颠茄分散片的制备及溶出度测定

Preparation and Dissolution Determination of Belladonnae Herba Dispersible Tablets

目的：制备颠茄分散片并建立其溶出度测定方法.方法：选择交联聚乙烯吡咯烷酮（PPVP）＋羧甲基淀粉钠（CMS-Na）内外加法为崩解剂,磷酸氢钙、蔗糖、CMS-Na为填充剂,含5％羟丙甲纤维素（HPMC）的60％乙醇溶液为黏合剂,微晶纤维素为助流剂,滑石粉为润滑剂,采用HPLC测定颠茄分散片的溶出度,流动相乙腈-甲醇-含0.005 mol·L^-1庚烷磺酸钠的0.01 mol·L^-1磷酸盐溶液（磷酸二氢钾-磷酸氢二钾1∶1）（25∶10∶65）,检测波长211 nm.结果：硫酸阿托品线性范围0.003 38～0.026 624 μg,精密度RSD 1.29％,平均加样回收率99.76％,RSD 0.86％.颠茄分散片在2,5,10,15,30,45 min的溶出度分别为0％,15.29％,25.74％,40.40％,67.42％,73.30％,市售颠茄片45 min的溶出度仅23.22％.结论：制备的颠茄分散片分散均匀性合格.建立的测定方法简便、准确,适用于本品的质量控制.

Objective ： To determination of its dissolution prepare Belladonnae Herba dispersible tablets and establish a method for Method： Taking cross-linked polyvinylpyrrolidone （PPVP） ＋ sodium carboxymethyl starch （CMS-Na） inside and outside addition as disintegrating agents, calcium hydrogen phosphate, sucrose and CMS-Na as fillers, 60% ethanol solution containing 5% hydroxypropyl methyl cellulose （HPMC） as adhesives, microcrystalline cellulose as glidants, talcum powder as lubricants, HPLC was adopted to determine dissolution of Belladonnae Herba dispersible tablets with mobile phase of acetonitrile-methanol-0. 01 mol·L^-1 phosphate solution containing 0. 005 mol·L^-1 sodium heptanesulfonate （potassium dihydrogen phosphate-dibasic potassium phosphate 1：1） （25： 10： 65） and detection wavelength at 211 nm. Result： Atropine sulfate showed a linear relationship in the range of 0. 003 38-0. 026 624 Ixg, RSD of precision was 1.29% , average recovery was 99.76% with RSD of O. 86%. Dissolutions of Belladonnae Herba dispersible tablets in 2, 5, 10, 15, 30 and 45 min were 0% , 15.29% , 25.74% , 40.40% , 67.42% and 73.30% , respectively. Dissolution of ordinary Belladonnae Herba tablets was 23.22% within 45 min. Conclusion： These prepared Belladonnae Herba dispersible tablets had good uniformity. This determination was simple, accurate and suitable for quality control of this product.