摘要
目的优选小儿清肺分散片制备工艺处方。方法采用单因素试验对填充剂、崩解剂、黏合剂、润滑剂及载药量进行筛选,采用正交试验对交联聚乙烯吡咯烷酮(PVPP)、羧甲基淀粉钠(CMS-Na)、低取代羟丙基纤维素(L-HPC)3种崩解剂的联合应用比例进行优化。结果分散片的最佳处方工艺为:以微晶纤维素为填充剂,微粉硅胶为润滑剂,75%乙醇为黏合剂,PVPP、L-HPC、CMS-Na为联合崩解剂(L-HPC∶PVPP∶CMS-Na=4∶3∶6),制得的分散片崩解时间<3 min,且全部通过2号筛,分散均匀性符合规定。结论按该处方制备的小儿清肺分散片工艺稳定可行,适于临床需要。
Objective To optimize the prescription of preparation technology of Xiaoer Qingfei Dispersible Tablets. Methods The filler, disintegrant, adhesive, lubricant, and drug loading were screened by single factor tests. The combined application proportion of three disintegrating agents, PVPP, CMS-Na, and L-HPC, were optimized by orthogonal test. Results The best prescription of preparation technology of dispersible tablets：microcrystalline cellulose as filler;silica gel powder as lubricant;75%alcohol as the adhesive;PVPP, L-HPC, and CMS-Na as combined disintegrants （L-HPC∶PVPP∶CMS-Na=4∶3∶6）. The disintegration time of prepared dispersible tablets was less than 3 minutes, and all through the No.2 sieve. Dispersible uniformity was in accordance with the provisions. Conclusion Xiaoer Qingfei Dispersible Tablets prepared by the optimized preparation process are stable and feasible, and suitable for clinical application.
出处
《中国中医药信息杂志》
CAS
CSCD
2015年第3期83-86,共4页
Chinese Journal of Information on Traditional Chinese Medicine
基金
黑龙江省中医药科研项目(ZHY12-W027)
关键词
小儿清肺分散片
制备工艺
处方优化
Xiaoer Qingfei Dispersible Tablets
preparation technology
prescription optimization
