国产盐酸溴己新片溶出度评价  

Evaluation of Dissolution of Domestic Bromhexine Hydrochloride Tablets

作　　者：李文东[1] 王成刚[1] 吴科春[1] 刘海涛[1] 李宁[1] 王俊秋[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药品标准》2014年第1期23-26,共4页Drug Standards of China

摘　　要：目的:对国产盐酸溴己新片的溶出度进行评价。方法:以原研产品作为参比制剂,以国内6家企业的6批产品作为样品,以4种溶液作为溶出介质,按照《中国药典》2010年版二部盐酸溴己新片项下方法进行溶出曲线测定,计算参比制剂与仿制制剂平均溶出率偏差,同时利用威布尔方程计算关键点Td,T50,T70点的溶出参数。结果:以水为溶出介质时,D样品的溶出曲线均与原研产品具有相似性;以pH 1.2溶液作为溶出介质时,除A样品、B样品和C样品外,其余样品与原研产品的溶出曲线具有相似性;以pH 4.0醋酸盐缓冲液为溶出介质时,除A样品和B样品外,其余样品与原研产品的溶出曲线具有相似性;以pH 6.8磷酸盐缓冲液为溶出介质时,所有样品在120 min的溶出曲线测定中最大溶出度均约为20%。威布尔方程计算结果显示国产盐酸溴己新片的工艺稳定性仍需提高。结论:虽然一些企业生产的盐酸溴己新片与原研产品的溶出行为仍存在差距,但D企业样品的溶出行为与原研产品很接近,说明国内产品的处方工艺水平能够达到与原研产品相当的要求。To evaluation the dissolution of domestic bromhexine hydrochloride tablets. Methods： Bromhexine hydrochlo ride tablets produced by Boehringer Ingelheim Pharmaceuticals were used as reference products, and 6 batches of bromhexine hydro chloride tablets produced by 6 manufacturers were used as samples. Four different solutions were used as dissolution media. Dissolution profile test was determined according to Ch. P 2010 11. Calculate the deviation of average dissolution between reference sample and do mestic samples. Meanwhile the dissolution parameters at key point Td, Ts0 and T70 were calculated using Weibull equation. Results： When water was used as dissolution media, dissolution curves of D sample were similar to the reference; when solution（ pH 1.2）was used , dissolution curves of all the samples but A, B and C were similar to the reference; when acetate buffer （ pH 4.0） was used , dissolution curves of all the samples but A and B were similar to the reference; when phosphate buffer （ pH 6. 8） was used, the maxi mum dissolution during 120 minutes of all samples were about 20%. The calculation results of Weibull equation showed that the process stability should be improved. Conclusion： Although there are gaps between dissolution of bromhexine hydrochloride tablets produced by several domestic manufacturers and by Boehringer Ingelheim Pharmaceuticals, dissolution of D sample is similar to refer ence sample, which demonstrate that the level of prescription and production technique of domestic manufacturer can accord with therequest of original manufacturer.

关 键 词：盐酸溴己新片 溶出度 相似性评价 

分 类 号：R921.2[医药卫生—药学]