WO2017080049A1 - 一种止痒软膏及其制备方法 - Google Patents

一种止痒软膏及其制备方法 Download PDF

Info

Publication number
WO2017080049A1
WO2017080049A1 PCT/CN2015/098907 CN2015098907W WO2017080049A1 WO 2017080049 A1 WO2017080049 A1 WO 2017080049A1 CN 2015098907 W CN2015098907 W CN 2015098907W WO 2017080049 A1 WO2017080049 A1 WO 2017080049A1
Authority
WO
WIPO (PCT)
Prior art keywords
parts
extract
weight
preparation
comfrey
Prior art date
Application number
PCT/CN2015/098907
Other languages
English (en)
French (fr)
Inventor
谭惠娟
Original Assignee
谭惠娟
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 谭惠娟 filed Critical 谭惠娟
Publication of WO2017080049A1 publication Critical patent/WO2017080049A1/zh

Links

Classifications

    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A61K31/125—Camphor; Nuclear substituted derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/722—Chitin, chitosan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02—Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • 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)
    • A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • 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
    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/756—Phellodendron, e.g. corktree

Definitions

  • the invention relates to the field of medicine.
  • the present invention provides an antipruritic ointment and a preparation method thereof.
  • the antipruritic ointment of the present invention comprises an active ingredient and a matrix, characterized in that the active ingredient is composed of the following components by weight: 1 to 5 parts of sublimed sulfur, 1 to 5 parts of paeonol, and 0.5 to 3 of dexamethasone acetate.
  • the active ingredient is composed of the following components by weight: 2 to 4 parts of sublimed sulfur, 2 to 4 parts of paeonol, 0.8 to 2 parts of dexamethasone acetate, 2 to 4 parts of camphor, and chitosan 0.2. ⁇ 0.4 parts, 5-7 parts of Sophora flavescens extract, 5-7 parts of comfrey extract, 0.8-3 parts of eucalyptus oil, 5-7 parts of Phellodendron extract, 2-4 parts of borneol, 2 ⁇ 4 parts of peppermint oil .
  • the active ingredient is composed of the following components by weight: 3 parts of sublimed sulfur, 3 parts of paeonol, 1 part of dexamethasone acetate, 3 parts of camphor, 0.3 parts of chitosan, and extract of Sophora flavescens. 6 parts, 6 parts of comfrey extract, 2 parts of eucalyptus oil, 6 extracts of Phellodendron chinense, 3 parts of borneol, and 3 parts of peppermint oil.
  • the chitosan is chitosan having a degree of deacetylation of greater than 85%.
  • the substrate is composed of the following components by weight: 13 to 18 parts of white petrolatum, 5 to 13 parts of lauric acid glyceride, 20 to 30 parts of cetyl alcohol, and 3 to 10 parts of sodium lauryl sulfate. 13 to 18 parts of beeswax, 10 to 15 parts of glycerin, 0.1 to 0.5 parts of preservative, and 50 to 80 parts of deionized water.
  • the matrix is composed of the following components by weight: 14-17 parts of white petrolatum, 8-10 parts of lauric acid glyceride, 23-28 parts of cetyl alcohol, 5-8 parts of sodium lauryl sulfate, 14 to 16 parts of beeswax, 12 to 14 parts of glycerin, 0.2 to 0.4 parts of preservative, and 60 to 73 parts of deionized water.
  • the preservative is one or a combination of two of phenoxyethanol and methylparaben.
  • a method for preparing an antipruritic ointment of the present invention comprising the steps of:
  • Preparation of aqueous phase According to the formula amount, appropriate amount of water is used to dissolve chitosan and sodium lauryl sulfate, and with Sophora flavescens The extract, the cortex extract, the comfrey extract and the balance water are uniformly mixed and heated to 60-80 ° C;
