Discussion on the Quality Standard of Traditional Chinese Medicine Formula Granules Based on Sampling Inspection
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1.Jiangxi Institute For Drug Control/NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine/Jiangxi Provincial Engineering Research Center of Drug and Medical Device Quality， Nanchang， Jiangxi， 330029， China； 2.Jiangxi Medical Device Testing Center， Nanchang， Jiangxi， 330029， China
Objective： Based on the analysis of the sampling inspection of traditional Chinese medicine formula granules (TCMFGs) in Jiangxi Province from 2022 to 2023， the problems existing in the TCMFGs standard were found， providing the standard improvement and quality supervision of TCMFGs. Methods： The sampled TCMFGs were inspected according to the corresponding standards， and the quality evaluation was carried out in terms of characteristics， identification， fingerprint (characteristic) map， leachable， inspection and content determination. Results： A total of 548 batches of TCMFGs were sampled， involving 317 varieties， were in compliance with the regulations and elaborated on the problems with the quality standards of TCMFGs. Conclusion： By analyzing the inspection of TCMFGs in the past two years， it is found that the overall quality of TCMFGs in Jiangxi Province is quite good， but the inspection standards need to be improved， and it is suggested to continue to improve the quality standard and strengthen the quality supervision of TCMFGS.
