苦玉消渴胶囊质量标准提高

Development of quality control standard for Kuyu Xiaoke capsules

目的建立苦玉消渴胶囊的质量标准,以控制药品质量。方法采用高效液相色谱法同时测定葛根素、马钱苷含量,以及测定盐酸二甲双胍含量。结果标准曲线:马钱苷为Y=17.62X-65.59,r=0.9995,葛根素为Y=59.15X-11.90,r=0.9995,盐酸二甲双胍为Y=5.029×104X-50.55,r=0.9996。线性范围分别为10~80μg·mL^(-1)、3~9μg·mL^(-1)、10~60μg·mL^(-1)。回收率均大于91.9%。结论建立的测定方法快速灵敏,结果均符合方法学要求,可作为苦玉消渴胶囊的质量标准。

Objective To develop the quality control standards for Kuyu Xiaoke capsules. Methods Puerarin, loganin and metformin hydrochloride were determinated by HPLC. Results The method had a good linearity for loganin： Y= 17.62X - 65.59 （10 - 80 μg · mL - 1）, r = 0.9995; puerarin： Y= 59.15X - 11.90 （3 - 9 μg·mL-1）, r = 0.9995; metformin hydrochloride： Y= 5.029× 10^4X- 50.55 （10 - 60 μg·mL- 1）, r =- 0.9996. The recovery was greater than 91.9%. Conclusion This method is rapid, simple, and accurate, which can be used for the quality control of Kuyu Xiaoke capsules.