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作 者:石伟[1,2] 倪付勇[2,3] 李云[1,2] 张晖[2,3] 孙仙玲[1,2] 黄道省[2,3] 李家春[2,3] 王振中[2,3] 萧伟[2,3]
机构地区:[1]南京中医药大学药学院,南京210000 [2]中药制药过程新技术国家重点实验室,连云港222001 [3]江苏康缘药业股份有限公司,连云港222001
出 处:《世界科学技术-中医药现代化》2016年第3期537-542,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基 金:国家科技部"重大新药创制"科技重大专项(2013ZX09402203):现代中药创新集群与数字制药技术平台;负责人:王振中
摘 要:目的:本研究以没食子酸、5-羟甲基糠醛、莫诺苷、马钱苷、芍药苷5个成分的含量为溶出指标,建立多成分指标评价六味地黄浓缩丸溶出度的方法。方法:测定条件为浆法,以900 m L 0.1 mol·L-1盐酸作为溶出介质,转速100 r·min-1,温度(37.0±0.5)℃。采用RP-HPLC外标法定量,Agilent TC-C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.02%三氟乙酸溶液为流动相,梯度洗脱;流速为1.0 m L·min-1;柱温为30℃;检测波长:238 nm。结果:该厂家10个批次的六味地黄浓缩丸中5个成分的溶出曲线相似因子?2大部分高于50,表明该厂家不同批次间六味地黄浓缩丸的溶出度差异性较小。结论:该方法简便,重复性良好,适用于六味地黄浓缩丸中5个成分的溶出度测定。This study aimed to establish a dissolution determination method for multi-index components in Liuwei Dihuang concentrated pills with the content of gallic acid, 5-hydroxymethyl furfural, morroniside, loganin and paeoniflorin as indexes. The paddle method was adopted with 900 m L of 0.1 mol·L^-1 hydrochloric acid as the dissolution medium at a rotation rate of 100 r·min^-1 and the temperature of 37.0±0.5℃. Adopting RP-HPLC method(an external standard method) was applied for quantitative, while Agilent TC-C18(250 mm × 4.6 mm, 5 μm) column was with acetonitrile-0.02% TFA as mobile phase gradient elution volume flow of 1.0 m L·min^-1, column temperature at 30℃, and detection wavelength at 238 nm. It was found that similarity factors f2 of the dissolution curve of the five main components of different batches of Liuwei Dihuang concentrated pills were mostly higher than 50, which referred to the dissolution of a smaller difference between these samples. It was demonstrated that this method was simple, reproducible, applicable for measuring the five components dissolution of Liuwei Dihuang concentrated pills.
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