CN102335152B - 盐酸特比萘芬阴道缓释片及其制备方法 - Google Patents
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Abstract
本发明涉及盐酸特比萘芬阴道缓释片及其制备方法，所述的阴道缓释片包括盐酸特比萘芬5％～15％、填充剂10％～30％、泡腾剂20％～40％和缓释材料20％～40％。本发明盐酸特比萘芬阴道缓释片，抗菌效果非常好，而且直接针对患处，起效快、生物利用度高，在片剂中添加了泡腾剂和缓释材料，使本发明片剂在能够迅速发挥疗效的同时能维持有效的血药浓度，持续时间比较长。
Description
技术领域
本发明涉及一种抗真菌的药物制剂，尤其涉及盐酸特比萘芬阴道缓释片及其制备方法。
背景技术
盐酸特比萘芬是在萘替芬基础上发展起来的新一代丙烯胺类看真菌药物。特比萘芬抗菌谱广，抑菌浓度低，临床效果显著。盐酸特比萘芬具有抑菌、杀菌双重疗效，其作用机理是选择性抑制真菌角鲨烯环氧化酶，使真菌细胞膜形成受阻，从而起到抑菌作用；同时，在抑制角鲨烯环氧化酶后，前体角鲨烯仍在真菌细胞内大量积聚，导致真菌细胞中毒死亡，从而起到杀菌作用。
念珠菌性阴道炎是一种常见的阴道炎，由白色念珠菌感染所致。临床表现主要为外阴瘙痒和白带增多呈白色稠厚豆渣样。本病发病率仅次于滴虫性阴道炎。念珠菌繁殖的最佳PH值为5.5～6.5，当阴道中糖原增多，酸度增加时，即迅速繁殖引起炎症，故多见于孕妇、糖尿病病人及接收大量雌激素者。而长期使用抗菌素，改变了阴道内微生物之间的相互抑制关系，亦易使念珠菌得以繁殖而引起感染。念珠菌可存在人的口腔、肠道与阴道粘膜上，这三个部位的念珠菌可互相传染，当局部环境条件适合时易发病。因为其易于复发的特点，已经成为医患双方其同关注的课题。
发明内容
本发明的目的在于提供一种治疗效果明确、起效快、生物利用度高的盐酸特比萘芬制剂。
本发明的另一目的在于提供一种盐酸特比萘芬制剂的制备方法。
为了实现上述发明目的，本发明采用如下技术方案：
盐酸特比萘芬阴道缓释片包括如下组分：
盐酸特比萘芬 5％～15％ 填充剂10％~30％
泡腾剂 20％~40％ 缓释材料 20％~40％
本发明还可以包括1％~3％的润滑剂和2％~6％的助流剂。
其中所述的填充剂为微晶纤维素、乳糖、淀粉、磷酸氢二钠中的一种或多种混合。
所述的泡腾剂为有机酸与碳酸盐的组合，其中有机酸为柠檬酸、枸橼酸、酒石酸、富马酸苹果酸中的一种或多种，碳酸盐为碳酸钠、碳酸氢钠的一种或其组合。
所述的缓释材料为羟丙甲纤维素、卡波姆、羟丙基纤维素中的一种或多种混合。
作为本发明的优选，每1000片盐酸特比萘芬阴道缓释片中含盐酸特比萘芬100g、微晶纤维素200g、柠檬酸100g、碳酸氢钠200g、羟丙甲纤维素(HPMC)K4M 80g、卡波姆934p 190g、硬脂酸镁20g、二氧化硅40g。
本发明还公开了一种盐酸特比萘芬阴道缓释片的制备方法，首先将盐酸特比萘芬、填充剂、缓释材料、泡腾剂中的酸过筛后混合均匀，再经制粒、整粒，然后加入剩余辅料混合均匀，再压片即得。
本发明盐酸特比萘芬阴道缓释片，抗菌效果非常好，而且直接针对患处，起效快、生物利用度高，在片剂中添加了泡腾剂和缓释材料，使本发明片剂在能够迅速发挥疗效的同时能维持有效的血药浓度，持续时间比较长。
具体实施方式
下面通过具体实施例对本发明做进一步的说明。
实施例1：制备1000片盐酸特比萘芬阴道缓释片的处方：
盐酸特比萘芬100g 微晶纤维素(MCC) 200g
柠檬酸 100g 碳酸氢钠 200g
HPMC K4M 80g Carbopol 934p 190g
硬脂酸镁 20g 二氧化硅 40g
制备方法：
将盐酸特比萘芬、MCC、柠檬酸、HPMC K4M、Carbopol 934p过100目筛混合均匀，用70％乙醇溶液润湿，喷雾润湿后20目筛制粒，干燥后过18目筛整粒，然后加入剩余的辅料混合均匀，压片即得。
本实施例制备得到的盐酸特比萘芬阴道缓释片，抗菌效果好，而且直接针对患处，起效快、生物利用度高，在片剂中添加了泡腾剂和缓释材料，使本发明片剂在能够迅速发挥疗效的同时能维持有效的血药浓度，持续时间比较长。
实施例2：制备1000片盐酸特比萘芬阴道缓释片的处方：
盐酸特比萘芬 120g 乳糖 250g
柠檬酸 100g 碳酸氢钠 200g
乙基纤维素 100g Carbopol 934p 150g
硬脂酸镁 15g 二氧化硅 35g
制备工艺和实施例1相同。
Claims (1)
1.盐酸特比萘芬阴道缓释片，其特征在于制备1000片盐酸特比萘芬阴道缓释片的处方为：盐酸特比萘芬100g、微晶纤维素200g、柠檬酸100g、碳酸氢钠200g、羟丙甲基纤维素K4M 80g、卡波姆934p 190g、硬脂酸镁20g、二氧化硅40g，并采用如下制备方法制备得到：
将盐酸特比萘芬、微晶纤维素、柠檬酸、羟丙甲基纤维素K4M、卡波姆934p过100目筛混合均匀，用70％乙醇溶液润湿，喷雾润湿后20目筛制粒，干燥后过18目筛整粒，然后加入剩余的辅料混合均匀，压片即得。
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1279944A (zh) * | 1999-07-08 | 2001-01-17 | 齐鲁制药厂 | 一种治疗阴道炎的泡腾片剂及其制法 |
| CN1586497A (zh) * | 2004-08-02 | 2005-03-02 | 程月发 | 克林霉素甲硝唑阴道泡腾片及其制备方法和用途 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1279944A (zh) * | 1999-07-08 | 2001-01-17 | 齐鲁制药厂 | 一种治疗阴道炎的泡腾片剂及其制法 |
| CN1586497A (zh) * | 2004-08-02 | 2005-03-02 | 程月发 | 克林霉素甲硝唑阴道泡腾片及其制备方法和用途 |
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