  • the preparation method of the Sophora flavescens extract is: after washing the Sophora flavescens, drying and pulverizing, adding Sophora flavescens powder into a 5 times weight 50% ethanol solution, ultrasonically extracting for 20-30 min, and extracting 2 times in total.
  • the extracts were combined and concentrated under reduced pressure to a concentrated solution having a relative density of 1.1 to 1.3 at 60 ° C.
  • the comfrey extract is prepared by washing the comfrey, drying and pulverizing, adding the comfrey powder to a 5 times weight 50% ethanol solution, ultrasonically extracting for 20-30 minutes, and extracting 2 times.
  • the extracts were combined and concentrated under reduced pressure to a concentrated solution having a relative density of 1.1 to 1.3 at 60 ° C.
  • the preparation method of the cortex extract is: after washing the cork, drying and pulverizing, adding the cork powder to a 5 times weight 50% ethanol solution, ultrasonically extracting for 20-30 min, extracting twice, and extracting the extract.
  • the liquid is concentrated under reduced pressure to a concentrated liquid having a relative density of 1.1 to 1.3 at 60 ° C.
  • Chitosan has good antibacterial activity and can inhibit the growth and reproduction of some fungi, bacteria, and viruses. It is believed that there are three possible mechanisms: one is to change the fluidity and permeability of the pathogenic bacteria cell membrane; the other is to interfere with DNA replication and transcription; and the third is to block the metabolism of pathogenic bacteria. Chitosan has good moisture absorption and moisturizing effect, and can form a thin protective film on the skin surface to slow down the evaporation of skin moisture and protect the skin against external stimuli.
  • Eucalyptus oil is a colorless to slightly yellow oily liquid. It is extracted from eucalyptus oil, eucalyptus oil, camphor oil, bay leaf oil and other substances. It has a characteristic cool thorny scent and a hint of camphor smell. Some medicines have a certain bactericidal effect.
  • Kushen is bitter and bitter. Heart, liver, stomach, large intestine, bladder. It has the effects of clearing heat and dampness, killing insects and diuresis. For phlegm, blood in the stool, jaundice, urinary tract, red and white, edema, pruritus, eczema, wet sores, itchy skin, phlegm, external treatment of trichomonas vaginitis.
  • the comfrey is sweet, salty, and cold. It can cool the blood, promote blood circulation, and detoxify the rash.
  • the antipruritic ointment of the invention is fine and white, has a fresh scent and is easily accepted by most people. Natural plant extracts work synergistically with a mild ointment base that is mild and non-irritating. It has antipruritic bactericidal and anti-inflammatory effects, can control and alleviate most of the itching phenomenon and skin lesions, and has rapid onset and no toxic and side effects, especially after stopping the drug, the symptoms do not rebound, and there is no dependence.
  • the preparation method of the antipruritic ointment of the present invention is as follows:
  • aqueous phase According to the formula amount of Table 1, an appropriate amount of water is used to dissolve chitosan with sodium decarboxylate having a degree of deacetylation of more than 85%, and is prepared with steps (1) to (3). Sophora flavescens extract, cork extract, comfrey extract and the balance water are uniformly mixed and heated to 60-80 ° C;
