冠心七味片提取工艺优化研究

Study on Optimization of Extraction Process of Guanxin Qiwei tablets

目的:分析识别冠心七味片提取生产过程中影响丹参酮Ⅱ_(A)含量的因素,通过单因素试验法确定冠心七味片提取工艺优化的方案,为冠心七味片生产工艺关键控制点的制定提供依据。方法:采用HPLC法测定冠心七味片中丹参酮Ⅱ_(A)的含量,通过对冠心七味片提取工艺中的湿热因素进行分析,识别影响丹参酮Ⅱ_(A)含量的关键因素,并以提取过程丹参酮Ⅱ_(A)的含量和转移率为指标,通过单因素实验法考察一遍煎液与二遍煎液先混合后浓缩或先浓缩后混合、烘干温度、稠膏放置时间三个因素对丹参酮Ⅱ_(A)含量的影响。结果:确定优化的工艺为:一遍煎液与二遍煎液先混合后浓缩;烘干温度控制在55~60℃之间;稠膏放置时间不超过24h。验证试验结果显示按照优化方案提取,丹参酮Ⅱ_(A)含量能够满足质量标准要求,转移率较高,转移率RSD为1.64%。结论:本研究中优化方案方法稳定、可行。

Objective:Analyze and identify the factors affecting the content of tanshinoneⅡ_(A)during the extraction production process of Guanxin Qiwei tablets,and determine the optimal plan for the extraction process of Guanxin Qiwei tablets through a single factor experiment to provide a basis for the formulation of key control points in the production process of Guanxin Qiwei tablets.Methods:The content of tanshinoneⅡ_(A)in Guanxin Qiwei tablets was determined by HPLC.The damp and heat factors in the extraction process of Guanxin Qiwei tablets were analyzed to identify the key factors affecting the content of tanshinoneⅡ_(A).And taking the content and transfer rate of tanshinoneⅡ_(A)during the extraction process as an indicator,the single factor experiment was used to investigate the effect of the three factors,which include the first extracting solution and the second extracting solution being mixed and then concentrated or concentrated and then mixed,the drying temperature,and the storage time of the thick paste,on tanshinoneⅡ_(A)content.Results:The optimized process is as follows:the first extracting solution and the second extracting solution should be mixed and then concentrated;The drying temperature should be controlled between 55~60℃;The storage time of the thick paste shuould not exceed 24 h.The results of the verification test showed that the content of tanshinoneⅡ_(A)can meet the requirements of the quality standard,and the transfer rate was high,and the transfer rate RSD was 1.64%.Conclusion:The optimization scheme method is stable and feasible.