桔贝合剂质量标准提升研究
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篇名: 桔贝合剂质量标准提升研究
TITLE: Study on the improvement of quality standard for Jubei mixture
摘要: 目的 提升桔贝合剂的质量标准。方法采用三硝基苯酚与氢氰酸的化学反应鉴别苦杏仁水;采用薄层色谱(TLC)法定性鉴别桔贝合剂中桔梗、浙贝母、黄芩、枇杷叶、甘草;采用高效液相色谱(HPLC)法同时测定该制剂中苦杏仁苷、黄芩苷、汉黄芩苷、甘草酸铵4种成分的含量。结果三硝基苯酚试纸显砖红色。5味药材的TLC斑点清晰,阴性对照无干扰。苦杏仁苷、黄芩苷、汉黄芩苷和甘草酸铵的进样量线性范围分别为0.0668~1.3355μg(R2=0.9994)、0.1898~3.7969μg(R2=0.9999)、0.0626~1.2513μg(R2=0.9999)、0.0418~0.8355μg(R2=0.9998);精密度、重复性、稳定性试验的RSD均小于2%;平均加样回收率分别为98.2%、99.5%、98.3%、99.6%,RSD分别为0.7%,1.6%、1.5%、1.1%(n=6)。15批样品的含量存在差异,A公司样品的含量普遍低于B、C公司。结论所建质量标准可较好地反映桔贝合剂的内在质量。
ABSTRACT: OBJECTIVE To improve the quality standard for Jubei mixture . METHODS The chemical reaction of trinitrophenol and hydrocyanic acid was used to identify Armeniacae Amarum solution . Platycodon grandiflorus ,Fritillaria thunbergii,Scutellaria baicalensis ,the leaves of Eriobotrya japonica and Glycyrrhiza uralensis in Jubei mixture were identified by thin-layer chromatography (TLC). High-performance liquid chromatography was used to simultaneously determine the contents of four active components ,such as amygdalin ,baicalin,wogonoside and monoammonium glycyrrhizinate in Jubei mixture . RESULTS Trinitrophenol test paper showed brick red . TLC spots of five medicinal materials were clear ,without interference from negative control . The linear ranges of amygdalin ,baicalin,wogonoside and monoammonium glycyrrhizinate were 0.066 8-1.335 5 μg(R2=0.9994),0.189 8-3.796 9 μg(R2=0.999 9),0.062 6-1.251 3 μg(R2=0.999 9),0.041 8-0.835 5 μg(R2=0.999 8), respectively. RSDs of precision ,repeatability and stability tests were all lower than 2%. The average recoveries were 98.2%, 99.5%,98.3%,99.6%,and RSDs were 0.7%,1.6%,1.5%,1.1%(n=6). The contents of 15 batches of samples were different , and the content of sample from company A was generally lower than those from companies B and C . CONCLUSIONS The standard established can reflect the inherent quality of Jubei mixture well .
期刊: 2022年第33卷第21期
作者: 洪挺,周志强,肖小武,陈丹丹,杨毅生
AUTHORS: HONG Ting,ZHOU Zhiqiang,XIAO Xiaowu,CHEN Dandan,YANG Y isheng
关键字: 桔贝合剂;质量标准;化学反应;薄层色谱法;高效液相色谱法
KEYWORDS: Jubei mixture ; quality standard ; chemical reaction ; thin-layer chromatography ; high-performance liquid
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