摘要
目的建立测定华蟾素胶囊释放度的方法。方法采用高效液相色谱法,测定华蟾素胶囊中华蟾酥毒基和酯蟾毒配基的溶出量,色谱柱为Ultimate AQ-C_(18),以乙腈-0.5%磷酸盐缓冲液(50∶50)(用磷酸调节pH值为3.2)为流动相,流速为0.5mL·min^(-1);检测波长为296nm;进样量10μL;柱温为40℃;考察不同的溶出介质、转速下华蟾素胶囊中华蟾酥毒基和酯蟾毒配基的溶出情况。结果建立了以磷酸盐缓冲液(pH值为6.8)100mL为溶出介质,转速为100r·min^(-1)的溶出方法。结论所建立的方法简便,准确,结果可靠,该方法可以用于该制剂的质量控制。
OBJECTIVE To establish a method to assay release of Cinobufacin capsules by HPLC. METHODS The dissolution of cinobufagin and recibufogenin in Cinobufacin capsules was determined by HPLC,The column was Ultimate AQ-C 18 ,the mobile phase was acetonitrile-0.5% potassium dihydrogen phosphate (50∶ 50,v/v)(use the phosphoric acid adjusted to pH=3.2) with a flow rate of 0.5mL·min -1 ,detection wavelength was 296nm,column temperature was 40℃,injection volume was 10μL.The dissolubilities of cinobufagin and recibufogenin in Cinobufacin capsules were discussed with different dissolution mediums and difierent rotation speeds. RESULTS The method of dissolution tests for Cinobufacin capsules were established with 100mL pH 6.8 phosphate buffer as dissolution media and the rotation speed was 100r·min -1 . CONCLUSION This method is simple and accurate,the results are reliable and it could be used for quality control of Cinobufacin capsules.
作者
孟建升
吕斌
蒋俊春
杨文文
MENG Jian-sheng;LV Bin;JIANG Jun-chun;YANG Wen-wen(Shangqiu Institute for Food and Drug Control,Shangqiu 476000,China;Henan Province Port Institute for Food Inspection and Testing,Zhengzhou 450003,China;Tiens Group Co.Ltd,Tianjin 301700,China)
出处
《海峡药学》
2019年第2期21-23,共3页
Strait Pharmaceutical Journal
