拉米夫定与齐多夫定联合溶出度试验方法的开发与验证，以适应EAEU药典的要求

Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology) Pub Date : 2023-04-05 DOI:10.33920/med-13-2302-01

A. Marakhova, A. M. Kuliková

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引用次数: 0

摘要

溶出度试验旨在测定在药典上规定的条件下，在一定时间内从固体剂型释放到溶出介质中的药用物质的量。开发用于将抗逆转录病毒药物拉米夫定和齐多夫定以剂型联合使用的方法至关重要，因为这将允许在评估药物等效性的同时，至少对药物的生物等效性进行近似评估

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Development and validation of the dissolution test method for a combination of lamivudine and zidovudine adapted to the requirements of the EAEU pharmacopoeia

The dissolution test is intended to determine the amount of a medicinal substance, which should be released into the dissolution medium from a solid dosage form over a certain period of time under the conditions specified in the pharmacopoeial article for the drug. Developing the method indicated for the combination of antiretroviral drugs lamivudine and zidovudine in a dosage form is crucial as this will allow, along with the assessment of pharmaceutical equivalence, at least an approximate assessment of the bioequivalence of the drug/

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Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)

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