Detection method of generic drugs pretending original drugs

Abstract

The invention provides a detection method of generic drugs pretending original drugs. The detection method comprises the following five steps: 1, acquiring Raman spectrum data of a sample to be detected; 2, calculating an HQI value of the sample to be detected according to standard Raman spectrum data of the original drugs and the Raman spectrum data of the sample to be detected, and carrying out first judgment on the sample to be detected according to the HQI value; 3, selecting characteristic peaks of the sample to be detected and characteristic peaks of the original drugs; 4, calculating a ratio t of the quantity of the characteristic peaks of the sample to be detected to the quantity of the characteristic peaks of the original drugs, and carrying out second judgment on the sample to be detected according to the t; and 5, calculating a ratio s of the quantity of matched characteristic peaks to the quantity of the characteristic peaks of the original drugs, and carrying out third judgment on the sample to be detected according to the s. The detection method provided by the technical scheme is high in accuracy and strong in reasonability; and the false positive rate of the judgment is remarkably reduced and the requirements of on-site rapid detection can be met.

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] Generic drugs and brand-name drugs usually contain the same active ingredient (API), and some even use the same excipients. In order to make illegal profits, some unscrupulous businesses use cheap generic drugs to sell as original drugs, which seriously infringes on the intellectual property rights of developers. Moreover, due to the different sources of APIs and excipients, there will also be certain quality differences between original drugs and generic drugs. Consumers using such counterfeit drugs may also cause serious medication safety problems. [0003] Because the generic drug and the original drug contain the same API and excipients, and the specifications are the same, false positive results are often obtained when testing this type of counterfeit drug ...

AI Technical Summary

Problems solved by technology

However, due to the complex composition of the drug, the spectral peaks of API, excipients and impurities may overlap, and the spectral peaks in the spectrum of the drug to be tested that can match the characteristic peaks of the original drug may also be the spectral peaks produced by other components in the drug to be tested , so it will lead to false positives in the judgment result

Moreover, this method screens out matching characteristic peaks based on peak positions. When the characteristic peaks of the drug to be tested become wider or shoulder peaks appear due to the influence of other substances, it will affect the screening of matching characteristic peaks, resulting in inaccurate test results.

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