肠康片质量标准提升研究  

Study on Improving Quality Standard of Changkang Tablets

作　　者：杨正奕 王廷龙 王其勇[1] Yang Zhengyi;Wang Tinglong;Wang Qiyong(Guizhou Food and Drug Laboratory,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004

出　　处：《山东化工》2023年第2期128-131,共4页Shandong Chemical Industry

基　　金：2019年国家药典委员会药品标准制修订研究课题(2019Z007)。

摘　　要：目的:通过增加木香显微鉴别,修订木香薄层鉴别、增加木香的含量测定,提高肠康片质量标准。方法:使用对照药材增加木香的显微鉴别;增加对照品、改变展开条件,修订木香的TLC鉴别;采用HPLC,以木香烃内酯和去氢木香内酯的含量作为指标,进行含量测定。结果:木香显微鉴别特征明显;TLC鉴别专属性好、耐用性强,斑点显色清晰,分离好,阴性无干扰;HPLC结果表明木香烃内酯:y=1757575.24234x-75774.20833(r=0.9996),平均回收率为99.5%、RSD=1.3%(n=6);去氢木香内酯:y=1510424.60319x-66181.54167(r=0.9996),平均回收率为98.9%,RSD=1.0%。结论:木香显微鉴别、TLC鉴别及HPLC研究,实验方法准确可靠,可用于提高肠康片的质量标准。Objective:The quality standard of Changkang tablets was improved by increasing the microscopical identification,revising the TLC identification and increasing the content determination of radix aucklandiae.Methods:The results showed that the microscopical identification of C.chinensis was improved by using the reference materials,the TLC identification of C.chinensis was optimized by adding the reference materials and changing the development conditions,and the content of hydrocarbon lactone and dehydrolignolide in C.chinensis was used as the index by HPLC,for content determination.Results:The results of HPLC showed that the hydrocarbon lactone of C.chinensis was y=1757575.24234x-75774.20833(r=0.9996),the average recovery was 99.5%and RSD was 1.3%(n=6),the average recovery was 98.9%and RSD was 1.0%for dehydrolignolide:y=1510424.60319x-66181.54167(r=0.9996).Conclusion:The method is accurate and reliable,and can be used to improve the quality standard of Changkang tablets.

关 键 词：肠康片 木香 显微鉴别 薄层鉴别 高效液相色谱法 

分 类 号：TQ460[化学工程—制药化工]