Reaserch Of Citicoline Sodium Prescription Technology

This paper is about the research and development of a Generic Drug(citicoline sodium tablets, Jinan Limin Pharmaceutical Co., Ltd.; license number: NMPN: H20080745; brand name: NUOBAIYI) and its quality consistency evaluation.After screening the prescription and quality control of the process parameters at small scale, then a trial test of Larger scale,three batches amplifier production and process validation, the key process parameters of main working procedures were got at the end. Through studying on indexes of citicoline sodium tablets and verification of the methodology,we concluded that the method we used could effectively control the product quality. Lot of tests about the self-made sample and original drug were carried out according to the requirements of pharmacopoeia and the guiding principles of chemical drug stability(Active Pharmaceutical Ingredient and drug preparation)(Draft).These tests included the influencing factors test,forced degradation test, accelerated test and long-term test. In addition, in the studying of the related substances of our product,the known single impurity(5’cytidine acid) and the unknown single impurity of our product could be reached less than 0.01%, which was better than the original drug(5’cytidine acid content:0.02%.) At the same time, the comparative research of our product with the original drug about impurities spectrometry analysis,quality,in vitro dissolution was carried out.Thus, we easily conclude that our product has reasonable prescription, stable process, controllable quality, good stability, similar impurities, better quality, good quality consistency evaluation comparison to the original drug.