摘要
目的：观察、比较了丹参粉针、丹参注射液加速稳定性实验（３７℃，ＲＨ７５％）后的色泽、澄明度，主成分丹参素的降解百分率以及抗血小板聚集功能，判断何者稳定性更佳。方法：丹参素含量测定采用反相ＨＰＬＣ，流动相采用甲醇－醋酸水（７：１）。血小板聚集功能试验采用Ｂｏｒｎ法。结果：粉针剂中丹参素降解百分率（３个月为０．５８％；６个月为２．０３％）远低于注射液（３个月为１１．１％；６个月为１６．０％）。低剂量组粉针剂与注射液血小板聚集率无显著差异，中、高剂量组粉针剂血小板聚集率明显低于注射液（Ｐ＜０．０５，Ｐ＜０．００１）。结论：丹参粉针剂稳定性优于注射液（理化性质及药效学两方面）。
OBJECTIVE :To compare the accelerated stability(37℃ RH75%)and platelet-aggregation functionof SMPl and SMLI. METHODS : The content of Danshensu (major component of the preparation ) was assayed byHPLC, The platelet-aggregation tests were determined by Bron’s method,RESULTS : The decomposition percent-ages of Danshensu in SMPI were much lower than those is SMLI after accelerated stability test. The platelet aggre-gation percentages of SMPl and SMLI,in low concentration group,showed no differences(P>0. 05),in middle andhigh concentration groups,the former was lower than that of the latter(SMSI) (P<0. 05,P<0. 001). CONCLU-SION:SMPl was more stable than SMLI.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1996年第12期730-732,共3页
Chinese Pharmaceutical Journal
关键词
丹参粉针
丹参注射液
稳定性
血小板聚集功能
SMPI(Salvia miltiorrhiza power for injection),SMLI(Salvia miltiorrhiza solution for injection),Danshensu ,accelerated stability test,platelet-aggergation action
