抑乳调经颗粒含量测定方法的研究

Study on Quality Control of Yiru Tiaojing Granule

目的通过定量测定抑乳调经颗粒中多种指标成分,公式评分法综合评价制剂的质量,进一步完善其质量标准。方法采用高效液相色谱法(HPLC)对抑乳调经颗粒中君药成分水晶兰苷,臣药成分苔黑粉葡萄糖苷,佐药成分芍药苷,使药成分甘草苷,进行含量测定。结果 4种成分分别在2.156~53.9μg·mL^(-1)(r=0.9999),2.03~50.75μg·mL^(-1)(r=0.9998),3.26~81.5μg·mL^(-1)(r=0.9999),1.42~35.5μg·mL^(-1)(r=0.9999)范围内线性关系良好,加样回收率分别为100.32%,99.43%,101.61%,98.96%。结论该方法准确可靠,能全面控制该颗粒的内在质量,可作为该颗粒的含量测定标准。

Objective To evaluate the quality control of Yiru Tiaojing granule by assaying the multiple index components with formula scoring method.Methods The contents of monotropein,orcinol glucoside,peoniflorin and liquiritin,which were the main component of the monarch drug,minister drug,assistant drug and guide drug of Yiru Tiaojing granule respectively,were determined by HPLC.Results The calibration curves of monotropein,orcinol glucoside,peoniflorin and liquiritin were linear in the ranges of 2.156- 53.9 μg·mL^（-1）（r=0.9999）,2.03- 50.75 μg·mL^（-1）（r=0.9998）,3.26-81.5 μg·mL^（-1）（r=0.9999）,1.42-35.5 μg·mL^（-1）（r=0.9999）,respectively.Their average recoveries（n=9） were 100.32%,99.43%,101.61%,and 98.96%,respectively.Conclusion This method is accurate and reliable,can be used for the quality control of Yiru Tiaojing granule.