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目的:考察豚鼠离体心脏灌流法检测丹参注射液生物活性的可行性,为进一步完善其质量控制标准提供参考。方法:采用豚鼠离体心脏灌流法检测丹参注射液对冠状动脉流量的影响,并以冠脉流量增量为指标考察其生物活性。分别进行量效关系考察和重复性研究,对4个厂家12批丹参注射液样品的生物活性进行检测。结果:丹参注射液在豚鼠离体心脏灌流模型中对冠脉流量有显著增加。在实验条件下,在原液0.1～0.6 mL剂量范围内,丹参注射液表现出一定的量效关系;在0.3 mL剂量下,在一定的时间内,丹参注射液对同一心脏和不同心脏的生物活性重复性都较好。结论:此模型用于丹参注射液生物活性质量控制指标具有一定的可行性,通过进一步方法改进和探索有望成为丹参注射液的有效性质量控制方法。
OBJECTIVE: To investigate the feasibility of detecting the biological activity of Danshen injection by guinea pig isolated cardiac perfusion method, and to provide reference for further improving its quality control standards. Methods: The effects of Danshen injection on coronary flow were detected by isolated guinea pig perfused heart perfusion method. The biological activity of coronary artery was evaluated by coronary flow increment. The relationship between dose-effect and repeatability were investigated respectively. The biological activity of 12 batches of Salvia miltiorrhiza injection in 4 factories was tested. Results: Salvia miltiorrhiza injection in isolated guinea pig cardiac perfusion model of coronary flow was significantly increased. Under the experimental conditions, Salvia miltiorrhiza injection showed a certain dose-effect relationship within the dose range of 0.1-0.6 mL; at the dose of 0.3 mL, the biological activity of Salvia miltiorrhiza on the same heart and different hearts in a certain period of time Repeatability is better. Conclusion: This model has some feasibility for the quality control index of Salvia miltiorrhiza injection. The quality control method of Salvia miltiorrhiza injection could be improved and explored through further methods.