CN105616388A - 一种复方丙酸氯倍他索涂膜剂 - Google Patents

一种复方丙酸氯倍他索涂膜剂 Download PDF

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CN105616388A
CN105616388A CN201610111518.1A CN201610111518A CN105616388A CN 105616388 A CN105616388 A CN 105616388A CN 201610111518 A CN201610111518 A CN 201610111518A CN 105616388 A CN105616388 A CN 105616388A
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clobetasol propionate
compound
coating agent
skin
polyvinyl alcohol
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何金蓉
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Chengdu Aibike Biotechnology Co Ltd
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Chengdu Aibike Biotechnology Co Ltd
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    • 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
    • A61K31/60—Salicylic acid; 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on

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Abstract

本发明公开了一种复方丙酸氯倍他索涂膜剂，用重量份表示，主要由丙酸氯倍他索0.1~1.6g，水杨酸30~80g，薄荷油5~15ml，聚乙烯醇50~100g，丙二醇80~120g，尼泊金乙酯0.5~2g，乙醇溶液200~600ml，足量的纯化水。本制剂涂于皮肤成膜后，产生水合作用促进药物透皮吸收，？增强了止痒和角质溶解作用，用于结节性痒疹、？角质增厚性皮肤病、皮炎及湿疹的外用疗法，使用方便安全，治疗效果良好。

Description

一种复方丙酸氯倍他索涂膜剂
技术领域
本发明涉及涂膜剂制备技术领域，具体是指一种复方丙酸氯倍他索涂膜剂。
背景技术
复方丙酸氯倍他索为肾上腺皮质激素药，抗炎和抗过敏作用较强，且较持久，外用皮肤制剂适用于各种皮肤病，水杨酸为皮肤科常用的消毒防腐药，价廉但实用性强，根据其使用浓度的不同有抑制细菌和真菌生长、止痒、角质溶解等作用。其复方能够治疗多种皮肤疾病，如神经性皮炎、湿疹、牛皮癣等，目前国内上市的剂型有注射液、片剂、胶囊剂，现有凝胶剂、滴眼液、滴耳液和栓剂等，但尚未见到有关复方丙酸氯倍他索涂膜剂的制备。
发明内容
本发明的目的在于提供一种对抗炎症和抗过敏作用较强的且较持久的外用皮肤的复方丙酸氯倍他索涂膜剂。
本发明通过下述技术方案实现：一种复方丙酸氯倍他索涂膜剂，用重量份表示，主要由丙酸氯倍他索0.1~1.6g，水杨酸30~80g，薄荷油5~15ml，聚乙烯醇50~100g，丙二醇80~120g，尼泊金乙酯0.5~2g，乙醇溶液200~600ml，足量的纯化水。
为了更好地实现本发明，进一步地，用重量份表示，所述丙酸氯倍他索为0.5g，水杨酸为50g，薄荷油为10ml，聚乙烯醇为70g，尼泊金乙酯为1g，乙醇溶液为400ml。
为了更好地实现本发明，进一步地，所述乙醇溶液为质量分数为80%的乙醇溶液。
本发明与现有技术相比，具有以下优点及有益效果：
本制剂涂于皮肤成膜后，产生水合作用促进药物透皮吸收，增强了止痒和角质溶解作用，用于结节性痒疹、角质增厚性皮肤病、皮炎及湿疹的外用疗法，使用方便安全，治疗效果良好。
具体实施方式
下面结合实施例对本发明作进一步地详细说明，但本发明的实施方式不限于此，在不脱离本发明上述技术思想情况下，根据本领域普通技术知识和惯用手段，做出各种替换和变更，均应包括在本发明的范围内。
实施例：
本实施例的复方丙酸氯倍他索涂膜剂，用重量份表示，主要由0.5g丙酸氯倍他索，50g水杨酸，10ml薄荷油，70g聚乙烯醇，1g尼泊金乙酯，400ml质量分数为80%的乙醇溶液，以及足量的纯化水组成。
本实施例中主要以丙酸氯倍他索和水杨酸为主药，以聚乙烯醇为成膜材料，以丙二醇及薄荷油为促渗剂制成。
丙酸氯倍他索为肾上腺皮质激素类药物，具有较强的抗炎、抗瘙痒和血管收缩作用，用于治疗皮肤炎症和瘙痒症等。水杨酸为皮肤科常用的消毒防腐药，价廉但实用性强，根据其使用浓度的不同有抑制细菌和真菌生长、止痒、角质溶解等作用。
其具体的制备方法，包括以下步骤：
（1）将100g丙二醇加入300ml纯化水，搅拌使其混合均匀，获得混合液；
（2）取70g聚乙烯醇完全浸泡入步骤（1）中所述的混合液中，加热使其完全溶解，放置冷却后待用；
（3）另称取0.5g丙酸氯倍他索和50g水杨酸，加入10ml薄荷油，搅拌，并同时缓缓加入步骤（2）中溶解有聚乙烯醇的混合液；
（4）再加入1g尼泊金乙酯，边加边搅拌，待其完全溶解后，加入足量纯化水制成1000ml溶液，充分搅拌均匀后，分装即得。
其中，所述步骤（2）中加热的过程使用的是水浴加热；所述步骤（4）中，搅拌均是通过玻璃棒手动搅拌完成。
一、皮肤刺激性试验
取健康家兔3只，体重2.0～2.5kg，将兔脊柱两侧去毛而不损伤皮肤，暴露两侧5cm至7cm的表皮，将本品1mL涂在左侧去毛区，右侧涂生理盐水对照，于24小时、48小时、72小时观察涂漠部位的反应，结果各涂药部位皮肤均无红肿，发疹，水疱等现象。说明本品对皮肤无刺激性。
二、成膜试验
用软毛刷蘸取本涂膜液在玻璃板上轻轻涂上薄层，同时在患者6名在手背或脚趾涂膜一层本品观察成膜时间结果本涂膜剂在玻璃板上成膜时间为150s，在人体上为120s。说明本品的成膜性良好。
三、临床疗效考察
治疗组50例，男30例，女20例，年龄12－72岁，病程1个月至6个月之间。对照组38例，男26例，女12例，年龄8－68岁，病程平均4.2个月，以上病例在不同部位患有神经性皮炎、湿疹、牛皮癣等病症。
治疗组：用医用酒精清洗病灶面后，涂抹丙酸氯倍他索剂复方涂膜剂适量，每日2次，共治疗7天。
对照组：水杨酸药膏，外擦，每日2次，共治疗27日。
观察方法及疗效判定标准:参照临床疗效判定标准进行。
治疗结果:治疗组，平均治愈时间7天，症状消失，治愈率92．1%，有效率96．1%；对照组平均治愈时间20天，治愈率56．3%，有效率72．6%。治疗组明显优于对照组。尽管已经示出和描述了本发明的实施例，本领域的普通技术人员可以理解：在不脱离本发明的原理和宗旨下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由权利要求及其等同物限定。

