消麻散质量标准研究  

Quality Standard of Xiaoma Powder

作　　者：罗群 杨忠明 唐定洪 黄锐 李能源 任桂林 赵剑 蒲清荣 LUO Qun;YANG Zhongming;TANG Dinghong;HUANG Rui;LI Nengyuan;REN Guilin;ZHAO Jian;PU Qingrong(The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Auzhou,Sichuan,,Jhina 646000)

机构地区：[1]西南医科大学附属中医医院,四川泸州646000

出　　处：《中国药业》2022年第24期58-62,共5页China Pharmaceuticals

基　　金：四川省中医药管理局中医药科学技术研究专项课题[2021MS020]。

摘　　要：目的 建立消麻散的质量标准。方法 采用薄层色谱(TLC)法对制剂中的4种药材进行定性鉴别;对制剂中的3种药材进行显微鉴别;采用高效液相色谱(HPLC)法测定制剂中异欧前胡素含量,色谱柱为Shim-pack VP-ODS柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸(58∶42,V/V),流速为1.0 mL/min,检测波长为320 nm,柱温为40℃,进样量为10μL。结果 黄芪、羌活、秦艽、冰片的TLC图斑点清晰,分离度好,阴性对照无干扰。制剂粉末显微镜下显示,桂枝、红花、土鳖虫药材特征结构明显且唯一。异欧前胡素质量浓度在6.10-390.43μg/mL(R^(2)=0.999 3,n=7)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于0.5%;平均加样回收率为101.13%,RSD为1.08%(n=9)。结论 所建方法简单可行,专属性强,稳定性及重现性好,适用于消麻散的质量控制。Objective To establish the quality standard of Xiaoma Powder.Methods The four kinds of medicinal materials in the preparation were identified by the thin-layer chromatography(TLC) method. The three kinds of medicinal materials in the preparation were identified by the microscopic identification. The content of isoimperatorin in the preparation was determined by the high-performance liquid chromatography(HPLC),the chromatographic column was Shim-pack VP-ODS column(250 mm ×4. 6 mm,5 μm),the mobile phase was acetonitrile-0. 1% phosphoric acid(58∶42,V/V),the flow rate was 1. 0 mL/min,the detection wavelength was 320 nm,the column temperature was 40 ℃,and the injection volume was 10 μL.Results The TLC spots of Astragali Radix,Notopterygii Rhizoma et Radix,Gentiana Macrophyllae Radix,and Borneol were clear and well separated,and the negative control had no interference. The microscopic image of the preparation powder showed that the characteristic structures of Cinnamomi Ramulus,Carthami Flos,and Eupolyphaga Steleophaga were obvious and unique. The linear range of isoimperatorin was 6. 10-390. 43 μg/mL(R^(2)= 0. 999 3,n = 7). The RSDs of precision,stability and repeatability tests were all less than 0. 5%. The average recovery of isoimperatorin was 101. 13% with an RSD of 1. 08%(n = 9).Conclusion The established method is simple,feasible,specific,stable and reproducible,which is suitable for the quality control of Xiaoma Powder.

关 键 词：消麻散 质量标准 薄层色谱法 高效液相色谱法 显微鉴别 异欧前胡素 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]