CN111067883A - 一种盐酸特比萘芬搽剂制备方法 - Google Patents

一种盐酸特比萘芬搽剂制备方法 Download PDF

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CN111067883A
CN111067883A CN202010042831.0A CN202010042831A CN111067883A CN 111067883 A CN111067883 A CN 111067883A CN 202010042831 A CN202010042831 A CN 202010042831A CN 111067883 A CN111067883 A CN 111067883A
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孔超
刘杰
欧阳佳龙
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Anhui Huiyu Technology Service Co Ltd
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Abstract

本发明公开了一种盐酸特比萘芬搽剂制备方法，所述制备方法包括以下步骤：按照以下重量份数的配方进行备料；将所有配方材料均匀粉碎后放入搅拌器中加入蒸馏水30‑40份进行混合搅拌，搅拌速度为2500r/min；搅拌均匀后升温至90‑100℃并持续30‑50min，然后过150目筛并留存滤液；将滤液真空浓缩至粘稠状，得到混合粘稠药物，其中相对密度为1.1‑1.3；调整pH值为3‑6，搅拌均匀冷却至室温；乳化30‑50分钟直至得到混合均匀的胶体，即盐酸特比萘芬搽剂成品。本发明搽剂具有光泽好、涂布性好、随环境温度变化膏体稠度变化小、膏体稳定，释药速度快，透皮吸收性能好，较之传统的制备技术相比具有操作简单易行，质量控制容易，用药方便，对皮肤刺激性小、疗效好，且质量稳定。

