穿王消炎胶囊制造工艺过程中3种穿心莲内酯含量变化追踪  

Tracking Changes of Three Andrographolides Content in Production Process of Chuanwang Xiaoyan Capsules

作　　者：刘晟楠[1] 魏惠珍[1] 段奕倩 殷文静[1] 罗小妹[1] 刘文霞[1] 朱益雷 饶毅[1] LIU Sheng-nan WEI Hui-zhen DUAN Yi-qian YIN Wen-jing LUO Xiao-mei LIU Wen-xia ZHU Yi-lei RAO Yi(Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, Chin)

机构地区：[1]江西中医药大学,南昌330004

出　　处：《中国实验方剂学杂志》2016年第20期39-42,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中医药行业科技专项(201307009)

摘　　要：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 changes of three lactone components of Andrographis Herba during the production process of Chuanwang Xiaoyan capsules,and select the reasonable components as the detection indexes to strengthen the quality control. Method： The production process of Chuanwang Xiaoyan capsules was tracked,and the key process points were selected as monitoring points. Quality was monitored by using HPLC. The dynamic content changes of andrographolide,neoandrographolide and didehydroandrographolide were tracked; the losses amount was calculated and relative change trend of transfer rate was compared. Result： The losses amount of andrographolide,neoandrographolide and didehydroandrographolide in the whole production process was different,and it was also greatly different during different process stages. The losses amount was 410. 65-619. 79 mg for andrographolide, 375. 97-381. 12 mg for neoandrographolide, and 147. 52-261. 04 mg for didehydroandrographolide. Conclusion： By exploring the changes regularity of the three andrographolide contents in the process,it provides a reference for relevant enterprises to establish reasonable detection indexes. It lays a foundation for improving the quality controllability of the formulation containing Andrographis Herba,with more practical reference values.

关 键 词：穿心莲内酯 新穿心莲内酯 脱水穿心莲内酯 穿王消炎胶囊 

分 类 号：R284.1[医药卫生—中药学]