目的:研究穿心莲药材中3种内酯类成分在穿王消炎胶囊制造过程中的变化规律,选择建立合理科学的成分作为检测指标,加强穿王消炎胶囊的质量控制。方法:跟踪穿王消炎胶囊的生产工艺,并从中选取关键工艺点作为监控点,采用HPLC对其进行质量监测,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规律,计算其损失量,比较转移率相对变化趋势。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损失量各不相同,各个工艺阶段也各自不相同,均有较大变化。穿心莲内酯损失量在410.65~619.79 mg,新穿心莲内酯损失量在375.97~381.12 mg,脱水穿心莲内酯损失量在147.52~261.04 mg。结论:通过探究工艺过程中3种穿心莲内酯含量变化规律,为相关生产企业合理建立检测指标提供参考,并为提高含有穿心莲药材制剂的质量可控性奠定基础,具有较实用的参考价值。 OBJECTIVE: To study the variation regularity of three kinds of lactones in Andrographis Paniculata during the manufacturing process of Wang Xiaoyan Capsules, and to choose reasonable scientific components as test indexes to enhance the quality control of Wangliangxiaoyan Capsules. Methods: The production process of Wangyouyan capsule was followed, and the key process points were selected as the monitoring points. The quality of the preparation was monitored by HPLC, the dynamic changes of andrographolide, andrographolide and dehydroandrographolide content were tracked and calculated Its loss, compare the relative change trend of transfer rate. Results: Andrographolide, neoandrographolide and dehydroandrographolide lost a great deal of losses in the whole production process, with different process stages. Andrographolide loss of 410.65 ~ 619.79 mg, new andrographolide loss of 375.97 ~ 381.12 mg, dehydroandrographolide loss of 147.52 ~ 261.04 mg. CONCLUSION: By studying the changes of the content of three kinds of andrographolide in the process, it provides a reference for the establishment of the detection index in the relevant manufacturing enterprises and lays the foundation for improving the quality controllability of the preparation containing the Andrographis paniculata.