肠肽胶囊的质量标准  

Quality Standard for Changtai Capsules

作　　者：李晰[1] 张琰[1] 吴丹[1] 赵玫[1] 窦晓飞[1] 刘梅[1] 

机构地区：[1]第四军医大学唐都医院药剂科,西安710038

出　　处：《中国药师》2015年第10期1792-1795,共4页China Pharmacist

基　　金：军队医疗机构制剂标准提高专项课题(编号:13ZJZ12-6)

摘　　要：目的：本研究旨在建立肠肽胶囊的质量标准。方法：采用薄层色谱法鉴别薏苡仁、蒲公英、白芷、厚朴,采用HPLC法测定三七中有效成分三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1的含量。结果：薄层鉴别斑点清晰,阴性对照无干扰;三七中有效成分三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1分别在40-300μg·ml-1、320-2 400μg·ml-1、80-600μg·ml-1范围内线性关系良好;平均加样回收率分别为99.76%、99.33%、99.48%,RSD分别为0.42%、0.48%、0.63%（n=9）。结论：该方法可用于肠肽胶囊的质量控制。Objective： To establish the quality standard for Changtai capsules. Methods： The components including coicis semen, taraxaci herba, angelicae dahuricae radix and magnoliae officinalis cortex were identified by TLC. The content of notoginsenoside R1 , ginsenoside Rg1 and ginsenoside Rb1 in notoginseng radix et ehizoma was detected by HPLC. Results： The characteristic spots in TLC were clear without any interference. The linear range of notoginsenoside Rt, ginsenoside Rg1 and ginsenoside Rb1 was 40-300 μg · ml-1 , 320-2 400 μg· ml-1 and 80-600μg · ml-1, respectively. The average recovery was 99.76%, 99.33% and 99.48% with RSD of 0.42%, 0.48% and 0.63% （ n = 9）, respectively. Conclusion： The methods used for the identification and quantification are sensitive, simple and accurate, which can be used for the quality control of Changtai capsules.

关 键 词：肠肽胶囊 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]