补阴怡神颗粒质量标准研究

Research on Quality Standards of the Reinforcing Yin and Anchoring Mind Particle

目的:建立补阴怡神颗粒的质量标准。方法:采用TLC对制剂中的知母进行鉴别,采用ELSD-HPLC测定菝葜皂苷元的含量。结果:在TLC色谱中,知母与对照品相同位置显相同颜色斑点,阴性无干扰;菝葜皂苷元在1.072～5.360μg范围内线性良好,r=0.9994,平均回收率99.65%,RSD=2.66%。结论:所建立的鉴别方法专属性强,定量方法简便、准确,可用于补阴怡神颗粒的质量标准控制。

Objective ： Established quality standards of the reinforcing yin and anchoring mind particle. Methods： Identi- fied anemarrhena asphodefoides of preparation with TLC, determined the content of sarsasapogenin using ELSD - HPLC. Results：Anemarrhena sphodefoides had the same color dot the same position in the TLC. sarsasapogenin had good linear between 1. 072 - 5. 360μg, r = 0. 999 4, the average recovery was 99.65%, RSD% = 2.66. Conclusion： Identification method established was strong specificity, quantitative method was simple and accurate, it can control quality standards of the reinforcing yin and anchoring mind particle.