复方党参颗粒制备工艺优化及4种成分的同时测定  

Preparation optimiztion of compound Codonopsis Radix granules and simultaneous determination of its four components

作　　者：杨杰 景彩芳 李少创 刘思彤 李董明 李钦青 贺文彬 Jie Yang;Caifang Jing;Shaochuang Li;Sitong Liu;Dongming Li;Qinqing Li;Wenbin He(National International Joint Research Center of Molecular Chinese Medicine,Shanxi University of Traditional Chinese Medicine,Taiyuan 030024,Shanxi,China;Shanxi Key Laboratory of Chinese Brain Diseases,Shanxi University of Traditional Chinese Medicine,Taiyuan 030024,Shanxi,China)

机构地区：[1]山西中医药大学国家级分子中医药学国际联合研究中心,山西太原030024 [2]山西中医药大学中医脑病学山西省重点实验室,山西太原030024

出　　处：《Journal of Chinese Pharmaceutical Sciences》2023年第8期665-676,共12页中国药学（英文版）

基　　金：The State Administration of Traditional Chinese Medicine Young Qihuang Scholars Support Project(Approval Document No.:National Traditional Chinese Medicine[2020]No.7);Key Research and Development Program of Shanxi Province(International Science and Technology Cooperation)Major Regional Innovation Cooperation Project(Grant No.201803D421006);Shanxi University of Traditional Chinese Medicine,Postgraduate Innovation and Entrepreneurship Project(Grant No.2021CX046);Shanxi University of Traditional Chinese Medicine,Science and Technology Innovation Ability Cultivation Project(Grant No.2020PY-YC-35,2021PY-QN-10)。

摘　　要：本研究采用单因素试验和响应面法优化复方党参颗粒喷雾干燥工艺,获得最佳的喷雾干燥工艺参数;以成型率和吸湿率为指标考察辅料的配比用量;建立高效液相色谱(HPLC)法同时测定党参炔苷、阿魏酸、毛蕊异黄酮葡萄糖苷、甘草苷的含量。当喷雾干燥的进风温度为145℃,进风速率为75%,进料速率为8%,助干剂为5%,喷雾干燥得粉率最高;辅料用量为糊精:糖粉为2:1时,颗粒成型率和吸湿率均较好,有效优化了复方党参颗粒的喷雾干燥工艺和辅料配比用量,为复方党参颗粒的生产制备提供参考;HPLC同时测定复方党参颗粒中党参炔苷、阿魏酸、甘草苷、毛蕊异黄酮葡萄糖苷的含量分别为0.38 mg/g,0.22 mg/g,0.45 mg/g和0.25 mg/g,为复方党参颗粒质量控制方法的建立奠定基础。In the present study a single-factor experiment and response surface methodology were utilized to optimize the spray-drying process of compound Codonopsis Radix granules and determine the optimal spray-drying process parameters.The proportions of excipients were examined using indicators of molding rate and moisture absorption rate.High-performance liquid chromatography(HPLC)was established to simultaneously determine the contents of lobetyolin,ferulic acid,calycosin-7-O-β-D-glucoside(CG),and glycyrrhizin in the compound Codonopsis Radix granules.The findings indicated that the highest spray-drying yield was achieved when the inlet temperature of spray drying was set at 145ºC,the inlet air velocity at 75%,the feed rate at 8%,and the drying aid at 5%.A ratio of paste starch to powdered sugar at 2:1 resulted in a good particle molding rate and moisture absorption rate.By effectively optimizing the spray-drying process of compound Codonopsis Radix granules and excipient dosage this study provides a valuable reference for the production and preparation of these granules.The contents of lobetyolin,ferulic acid,glycyrrhizin,and CG in the compound Codonopsis Radix granules were found to be 0.38,0.22,0.45,and 0.25 mg/g,respectively.These results provided a foundation for establishing a quality control method for compound Codonopsis Radix granules.

关 键 词：复方党参颗粒 响应面优化 喷雾干燥 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]