摘要
目的:建立玉女煎颗粒剂的质量标准。方法:采用TLC对处方中熟地、知母、牛膝进行鉴别;用HPLC测定地黄中毛蕊花糖苷的含量。色谱柱为SunfireTMC18(250 mm×4.6 mm,5μm);流动相为乙腈-0.1%醋酸溶液(16∶84),柱温:30℃,流速:1.0 ml·min-1,检测波长334 nm,进样量:20μl。结果:在TLC色谱中检出熟地的特征成份毛蕊花糖苷、知母的特征成份菝葜皂苷元、牛膝特征成份杯苋甾酮,斑点清晰,分离度好;毛蕊花糖苷在0.163-0.612μg与峰面积呈良好的线性关系,r=0.999 9,平均回收率为101.3%,RSD为2.7%(n=6)。结论:该方法简便、可靠、准确,适用于该剂型的质量控制。
Objective： To establish the quality standard for Yunüjian granules. Methods： Rehmannia glutinosa,rhizoma anemarrhenae and achyranthes in the granules were identified by TLC. The HPLC method was adopted. A SunfireTMC18column（ 250 mm ×4. 6 mm,5 μm） was used with the mobile phase consisting of acetonitrile-0. 1% acetic acid solution（ 16∶ 84） at the column temperature of 30 ℃. The flow rate was 1. 0 ml·min- 1,the detection wavelength was 334 nm,and the imjection volume was 10 μl. Results：The TLC spots of verbascoside,and sarsasapogenin in rhizoma anemarrhenae and cyasterone in achyranthes were quite clear with good seperation. The linear range of verbascoside was within the range of 0. 163-0. 612 μg（ r = 0. 999 9）,and the average recovery was101. 3%（ RSD = 2. 7%,n = 6）. Conclusion： The method is simple,reliable and accurate,and can be applied in the quality control of Ynnüjian granules.
出处
《中国药师》
CAS
2014年第9期1460-1463,共4页
China Pharmacist
基金
中药配方颗粒生产自动化及在线质量监控技术改造项目(编号:粤中小企[2010]58号)
