A method for measuring the dissolution profile of simvastatin tablets

Abstract

The invention relates to a method for detecting the dissolution curve of a simvastatin tablet. The method comprises the following steps: (1) preparing a dissolution medium: preparing the dissolution medium at a dissolution temperature of 40 DEG C or less by using Tween-80 as a medium; 2) taking a simvastatin reference substance, and preparing a reference substance solution; (3) preparing a samplesolution by using a dissolvability detection technology; (4) detecting the dissolution quantity by high performance liquid chromatography, wherein the sample introduction temperature of a sample chamber is 4-5 DEG C; (5) repeating step (3) and step (4) twice or more; and (6) evaluating: calculating a similarity factor f2 by using a similarity factor technology, and comparing the similarity betweenthe dissolution curve of a generic preparation and the dissolution curve of a reference preparation by using the similarity factor f2. The method is scientific, durable and reproducible, can be usedfor evaluating the quality consistency evaluation of a generic drug and an original drug, and also can provide a guarantee for the consistency of the inter-batch quality of the drug.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a method for measuring the dissolution curve of simvastatin tablets. Background technique [0002] Since 2012, the State Food and Drug Administration (CFDA) has launched the quality consistency evaluation of generic drugs. The generic drugs that have been approved for marketing will be carried out in stages and batches according to the principle of consistent quality and efficacy with the original drugs. Evaluation, so that generic drugs are consistent with original drugs in terms of quality and efficacy. Among them, formulating a scientific and reasonable solid preparation dissolution curve is an important step to improve the success rate of bioequivalence tests in vivo, and provides a basis for including the characteristic dissolution curve of the drug in the corresponding quality standards, and provides a basis for the consistency of drug quality between batches a...

AI Technical Summary

Problems solved by technology

[0003] In the prior art, the method for measuring the dissolution profile of simvastatin tablets is recorded in the United States Pharmacopoeia and the Japanese Orange Book; wherein the method recorded in the United States Pharmacopoeia is the dissolution profile method using SDS as the dissolution medium, and the dissolution rate of this method is too fast. There is no ability to distinguish the difference between the generic drug and the original research drug process. The dissolution curves of almost all generic drugs and reference preparations can be similar, and it is impossible to distinguish the quality of the generic drug companies; the Japanese Orange Book method uses 0.3% Tween-80 is the dissolution medium, and the dissolution of simvastatin tablets is too slow, the test time is too long, and there is over-discrimination of the reference preparation itself, and the quality of Tween and operation methods will affect the reproducibility of experimental data

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