清脑复神液质量标准再评价研究  

Re-evaluation of Quality Standard of Qinnaofusheng Oral Liquid

作　　者：徐玉玲[1] 伍利华[2] 谭平 刘婷[1] 张文文[1] 伍月[1] 刘涛[1] 

机构地区：[1]成都大学药学与生物工程学院,四川成都610106 [2]广西中医药大学药学院,广西南宁530001 [3]湖北省秭归县人民医院,湖北秭归443600

出　　处：《成都大学学报（自然科学版）》2015年第4期326-330,共5页Journal of Chengdu University（Natural Science Edition）

基　　金：四川省经信委产业技术研究与开发(〔2014〕1124号);四川省科技厅科技支撑计划(2014SZ0139)资助项目

摘　　要：目的：对清脑复神液的质量标准进行再评价研究,以完善其质量标准.方法：在原标准基础上增加了葛根、枳壳、赤芍的薄层色谱鉴别,同时以盐酸小檗碱、芦丁为对照品建立了小檗碱、总黄酮的含量测定方法.结果：葛根、枳壳、赤芍定性鉴别的专属性强;盐酸小檗碱在0.06~0.96μg范围内与峰面积呈现良好的线性关系（R2=0.999）,芦丁在6.00~30.01μg范围内,浓度与吸光度线性关系良好（R2=0.999）,平均回收率为101.24%、99.99%,RSD为1.48%（n=6）、1.74%（n=6）.结论：清脑复神液现行质量标准可控性不强,经本研究所修订后的标准可增强产品质量的可控性.The paper re-evaluates the quality standard of Qingnaofushen oral liquid in order to improve its quality standard. The TLC identification of Radix Puerariae,Fructus,Aurantii,Radix Paeoniae Rubra is added; meanwhile,by taking berberine hydrochloride and rutin as comparison products,the content determination for berberine and total flavonoids is established. The results show that the TLC identification of Radix Puerariae,Fructus Aurantii,and Radix Paeoniae Rubra is specific. Two good linear relationships are achieved over the concentration range between 0. 06 ~ 0. 96 μg（ R2= 0. 999） for berberine hydrochloride and 6. 00 ~ 30. 01 μg（ R2= 0. 999） for rutin with average recoveries of101. 24% and 99. 99% respectively,and RSD： 1. 48%（ n = 6）,1. 74%（ n = 6） respectively. Therefore,a conclusion is drawn that the controllability of current quality standard is weak; the quality standard after revision can enhance the controllability of the quality of the products.

关 键 词：清脑复神液 质量标准 薄层鉴别 含量测定 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]