  • the antibacterial effect of the antipruritic ointment prepared in Examples 1 to 5 of the present invention was determined in accordance with GB 15979-2002 "Sanitary Standard for Sanitary Hygiene Products", Appendix C.
  • Test bacteria bacteria: Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 25922);
  • Yeast Candida albicans (ATCC 10231).
  • Preparation of bacterial solution Take fresh culture of slanted surface of nutrient agar medium of strains 3 to 14 for 18 to 24 hours, wash the lawn with 5 ml of 0.03 mol/L phosphate buffer (hereinafter referred to as PBS), and suspend the bacteria evenly.
  • PBS 0.03 mol/L phosphate buffer
  • test cultivar 24h slant culture was washed with PBS to prepare a bacterial suspension.
  • the required concentration was: 100 ⁇ l was dropped on the control swatch, and the number of bacteria recovered was 1 ⁇ 10 4 to 9 ⁇ 10 4 cfu/tablet.
  • test piece 2.0 cm ⁇ 3.0 cm
  • control piece Four pieces of the test piece (2.0 cm ⁇ 3.0 cm) and the control piece were taken, and divided into four groups and placed in four sterilized dishes.
  • the control sample is of the same size as the sample, but is of the same size but does not contain an antibacterial material and is sterilized.
  • Test articles Inventive Examples 1 to 5 and commercially available dermatitis.
  • mice 80 primary ICR mice, weighing 20-22 g, male and female, divided into groups 1 to 5 (1.0 g / kg) of the present invention, positive control group: dermatitis (3.0 g / kg), Single ointment group, 12 mice per group.
  • positive control group dermatitis (3.0 g / kg)
  • Single ointment group 12 mice per group.
  • the doses of each group were applied to the right ear of the animal (both sides of the auricle); after 60 minutes of treatment, the drug was wiped with a dry cotton ball, and p-xylene was applied to the right ear (both sides of the auricle). 30ul/only, at the same time, apply the medicine once again.
  • Test articles Inventive Examples 1 to 5 and commercially available dermatitis.
  • Eighty guinea pigs weighing 250-300 g were divided into groups 1 to 5 (1.0 g/kg) of the present invention, dermatitis ointment (3.0 g/kg) of the positive control group, and a single ointment group.
  • groups 1 to 5 (1.0 g/kg) of the present invention dermatitis ointment (3.0 g/kg) of the positive control group, and a single ointment group.
  • 24 hours before the experiment each group of guinea pigs were shaved on the right hind paw, and the rats were shaved and applied once a day according to the dose of the group, and the drug was applied once.
  • the shaved area of the right hind paw was scratched with coarse sandpaper.
  • the area of the abrasion was 1 cm 2 , and the area was reapplied once.
  • Test substance Samples obtained in Examples 1 to 5 prepared in the examples were prepared.
  • Subjects A total of 36 people, male and female, aged 20 to 30 years old, in line with the subject's voluntary inclusion criteria.
  • Test method The test object was placed in a spot tester in an amount of 0.023 g. Control wells were blank controls (no substance). The spot tester to which the test substance was applied was applied to the back of the subject or the curved side of the forearm with a non-irritating tape, and gently pressed with the palm to uniformly apply it to the skin for 3 minutes. The skin reaction was observed 30 minutes after the test specimen was removed, and the indentation disappeared. If the result is negative, observe again at 24h and 48h after the patch test. The results of the reaction were recorded according to Table 5 (Skin Adverse Reaction Grading Standard Table).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

