离体心脏灌流法在丹参注射液生物活性检测中的应用

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。

Application of Isolated Heart Perfusion Technique to Evaluate the Bioactivity of Danshen Injection

Objective:To investigate the application of isolated heart perfusion technique on evaluating the bioactivity of Danshen Injection, and lay the foundation for further improving the standards of quality control. Method: Isolated guinea pig heart perfusion was performed with Langendorff method to measure the Danshen Injection if it had any effects on coronary flow and then use the percentage increase in coronary flow as an index to investigate its biological activity. After inspection of dose-effect relationship and reproducibility studies, the biological activity would be tested from 12 batches of Danshen Injection from the four manufacturers. Result: Danshen Injection has a significant effect on increasing the coronary flow. Under a certain condition, Danshen Injection showed some dose-effect relationship in the range of 0.1 to 0.6 mL, and in the dose of 0.3 mL, repeatability of the activity was good both in the same or different isolated heart within a certain time. Conclusion: It may be of great possibility that Langendorff isolated heart perfusion technique will become a good method for evaluating the bioactivity of Danshen Injection after further improvement and exploration.