乳核内消软胶囊质量标准研究

目的:建立乳核内消软胶囊的质量标准。方法:采用薄层色谱法对乳核内消软胶囊中的赤芍、当归和夏枯草进行定性鉴别;采用高效液相色谱法对制剂中芍药苷进行含量测定。色谱柱:DiamonsilTMC18(250mm×4.6mm,5μm);流动相:乙腈-水(13∶87);检测波长:230nm;进样量:20μL。结果:薄层色谱中,供试品溶液在与对照药材或对照品相应位置上显相同颜色的斑点,阴性对照无干扰;高效液相色谱中,芍药苷检测浓度在5.1～40.8mg.mL-1范围内线性关系良好(r=0.9977),平均回收率为98.91%(RSD=0.34%,n=5)。结论:薄层色谱法斑点清晰、专属性强,可用于该制剂的鉴别;高效液相色谱法简便快速,精密度和准确度高,所建标准可用于该药的质量控制。

Study on Quality Standard for Ruheneixiao Soft Capsules

OBJECTIVE:To establish the quality standard for Ruheneixiao soft capsules.METHODS:Radix Paeoniae Rubra,Radix Angelicae Sinensis and Spica Prunellae were identified using TLC.The content of Paeoniflorin in Ruheneixiao Soft Capsules was determined with HPLC.HPLC analytical method was carried out using a C18 column and a mixture containing 13 volume of acetonitrile and 87 volume of water as the mobile phase.The detection wavelength was set at 230nm.RESULTS:Spots obtained from the test solutions had the same color in reference solution and medical material in the same location,and the blank solution had no interference.The linear range of Paeoniflorin was from 5.1 to 40.8mg· mL-1(r=0.997 7)and the average recovery was 98.91%(RSD=0.34%,n=5).CONCLUSIONS:The TLC method produced distinctive spots,and was highly specific for use in the determination of Ruheneixiao soft capsules.The HPLC method was simple and fast,with high accuracy and precision.The standard can be used for the quality control of the drug.