不同指标预测葛根注射液稳定性的研究  

Studies on stability of PUERARIN INJECTION based on changes of different active principles in preparation

作　　者：毛声俊 侯世祥 李超英 王新春 黄晓东[1] 郭勃 

机构地区：[1]四川大学华西药学院 [2]四川宝光药业股份有限公司,四川成都610031

出　　处：《中草药》2001年第7期595-597,共3页Chinese Traditional and Herbal Drugs

摘　　要：目的　比较不同指标预测葛根注射液稳定性的差异 ,为稳定性评价指标选择的必要性提供实验依据。方法　采用经典恒温加速试验法预测稳定性 ,注射液中葛根总黄酮与葛根素的含量测定分别采用紫外分光光度法与HPL C法。结果　注射液中有效部位总黄酮与有效成分葛根素的降解符合一级反应规律 ,分别以二者为指标的 t2 5℃0 .9为 0 .63 a和 1.82 a。结论　不同类型的稳定性评价指标对制剂的稳定性预测结果存在较大影响 ,提供充分的稳定性评价指标选择依据是必要的。Object To compare the stability of PUERARIN INJECTION as predicted by the change of total Puerarin flavonoids and kakonein in the preparation during stability test, to provide an example showing the importance for the proper choice of stability index based upon different active principles present in the preparation. Methods The stability of the preparation under study were tested by the classical accelerated isothermal method and the change of total Puerarin flavonoids and kakonein were determined by UV and HPLC. Results The degradation of both active principles followed the first order reaction. The t 25℃ 0.9 were 0.63 a and 1.82 a respectively. Conclusion The stability of PUERARIN INJECTION will show different values when based upon either single ingredient, suggesting the necessity to provide a logical basis for the determination of stability index.

关 键 词：葛根注射液 稳定性 葛根总黄酮 葛根素 评价指标 中药注射液 

分 类 号：R286.0[医药卫生—中药学]