摘要
目的建立异功散的质量评价方法,为其质量标准建立及生产质量可控的临床样品提供数据支撑和研究基础。方法采用高效液相色谱(HPLC)法建立异功散含量测定方法,并进行相关方法学考察;进行3批中试生产放大样品的有效成分转移率监测,验证质量标准的可行性。结果含量测定指标成分确定为人参皂苷Rb1、甘草苷、橙皮苷、甘草酸,其方法学考察均符合规定。中试3批样品的转移率均值分别为63.5%、77.9%、25.0%、72.7%,所有数据均未出现离散。结论建立的异功散质量标准能够较全面反映其样品的关键质量属性,综合体现各处方药味的信息;并通过3批中试放大验证,可为后期异功散生产临床样品及上市提供参考。
Objective To establish the quality evaluation method of Yigong powder,and to provide data support and research basis for the quality standard and production of stable and controllable clinical samples.Methods HPLC method was used to establish the char-acteristic chromatogram and content determination of Yigong powder,and the relevant methodology was investigated.The transfer rate of index components of three batches of pilot production samples was monitored to verity the feasibility of quality standards.Results The content determination indexes were determined as ginsenoside Rb1,glycyrrhizin,hesperidin and glycyrrhizic acid,and the con-tend determination methods were in line with the regulations.The average transfer rates of the three batches of samples in the pilot trial were 63.5%,77.9%,25.0%,72.7%,and no dispersion was found in all the data.Conclusion The established quality standard can reflect the key quality attributes of the samples,and comprehensively reflect the information of each prescription drug flavor,and three batches of pilot scale test was verified,providing reference for the production and marketing of clinical samples of Yigong powder in the later stage.
作者
杨晓阳
闫会晓
王欢
赵婷
李菲
侯金才
姜国志
YANG Xiaoyang;YAN Huixiao;WANG Huan;ZHAO Ting;LI Fei;HOU Jincai;JIANG Guozhi(China Shineway Pharmaceutical Group Limited,Hebei Province,Shijiazhuang 051430,China;Hebei Key Laboratory of Quality Process Control of Classic Famous Prescription and Modern Chinese Medicine,Hebei Province,Shijiazhuang 051430,China)
出处
《中国中医药现代远程教育》
2024年第17期161-164,共4页
Chinese Medicine Modern Distance Education of China
基金
河北省科技厅中央引导地方科技发展资金项目【No.206Z2502G】。
关键词
异功散
特征图谱
含量测定
转移率
Yigong powder
characteristic chromatogram
content determination
transfer rate