一种止痒软膏及其制备方法，其中该止痒软膏的活性成分由1-5份升华硫、1-5份丹皮酚、0.5-3份醋酸***、1-5份樟脑、0.1-0.5份壳聚糖、3-8份苦参提取物、3-8份紫草提取物、0.5-5份桉叶油、3-8份黄柏提取物、1-5份冰片和1-5份薄荷油组成。该止痒软膏的制备方法包括制备水相、制备油相和制备产品的步骤。

Description

一种止痒软膏及其制备方法 技术领域
本发明涉及医药学领域。
背景技术
人的活动不可避免的会接触各种各样的环境，首当其冲受到影响的就是皮肤。由于受高温、潮湿等环境因素的影响，以及持续精神紧张、情绪激动和过度疲劳等，均可引发皮肤病，湿疹、疖肿、足癣、痱子等多种皮肤疾患比较常见。瘙痒是很多皮肤病的表现之一，严重的瘙痒会给人们的日常工作生活带来很大不便。而且皮肤病容易复发，难以根治。因此开发一种能够控制和缓解该类皮肤疾病的药物具有十分巨大的意义。
发明内容
针对上述问题，本发明提供一种止痒软膏及其制备方法。本发明的止痒软膏包括有效成分与基质，其特征在于所述有效成分由以下重量份的组分组成：升华硫1～5份、丹皮酚1～5份、醋酸***0.5～3份、樟脑1～5份、壳聚糖0.1～0.5份、苦参提取物3～8份、紫草提取物3～8份、桉叶油0.5～5份、黄柏提取物3～8份、冰片1～5份、薄荷油1～5份。
进一步地，所述有效成分由以下重量份的组分组成：升华硫2～4份、丹皮酚2～4份、醋酸***0.8～2份、樟脑2～4份、壳聚糖0.2～0.4份、苦参提取物5～7份、紫草提取物5～7份、桉叶油0.8～3份、黄柏提取物5～7份、冰片2～4份、薄荷油2～4份。
进一步地，其特征在于所述有效成分由以下重量份的组分组成：升华硫3份、丹皮酚3份、醋酸***1份、樟脑3份、壳聚糖0.3份、苦参提取物6份、紫草提取物6份、桉叶油2份、黄柏提取物6、冰片3份、薄荷油3份。
具体地，所述壳聚糖为脱乙酰度大于85％的壳聚糖。
进一步地，所述基质由以下重量份的组分组成：白凡士林13～18份、月桂酸甘油酯5～13份、鲸蜡醇20～30份、十二烷基硫酸钠3～10份、蜂蜡13～18份、甘油10～15份、防腐剂0.1～0.5份、去离子水50～80份。
进一步地，所述基质由以下重量份的组分组成：白凡士林14～17份、月桂酸甘油酯8～10份、鲸蜡醇23～28份、十二烷基硫酸钠5～8份、蜂蜡14～16份、甘油12～14份、防腐剂0.2～0.4份、去离子水60～73份。
具体地，所述防腐剂为苯氧乙醇、羟苯甲酯中的一种或两种的组合。
一种本发明的止痒软膏的制备方法，其特征在于包括以下步骤：
(1).水相的制备：按所述配方量，取适量水将壳聚糖与十二烷基硫酸钠溶解，并与苦参 提取物、黄柏提取物、紫草提取物和余量水混合均匀，并加热至60～80℃；
(2).油相的制备：将丹皮酚、醋酸***、樟脑、桉叶油、冰片、薄荷油、白凡士林、月桂酸甘油酯、鲸蜡醇、蜂蜡、甘油与防腐剂混合均匀，并加热至60～80℃；
(3).成品的制备：保温下，将步骤(1)制得的水相、步骤(2)制得的油相与配方量的升华硫置于软膏剂中，3000r/min搅拌下使其均质化；20r/min搅拌下逐渐冷却至室温，出料得成品。
具体地，所述苦参提取物的制备方法为：将苦参洗净后晒干粉碎，将苦参粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
具体地，所述紫草提取物的制备方法为：将紫草洗净后晒干粉碎，将紫草粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
具体地，所述黄柏提取物的制备方法为：将黄柏洗净后晒干粉碎，将黄柏粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
