荆花胃康胶丸含量测定及特征图谱鉴别方法研究  

Study on the assay and characteristic chromatogram of Jinghua Weikang gelatin capsules

作　　者：魏嘉锡 郭晓晗 高展 丁文侠 程显隆[1] WEI Jia-xi;GUO Xiao-han;GAO Zhan;DING Wen-xia;CHENG Xian-long(National Institutes for Food and Drug Control,Beijing 100050,China;Tasly Pharmaceutical Group Pharmaceutical Co.,Ltd.,Tianjin 300000,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]天士力医药集团制药股份有限公司,天津300000

出　　处：《药物分析杂志》2023年第8期1321-1325,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立荆花胃康胶丸中对伞花烃的气相色谱含量测定以及特征图谱方法。方法:采用Agilent DB-17毛细管柱(30 m×0.32 mm,0.25μm,固定相以50%苯基-甲基聚硅氧烷为填料),柱温为程序升温(初始温度为60℃,以1.5℃·min^(-1)的升温速率至80℃,再以60℃·min^(-1)的升温速率至200℃),进样口温度为250℃,检测器为FID,检测器温度为250℃,对荆花胃康胶丸特征图谱中对伞花烃进行含量测定,同时建立荆花胃康胶丸的GC特征图谱并进行相似度分析。结果:特征图谱及含量测定的方法学验证均良好,20批荆花胃康胶丸的GC特征图谱相似度均>0.90,选取了10个色谱峰作为特征图谱共有峰;对伞花烃进样量在0.0494~2.4700μg范围内线性良好、平均回收率为97.8%;对伞花烃的含量范围4.3~5.6 mg·粒-1。结论:基于统一色谱分析条件的特征图谱定性与定量分析操作方便、准确可靠,可为荆花胃康胶丸的质量标准建立及质量评价提供依据。Objective:To establish a method for the determination of p-cymene and characteristic chromatogram of Jinghua Weikang gelatin capsules by gas chromatography.Methods:Agilent DB-17 capillary column(30 m×0.32 mm,0.25μm,the stationary phase was filled with 50%phenyl-methyl polysiloxane)was adopted.The temperature program was as follows:initial temperature:60℃,increased to 80℃at a rate of 1.5℃·min^(-1),and increased to 200℃at a rate of 60℃·min^(-1).The temperature of FID detector and the inlet was both set at 250℃.The content of p-cymene in Jinghua Weikang gelatin capsule was determined by GC,and the GC char⁃acteristic chromatogram of Jinghua Weikang gelatin capsule was established.Results:The methodology of the assay and characteristic chromatogram were verified well.The GC fingerprints of 20 batches of Jinghua Weikang gelatin capsules were all more than 0.90 in similarity and ten common peaks were identified.p-cymene showed good linear relationship in the range of 0.0494-2.4700μg.The average recovery rate was 97.8%.The contents of the above component ranged from 4.3 mg to 5.6 mg per capsule.Conclusion:The method is convenient,accu⁃rate and reliable,and can be used to establish the quality standard and evaluate the quality of Jinghua Weikang gelatin capsules.

关 键 词：荆花胃康胶丸 对伞花烃 进气相色谱法 特征图谱 含量测定 

分 类 号：R917[医药卫生—药物分析学]