通络颗粒制备工艺优选  

Optimization of Preparation Process for Tongluo Granules

作　　者：王云静 张雪盈 贾雨熹 刘诗怡 刘嵩[1] 陈亚军[1] WANG Yunjing;ZHANG Xueying;JIA Yuxi;LIU Shiyi;LIU Song;CHEN Yajun(School of Medicine,Wuhan University of Science and Technology,Wuhan,Hubei,China 430065)

机构地区：[1]武汉科技大学医学院,湖北武汉430065

出　　处：《中国药业》2024年第22期73-77,共5页China Pharmaceuticals

基　　金：湖北省自然科学基金[2022CFB249]。

摘　　要：目的选化通络颗粒制备工艺。方法采用高效液相色谱(HPLC)法测定葛根素含量。以加水倍数、提取时间、提取次数为考察因素,以葛根素含量、浸膏得率的综合评分为评价指标,采用L_(9)(3^(4))正交试验法优选样品的提取工艺;常压压缩,考察(65±5)℃温度下浸膏密度以考察浓缩工艺;通过改变辅料种类及与浸膏的用量比考察成型工艺;并验证。结果优选的提取工艺为,按处方量称取各味药材,提取2次(分别加8倍及6倍量水),每次1 h;浓缩工艺为,浓缩滤液至密度为1.25~1.32 g/mL;成型工艺为,按辅料∶浸膏=2∶1(m/m)加入辅料糊精制粒、干燥、整粒。验证试验结果表明,优化后的制备工艺稳定可行。结论优化后的制备工艺可为通络颗粒的工业化生产提供参考。Objective To optimize the preparation process of Tongluo Granules.Methods High-performance liquid chromatography(HPLC)method was used to determine the content of puerarin.The extraction process was optimized by the L_(9)(3^(4))orthogonal test,with the water addition amount,extraction time and extraction frequency as the investigation factors,and with the comprehensive score of puerarin content and extract yield as the evaluation indicator.The atmospheric compression was adopted,the density of the extract at a temperature of(65±5)℃was calculated to investigate the concentration process.The type of excipients and the ratio of their dosage to the concentrated solution dosage were changed to investigate the molding process.The verification test was carried out.Results The optimal extraction process was to weigh each medicinal herb based on the prescription amount and extract twice(adding eight times and six times the amount of water respectively),each time for 1 h.The concentration process was to concentrate the filtrate to a density of 1.25-1.32 g/mL.The molding process was to add excipient dextrin at a ratio of 2∶1(m/m)to the extract for granulation,followed by drying and grain-size stabilization.The verification test showed that the optimal preparation process was stable and feasible.Conclusion The optimal preparation process can provide a reference for the industrial production of Tongluo Granules.

关 键 词：通络颗粒 制备工艺 优化 质量标准 

分 类 号：R94[医药卫生—药剂学]