壳聚糖具有较好的抗菌活性，能抑制一些真菌、细菌、和病毒的生长繁殖。认为其可能的机制有三：一是改变病原菌细胞膜的流动性和通透性；二是干扰DNA的复制与转录；三是阻断病原菌代谢。壳聚糖具有良好的吸湿、保湿的功效，可以在皮肤表面形成一层薄薄的保护膜，减缓皮肤水分蒸发的同时也保护皮肤抵御外界的刺激。
桉叶油是一种无色至微黄色油状液体，在桉树油、玉树油、樟脑油、月桂叶油等物质中提取而来，呈特有清凉尖刺桉叶香气并带几分樟脑气味，带些药气，具有一定的杀菌作用。
苦参味苦，性寒。归心、肝、胃、大肠、膀胱经。具有清热燥湿，杀虫，利尿之功效。用于热痢，便血，黄疸尿闭，赤白带下，阴肿阴痒，湿疹，湿疮，皮肤瘙痒，疥癣麻风，外治滴虫性***炎。
黄柏味苦，性寒，归肾、膀胱经。有清热燥湿，泻火除蒸，解毒疗疮的功效。用于湿热泻痢，黄疸尿赤，带***痒，热淋涩痛，脚气痿蹙，骨蒸劳热，疮疡肿毒，湿疹湿疮。
紫草味甘、咸，性寒，能够凉血，活血，解毒透疹。用于血热毒盛，斑疹紫黑，麻疹不透，疮疡，湿疹，水火烫伤等。
本发明的止痒软膏呈细腻洁白，气味清新，易于被大多数人所接受。天然植物提取物相互协同作用，并配以温和的软膏基质，质地温和无刺激性。具有止痒杀菌和抗炎效果，能够控制和缓解大部分瘙痒现象和皮肤病变，起效迅速，无毒副作用，尤其是停药后症状不反弹，无依赖现象。
为了更好地理解和实施，下面详细说明本发明。
具体实施方式
制备实施例
本发明的止痒软膏的制备方法如下：
(1).苦参提取物的制备：将苦参洗净后晒干粉碎，将苦参粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
(2).紫草提取物的制备：将紫草洗净后晒干粉碎，将紫草粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
(3).黄柏提取物的制备：将黄柏洗净后晒干粉碎，将黄柏粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
(4).水相的制备：按表1配方量，取适量水将脱乙酰度大于85％的壳聚糖与十二烷基硫酸钠溶解，并与步骤(1)～(3)制得的苦参提取物、黄柏提取物、紫草提取物和余量水混合均匀，并加热至60～80℃；
(5).油相的制备：将丹皮酚、醋酸***、樟脑、桉叶油、冰片、薄荷油、白凡士林、月桂酸甘油酯、鲸蜡醇、蜂蜡、甘油与防腐剂混合均匀，并加热至60～80℃；
(6).成品的制备：保温下，将步骤(4)制得的水相、步骤(5)制得的油相与配方量的升华硫置于软膏剂中，3000r/min搅拌下使其均质化；20r/min搅拌下逐渐冷却至室温，出料得成品。
<表1各组分以重量份计>
Figure PCTCN2015098907-appb-000001
Figure PCTCN2015098907-appb-000002
抗菌效果实施例
根据GB 15979-2002《一次性使用卫生用品卫生标准》附录C测定本发明实施例1～5制备的止痒软膏的抗菌效果。
试验菌：细菌：金黄色葡萄球菌(ATCC 6538)，大肠杆菌(ATCC 25922)；
酵母菌：白色念珠菌(ATCC 10231)。
菌液制备:取菌株第3～14代的营养琼脂培养基斜面新鲜培养物18～24h，用5ml 0.03mol/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。
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，回收菌数为1×104～9×104cfu/片。
取被试样片(2.0cm×3.0cm)和对照样片各4片，分成4组置于4个灭菌平皿内。所述对照样片与试样同质材料，同等大小，但不含抗菌材料，且经灭菌处理。
