穿心莲注射液制备工艺过程中3种穿心莲内酯含量变化追踪

Track the Content Change of Three Kinds of Lactones in the Process of Chuanxinlian Injection

摘要:

目的：通过研究穿心莲注射液工艺过程中穿心莲内酯、新穿心莲内酯以及脱水穿心莲内酯含量的动态变化来加强穿心莲注射液的质量控制。方法：模拟穿心莲注射液生产工艺，并从中选取6个关键工艺作为监控点，利用UV-HPLC对其进行在线质量监测，追踪穿心莲内酯、新穿心莲内酯以及脱水穿心莲内酯含量的动态变化，计算转移率。结果：穿心莲内酯、新穿心莲内酯以及脱水穿心莲内酯在整个生产工艺中总的转移率不同，总的转移率分别是56.3%，74.0%，42.5%；3种内酯在不同的生产工艺转移率亦不同，在活性炭回流脱色工艺中的损失最为严重，总内酯类成分转移率仅为75.2%。结论：将穿心莲注射液的质量控制由从药材、中间体、制剂的静态控制变为对工艺过程的动态监控全方位的控制，可更准确地分析可能存在质量问题的环节，为相关生产企业实际生产提供参考，并为提高穿心莲注射液乃至中药注射剂的质量可控性奠定基础，具有较高的参考价值。

Abstract:

Objective: To strength the quality control method of Chuanxinlian injection by determining the content of andrographolide, neoandrographolide and dehydroandrographolide in the process of production. Method: Adopt UV-HPLC to track the dynamic variation of andrographolide, neoandrographolide and dehydroandrographolide in six key process steps, which were picked up from Chuanxinlian injection production process. And metastasis rate of 3 kinds of lactones were analyzed. Result: During the production, the metastasis rate of Andrographolide, neoandrographolide and dehydroandrographolide is different. It is 56.3%, 74.0% and 42.5% respectively. The metastasis rate of three kinds of lactones in different production process is different. The loss in the progress of decolorization activated carbon is most serious. And the metastasis rate of three kinds of lactones is only 75.2%. Conclusion: This research may give a mind of Chuanxinlian injection quality control change from static control to dynamic control. And a great number of possible quality problems in the process of production may be analyzed and summarized more accurate. It provides a solid scientific experimental basis for practical production of Chuanxinlian injection and feasible recommendations for related manufacturing enterprises. Therefore, this paper could offer a new thought for quality control of Chuanxinlian injection even traditional Chinese medicine injections.