摘要
目的对中药复方制剂因宁片中的君药昆明山海棠药材进行定性及定量分析。方法采用薄层色谱(TLC)法对因宁片中昆明山海棠药材进行定性分析并对其分析方法进行优化;采用高效液相色谱(HPLC)法对因宁片中的君药昆明山海棠药材主要成分雷公藤甲素进行定量分析并确定其含量的限量标准。结果TLC法定性研究表明:因宁片供试品和阳性对照品均在相应色谱位置显色,且分离度好、斑点清晰,阴性无干扰,对不同厂家薄层板、温度、湿度的影响因素考察表明:耐用性良好;HPLC定量分析雷公藤甲素浓度1~100μg/mL内,以峰面积对雷公藤甲素浓度进行线性拟合,得回归方程A=22.219C-19.165,r=0.9999,线性关系良好;测得3批因宁片试验品雷公藤甲素含量分别为0.34μg/片、0.34μg/片、0.28μg/片,范围0.28~0.34μg/片,最终确定因宁片中每片含雷公藤甲素含量不得高于0.6μg。结论TLC法和HPLC法对中药复方制剂因宁片中昆明山海棠药材进行定性与定量分析研究,该技术稳定、方法简便、准确、系统耐用性良好、专属性强,可为其药材在中药复方制剂中的定性与定量研究提供参考与借鉴。
Objective To conduct qualitative and quantitative analyses of Tripterygium hypoglaucum in Yinning Tablets,a compound preparation of traditional Chinese herbal medicine.Methods Thin-layer chromatography(TLC)was used for qualitative analysis of Tripterygium hypoglaucum in Yining Tablets and the analytical protocols were optimized.High-performance liquid chromatography(HPLC)was used to quantitatively analyze the content of triptolide(the main active ingredient of Tripterygium hypoglaucum)in Yinning Tablets.Results The results of TLC analysis showed that the test sample of Yinning Tablets and the positive control samples both produced clear,well separated spots without obvious interference in the blank samples.Assessment of the influences of the thin-layer plates from different manufacturers,temperature and humidity on the test results demonstrated good durability of the test.HPLC analysis of triptolide showed a good linear relationship within the concentration range of 1-100μg/mL(regression equation:A=22.219C-19.165,r=0.9999);the contents of triptolide in 3 batches of Yinning tablets were 0.34,0.34,and 0.28μg per tablet,all within the range of 0.28-0.34μg per tablet.It was finally determined that each Yinning tablet should not contain more than 0.6μg of triptolide.Conclusion TLC and HPLC are simple,accurate,durable and specific for qualitative and quantitative analyses of Tripterygium hypoglaucum in Yinning Tablets.
作者
吴江杰
杨琴
侯楚祺
吴馥凌
王龙
刘文钦
侯连兵
WU Jiangjie;YANG Qin;HOU Chuqi;WU Fuling;WANG Long;LIU Wenqin;HOU Lianbing(Department of Pharmacy,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China)
出处
《南方医科大学学报》
CAS
CSCD
北大核心
2022年第6期949-954,共6页
Journal of Southern Medical University
基金
中国医药教育协会2020重大科学攻关问题和医药技术难题科研课题(2020KTE003)
广东省科技计划项目(2011A080300004)
广州市产学研新药创制重大专项(201604020113)。
关键词
因宁片
昆明山海棠
雷公藤甲素
薄层色谱法
高效液相色谱法
Yinning Tablets
Tripterygium hypoglaucum
triptolide
thin-layer chromatography
high-performance liquid chromatography
