清炎滴丸的稳定性考察  

Stability of Qingyan drop pills

作　　者：郭美华[1] 张新建[1] 刘志宇[1] 胡宝荣[1] 李小红[1] 白建海[2] 

机构地区：[1]哈尔滨医科大学附属第一医院药学部,150001 [2]哈尔滨医科大学附属第一医院眼科,150001

出　　处：《中国药物与临床》2014年第6期724-728,共5页Chinese Remedies & Clinics

基　　金：黑龙江省中医药科研项目(ZHY12-Z156)

摘　　要：目的考察清炎滴丸的稳定性。方法用高效液相色谱(HPLC)法测定清炎滴丸中异嗪皮啶和苦玄参苷ⅠA的含量,并考察性状、鉴别、溶散时限、微生物限度等其他指标。结果清炎滴丸样品在加速实验及长期实验中,考察前后各项检查指标均无明显变化。结论清炎滴丸在室温条件下稳定性较好。本品的工艺及包装等设计合理,符合制剂稳定的要求。Objective To investigate the stability of Qingyan drops. Methods The active ingredients （isofraxidin and piefeharraenin I A） in the samples were assayed by using high-performance liquid chromatography （HPLC）. Other indices, including character, identification and microbial limit, were also determined. Results No significant changes in individual parameters were found in the acceleration test and long-term test. Conclusion Qingyan drops are stable at room temperatures. The designs, preparation processes and package are in keeping with the standards for maintaining stability.

关 键 词：药物稳定性 色谱法 高压液相 清炎滴丸 

分 类 号：R286[医药卫生—中药学] O657.7[医药卫生—中医学]