鹳榆止泻颗粒剂的成型工艺优化与质量标准研究  

Optimization of Molding Process and Quality Standard of Guanyuzhixie Granules

作　　者：胥晨 纪鹏[1] 马挺 武振帅 张晓松[1] 华永丽[1] 姚万玲 袁子文[1] 王东升[2] 魏彦明[1] XU Chen;JI Peng;MA Ting;WU Zhen-shuai;ZHANG Xiao-song;HUA Yong-li;YAO Wan-ling;YUAN Zi-wen;WANG Dong-sheng;WEI Yan-ming(College of Veterinary Medicine,Gansu Agricultural University,Lanzhou,Gansu,730070,China;Lanzhou Institute of Animal Husbandry and Pharmaceutical,Lanzhou,Gansu,730050,China)

机构地区：[1]甘肃农业大学动物医学院,甘肃兰州730070 [2]中国农业科学院兰州畜牧与兽药研究所,甘肃兰州730050

出　　处：《动物医学进展》2023年第8期65-71,共7页Progress In Veterinary Medicine

基　　金：甘肃省高校产业支撑项目(2020C-14);财政部和农业农村部:国家现代农业产业技术体系(CARS-37);国家自然科学基金项目(32060812)。

摘　　要：优化鹳榆止泻颗粒剂的制备工艺并建立其质量标准,以辅料配比、润湿剂浓度、干燥温度为考察因素,颗粒成型率、吸湿率、水分、休止角为评价指标,用单因素结合正交试验优化鹳榆止泻颗粒剂的制备工艺。采用薄层色谱分析法、高效液相色谱法(HPLC)对鹳榆止泻颗粒剂中槲皮素、没食子酸、苦参碱、甘草酸分别开展定性和定量鉴别研究,建立其质量标准。结果表明,没食子酸、槲皮素、苦参碱和甘草酸检测质量浓度的线性范围分别为1.325~21.200μg/mL、11.875~190.000μg/mL、7.813~125.000μg/mL、16.250~260.000μg/mL,精密度、重复性、稳定性(24 h)试验的RSD均<3.0%(n=6),平均回收率为101.39%、101.94%、101.92%、101.72%,RSD均<3.0%(n=9)。说明优化的鹳榆止泻颗粒剂成型工艺稳定可行,建立的鹳榆止泻颗粒剂的薄层鉴别及含量测定方法可用于鹳榆止泻颗粒剂的质量控制。This article optimized the preparation process and established the quality standard of Guanyuzhixie granules.The proportion of excipients,the concentration of wetting agent and drying temperature were taken as the investigation factors.And the molding rate,moisture absorption rate,moisture content and angle of repose were taken as the evaluation indexes.The preparation process of Guanyuzhixie granules was optimized by single factor combined with the orthogonal test.Gallic acid,matrine and glycyrrhizic acid in Guanyuzhixie granules were identified qualitatively and quantitatively by thin layer chromatography(TLC)and high performance liquid chromatography(HPLC),and their quality standards were established.Results showed that the linear ranges of the detected mass concentrations of gallic acid,quercetin,matrine and glycyrrhizic acid were 1.325-21.2μg/mL,11.875-190.0μg/mL,7.813-125.0μg/mL and 16.250-260.0μg/mL,respectively,and the RSDs of the precision,reproducibility and stability(24 h)tests were<3.0%(n=6).And the mean recoveries were 101.39%,101.94%,101.92%,101.72%with RSD<3.0%(n=9).It indicated that the molding process of the granules optimized according to the above method is stable and feasible,and the established thin-layer identification and content determination method of the granules can be used for the quality control of the Guanyuzhixie granules.

关 键 词：鹳榆止泻颗粒剂 制备工艺 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：S853.7[农业科学—临床兽医学]