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目前临床上应用的莨菪碱类药物绝大部分是人工合成品——消旋山莨菪碱(654-2),其分子结构为四个光学异构体即二对差向异构体(6R,2’R和6S,2’S;6S,2’R和6R,2’S),其药理作用和临床疗效与天然品相同;但消旋山莨菪碱极易混入边链脱水的副产物——阿托酸6β-羟基-3α-托品酯。作者采用高效液相色谱法对消旋山莨菪碱(Ⅰ)及副产物(Ⅱ)的纯品进行研究,选择最佳分离条件,考察多批消旋山莨菪碱的质量,并用此法进行定量分析研究。
At present, most of the clinically applied osmidine drugs are synthetic products, racemic aniline (654-2), whose molecular structure is four optical isomers, ie, two pairs of epimers (6R, 2’R and 6S, 2’S; 6S, 2’R and 6R, 2’S), its pharmacological effects and clinical efficacy are the same as those of natural products; but racemic aniline is very easy to incorporate into the side chain dehydration byproducts - atropine 6β-Hydroxy-3α-tropine ester. The authors used high performance liquid chromatography to study pure products of racemic anisodamine (I) and by-products (II), selected the best separation conditions, and investigated the quality of multi-strands of racemic anisodamine, and used this method for quantification. Analysis.