Claims (3)

1.一种复方丙酸氯倍他索涂膜剂，其特征在于，用重量份表示，主要由丙酸氯倍他索0.1~1.6g，水杨酸30~80g，薄荷油5~15ml，聚乙烯醇50~100g，丙二醇80~120g，尼泊金乙酯0.5~2g，乙醇溶液200~600ml，足量的纯化水。
2.根据权利要求1所述的一种复方丙酸氯倍他索涂膜剂，其特征在于，用重量份表示，所述丙酸氯倍他索为0.5g，水杨酸为50g，薄荷油为10ml，聚乙烯醇为70g，尼泊金乙酯为1g，乙醇溶液为400ml。
3.根据权利要求1所述的一种复方丙酸氯倍他索涂膜剂，其特征在于：所述乙醇溶液为质量分数为80%的乙醇溶液。
CN201610111518.1A 2016-02-29 2016-02-29 一种复方丙酸氯倍他索涂膜剂 Withdrawn CN105616388A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106138055A (zh) * 2016-07-30 2016-11-23 成都薇诺娜生物科技有限公司 一种复方酮康唑涂膜剂及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
庞露等: "复方丙酸氯倍他索涂膜剂的质控研究", 《中国药房》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106138055A (zh) * 2016-07-30 2016-11-23 成都薇诺娜生物科技有限公司 一种复方酮康唑涂膜剂及其制备方法

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Application publication date: 20160601