发为显效；一个疗程后腋下狐臭减轻，近处有味道，远处无臭味，二月内不复发为有效；一个疗程后症状无明显改善为无效。
5、具体实验结果如下表2所示：
表2各组治疗狐臭的实验结果
Figure PCTCN2019092093-appb-000002
Figure PCTCN2019092093-appb-000003
从表2可以知道，苦参生物碱和九头狮子草提取物配伍后，可起到明显协同增效的治疗狐臭的作用，有效率100％，特别是实施例3的组合物显效率为80％。相比相同剂量的苦参生物碱和九头狮子草提取物具有更好的抗狐臭的作用。
实施例7狐臭病例
周某，女，职业公司白领，年龄33岁，采用本发明实施例3的苦参生物碱和九头狮子草提取物乙醇溶液，每1天喷2次，连续治疗2周后狐臭气味明显减弱，近处(1米内)也闻不到狐臭气味；连续治疗1个月后狐臭明显好转，运动后未出现狐臭气味，连续治疗2月后，腋下狐臭气味完全消除。1年后随访，未再复发。
张某，男，驾驶员，年龄45岁，为中度狐臭患者，运动后加剧，采用本发明实施例3的苦参生物碱和九头狮子草提取物乙醇溶液，每1天喷2次，连续治疗2周后狐臭气味明显减弱，近处(2米内)也闻不到狐臭气味；连续治疗1个月后狐臭明显好转，近处(1米内)也闻不到狐臭气味，连续治疗2月后，运动后未出现狐臭气味，连续治疗3月后，腋下狐臭气味完全消除。1年后随访，未再复发。
刘某，男，在校学生，年龄19岁，青春期开始发病，夏季或多汗时腋下很容易被闻到特殊有刺鼻的臭味，采用本发明实施例3的苦参生物碱和九头狮子草提取物乙醇溶液，每1天喷2次，连续治疗4周后狐臭气味明显减弱，近处(2米内)也闻不到狐臭气味；连续治疗1个月后狐臭明显好转，近处(2米内)也闻不到狐臭气味，连续治疗2月后，运动后未出现狐臭气味，连续治疗3月后，腋下狐臭气味完全消除。1年后随访，未再复发。
以上实施方式只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人了解本发明内容并加以实施，并不能以此限制本发明的保护范围，凡根据本发明精神实质所做的等效变化或修饰，都应涵盖在本发明的保护范围内。

Claims (18)

  1. 一种具有治疗脚气作用的中药组合物，其特征在于，它包括苦参和九头狮子草。
  2. 根据权利要求1所述的具有治疗脚气作用的中药组合物，其特征在于，它由苦参1～5份和九头狮子草1～5份制成。
  3. 根据权利要求2所述的具有治疗脚气作用的中药组合物，其特征在于，它由苦参生物碱和九头狮子草水提物或有机溶剂提取物制成。
  4. 根据权利要求3所述的具有治疗脚气作用的中药组合物，其特征在于，所述的苦参生物碱包括苦参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、巴普叶碱和去氢苦参碱。
  5. 权利要求4所述的具有治疗脚气作用的中药组合物，其特征在于，所述的苦参生物碱包括苦参碱和氧化苦参碱。
  6. 权利要求3所述的具有治疗脚气作用的中药组合物，其特征在于，九头狮子草水提物由以下制备方法制备得到：取九头狮子草，加入药材5至20倍量的水，采用浸渍法、煎煮法、回流提取法或连续回流提取法，提取1～3次，每次0.5～2小时，过滤，合并提取液，浓缩既得。
  7. 权利要求3所述的具有治疗脚气作用的中药组合物，其特征在于，所述的苦参碱是通过以下方法制备得到的：取苦参碱，加5至20倍酸水溶液提取1至5次，每次0.5～3小时，合并酸水提取液，加碱碱化，然后用氯仿萃取1至5次，合并氯仿萃取液，浓缩至干，加水分散，过阳离子交换树脂柱，先采用水洗，然后用氨水洗脱，得氨水洗脱液，浓缩既得。
  8. 权利要求1至7任一项所述的具有治疗脚气作用的中药组合物在制备防治脚气的外用制剂中的应用。
  9. 根据权利要求8所述的具有治疗脚气作用的中药组合物在制备防治脚气的外用制剂中的应用，所述的外用制剂为洗液、膏剂、酊剂、喷雾剂、气雾剂、凝胶剂等。
  10. 一种具有治疗狐臭作用的中药组合物，其特征在于，它包括苦参和九头狮子草。
  11. 根据权利要求10所述的具有治疗狐臭作用的中药组合物，其特征在于，它由苦参1～5份和九头狮子草1～5份制成。
  12. 根据权利要求11所述的具有治疗狐臭作用的中药组合物，其特征在于，它由苦参生物碱和九头狮子草水提物或有机溶剂提取物制成。
  13. 根据权利要求12所述的具有治疗狐臭作用的中药组合物，其特征在于，所述的苦参生物碱包括苦参碱、氧化苦参碱、羟基苦参碱、n-甲基金雀花碱、安那吉碱、巴普叶碱和去氢苦参碱。
  14. 权利要求12所述的具有治疗狐臭作用的中药组合物，其特征在于，所述的苦参生物碱包括苦参碱和氧化苦参碱。
  15. 权利要求12所述的具有治疗狐臭作用的中药组合物，其特征在于，九头狮子草水提 物由以下制备方法制备得到：取九头狮子草，加入药材5至20倍量的水，采用浸渍法、煎煮法、回流提取法或连续回流提取法，提取1～3次，每次0.5～2小时，过滤，合并提取液，浓缩既得。
  16. 权利要求12所述的具有治疗狐臭作用的中药组合物，其特征在于，所述的苦参碱是通过以下方法制备得到的：取苦参碱，加5至20倍酸水溶液提取1至5次，每次0.5～3小时，合并酸水提取液，加碱碱化，然后用氯仿萃取1至5次，合并氯仿萃取液，浓缩至干，加水分散，过阳离子交换树脂柱，先采用水洗，然后用氨水洗脱，得氨水洗脱液，浓缩既得。
  17. 权利要求10至16任一项所述的具有治疗狐臭作用的中药组合物在制备防治狐臭的外用制剂中的应用。
  18. 根据权利要求17所述的具有治疗狐臭作用的中药组合物在制备防治狐臭的外用制剂中的应用，所述的外用制剂为洗液、膏剂、酊剂、喷雾剂、气雾剂、凝胶剂。
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