银翘解毒丸制备工艺中绿原酸转移率的影响因素研究

目的 研究银翘解毒丸各工艺因素对绿原酸转移率的影响,为制备工艺优化及质量标准修订提供实验数据。方法 按《中国药典》所载银翘解毒丸处方和制法,用HPLC跟踪绿原酸在各工艺步骤中的转移率;单因素考察提取温度、浓缩温度、干燥温度对绿原酸转移率的影响。结果 处方饮片粉碎后,经提取、浓缩、干燥、制丸4个环节绿原酸的转移率分别为78.0%、69.53%、55.90%、55.41%;制备过程中温度是影响绿原酸转移率的主要因素。结论 规范银翘解毒丸的制备工艺条件可提高绿原酸的转化率,保证产品质量稳定可控。

Study on factors affecting the transfer rate of chlorogenic acid in process of preparing Yinqiaojiedu Pills

Objective To investigate the transfer rates of chlorgenic acid in the preparation process of Yinqiao Jiedu Pills (YJP), and to provide experimental data for technical improvement and quality control. Methods According to the recipe and technique of YJP contained in pharmacopoeia, the transfer rates of chlorgenic acid in the preparation process of YJP were determined by HPLC. Meanwhile, single factor experiment was used to investigate the effect of extraction temperature, condensation temperature, and drying temperature on the transfer ratio of chlorogenic acid. Results The preparation process contained four steps: extraction, concentration, drying, and pelletizing. The mean transfer rates of chlorgenic acid in above step were 78.0%, 69.53%, 55.90%, and 55.41%, and in the process of preparation, temperature was the main factor affecting the transfer ratio of chlorogenic acid. Conclusion Standardization of YJP preparation conditions can improve the conversion rate of chlorogenic acid, to ensure the quality stable and controllable.