取上述菌悬液.分别在每个被试样片和对照样片上滴加100μl，均匀涂布，开始计时，作用2min，用无菌镊分别将样片投人含5m1，相应中和剂的试管内，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)或沙氏琼脂培养基(酵母菌)15m1作倾注，转动平皿，使其充分均匀，琼脂凝固后翻转平板，35℃士2℃培养48h(细菌)或72h(酵母菌)，作活菌菌落计数。试验重复3次，按下式计算杀菌率：X＝(A-B)/A×100份
式中：X---杀菌率，份；
A---对照样品平均菌落数；
B---被试样品平均菌落数。
评价标准：杀菌率≥90份，产品有杀菌作用。结果如下表2：
<表2杀菌率，作用浓度为1:1>
Figure PCTCN2015098907-appb-000003
抗炎效果实施例
试验品：本发明实施例1～5和市售皮炎平。
实验方法：一级ICR小鼠80只，体重20-22g，雌雄各半，分为本发明实施例1～5组(1.0g/kg)、阳性对照组：皮炎平(3.0g/kg)、单软膏组，每组12只小鼠。实验当天，按各组剂量于动物右耳(耳廓正反两侧)涂药；用药后60min，用干棉球擦净药物，于右耳(耳廓正反两侧)滴涂对二甲苯，30ul/只，同时再涂药一次，20min后脱颈处死动物，剪下两耳，用直径0.8cm打孔器将两耳打成圆片，称重，右耳减左耳重量差为肿胀度，比较药物组与对照组间的差异，并求出抑制率。结果见表3。
<表3对二甲苯致小鼠耳廓炎证的影响>
Figure PCTCN2015098907-appb-000004
*为市售品相比，p＜0.05。
止痒效果实施例
试验品：本发明实施例1～5和市售皮炎平。
豚鼠80只，体重250～300g，将豚鼠分为本发明实施例1～5组(1.0g/kg)、阳性对照组皮炎平软膏(3.0g/kg)，以及单软膏组。实验前24hr，给各组豚鼠右后足背剃毛，按本组剂量于动物右后足背剃毛涂药一次，涂药1次。实验当日，用粗砂纸擦伤右后足剃毛处，擦伤处面积为1cm2，局部再涂药1次，10min后开始在创面处滴0.01％磷酸组织胺0.05ml/只，此后每隔3min依次用0.02％、0.03％、0.04％...递增浓度涂药，每次均为0.05ml/只。直至豚鼠回头添右后足时所给予的磷酸组织胺总量(μg)为致痒阈，记录并比较各组的致痒阈。结果见表4。
<表4磷酸组织胺致豚鼠足痒的影响>
Figure PCTCN2015098907-appb-000005
刺激性试验实施例
参照文献方法进行试验。
受试物：制备实施例制得的实施例1～5所得样品.
受试者：共36人，男女各半，年龄20～30岁，符合受试者志愿入选标准。
试验方法：将受试物放入斑试器内，用量为0.023g。对照孔为空白对照(不置任何物质)。将加有受试物的斑试器用无刺激胶带贴敷于受试者的背部或前臂曲侧，用手掌轻压使之均匀地贴敷于皮肤上，持续3min。去除受试物斑试器后30min，待压痕消失后观察皮肤反应。如结果为阴性，于斑贴试验后24h和48h分别再观察一次。按表5(皮肤不良反应分级标准表)记录反应结果。
<表5皮肤不良反应分级标准表>
Figure PCTCN2015098907-appb-000006
试验结果见表6：
<表6除去受试物后评估结果>
Figure PCTCN2015098907-appb-000007
斑贴试验后24h和48h分别再观察的结果同表5。以上结果显示，本发明的止痒软膏对人体皮肤无刺激性作用。
本发明并不局限于上述实施方式，如果对本发明的各种改动或变形不脱离本发明的精神和范围，倘若这些改动和变形属于本发明的权利要求和等同技术范围之内，则本发明也意图包含这些改动和变形。

