蒙成药苏格木勒-7味丸质量控制方法研究  

Quality control of Mongolia drug Suge Mule-7 Pills

作　　者：籍学伟 包顺茹 白妍 崔黎 韩峰 JI Xuewei;BAO Shunru;BAI Yan;CUI Li;HAN Feng(Inner Mongolia Institute for Drug Control,Inner Mongolia key laboratory for standard research of the Chinese and Mongolian medicine,Hohhot,Inner Mongolia 010020,China)

机构地区：[1]内蒙古自治区药品检验研究院内蒙古自治区中蒙药标准研究重点实验室,呼和浩特010000

出　　处：《中国药品标准》2023年第6期616-621,共6页Drug Standards of China

基　　金：内蒙古自治区科技计划项目(编号:2020GG0199);内蒙古自治区市场监督管理局服务产业高质量发展“蒙中药标准勘误项目”(项目编号:[2021]09197)。

摘　　要：目的:完善质量标准体系,建立蒙成药苏格木勒-7味丸质量控制方法。方法:增加了豆蔻、沉香、肉豆蔻的薄层鉴别方法;建立沉香中沉香四醇的HPLC含量测定方法,应用Waters XBridge C_(18)(250 mm×4.6 mm,5μm),以乙腈-水(15∶85)为流动相,流速1.0 mL·min^(-1),检测波长252 nm。结果:薄层斑点清晰,阴性对照无干扰;沉香四醇进样量在67.8~678.0 ng范围内与峰面积呈良好线性关系(r=0.999 8),平均回收率为94.01%,RSD为1.49%。测定样品9批,沉香四醇含量为0.032~1.07 mg·g^(-1)。结论:所建立的定性、定量分析方法简便、准确,能显著提升苏格木勒-7味丸质量控制水平。Objective:To perfect the quality standard system and establish the quality control method of Mongolian medicine Suge Mule-7 pills.Methods:Amomum kravanh,Aquilaria sinensis and Myristia fragrans were identified by TLC.Agarotetrol in Aquilaria sinensis was determined by HPLC.Waters XBridge C_(18)(250 mm×4.6 mm,5 μm) column was used with the mobile phase of acetonitrile-water(15∶85) at the flow rate of 1.0 mL·min~(-1),the detection wavelength was 252 nm.Results:The TLC spots developed was fairly clear and there were no interferences on the negatives controls.It was a good linear relationship(r=0.999 8) between the amount of agarotetro land the peak area in the range of 67.8-678.0 ng,the average recovery was 94.01% with the RSD was 1.49%.The content of agarotetrol in 9 batches of samples was 0.032-1.07 mg·g~(-1).Conclusion:This method is simple,sensitive and accurate,It can be used fordetermination and quality control for Suge Mule-7 pills.

关 键 词：苏格木勒-7味丸 豆蔻 沉香 肉豆蔻 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R921.2[医药卫生—药学]