桂枝茯苓胶囊的溶出度测试及评价研究  

Dissolution test and evaluation of Guizhi Fuling Capsules

作　　者：黄照博 王龙 康瑶 王团结[2,3] 王振中[2,3] 张宏达[2,3] 白钢[4] 李正 李文龙 HUANG Zhao-bo;WANG Long;KANG Yao;WANC Tuan-jie;WANG Zhen-zhong;ZHANG Hong-da;BAI Gang;LI Zheng;LI Wen-long(College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang 222001,China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process,Lianyungang 222001,China;College of Pharmacy,Nankai University,Tianjin 300071,China)

机构地区：[1]天津中医药大学中药制药工程学院,天津300193 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室,江苏连云港222001 [4]南开大学药学院,天津300071

出　　处：《中国中药杂志》2022年第19期5256-5263,共8页China Journal of Chinese Materia Medica

基　　金：中药制药过程新技术国家重点实验室开放基金项目(SKL2020Z0203);天津市科技计划项目(20ZYJDJC00090)。

摘　　要：桂枝茯苓胶囊成分复杂,简单的含量测定难以反映其整体质量,因此有必要开展多成分的溶出测定研究.不同厂家不同批次产品质量具有的差异性,也是中药固体制剂的一个共性问题.为了更全面地对桂枝茯苓胶囊的质量进行控制,研究了桂枝茯苓胶囊中7种指标性成分在不同条件下的溶出行为,同时考察了同一厂家不同批次产品的溶出行为一致性.采用《中国药典》通则0931第一法篮法,分别设置转速为50、75、100 r·min^(-1),以pH=1.2的盐酸溶液、pH=4.0的醋酸盐缓冲液、纯水和pH=6.8的磷酸盐缓冲液作为溶出介质,分别在5、10、20、30、45、60 min时自动取样,以UPLC测量并计算7个指标成分的累积溶出度;采用差异因子f_(1)和相似因子f_(2)综合评价8批不同批次桂枝茯苓胶囊产品的溶出曲线的相似性,并拟合了多种溶出释放方程.结果显示,所有成分在较高的转速和盐酸介质条件下有较快的溶出速率,8批桂枝茯苓胶囊平均f_(1)<15,且f_(2)>50,表明不同批次的产品具有相似的溶出行为,多种成分的溶出行为具有同步性且有相似的释药特点.该研究可为桂枝茯苓胶囊质量批次一致性评价,工艺优化乃至剂型的改进提供参考.Because of the complex components,simple content determination can hardly reflect the overall quality of Guizhi Fuling Capsules.Therefore,it is necessary to carry out a multi-component dissolution test.The variability of quality among different batches of products from different manufacturers is a common problem of Chinese medicine solid preparations.To comprehensively control the quality of Guizhi Fuling Capsules,we studied the dissolution behaviors of 7 index components in the capsules under different conditions,and investigated the consistency of dissolution behaviors among different batches of products from the same manufacturer.The basket method of general rule 0931 in Chinese Pharmacopoeia was adopted,and the rotating speeds were set at 50,75,and 100 r·min^(-1),respectively.The hydrochloric acid solution(pH 1.2),acetate buffer solution(pH 4.0),pure water,and phosphate buffer solution(pH 6.8)were used as the dissolution media.Automatic sampling was carried out at the time points of 5,10,20,30,45,and 60 min,respectively.The cumulative dissolution of 7 index components was measured through ultra-performance liquid chromatography(UPLC).The difference factor f_(1) and similarity factor f_(2) were calculated to comprehensively evaluate the similarity of the dissolution curves among 8 batches of Guizhi Fuling Capsules,and a variety of dissolution and release equations were fitted.The results showed that multiple components had faster dissolution rates at higher rotating speed and in hydrochloric acid medium.The 8 batches of Guizhi Fuling capsules showed the average f_(1) value lower than 15 and the average f_(2) value higher than 50,which indicated that different batches of products had similar dissolution behaviors.Most components had synchronous dissolution behaviors and similar release cha-racteristics.This study provides a reference for the quality consistency evaluation among batches,processing optimization,and dosage form improvement of Guizhi Fuling Capsules.

关 键 词：桂枝茯苓胶囊 溶出行为 质量控制 批次一致性 

分 类 号：R284.1[医药卫生—中药学]