Claims (9)

  1. 一种止痒软膏，包括有效成分与基质，其特征在于所述有效成分由以下重量份的组分组成：升华硫1～5份、丹皮酚1～5份、醋酸***0.5～3份、樟脑1～5份、壳聚糖0.1～0.5份、苦参提取物3～8份、紫草提取物3～8份、桉叶油0.5～5份、黄柏提取物3～8份、冰片1～5份、薄荷油1～5份。
  2. 根据权利要求1所述的止痒软膏，其特征在于所述有效成分由以下重量份的组分组成：升华硫2～4份、丹皮酚2～4份、醋酸***0.8～2份、樟脑2～4份、壳聚糖0.2～0.4份、苦参提取物5～7份、紫草提取物5～7份、桉叶油0.8～3份、黄柏提取物5～7份、冰片2～4份、薄荷油2～4份。
  3. 根据权利要求2所述的止痒软膏，其特征在于所述有效成分由以下重量份的组分组成：升华硫3份、丹皮酚3份、醋酸***1份、樟脑3份、壳聚糖0.3份、苦参提取物6份、紫草提取物6份、桉叶油2份、黄柏提取物6、冰片3份、薄荷油3份。
  4. 根据权利要求1～3任意一项所述的止痒软膏，其特征在于：所述壳聚糖为脱乙酰度大于85％的壳聚糖。
  5. 根据权利要求1～3任意一项所述的止痒软膏，其特征在于所述基质由以下重量份的组分组成：白凡士林13～18份、月桂酸甘油酯5～13份、鲸蜡醇20～30份、十二烷基硫酸钠3～10份、蜂蜡13～18份、甘油10～15份、防腐剂0.1～0.5份、去离子水50～80份。
  6. 根据权利要求1～3任意一项所述的止痒软膏，其特征在于所述基质由以下重量份的组分组成：白凡士林14～17份、月桂酸甘油酯8～10份、鲸蜡醇23～28份、十二烷基硫酸钠5～8份、蜂蜡14～16份、甘油12～14份、防腐剂0.2～0.4份、去离子水60～73份。
  7. 根据权利要求5～6任意一项所述的止痒软膏，其特征在于：所述防腐剂为苯氧乙醇、羟苯甲酯中的一种或两种的组合。
  8. 一种制备权利要求5～6任意一项所述的止痒软膏的方法，其特征在于包括以下步骤：
    (1).水相的制备：按所述配方量，取适量水将壳聚糖与十二烷基硫酸钠溶解，并与苦参提取物、黄柏提取物、紫草提取物和余量水混合均匀，并加热至60～80℃；
    (2).油相的制备：将丹皮酚、醋酸***、樟脑、桉叶油、冰片、薄荷油、白凡士林、月桂酸甘油酯、鲸蜡醇、蜂蜡、甘油与防腐剂混合均匀，并加热至60～80℃；
    (3).成品的制备：保温下，将步骤(1)制得的水相、步骤(2)制得的油相与配方量的升华硫置于软膏剂中，3000r/min搅拌下使其均质化；20r/min搅拌下逐渐冷却至室温，出料得成品。
  9. 根据权利要求8所述的止痒软膏的制备方法，其特征在于：
    所述苦参提取物的制备方法为：将苦参洗净后晒干粉碎，将苦参粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得；
    所述紫草提取物的制备方法为：将紫草洗净后晒干粉碎，将紫草粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得；
    所述黄柏提取物的制备方法为：将黄柏洗净后晒干粉碎，将黄柏粉末加入5倍重量的50％的乙醇溶液中，超声提取20～30min，共提取2次，合并提取液，减压浓缩至60℃时相对密度为1.1～1.3的浓缩液，即得。
PCT/CN2015/098907 2015-11-13 2015-12-25 一种止痒软膏及其制备方法 WO2017080049A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510782720.2 2015-11-13
CN201510782720.2A CN106692403A (zh) 2015-11-13 2015-11-13 一种止痒软膏及其制备方法

Publications (1)

Publication Number Publication Date
WO2017080049A1 true WO2017080049A1 (zh) 2017-05-18

Family

ID=58694673

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2015/098907 WO2017080049A1 (zh) 2015-11-13 2015-12-25 一种止痒软膏及其制备方法

Country Status (2)

Country Link
CN (1) CN106692403A (zh)
WO (1) WO2017080049A1 (zh)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111956691A (zh) * 2019-05-18 2020-11-20 云南伦扬科技有限公司 一种紫草桉叶油微乳凝胶制备方法及应用
CN112870137A (zh) * 2021-01-22 2021-06-01 上海加新生物科技有限公司 一种女性私密护理液用复合原料及其制备方法
CN116421635A (zh) * 2023-04-27 2023-07-14 小布悠(杭州)科技有限公司 一种低刺激性的止痒滚珠配方及其制备方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108578287A (zh) * 2018-04-27 2018-09-28 广东名辰堂健康产业股份有限公司 一种止痒的清凉油及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1605358A (zh) * 2004-09-08 2005-04-13 郁增舜 一种治疗顽固性皮肤病的外用药
CN103432584A (zh) * 2013-08-14 2013-12-11 金红叶纸业集团有限公司 清凉止痒组合物及应用其的纸巾
CN104997918A (zh) * 2015-07-17 2015-10-28 柳培健 一种治疗脚癣的中药组合物

