摘要
目的探讨对胃速康胶囊主要成分进行定性定量的质量控制方法。方法显微鉴别处方中的香附和白及;采用薄层色谱法(TLC)鉴别处方中丁香、香附和甘草;采用高效液相色谱法(HPLC)测定其中甲硝唑含量,色谱柱为菲罗门C18(C18,5μm,4.6 mm×150.0 mm),以甲醇:水(20:80)为流动相;检测波长320 nm;流速1.0 ml/min;柱温26℃。结果香附和白及的显微鉴别特征均明显,可用于定性鉴别。TLC法测定丁香、香附和甘草,斑点清晰、分离效果好。HPLC法测定甲硝唑,进样量在15~300μg范围内与峰面积呈良好的线性关系(r=0.9996),平均加样回收率为98.64%,相对标准偏差(RSD)为0.41%(n=6)。结论本实验采用的HPLC及TLC可做为胃速康胶囊的定性定量控制方法。
Objective To investigate the qualitative and quantitative quality control methods for the main components of Wei Sukang capsule.Methods Cyperi rhizoma and Bletillae rhizoma were identified by microscopic identification and syzygium aromaticum,cyperi rhizome and glycyrrhiza were identified by thin-layer chromatography(TLC).The metronidazole were determined by high performance liquid chromatography(HPLC).Chromatography conditions were C18(C18,5.0μm,4.6 mm×150.0 mm)column.The mobile phase of gradient elution is the methanol and water(20:80).UV detection wavelength was set at 320 nm and the column temperature was 26℃with the flow rate of 1.0 ml/minute.Results The microscopic identification characteristics of cyperus rotundus and rhizome bletillae are obvious and can be used for qualitative identification.TLC method was used to determine clove,cyperus rotundus and liquorice with clear spots and good separation effect.Metronidazole was determined by HPLC,and the peak area showed a good linear relationship(r=0.9996)in the range of 15~300μg.The average recovery was 98.64%and relative standard deviation(RSD)was 0.41%(n=6).Conclusion In this study,HPLC and TLC can be used as the qualitative and quantitative control methods for Wei Sukang capsules.
作者
赵昕
张宝宝
贺康洪
ZHAO Xin;ZHANG Bao-bao;HE Kang-hong(Shenyang Joint Logistics Support Center Pharmaceutical Instruments Supervision and Inspection Station,Shenyang 110026,China;No.964 Hospital of Shenyang Joint Logistics Support Center,Changchun 13000,China)
出处
《临床军医杂志》
CAS
2020年第7期754-757,共4页
Clinical Journal of Medical Officers
基金
军队医疗机构制剂标准提高科研专项课题(14JZ13-3)。
关键词
胃速康胶囊
显微鉴别
薄层色谱法
高效液相色谱法
Wei Sukang capsule
Microscopic identification
Thin layer chromatography
High performance liquid chromatography
