摘要
目的:研究医院制剂三味板蓝根颗粒的质量标准,提升该制剂的质量。方法:采用薄层色谱法(thin layer chromatography,TLC)对三味板蓝根颗粒进行原药材的定性鉴别研究;采用紫外-可见分光光度法(ultraviolet and visible spectrophotometry,UV-Vis)对该制剂的总有效成分之一的多糖进行含量测定研究;采用高效液相色谱法(high performance liquid chromatography,HPLC)对该制剂的活性成分(R,S)-告依春进行含量测定研究。结果:经TLC法进行定性鉴别研究,三味板蓝根颗粒中板蓝根、山芝麻均与相应的对照药材及对照品在同一位置呈相同斑点,且阴性无干扰;经UV-Vis法测定,该制剂的多糖含量为6.31%,RSD为0.67%;经HPLC法测定,该制剂中(R,S)-告依春的含量为0.0355 mg/g,RSD为5.98%。结论:与三味板蓝根颗粒原有的质量标准相比,本研究增加了TLC、UV-Vis和HPLC法进行研究,研究方法简便快速、稳定可靠,可纳入医院制剂三味板蓝根颗粒的质量标准,为控制该制剂的质量提供依据。
OBJECTIVE:To study the quality standard of hospital preparation Sanwei radix isatidis granules,so as to improve the quality of the preparation.METHODS:Thin Layer chromatography(TLC)was used for the qualitative identification of Sanwei radix isatidis granules.Ultraviolet and visible spectrophotometry(UV-Vis)was used to determine the content of polysaccharides,which was one of the total active ingredients of the preparation.High performance liquid chromatography(HPLC)was used to determine the content of the active ingredient(R,S)-goitrin in this preparation.RESULTS:According to the qualitative identification by TLC method,radix isatidis and screwtree root in Sanwei isatidis radix isatidis granules showed the same spots in the same position with the corresponding control materials and control substances,and the spots were negative without interference.According to UV-Vis,the content of polysaccharide was 6.31%and RSD was 0.67%.The content of(R,S)-goitrin in the preparation was 0.0355 mg/g and RSD was 5.98%by HPLC method.CONCLUSIONS:Compared with the original quality standard of Sanwei radix isatidis granules,TLC,UV-Vis and HPLC methods are enrolled into the study,which are simple,rapid,stable and reliable,and can be incorporated into the quality standard of hospital preparation Sanwei radix isatidis granules to provide basis for controlling the quality of the preparation.
作者
梁国成
陈斯宁
陈舒茵
杨红梅
黄小鸥
覃忠桂
秦辛
韦世民
LIANG Guocheng;CHEN Sining;CHEN Shuyin;YANG Hongmei;HUANG Xiao’ou;QIN Zhonggui;QIN Xin;WEI Shimin(Drug Research and Development Center,Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Guangxi Nanning 530011,China;College of Guangxi Chemistry and Chemical Engineering,Guangxi Nanning 530004,China;Guangxi Zhuang Yao Medicine Center of Engineering and Technology,Guangxi Nanning 530200,China)
出处
《中国医院用药评价与分析》
2021年第8期938-943,共6页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
广西壮族自治区中医药管理局中药壮瑶药医院制剂质量提升项目(No.GZZJ202010)
2019年度广西中医药大学自然科学研究项目(No.2019MS036)。
关键词
三味板蓝根颗粒
薄层色谱法
紫外-可见分光光度法
高效液相色谱法
质量标准提升
Sanwei radix isatidis granules
Thin layer chromatography
Ultraviolet and visible spectrophotometry
High performance liquid chromatography
Improvement of quality standard
