Method for detecting generic drug pretended to be reference listed drug

Abstract

A method for detecting a generic drug pretended to be an reference listed drug comprises the following steps: step 1, obtaining reference listed drug standard spectral data and to-be-measured sample spectral data; step 2, choosing reference listed drug characteristic peaks and to-be-measured sample characteristic peaks; step three, screening matched characteristic peaks in the to-be-measured sample characteristic peaks conforming to matching conditions, and calculating the number of the matched characteristic peaks; and step four, comparing a difference value between the number of the reference listed drug characteristic peaks and the number of the matched characteristic peaks with a predetermined standard threshold t, when the difference value is less than or equal to t, judging a to-be-measured sample to be a real drug, and when the difference value is greater than t, judging the to-be-measured sample to be a fake drug, wherein t is an arbitrary integer value of 1-10. According to the method provided by the invention, the difference between the generic drug and the reference listed drug can be intuitively and comprehensively displayed, and a drug system with relatively low API content and with the other components in the drug and with relatively large interference on API characteristic peaks also can be effectively detected.

Description

technical field [0001] The invention relates to a detection method for a generic drug pretending to be an original research drug, and belongs to the technical field of medical analysis. Background technique [0002] The research and development of an original research drug usually requires a lot of manpower, material and financial resources, and once the original research drug is launched, it can usually occupy a large market share and obtain huge economic benefits. When the patent of the original drug expires, a large number of generic drugs will appear. Because the price of generic drugs is usually lower than that of the original drug, some unscrupulous businesses use generic drugs to sell as the original drug in order to seek high profits, which disrupts the pharmaceutical market and sometimes endangers the health of patients. Therefore, testing drugs and judging the authenticity of products marked as "original research drugs" is an important task for the drug regulatory...

AI Technical Summary

Problems solved by technology

The purpose of this method is to determine whether the drug to be tested contains the marked active ingredient. For the drug system with high API content and other components in the drug that have little interference with the API characteristic peak, the above counterfeit drug identification method has a better effect. However, for counterfeit drugs such as generic drugs posing as original drugs, since the API, specifications, dosage forms and excipients used in generic drugs and original drugs are the same, the above-mentioned counterfeit drug identification method based on API spectrum cannot be effectively detected and discrimination

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