基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度  

Determination of Dissolution of Eight Active Ingredients in Guizhi Fuling Capsules by UPLC

作　　者：何艳梅[1] 林虓[1] 王雪[1] 李家春[1] 黄文哲[1] 萧伟[1] HE Yan-mei;LIN Xiao;WANG Xue;LI Jia-chun;HUANG Wen-zhe;XIAO Wei(State Key Laboratory of Pharmaceutical New-Tech for Chinese Medicine, Jiangsu Kanion Pharmaceutical Co. Ltd. , Lianyungang 222001, China)

机构地区：[1]江苏康缘药业股份有限公司中药制药过程新技术国家重点实验室

出　　处：《中国实验方剂学杂志》2018年第1期14-19,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家“重大新药创制”科技重大专项(2011ZX09101-403)

摘　　要：目的：建立桂枝茯苓胶囊溶出度的测定方法,为该制剂的质量评价提供参考。方法：采用UPLC,没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚、肉桂酸、桂皮醛的流动相为0.02%三氟乙酸水溶液-乙腈梯度洗脱,检测波长分别为230 nm（没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚）和275 nm（肉桂酸、桂皮醛）。苦杏仁苷的流动相为水-甲醇（80∶20）,检测波长218 nm。结果：确定溶出介质为0.1 mol·L^-1盐酸,转速50 r·min^-1,采用转篮法测定溶出度。没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚、肉桂酸、桂皮醛、苦杏仁苷的线性范围分别为0.097 6-24.389 9,0.097 1-24.275 4,0.052 6-5.262,0.053-5.295 6,0.108 3-27.062 9,0.050 1-5.005,0.052 4-5.236 4,0.096 6-24.139 5 mg·L^-1,平均加样回收率分别为102.3%,97.3%,99.3%,97.9%,97.8%,95.8%,97.0%,100.4%。样品溶出度均一性良好,45 min内各成分溶出度均能达到80%以上。结论：该方法操作简便、结果准确、重复性较好,可用于桂枝茯苓胶囊溶出度的测定,为中药复方制剂的质量标准评价提供了参考。Objective： To establish a method for the determination of dissolution of 8 active ingredients in Guizhi Fuling capsules. Method： UPLC was employed,mobile phase of gallic acid,paeoniflorin,benzoic acid,benzoylpaeoniflorin, paeonol, cinnamic acid and cinnamaldehyde was 0. 02% trifluoroacetic acid aqueous solution-acetonitrile for gradient elution,their detection wavelengthes were 230 nm and 275 nm. The mobile phase of amygdalin was water-methanol（ 80 ∶ 20） and its detection wavelength was 218 nm. Result： The soluble medium was determined to be 0. 1 mol·L^-1 hydrochloric acid, the rotation speed was 50 r·min^-1,the solubility measurement was carried out by the basket method. The linear ranges of gallic acid,paeoniflorin,benzoic acid,benzoylpaeoniflorin,paeonol,cinnamic acid, cinnamaldehyde, amygdalin were 0. 097 6-24. 389 9,0. 097 1-24. 275 4,0. 052 6-5. 262,0. 053-5. 295 6,0. 108 3-27. 062 9,0. 050 1-5. 005,0. 052 4-5. 236 4,0. 096 6-24. 139 5 mg·L^-1,their average recovery rates were 102. 3%,97. 3%,99. 3%,97. 9%,97. 8%,95. 8%,97. 0% and 100. 4%,respectively. The dissolution rate of samples was good,and the dissolution rate of each component in 45 min could reach 80%. Conclusion： This method is simple,accurate and reproducible,and it can be used for determination of dissolution of Guizhi Fuling capsules.

关 键 词：桂枝茯苓胶囊 溶出度 转篮法 没食子酸 肉桂酸 苯甲酸 芍药苷 

分 类 号：R283.6[医药卫生—中药学] R284[医药卫生—中医学]