健脾养胃膏质量标准研究  

A study on the quality standard of the Jianpi Yangwei ointment

作　　者：薛敏菲[1] 严慕贤[1] 吴舜芳[1] Xue Minfei

机构地区：[1]佛山市中医院

出　　处：《中医临床研究》2019年第19期13-16,共4页Clinical Journal Of Chinese Medicine

基　　金：佛山市卫生和计生局医学科研课题(项目编号:20170073)(佛山市医学科研基金资助)

摘　　要：目的:建立健脾养胃膏的质量控制体系。方法:采用薄层色谱法对健脾养胃膏中白术和黄芪2种成分进行定性鉴别;采用高效液相色谱法同时测定健脾养胃膏中芍药苷和党参炔苷2种成分的含量,色谱柱为XTerra?Rp18(4.6 mm×250 mm,5μm);流动相为乙腈-0.1%磷酸水溶液梯度洗脱;流速为1.0 mL/min;柱温为35℃。并观察其在拟定的3个月储存期内的变化,同时进行微生物限度检查。结果:薄层色谱中均斑点清晰,无阴性干扰,分离度好,专属性强。芍药苷和党参炔苷分别在0.254~3.175μg(r=0.999 7)、1.768~22.10μg(r=0.999 7)范围内线性关系良好,加样回收率分别为97.47%[相对标准偏差(Relative Standard Deviation,RSD)=2.56%)]、98.30%(RSD=1.77%)。健脾养胃膏于制备第90 d芍药苷和党参炔苷含量损失率分别为4.04%、4.15%。微生物限度检查结果均符合药品卫生学标准。结论:本方法简单易行、灵敏度高、重现性好、专属性强,可用于健脾养胃膏的质量控制。健脾养胃膏于2~8℃下保存90 d质量稳定。Objective:To establish the quality control system of the Jianpi Yangwei ointment(健脾养胃膏).Methods:TLC was used to identify two components of the Jianpi Yangwei ointment,including Baizhu(白术)and Huangqi(黄芪).HPLC was used to determine the content of paeoniflorin and lobetyolin.The determination was performed on XTerra?Rp18(4.6 mm×250 mm,5μm)with acetonitrile and 0.1%phosphoric acid as the mobile phase for the gradient elution,at the flow rate of 1.0 ml/min.The column temperature was 35℃.Their changes in 3 months were observed.At the same time,microbial limit test was carried out.Results:TLC showed clear spots,no negative interference,good separation and strong specificity.Paeoniflorin was linear in the range of 0.254 to 3.175μg(r=0.999 7),and the average recovery rate was 97.47%(RSD=2.56%).Lobetyolin was linear in the range of 1.768 to 22.10μg(r=0.999 7),and the average recovery rate was 98.30%(RSD=1.77%).On the ninetieth day,the loss rate of paeoniflorin was 4.04%,and the loss rate of lobetyolin was 4.15%.The results of microbial limit test met the sanitary standards of drugs.Conclusion:The method is simple,sensitive,reproducible and specific,and can be used for quality control of Jianpi Yangwei soft extract.The Jianpi Yangwei ointment was preserved for 90 days at 2~8℃and the quality was stable.

关 键 词：健脾养胃膏 薄层色谱法 高效液相色谱法 微生物限度检查 

分 类 号：R284.1[医药卫生—中药学]