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乙酰螺旋霉素为碱性的多组分抗生素,是以螺旋霉素为起始原料的半合成抗生素。乙酰螺旋霉素原料药中除了单-乙酰螺旋霉素Ⅱ和Ⅲ、双-乙酰螺旋霉素Ⅱ和Ⅲ四种主成分外,还能检出70多种小组分,这些小组分的结构与主成分相似或为主成分的同分异构体,故将乙酰螺旋霉素的各组分基线分离很具挑战性;在实际工作中还发现,采用不同品牌的C_(18)柱所得的乙酰螺旋霉素组分测定结果有时差异较大,有必要采用科学的方式理性挑选适宜的色谱柱进行其组分测定。本文利用国际上较有影响力的鲁汶大学所建的色谱柱分类系统数据库,以文献报道的CAPCELL PAK MG C_(18)柱(250 mm×4.6 mm,5μm)作为参比柱,选择了3组选择性不同的色谱柱,并按照中国药典2010版乙酰螺旋霉素各论项下的方法考察了这3组色谱柱的实际分离情况。与参比柱的结果相比,F<2组的分离效果最好,F>6组的分离效果最差,而26组色谱柱(F≥9.9)的绝对差异则超过2.5%,甚至高达8.2%,进一步验证了该色谱柱分类系统在适宜色谱柱选择方面的作用。
Acetylspiramycin is a basic multi-component antibiotic, which is spiramycin as a starting material of semi-synthetic antibiotics. Acetylspiramycin API in addition to mono-acetylspiramycin Ⅱ and Ⅲ, bis-acetyl-spiramycin Ⅱ and Ⅲ the four main components, but also detected more than 70 kinds of small components, the structure of these small components and the Lord It is very challenging to separate the components of acetylspiramycin from baseline. It has also been found in practical work that acetyl helixes obtained from C 18 columns of different brands The results of the determination of the composition of the sometimes quite different, it is necessary to adopt a scientific way to rationally select the appropriate column for its component determination. In this paper, we use the CAPLCELL PAK MG C_ (18) column (250 mm × 4.6 mm, 5 μm) reported in the literature as the reference column for the column system of the classification system built by the more influential Leuven in the world. Group of different selectivity of the column, and in accordance with the Chinese Pharmacopoeia 2010 version of acetylspiramycin various theses under the investigation of the actual separation of these three groups of columns. Compared with the reference column, F <2 group had the best separation efficiency, F> 6 group had the worst separation effect, while 2 6 columns (F ≥9.9) was over 2.5%, even as high as 8.2%, further confirming the role of this column classification system in the choice of suitable columns.