摘要
目的制备余苣降酸茶并建立其质量标准。方法按处方和制备工艺要求制备余苣降酸茶。依据《中华人民共和国药典》2015年版中茶剂相关规定,制定符合规定的质量标准,对其性状、水分、装量差异、微生物限度等项目进行检查;采用薄层色谱(TLC)法对处方中桑叶、淡竹叶进行鉴别;采用高效液相色谱(HPLC)法对该制剂中余甘子、粉葛主要成分没食子酸、葛根素进行定性定量分析。结果各检查项目符合标准规定;TLC中特征斑点清晰;HPLC色谱图中没食子酸、葛根素与其他成分分离良好,没食子酸进样量在45.58~911.6μg·mL^-1范围内与峰面积呈良好线性关系,平均回收率100.47%,RSD为4.16%,葛根素进样量在15.69~313.8μg·mL^-1范围内与峰面积呈良好的线性关系,平均回收率95.41%,RSD为3.70%。结论余苣降酸茶制备工艺简单可行,所建立的质量标准可用于该制剂的质量控制。
Objective To establish the quality standard of Yujujiangsuan tea. Methods The Yujujiangsuan tea was prepared according to the prescription and preparation process.The quality standards of Yujujiangsuan tea was established according to Chinese pharmacopoeia(2015 edition).Then, the properties, water content,loading difference,and microbial limit were checked.We thin layer chromatography(TLC) was used to identify the leaves of mulberry and bamboo.High performance liquid chromatography(HPLC) was used to analyze the main components of gallic acid and puerarin. Results All the inspection items met the standards.The characteristic spots on TLC were clear.In the HPLC chromatogram, the resolution of gallic acid,puerarin and other components was good.The result of gallic acid showed good linearity in the range of 45.58 to 911.6 μg·mL^-1.And the average recovery was 100.47%(RSD 4.16%).The linearity range of puerarin was 15.69 to 313.8 μg·mL^-1, and the average recovery of 95.41%(RSD 3.70%). Conclusion The preparation technology of yujujiangsuan tea is simple and the quality standard can be used to control its quality.
作者
郑江萍
张志权
吉慧敏
黄良永
ZHENG Jiangping;ZHANG Zhiquan;JI Huimin;HUANG Liangyong(Department of Pharmacy,Taihe Hospital Affiliated with Hubei University of Medicine,Shiyan 442000,China;School of Pharmacy,Hubei University of Medicine,Shiyan 442000,China)
出处
《医药导报》
CAS
北大核心
2020年第3期376-380,共5页
Herald of Medicine
基金
2014年湖北省中青年创新团队项目(T201414)。
关键词
余苣降酸茶
色谱法
薄层
色谱法
高效液相
质量标准
Yujujiangsuan tea
Chromatography,thin-layer
Chromatography,high performance liquid
Quality standard
