平疣颗粒的质量标准提升研究  

Improvement of Quality Standard for Pingyou Granules

作　　者：苏华[1] 廖欣[1] 乔立业[1] 陆崟[1] 任海祥[1] 

机构地区：[1]南京军区南京总医院制剂科,南京210002

出　　处：《中国药师》2015年第8期1305-1308,共4页China Pharmacist

基　　金：全军医疗机构制剂标准提高科研专项课题重点项目(编号:14ZJZ08)

摘　　要：目的：研究建立平疣颗粒的质量控制标准。方法：采用薄层色谱法对方中赤芍、红花、薏苡仁、香附进行定性鉴别；采用高效液相色谱法测定赤芍中芍药苷的含量：色谱柱为Lichrospher-C18（250 mm x4.6 mm,5μm）,流动相为甲醇-0.2%醋酸（24∶76）,检测波长为232 nm。结果：薄层色谱鉴别斑点清晰、阴性对照无干扰；芍药苷在6.560-104.920μg·ml-1的范围内呈良好的线性关系（r=0.9999）,平均回收率为98.77%,RSD为2.73%（n=9）。结论：所建立的定性鉴别方法专属性强,重复性好,定量方法操作简便,准确可靠,可用于平疣颗粒的质量控制。To establish the quality standard for Pingyou granules. Methods： Paeoniae radix, Carthamus tinctorius, Coicis semen and Nutgrass galingale rhizome were qualitatively identified by TLC. The content of peoniflorin was determined by HPLC. The separation was performed on a Lichrospher-C18 （250 mmx 4. 6 mm, 5 μm） column with the mobile phase of methanol-acetic acid （24∶76）. The detection wavelength was 232nm. Results：Paeoniae radix, Carthamus tinctorius, Coicis semen and Nutgrass galingale rhizome could be identified by TLC without any interference from the negative control. The linear range of peoniflorin was 6. 560-104. 920 μg·ml-1（r=0. 999 9） with the average recovery of 98. 77%（RSD=2. 73%,n=9）. Conclusion：The qualitative identifi-cation is specific and reproducible, and the quantitative method is simple, accurate and reliable, which can be used in the quality con-trol of Pingyou granules.

关 键 词：平疣颗粒 质量标准 薄层色谱 赤芍 红花 高效液相色谱 芍药苷 

分 类 号：TQ460.72[医药卫生—药物分析学]