替柯planin制剂中6种主要成分组成比的变化。

Kana Matsumoto, K. Ueno, M. Takada, M. Shibakawa
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引用次数: 1

摘要

目的:Teicoplanin是一种抗生素复合物,由五种相近极性的密切相关成分A2-1、2、3、4和5以及极性更高的因子a3组成。测定了六种主要成分组成比的变化,评价了替柯planin制剂的有效性。方法:采用高效液相色谱法测定14批替柯planin中各组分的浓度。结果:a2组和a3组的体质比变化无显著差异。然而,在A 2-1成分中发现了显著差异。结论:替柯planin制剂中组成比的变化可能影响替柯planin的药代动力学。因此,在制造过程中需要更加小心。
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Variation of Constitution Ratio of Six Major Components in Teicoplanin Preparations.
Objectives: Teicoplanin is an antibiotic complex consisting of five closely related components of similar polarity designated A2-1, 2, 3, 4 and 5 and a more polar factor A 3. The variations in the constitution ratio of the six major components were measured to evaluate the validation of teicoplanin preparations.Methods: The concentrations of each component of teicoplanin were measured in 14 lots by high performance liquid chromatography.Results: No significant differences were observed regarding the variation in the constitution ratio between the A 2 and A 3 groups. However, significant differences were found in the A 2-1 component.Conclusions: Variations of the constitution ratio in Teicoplanin preparations may possibly affect the pharmacokinetics of teicoplanin. More care is thus called for during the manufacturing process.
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