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盐酸多西环素(DC)是以土霉素(OTC)为原料的半合成四环素类广谱抗生素,合成过程中可能产生美他环节(MeC)、β-差向异构体(EDC)等有关物质,使毒性增大,效疗降低,因此,有必要进行有关物质检查。文献法样品溶液的斑点拖尾严重,DC、OTC、MeC、EDC的混合溶液只能显示出三个斑点;现介绍检测盐酸多西环素及有关物质的改进薄层色谱法。1 仪器与药品1.1 薄层层析缸,薄层板(20cm×10cm),紫外灯(365nm)。1.2 DC原料(河南开封抗生素制药厂);DC、OTC、MeC标准品及EDC对照品(中国药品生物制品检定所);硅胶H(青岛海洋化工厂);EDTA-2Na、氢氧化钠、二氯甲烷、甲醇均为分析纯。2 实验方法
Doxycycline Hydrochloride (DC) is a semi-synthetic tetracycline broad-spectrum antibiotic with oxytetracycline (OTC) as its raw material, which may produce MeC, β-epimer (EDC), etc. during the synthesis process. Related substances, increased toxicity, reduced efficacy, therefore, the need for the relevant material inspection. The sample solution of the literature sample had severe smearing, and the mixed solution of DC, OTC, MeC, and EDC showed only three spots. An improved TLC for the detection of doxycycline hyclate and related substances is now described. 1 instruments and medicines 1.1 thin layer chromatography cylinder, thin plate (20cm × 10cm), UV lamp (365nm). 1.2 DC raw materials (Henan Kaifeng antibiotic pharmaceutical factory); DC, OTC, MeC standards and EDC reference substance (China Pharmaceutical and Biological Products); silica gel H (Qingdao Ocean Chemical Factory); EDTA-2Na, sodium hydroxide, Methane, methanol are of analytical grade. 2 experimental methods