滋阴清热降糖丸质量标准研究  

Study on the quality standard of Ziyin Qingre Jiangtang pills

作　　者：顾崇梅 李瑶 何元 GU Chongmei;LI Yao;HE Yuan(Jiuquan Municipal Center for Drug Inspection and Testing in Gansu Province,Jiuquan Gansu 735000,China)

机构地区：[1]甘肃省酒泉市药品检验检测中心,甘肃酒泉735000

出　　处：《中兽医医药杂志》2022年第4期17-22,共6页Journal of Traditional Chinese Veterinary Medicine

基　　金：甘肃省药品监督管理局科研项目(2020GSMPA022)。

摘　　要：通过对滋阴清热降糖丸的薄层色谱鉴别和含量测定研究,建立切实可行的定性、定量质量控制方法。参照《中国药典》2020年版一部、四部通则相关要求,建立滋阴清热降糖丸中黄连、盐酸小檗碱、知母、芒果苷、大黄、大黄酸、麦冬的薄层色谱鉴别(TLC)方法;采用高效液相色谱(HPLC)法建立处方中君药成分异补骨脂素、补骨脂素、异欧前胡素、欧前胡素、甲基麦冬二氢高异黄酮A和甲基麦冬二氢高异黄酮B的含量测定方法。定性方法(TLC法)色谱图斑点清晰,分离度好,阴性样品无干扰;定量方法(HPLC法)方法学验证试验表明,补骨脂素在1.670 4~53.452 8μg/mL(r=0.999 6)、异补骨脂素在2.550 0~81.600 0μg/mL(r=0.999 7)、欧前胡素在5.072 0~165.504 0μg/mL(r=0.999 6)、异欧前胡素在6.990 0~223.680 0μg/mL(r=0.999 8)、甲基麦冬二氢高异黄酮A在2.428 0~77.696 0μg/mL(r=0.999 9)、甲基麦冬二氢高异黄酮B在2.001 2~64.038 4μg/mL(r=0.999 6)浓度范围内与峰面积呈良好的线性关系,平均加样回收率为97.90%~100.25%,RSD≤2.11%。本研究建立的定性、定量方法专属性强,重复性、稳定性良好,操作简便,可作为滋阴清热降糖丸的质量标准提升依据。Through the TLC identification and content determination of Ziyin Qingre Jiangtang pills,a feasible qualitative and quantitative quality control method was established.Referring to the relevant requirements of the first and fourth general chapters of the 2020 edition of Chinese Pharmacopoeia,the TLC method for Rhizoma Coptidis,berberine hydrochloride,Rhizoma Anemarrhenae,mangiferin,Rhubarb,rhein and Radix Ophiopogonis in the prescription was established;HPLC was used to establish the content determination method for the monarch medicine ingredients in the prescriptions:isopsoralen,psoralen,isoimperatorin,imperatorin,methylophiopogonanone A and methylophiopogonanone B.TLC method present clear chromatogram spots,good separating degree and negative samples without interference.HPLC method ological validation experiment showed that there was a good linear relationship between the concentration with the peak area for psoralen,isopsoralen,imperatorin,isoimperatorin,methylophiopogonanone A and methylophiopogonanone B in the range of 1.670 4-53.452 8 μg·mL(r=0.999 6),2.550 0-81.600 0 μg·mL(r=0.999 7),5.072 0-165.504 0 μg·mL(r=0.999 6),6.990 0-223.680 0 μg·mL(r=0.999 8),2.428 0-77.696 0 μg·mL(r=0.999 9) and 2.001 2-64.038 4 μg·mL(r=0.999 6),respectively.The average recoveries were 97.90%-100.25%,and the RSD values ≤2.11%.The method is specific,repeatable,stable and easy to operate.It can be used to improve the quality standard of Ziyin Qingre Jiangtang pills.

关 键 词：滋阴清热降糖丸 质量标准 TLC法 HPLC法 

分 类 号：S853.7[农业科学—临床兽医学]