冠心颗粒剂是由人参、三七等名贵中药材,经加工提取制成的新药,临床主要用于治疗心绞痛、冠心病等症,为了在生产中控制该药的质量,我们确定以总皂甙Rg1含量为质控指标.由于该药成分复杂,测定时干扰因素很多,经反复试验,我们采用了甲醇回流水饱和正丁醇萃取,薄层层析等提取分离手段,提取分离出人参皂甙Rg1,并用双波长薄层扫描法对其进行了含量测定.
Objective: A UV spectrophotometry for the determination of sulfadiazine sodium injection was established. Method: Sulfadiazine sodium was determined at wavelength 254 nm using 0.1 mol/L NaOH as solvent. Results: The linear range of sulfadiazine sodium was 2 to 10μg/ml (r=0.9999). The average recovery was 99.8% to 100.1%, with RSD less than 1.01%. Conclusion: The method is simple, rapid and accurate. It is suitable for the determination of sulfadiazine sodium injection.