盐酸消旋山莨菪碱注射液处方的优化研究  

Formulation optimization of raceanisodamine hydrochloride injection

作　　者：刘言[1] 于润芳 刘明志[2] 张岚 赵健[3] 

机构地区：[1]天津市药品检验所,天津300070 [2]天津金耀氨基酸有限公司,天津300457 [3]天津泰普药品科技发展有限公司,天津300193

出　　处：《现代药物与临床》2013年第6期866-869,共4页Drugs & Clinic

摘　　要：目的 优化盐酸消旋山莨菪碱注射液工艺处方，提高产品稳定性。方法 盐酸消旋山莨菪碱注射液工艺处方改为预先配制盐酸溶液，再将消旋山莨菪碱缓缓加入盐酸溶液中，成盐时pH值控制在5.0～5.2。结果 工艺处方更改后，可降低产品的有关物质，提高稳定性。结论 经处方优化后，盐酸消旋山莨菪碱注射液可在室温条件下稳定储存。Objective To optimize the prescription of raceanisodamine hydrochloride injection and increase the stability of the product. Methods The prescription of raceanisodamine hydrochloride injection was amended as described below. Hydrochloric acid solution was prepared in advance, raceanisodamine was slowly added into hydrochloric acid solution slowly, and pH value was controlled at 5.0 to 5.2. Results After the process beening changed, it could reduce the amount of the related substance and increase the stability of the product. Conclusion Raceanisodamine hydrochloride injection can be stored at room temperature after the process beening optimized.

关 键 词：盐酸消旋山莨菪碱 PH值 有关物质 

分 类 号：R944.1[医药卫生—药剂学]