Study on rapid evaluation system of generic drug quality by Raman spectroscopy
Objective To establish a rapid evaluation method of drug that passed the consistency evaluation of generic drugs,which can be used to quickly evaluate the quality of the generic drugs in the market.Method Based on Raman spectroscopy,according to the quality control needs,the reference preparations,the submitted batch,and the batches of the same batch of the drug were used as reference standards respectively,and the similarity index,the confidence interval,and the uncertainty were used as evaluation indicators.The inspection process is divided into two parts:building a database and fast inspection.The building of the database:The Raman spectra of the reference preparations and the submitted batch are stored as standard spectra in the cloud database or built by taking a certain batch of a commercial imitation drug.The fast inspection:The Raman spectra of 10 drug preparations are collected and uploaded separately,and compared with the standard Raman spectra of the"four same"(same manufacturer,same variety,same specifications,and same batch number)samples in the Raman spectral database.When the standard Raman spectra of the database cannot be obtained,the comparison is made between the same batch of the commercial imitation drug and the same batch of the drug.Based on the China Raman Spectrum Cloud Computing Center's"Drug Traceability"module,the"Imitation Drug Evaluation"module is optimized and upgraded,combined with the imitation drug evaluation dedicated handheld Raman spectrometer,forming the"Imitation Drug Quality Raman Spectrum Rapid Evaluation System(CEVAR system)".This project was applied in the 2020 annual drug quality risk monitoring project in Shandong Province,a total of 18 enterprises from the province,45 varieties(73 specifications),and 225 batches of commercial batch samples were collected;3 enterprises,3 varieties,and 5 batches of reference preparations were collected.Three enterprises,four varieties,and twelve batches of application batch samples were collected.The reference reagent and the in-market batch-use Raman spectrometry imaging system were used for validation.Result A general threshold of similarity of 99％was used as the criterion;the majority of the varieties collected had a self-similarity of greater than 99％,but five varieties had an average similarity value greater than 99％,but 3-5 pieces per batch had a similarity value with the standard less than 99％.This strongly confirms the accuracy of the CEVAR system.The validation results of the Raman spectrometry imaging system for Rosuvastatin calcium tablets were consistent with those of the CEVAR system.Conclusion According to data of mass sample testing,the similarity of 99％can be used as the threshold value for the determination of quality,and this method is suitable for the general screening of process quality of pharmaceutical preparations
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