Method for detecting dissolution curve of simvastatin tablet

A simvastatin and curve technology, applied in the field of determination of the dissolution curve of simvastatin tablets, can solve the problems of long test time, affecting the reproducibility of experimental data, slow dissolution of simvastatin tablets, etc., and achieves good discrimination. Effect
CN108414656AActive Publication Date: 2018-08-17四川省食品药品检验检测院
6 Cites 2 Cited by

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
四川省食品药品检验检测院
Publication Date
2018-08-17

Smart Images

  • Figure 1
    Figure 1
  • Figure 2
    Figure 2
  • Figure 3
    Figure 3
Patent Text Reader

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.
Need to check novelty before this filing date? Find Prior Art

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...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More