癌复康胶囊Ⅱ号质量标准研究

Study on Quality Standard of Aifukang Ⅱ Capsules

目的:建立癌复康胶囊Ⅱ号的质量标准。方法:采用薄层色谱(TLC)法对方中葛根、西洋参进行定性鉴别,采用高效液相色谱法对葛根素进行含量测定。结果:TLC斑点清晰、分离度好,阴性对照无干扰;葛根素检测浓度在50.0～750.0μg·mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9999),平均回收率为99.51%,RSD=0.81%(n=6)。结论:定性定量方法操作简便,结果准确、可靠,精密度好,所建标准可用于该制剂的质量控制。

OBJECTIVE：To establish the quality standard for AifukangⅡcapsules.METHODS：TLC was used for the qualitative identification of Pueraria lobata and Panax quinquefolium.HPLC was used to determine the content of puerarin.RESULTS：TLC spots were clear and well-separated without negative interference.The linear range of puerarin was 50.0～750.0 μg·mL-1（r=0.999 9） with an average recovery of 99.51%（RSD=0.81%,n=6）.CONCLUSION：The method is simple,accurate and reliable with good precision.It can be used for the quality control of AifukangⅡ capsules.