摘要
目的:研制玄归止痛分散片并优化其处方工艺。方法:以崩解时限为指标,对填充剂、崩解剂、黏合剂类型或用量及压片压力进行单因素考察,并通过正交试验优化混合崩解剂、微晶纤维素和微粉硅胶的用量;对优选处方所制分散片进行质量检查,测定其崩解时限、延胡索乙素含量和溶出度;采用相似因子法对本制剂及其滴丸体外溶出的相似度进行评价。结果:优选处方以25%微晶纤维素为填充剂、9%交联聚乙烯吡咯烷酮和9%低取代羟丙基纤维素为混合崩解剂、85%乙醇溶液为黏合剂,微粉硅胶2%,3.0 kg/cm2压力压片;所得分散片崩解时限约为1.22 min,延胡索乙素含量为1.097 mg/g,溶出度10 min时大于80%、15 min时大于90%;以滴丸为参比制剂计算溶出曲线的相似因子为62。结论:所制玄归止痛分散片崩解迅速,且与滴丸的体外溶出行为相似。
OBJECTIVE： To prepare Xuangui zhitong dispersible tablets and optimize its formulation technology. METHODS： Using disintegration time as index, single factor test was conducted for filler, disintegrating agent, the types and amount of adhesives and compression pressure. The amount of mixed disintegrating agent, avicel and gum arabic were optimized by orthogonal test. The tablet quality by optimized formulation was detected, and disintegration time, the content and dissolution rate of tetrahydropalmatine were determined; the similarity of in vitro dissolution rate of dispersible tablets and dropping pills were evaluated by similarity factor test. RESULTS： The optimized formulation was composed of 25% MCC as fillers, 9% PVPP and 9% L-HPC as mixed disintegrants, 85% ethanol solution as adhesives, micro-silica gel 2%, compression pressure of 3.0 kg/cm^2. The average disintegration time was 1.22 min, and the content of tetrahydropalmatine was 1.097 mg/g. The accumulative dissolution rate was more than 80% at 10 min and more than 90% at 15 min. The similarity factor f2 of dissolution curve was 62, using dropping pills as reference preparation. CONCLUSIONS： Xuangui zhitong dispersible tablet had a rapid disintegration and the behavior of dissolution is similar to Xuangui zhitong dropping pills.
出处
《中国药房》
CAS
北大核心
2016年第7期959-962,共4页
China Pharmacy
基金
第四军医大学唐都医院科技创新发展基金自主创新探索项目(No.2013CXTS020)
关键词
玄归止痛分散片
处方工艺
正交试验
延胡索乙素含量
崩解时限
溶出度
相似因子
Xuangui zhitong dispersible tablets
Formulation technology
Orthogonal test
Content of tetrahydropalmatine
Disintegration time
Dissolution rate
Similarity factor