Description

一种盐酸特比萘芬搽剂制备方法
技术领域
本发明属于制药领域，尤其涉及一种盐酸特比萘芬搽剂制备方法。
背景技术
盐酸特比萘芬，其化学名为(E)-N-(6，6-二甲基-2-庚烯-4-炔基)-N-甲基-1-甲酰胺萘·盐酸。是一种具有广谱抗真菌活性的丙烯胺类药物。能特异地干扰真菌固醇的早期生物合成，高选择性抑制真菌的麦角鲨烯环氧化酶，使真菌细胞膜形成过程中麦角鲨烯环氧化反应受阻，从而达到杀灭或抑制真菌的作用。适用于：1.由毛癣菌(红色毛癣菌、须癣毛癣菌、疣状毛癣菌、断发癣菌和紫色毛癣菌等)、犬小孢子菌和絮状表皮癣菌等引起的皮肤、头发和甲的感染。2.各种癣病(体癣、股癣、手足癣和头癣等)以及由念珠菌(白色念珠菌等)引起的皮肤酵母菌感染。3.由发霉菌引起的甲癣(甲真菌感染)。是局部外用药，吸收很少。现有的盐酸特比萘芬乳膏不稳定，水分遗失，造成膏体不滋润，难以涂抹，吸收较慢，有破乳分层的现象。
发明内容
本发明的目的在于克服现有技术存在的以上问题，提供一种盐酸特比萘芬搽剂制备方法。
为实现上述技术目的，达到上述技术效果，本发明通过以下技术方案实现：
一种盐酸特比萘芬搽剂制备方法，所述制备方法包括以下步骤：
步骤一：按照以下重量份数的配方进行备料：盐酸特比萘芬4-9份、苯甲酸2-8份、氮酮1-3份、糖粉5-8份、羧甲基淀粉钠1-3份、黄连2-5份、丙二醇3-6份、石蜡4-7份、牡丹皮提取物1-3份、十二烷基硫酸钠1-3份、单硬脂酸甘油酯2-6份、十八醇4-8份、尼泊金乙酯1-4份、海藻5-7份、香附3-7份、缩砂仁2-4份、蝉蜕3-5份、凤眼果3-6份、聚氧乙烯脂肪酸酯1-6份、田葱4-7份、巴巴花2-4份、白鹤灵芝6-10份、黄柏2-5份、聚山梨醇5-7份、乙二胺四甲叉膦酸钠1-3份、液体石蜡1-3份、花蚁虫7-10份、吉丁虫2-6份、三乙醇胺2-4份、依地酸二钠2-5份、甘草3-5份、没药2-7份、苍术2-4份、吊干麻6-8份、白凡士林9-15份、硅酮2-6份、吐温2-7份、醋酸氯己定1-3份、醋酸曲安奈德2-8份；
步骤二：将所有配方材料均匀粉碎后放入搅拌器中加入蒸馏水30-40份进行混合搅拌，搅拌速度为2500r/min；
步骤三：搅拌均匀后升温至90-100℃并持续30-50min，然后过150目筛并留存滤液；
步骤四：将滤液真空浓缩至粘稠状，得到混合粘稠药物，其中相对密度为1.1-1.3；
步骤五：调整pH值为3-6，搅拌均匀冷却至室温；
步骤六：乳化30-50分钟直至得到混合均匀的胶体，即盐酸特比萘芬搽剂成品。
进一步地，所述步骤二中还混合加入相溶剂、防腐剂、增稠剂、水相溶剂、金属离子螯合剂、还原剂。
进一步地，所述步骤二中的搅拌温度维持在60-70℃。
本发明的有益效果是：
本发明搽剂具有光泽好、涂布性好、随环境温度变化膏体稠度变化小、膏体稳定，释药速度快，透皮吸收性能好，较之传统的制备技术相比具有操作简单易行，质量控制容易，用药方便，对皮肤刺激性小、疗效好，且质量稳定。
具体实施方式
下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。
实施例1：
一种盐酸特比萘芬搽剂制备方法，制备方法包括以下步骤：
步骤一：按照以下重量份数的配方进行备料：盐酸特比萘芬6份、苯甲酸5份、氮酮4份、糖粉7份、羧甲基淀粉钠5份、黄连4份、丙二醇5份、石蜡5份、牡丹皮提取物2份、十二烷基硫酸钠2份、单硬脂酸甘油酯4份、十八醇6份、尼泊金乙酯3份、海藻6份、香附5份、缩砂仁3份、蝉蜕4份、凤眼果5份、聚氧乙烯脂肪酸酯3份、田葱5份、巴巴花3份、白鹤灵芝8份、黄柏4份、聚山梨醇6份、乙二胺四甲叉膦酸钠2份、液体石蜡2份、花蚁虫8份、吉丁虫4份、三乙醇胺3份、依地酸二钠4份、甘草4份、没药5份、苍术3份、吊干麻7份、白凡士林13份、硅酮4份、吐温5份、醋酸氯己定2份、醋酸曲安奈德5份；
步骤二：将所有配方材料均匀粉碎后放入搅拌器中加入蒸馏水35份进行混合搅拌，同时还混合加入相溶剂、防腐剂、增稠剂、水相溶剂、金属离子螯合剂、还原剂，搅拌速度为2500r/min，搅拌温度维持在65℃；
步骤三：搅拌均匀后升温至95℃并持续40min，然后过150目筛并留存滤液；
步骤四：将滤液真空浓缩至粘稠状，得到混合粘稠药物，其中相对密度为1.2；
步骤五：调整pH值为5，搅拌均匀冷却至室温；
步骤六：乳化40分钟直至得到混合均匀的胶体，即盐酸特比萘芬搽剂成品。
实施例2：
一种盐酸特比萘芬搽剂制备方法，制备方法包括以下步骤：
步骤一：按照以下重量份数的配方进行备料：盐酸特比萘芬4份、苯甲酸2份、氮酮1份、糖粉5份、羧甲基淀粉钠1份、黄连2份、丙二醇3份、石蜡4份、牡丹皮提取物1份、十二烷基硫酸钠1份、单硬脂酸甘油酯2份、十八醇4份、尼泊金乙酯1份、海藻5份、香附3份、缩砂仁2份、蝉蜕3份、凤眼果3份、聚氧乙烯脂肪酸酯1份、田葱4份、巴巴花2份、白鹤灵芝6份、黄柏2份、聚山梨醇5份、乙二胺四甲叉膦酸钠1份、液体石蜡1份、花蚁虫7份、吉丁虫2份、三乙醇胺2份、依地酸二钠2份、甘草3份、没药2份、苍术2份、吊干麻6份、白凡士林9份、硅酮2份、吐温2份、醋酸氯己定1份、醋酸曲安奈德2份；
步骤二：将所有配方材料均匀粉碎后放入搅拌器中加入蒸馏水30份进行混合搅拌，同时还混合加入相溶剂、防腐剂、增稠剂、水相溶剂、金属离子螯合剂、还原剂，搅拌速度为2500r/min，搅拌温度维持在60℃；
步骤三：搅拌均匀后升温至90℃并持续30min，然后过150目筛并留存滤液；
步骤四：将滤液真空浓缩至粘稠状，得到混合粘稠药物，其中相对密度为1.1；
步骤五：调整pH值为3，搅拌均匀冷却至室温；
步骤六：乳化30分钟直至得到混合均匀的胶体，即盐酸特比萘芬搽剂成品。
实施例3：
一种盐酸特比萘芬搽剂制备方法，制备方法包括以下步骤：
步骤一：按照以下重量份数的配方进行备料：盐酸特比萘芬9份、苯甲酸8份、氮酮3份、糖粉8份、羧甲基淀粉钠3份、黄连5份、丙二醇6份、石蜡7份、牡丹皮提取物3份、十二烷基硫酸钠3份、单硬脂酸甘油酯6份、十八醇8份、尼泊金乙酯4份、海藻7份、香附7份、缩砂仁4份、蝉蜕5份、凤眼果6份、聚氧乙烯脂肪酸酯6份、田葱7份、巴巴花4份、白鹤灵芝10份、黄柏5份、聚山梨醇7份、乙二胺四甲叉膦酸钠3份、液体石蜡3份、花蚁虫10份、吉丁虫6份、三乙醇胺4份、依地酸二钠5份、甘草5份、没药7份、苍术4份、吊干麻8份、白凡士林15份、硅酮6份、吐温7份、醋酸氯己定3份、醋酸曲安奈德8份；
步骤二：将所有配方材料均匀粉碎后放入搅拌器中加入蒸馏水40份进行混合搅拌，同时还混合加入相溶剂、防腐剂、增稠剂、水相溶剂、金属离子螯合剂、还原剂，搅拌速度为2500r/min，搅拌温度维持在70℃；
步骤三：搅拌均匀后升温至100℃并持续50min，然后过150目筛并留存滤液；
步骤四：将滤液真空浓缩至粘稠状，得到混合粘稠药物，其中相对密度为1.3；
步骤五：调整pH值为6，搅拌均匀冷却至室温；
步骤六：乳化50分钟直至得到混合均匀的胶体，即盐酸特比萘芬搽剂成品。
在本说明书的描述中，参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。