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101199787B (zh) * 2007-12-06 2010-04-07 朱锋 一种治疗皮肤病的药物组合物
CN102366437A (zh) * 2011-07-15 2012-03-07 吉林敖东集团大连药业股份有限公司 一种复方***软膏及其制备方法
CN103565871A (zh) * 2012-08-08 2014-02-12 陕西盘龙药业集团股份有限公司 一种杀菌止痒的中药组合物及其制备方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1605358A (zh) * 2004-09-08 2005-04-13 郁增舜 一种治疗顽固性皮肤病的外用药
CN103432584A (zh) * 2013-08-14 2013-12-11 金红叶纸业集团有限公司 清凉止痒组合物及应用其的纸巾
CN104997918A (zh) * 2015-07-17 2015-10-28 柳培健 一种治疗脚癣的中药组合物

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111956691A (zh) * 2019-05-18 2020-11-20 云南伦扬科技有限公司 一种紫草桉叶油微乳凝胶制备方法及应用
CN111956691B (zh) * 2019-05-18 2023-03-14 云南伦扬科技有限公司 一种紫草桉叶油微乳凝胶制备方法及应用
CN112870137A (zh) * 2021-01-22 2021-06-01 上海加新生物科技有限公司 一种女性私密护理液用复合原料及其制备方法
CN116421635A (zh) * 2023-04-27 2023-07-14 小布悠(杭州)科技有限公司 一种低刺激性的止痒滚珠配方及其制备方法

Also Published As

Publication number Publication date
CN106692403A (zh) 2017-05-24

Similar Documents

Publication Publication Date Title
WO2017101790A1 (zh) 用于治疗皮肤瘙痒病症的药物组合物及其应用
Boonchum et al. Antimicrobial and anti-inflammatory properties of various seaweeds from the Gulf of Thailand.
WO2008140200A1 (en) External compositions for the skin
RU2536264C2 (ru) Композиция для наружного применения на коже, содержащая соль и сахар в качестве активных ингредиентов, для предотвращения и лечения вагиноза, и ее применение
WO2017080049A1 (zh) 一种止痒软膏及其制备方法
CN109199962A (zh) 一种祛痘组合物及化妆品
KR970003480B1 (ko) 약리학용 물질의 제조방법
CN104043098A (zh) 一种用于治疗妇***道炎的抗菌肽冻干制剂及制备方法
US20220362288A1 (en) Natural composition for use in gynaecology
WO2017080048A1 (zh) 一种用于浅度烧伤的喷膜剂及其制备方法
CA3061545A1 (en) Skin care composition
CN113940907B (zh) 一种含有协同抑菌成分的去屑组合物及其应用
CN104922248A (zh) 一种抗菌、消炎中药复方凝胶剂及制备方法
CN107582943B (zh) 一种防治动物疥螨病的复方中药透皮喷雾剂及制备方法
KR20200065521A (ko) 천연 항균제를 포함하는 여성청결제 조성물
CN106109293B (zh) 一种具有祛痘功效的组合物及其制备方法
CN111407773A (zh) 一种天然生物抗炎抗菌剂
JP2019178170A (ja) 抗微生物作用を備えた組成物の製造のためのパチョリ抽出物の使用
CN113456735B (zh) 一种灭活益生菌草本凝胶及其制备方法和应用
CN108078868A (zh) 一种用于护肤品的抗过敏组合物
CN108186440A (zh) 可抗菌护肤的中药植物沐浴露及其制备方法和用途
CN108079050A (zh) 本草皮肤抑菌组合物及其制备方法与应用
CN113827594A (zh) 一种基于固体分散技术的头皮抑菌消炎组合物及其制备方法
CN108619486B (zh) 一种治疗皮肤病的软膏剂及其制备方法
Igbeneghu The antimicrobial assessment of some Nigerian herbal

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15908179

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 24.10.2018)

122 Ep: pct application non-entry in european phase

Ref document number: 15908179

Country of ref document: EP

Kind code of ref document: A1