卷柏总黄酮片的质量控制研究  

Study on quality standard for tablet of Selaginellae Herba total flavones

作　　者：李彦超[1] 周宁[2] 郑晓珂[2] LI Yanchao;ZHOU Ning;ZHENG Xiaoke(NMPA Key Laboratory for Quality Control of Chinese Materia Medica and Prepared Slices,Henan Institute for Food and Drug Control,Zhengzhou,Henan 450008,China;School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou,Henan 450046,China)

机构地区：[1]河南省食品药品检验所国家药品监督管理局中药材及饮片质量控制重点实验室,河南郑州450008 [2]河南中医药大学药学院,河南郑州450046

出　　处：《上海中医药杂志》2021年第8期94-98,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家重大新药创制-科技重大专项(2013ZX09102-022)。

摘　　要：目的建立卷柏总黄酮片质量控制标准。方法采用薄层色谱法(TLC)对卷柏总黄酮片进行定性鉴别;用紫外分光光度法(UV)测定卷柏总黄酮片中卷柏总黄酮的含量;用高效液相色谱法(HPLC)测定卷柏总黄酮片中穗花杉双黄酮的含量;并对检查项中的重量差异、崩解时限进行控制。结果TLC法斑点清晰,专属性强;卷柏总黄酮在1.571~11.781μg/mL范围内呈良好的线性关系(r=0.9998),平均回收率为98.25%,RSD为1.02%。穗花杉双黄酮在6.545~327.246μg/mL范围内呈良好的线性关系(r=1.0000),平均回收率为96.03%,RSD=0.49%。检查项中的重量差异、崩解时限符合规定。结论建立了较为完善的卷柏总黄酮片质量标准,方法快速正确,重现性好,专属性强。Objective To establish the quality standard for tablet of Selaginellae Herba total flavones.Methods Thin layer chromatography(TLC)was used for qualitative determination.Ultraviolet spectrophotometry(UV)was used to determine the content of Selaginellae Herba total flavones and high performance liquid chromatography(HPLC)to determine the content of amentoflavone in Selaginellae Herba total flavones tablet.The weight variation and disintegration time limited in the inspection items were controlled.Results The TLC spots were clear with strong specificify.Selaginellae Herba total flavones showed a good linear relationship at the range of 1.571-11.781μg/mL(r=0.9998).The average recovery was 98.25%,and RSD was 1.02%.Amentoflavone showed a good linear relationship at the range of 6.545-327.246μg/mL(r=1.0000).The average recovery was 96.03%,and RSD was 0.49%.Weight variation and disintegration time limited were up to specification.Conclusion The established method is rapid,accurate,reproducible with a strong specificify.

关 键 词：卷柏总黄酮片 质量标准 穗花杉双黄酮 高效液相色谱法 紫外分光光度法 

分 类 号：R286.0[医药卫生—中药学]