腺苷钴胺片的质量评价

目的:通过省级基本药物评价性检验评价腺苷钴胺片的质量现状及存在问题。方法:按照2010年版《中国药典》二部腺苷钴胺片项下相关方法对5个生产厂家的33批样品进行法定检验和探索性研究(溶出度试验)以考察其质量状况。结果:依据法定标准检验产品合格率为97.0%;通过增加溶出度对比的探索性研究,结果54.5%的样品溶出度低于70%。结论:该品种的质量基本符合现行法定标准的要求,但在溶出度方面各厂家间差异较大。提示本品在处方及生产工艺方面需要提高,现行检验标准尚有待修订之处。

Quality Evaluation of Cobamamide Tablets

OBJECTIVE： To evaluate the quality and existing problems of Cobamamide tablets through provincial essential medicine evaluation. METHODS： According to related determination methods of Cobamamide tablets stated in the second part of Chinese Pharmacopeia （2010 edition）, the quality of 33 batches of samples from 5 manufacturers was investigated though prescribe examination mad the exploratory research. RESULTS： The results of prescribe examination showed that pass rate of samples was 97.0%. Through the exploratory research on dissolutions to test samples, the dissolution of 54.5% samples was lower than 70%. CONCLUSIONS： The quality of the tablet is up to the present requirements mostly, but there is great difference in dissolution of samples from different manufacturers. The formulation and production process needs to be improved. Current standard should be revised.