Claims (3)

1.一种盐酸特比萘芬搽剂制备方法，其特征在于：所述制备方法包括以下步骤：
步骤一：按照以下重量份数的配方进行备料：盐酸特比萘芬4-9份、苯甲酸2-8份、氮酮1-3份、糖粉5-8份、羧甲基淀粉钠1-3份、黄连2-5份、丙二醇3-6份、石蜡4-7份、牡丹皮提取物1-3份、十二烷基硫酸钠1-3份、单硬脂酸甘油酯2-6份、十八醇4-8份、尼泊金乙酯1-4份、海藻5-7份、香附3-7份、缩砂仁2-4份、蝉蜕3-5份、凤眼果3-6份、聚氧乙烯脂肪酸酯1-6份、田葱4-7份、巴巴花2-4份、白鹤灵芝6-10份、黄柏2-5份、聚山梨醇5-7份、乙二胺四甲叉膦酸钠1-3份、液体石蜡1-3份、花蚁虫7-10份、吉丁虫2-6份、三乙醇胺2-4份、依地酸二钠2-5份、甘草3-5份、没药2-7份、苍术2-4份、吊干麻6-8份、白凡士林9-15份、硅酮2-6份、吐温2-7份、醋酸氯己定1-3份、醋酸曲安奈德2-8份；
步骤二：将所有配方材料均匀粉碎后放入搅拌器中加入蒸馏水30-40份进行混合搅拌，搅拌速度为2500r/min；
步骤三：搅拌均匀后升温至90-100℃并持续30-50min，然后过150目筛并留存滤液；
步骤四：将滤液真空浓缩至粘稠状，得到混合粘稠药物，其中相对密度为1.1-1.3；
步骤五：调整pH值为3-6，搅拌均匀冷却至室温；
步骤六：乳化30-50分钟直至得到混合均匀的胶体，即盐酸特比萘芬搽剂成品。
2.根据权利要求1所述的一种盐酸特比萘芬搽剂制备方法，其特征在于：所述步骤二中还混合加入相溶剂、防腐剂、增稠剂、水相溶剂、金属离子螯合剂、还原剂。
3.根据权利要求1所述的一种盐酸特比萘芬搽剂制备方法，其特征在于：所述步骤二中的搅拌温度维持在60-70℃。
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