宣肺止嗽合剂中4种生物碱的含量测定方法研究  

Determination of Four Alkaloids in Xuanfei Zhisuo Mixture

作　　者：李岩 李成明[2] 张明童 李冬华 马潇 LI Yan;LI Chengming;ZHANG Mingtong;LI Donghua;MA Xiao(Audit and inspection center of Gansu Drug Administration,Lanzhou 730050,China;Department of Pharmacy,Gansu Hospital of Traditional Chinese Medicine,Lanzhou 730050,China;Gansu Provincial Institute of Drug Inspection(Gansu Provincial Chinese and Zang Medicine Inspection and Testing Technology Engineering Laboratory,National Medical Products Administration Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces),Lanzhou 730070,China)

机构地区：[1]甘肃省药品监督管理局审核查验中心,甘肃兰州730030 [2]甘肃省中医院药学部,甘肃兰州730050 [3]甘肃省药品检验研究院(甘肃省中藏药检验检测技术工程实验室,国家药品监督管理局中药材及饮片质量控制重点实验室),甘肃兰州730070

出　　处：《中国民族民间医药》2023年第1期43-47,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：甘肃省药品科研项目(No.2019GSMPA018);甘肃省药品产业技术扶持项目(No.2019KF011);中药材及饮片质量控制重点实验室项目2022GSMPA-KL12,2022GSMPA-KL10;甘肃省药品科研项目2022GSMPA0017;兰州市科技计划项目资助(2022-3-41)。

摘　　要：目的:建立同时测定宣肺止嗽合剂中4种生物碱含量的高效液相色谱分析方法。方法:色谱柱为安捷伦SB-C 18(250 mm×4.6 mm,5μm);流动相:乙睛-0.1%磷酸溶液(3∶97);检测波长:210 nm;流速:1.0 mL·min^(-1);柱温:30℃;进样量:10μL。结果:吗啡、磷酸可待因、蒂巴因、盐酸罂粟碱4种生物碱成分在各自的质量浓度范围内线性关系良好,相关系数r 2≥0.9960,平均回收率分别为97.8%、96.9%、97.4%、97.5%,对应的RSD分别为1.2%、1.2%、1.6%、1.4%(n=9)。10批宣肺止嗽合剂样品中吗啡的含量为0.078~0.160 mg·mL^(-1)、磷酸可待因的含量为0.008~0.025 mg·mL^(-1)、蒂巴因的含量为0.0002~0.0013 mg·mL^(-1)、盐酸罂粟碱的含量为0.010~0.025 mg·mL^(-1)。结论:该方法操作简便,结果准确,可用于宣肺止嗽合剂的质量控制,为其质量标准的提升提供参考依据。Objective To establish a HPLC method for simultaneous determination of four alkaloids in Xuanfei Zhisuo mixture.Methods Chromatographic column:Agilent SB-C 18(250 mm×4.6 mm,5μm);mobile phase:ethylene-0.1%phosphoric acid solution(3∶97),detection wavelength:210 nm;Flow rate:1.0 mL·min^(-1);column temperature:30℃;injection volume:10μL.Results The linearity of morphine,codeine phosphate,tibaine and papaverine hydrochloride in the range of their respective mass concentrations was good with correlation coefficient r≥0.9960.The average recoveries were 97.8%,96.9%,97.4%and 97.5%,respectively.The corresponding RSD were 1.2%,1.2%,1.6%,1.4%(n=9).The contents of morphine,codeine phosphate,dibaine and papaverine hydrochloride in 10 batches of Xuanfei Zhishou mixture were 0.078-0.160 mg·mL^(-1),0.008-0.025 mg·mL^(-1),0.0002-0.0013 mg·mL^(-1)and 0.010-0.025 mg·mL^(-1).Conclusion The method is simple and accurate,which can be used for the quality control of Xuanfei Zhisuo mixture and provide reference for the improvement of its quality standard.

关 键 词：宣肺止嗽合剂 吗啡 磷酸可待因 蒂巴因 盐酸罂粟碱 含量测定 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]