生化丸质量标准的提高和优化  

Improvement and Optimization of the Quality Standard for Shenghua Pills

作　　者：朱艳华 曹蓉蓉 张卫莲 

机构地区：[1]榆林市药品检验所,陕西榆林719000

出　　处：《中国药师》2017年第11期2082-2084,共3页China Pharmacist

摘　　要：目的:优化生化丸的提取工艺并建立薄层鉴别和高效液相测定有效成分的最佳方法,为定量和定性分析生化丸的质量提供有效手段和可靠依据。方法:采用TLC法对生化丸中主要药材当归、川芎、甘草进行鉴别;采用HPLC法测定生化丸中阿魏酸的含量,色谱柱:Agilent 5 TC-C_(18)(2)(250 mm×4.6 mm,5μm);流动相:甲醇-5.0%冰醋酸溶液(25∶75);检测波长:322 nm;流速:1.0 ml·min^(-1);柱温:室温。结果:TLC图谱中可检出当归、川芎、甘草的特征图谱,阿魏酸质量浓度在1.28~20.51μg·ml^(-1)内线性关系良好,r=0.999 9;平均回收率为98.47%,RSD=0.36%(n=6)。结论:采用此种方法,能高效提取生化丸中有效成分,方法可行、准确、重复性好,可用于生化丸的质量控制。Objective： To optimize the extraction process of Shenghua pills and establish the best method for the TLC identification and the HPLC determination of effective components to provide an effective method and reliable basis for the quantitative and qualitative analysis of Shenghua pills. Methods ： TLC was used for the identification of angelica, Rhizoma Chuanxiong and Licorice. Ferulic acid was determined by HPLC, and the separation was performed on an Agilent 5 TC- C18（2）（250mm×4.6mm,5μm）column using a mixture of methanol-5% acetic acid solution （25：75） as the mobile phase with the detection wavelength at 322nm. The flow rate was 1.0 ml· min-1 and the column temperature was room temperature, Results ： Angelica sinensis （ Oliv. ） Diels. , Ligusticum chuanxiong Hort. and Glycyrrhiza uralensis Fisch. could be detected by TLC. Ferulic acid was linear within the range of 1.28-20.51μg·ml-1 （r = 0. 999 9）. The average recovery was 98.47% with the RSD of 0.36% （n = 6）. Conclusion： The method can be used to efficiently extract the active components in Shenghua pills. The method is feasible, accurate and reproducible. It can be used for the quality control of Shenghua pills.

关 键 词：生化丸 薄层色谱法 高效液相色谱法 阿魏酸 

分 类 号：TQ460.72[医药卫生—药物分析学]