健脾通便合剂质量标准的研究  

Quality Control of Jianpi Tongbian Mixture

作　　者：亓淑芬 夏红旻[2] 张乐青 QI Shu-fen;XIA Hong-min;ZHANG Le-qing(People’s Hospital of Yanggu,Yanggu 25300,China;Shandong Academy of Chinese Medicine,Jinan 250014,China)

机构地区：[1]阳谷县人民医院,山东阳谷252300 [2]山东省中医药研究院,山东济南250014

出　　处：《食品与药品》2021年第6期539-542,共4页Food and Drug

摘　　要：目的建立健脾通便合剂的质量标准。方法薄层色谱法(TLC)定性鉴别木香和陈皮药材;药典方法测定p H值及相对密度;高效液相色谱法(HPLC)测定橙皮苷含量,色谱柱为ZORBAX SB-C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-醋酸-水(35:4:61),流速1.0 ml/min,进样量5μl,柱温30℃,检测波长为283 nm。结果两种药材TLC鉴别专属性强,阴性对照无干扰;pH平均值为5.16;相对密度平均值为1.045;橙皮苷在20~100μg/ml范围内线性关系良好,r=0.9996,平均回收率98.98%,RSD为0.43%。结论该方法简便、稳定、准确,可用于健脾通便合剂的质量控制。Objective To establish the quality standard of Jianpi Tongbian Mixture. Methods TLC was used to identify Aucklandiae radix and Citri reticulatae pericarpium;pH value and relative density were measured according to methods listed in Chinese Pharmacopeia. The content of hesperidin was determined by HPLC. The analysis was performed on ZORBAX SB-C_(18)(250 mm×4.6 mm, 5 μm) with methanol-acetic acid-water(35:4:61) as the mobile phase. The detection wavelength was 283 nm. The column temperature was 30 ℃. Results TLC identification of the two medicinal materials had strong specificity, and the negative control had no interference. The average pH value and relative density were 5.16 and 1.045, respectively. The linear range of hesperidin was 20-100 μg(r=0.9996) and the average recovery of hesperidin was 98.98 %, with RSD of 0.43 %. Conclusion The method is simple, stable and highly accurate, and can be used for the quality control of Jianpi Tongbian Mixture.

关 键 词：健脾通便合剂 高效液相色谱 薄层色谱 质量标准 

分 类 号：R917[医药卫生—药物分析学]