宣木瓜药材-饮片-提取物-配方颗粒的质量相关性分析  

Quality Correlation Analysis Among Raw Herbs,Decoction Pieces,Extract and Dispensing Granules of Chaenomelis Fructus from Xuancheng City

作　　者：吴蓓丽[1] 谢晓梅[1] 况作品 韩煜[1] 陈培胜[2] 廖彩震 成守玲[2] 

机构地区：[1]安徽中医药大学药学院现代中药安徽省重点实验室,合肥230012 [2]安徽济人药业有限公司,安徽亳州236800

出　　处：《中国实验方剂学杂志》2016年第5期9-12,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"十二五"科技支撑计划项目(2011BAI04B06);安徽高校省级自然科学研究项目(KJ2012A188)

摘　　要：目的:建立宣木瓜配方颗粒"原料-中间产品-成品"的质量相关性评价方法,为中药配方颗粒生产全过程的质量控制提供参考。方法:采用RP-HPLC测定药材、饮片、提取物和配方颗粒中齐墩果酸和熊果酸含量,流动相甲醇-水-冰乙酸-三乙胺(265∶35∶0.1∶0.05),检测波长210 nm,流速0.6 m L·min^(-1),柱温25℃,分析其色谱图特征。结果:5批宣木瓜药材中齐墩果酸和熊果酸含量符合2015年版《中国药典》的要求,由其炮制的饮片、加工的提取物和配方颗粒制成品中齐墩果酸和熊果酸含量相对稳定;药材、饮片、提取物和配方颗粒的特征图谱均有6个共有峰,呈现良好的相关性。结论:建立的方法能表征宣木瓜药材-饮片-提取物-配方颗粒在活性成分群组成上的一致性,可用于宣木瓜配方颗粒生产全过程的质量控制。Objective： To establish a method for evaluating quality correlation of raw herbs-decoction pieces-extract-dispensing granules of Chaenomelis Fructus from Xuancheng city,and to provide a basis for quality control of dispensing granules in whole process of production. Method： RP-HPLC was employed to determine contents of oleanolic acid and ursolic acid in samples with mobile phase of methanol-water-acetic acid-triethylamine （265 ： 35 ： 0.1 ： 0.05）,detection wavelength at 210 nm and flow rate of 0.6 mL · min^-1,their characteristic spectrum were analyzed. Result： Contents of oleanolic acid and ursolic acid in five batches of raw herbs of Chaenomelis Fructus met standard of the 2015 edition of Chinese Pharmacopoeia,which in its decoction pieces,extract and dispensing granules were relatively stable.There was a good correlation among characteristic spectrum of raw herbs,decoction pieces,extract and dispensing granules,there were six common peaks in all characteristic spectrum of them. Conclusion： This method can be used to characterize consistency of active ingredients in raw herbs,decoction pieces,extract and dispensing granules,and to control quality of Xuanmugua dispensing granules in whole process of production.

关 键 词：宣木瓜 配方颗粒 齐墩果酸 熊果酸 特征图谱 质量相关性 

分 类 号：R283.1[医药卫生—中药学] R284.1[医药卫生—中医学]