摘要
目的:制备二陈分散片并建立其质量控制方法。方法:采用交联羧甲基纤维素钠为崩解剂,加入聚乙烯吡咯烷酮等辅料制备分散片;采用高效液相色谱法测定制剂中橙皮苷含量,并进行成品稳定性考察。结果:橙皮苷进样量在1μg～80μg范围内线性关系良好,平均回收率为99.98%,RSD=0.98%;制剂稳定性良好。结论:该制剂处方合理,制备工艺简单,成品符合《中国药典》各项质量指标要求。
OBJECTIVE:To prepare erchen dispersible tablet and establish its quality control method.METHODS:cCMC-Na was used as disintegrating agent,and polyvinyl pyrrolidone as well as other adjuvants were added to prepare the tablet;The content of hesperidin was determined by HPLC,and the stability of the finished product was also evaluated.RESULTS:The sample size of hesperidin was linear in the range of1μg～80μg,the average recovery was99.98%,RSD=0.98%;The preparation showed good stability.CONCLUSION:The present formulatiom is rational,and the preparation technic is simple,the finished product meets the standards of Chinese Pharmacopenia.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第14期1067-1068,共2页
China Pharmacy
关键词
二陈分散片
半夏
橙皮苷
制备
质量控制
Erchen dispersible tablet
Pinellia
Hesperidin
Preparation
Quality control
