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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 observe and compare the color and clarity after the accelerated stability test (37°C, RH75%) of Salvia Miltiorrhiza powder and Salvia Miltiorrhizae Injection, and the percentage degradation of the main component Danshensu and the anti-platelet aggregation function, to determine which is more stable. . Methods: The content of Danshensu was determined by reversed-phase HPLC. The mobile phase was methanol-acetic acid water (7:1). The platelet aggregation test was performed using the Born method. Results: The percentage of danshensu degradation in powder injections (0.58% at 3 months; 2.03% at 6 months) was much lower than that of injections (11.1% at 3 months; 16.0 at 6 months). %). There was no significant difference in the platelet aggregation rate between the low-dose group and the injection. The platelet aggregation rate of the powder injection in the middle- and high-dose groups was significantly lower than that of the injection (P<0.05, P<0.001). Conclusion: The stability of Danshen injection is better than that of injection (physiochemical properties and pharmacodynamics).