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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。
OBJECTIVE: To evaluate the quality status and existing problems of adenosine cobalamin tablets by the provincial basic drug evaluation test. Methods: 33 batches of samples from 5 manufacturers were tested statically and exploratoryly (dissolution test) according to the related methods under the two parts of the Chinese Pharmacopoeia (2010 edition) of adenine cobalamin to examine their quality status. Results: According to the statutory standards, the qualified rate of the products was 97.0%. Through the exploratory study of increasing the dissolution ratio, the results showed that the dissolution rate of 54.5% samples was lower than 70%. Conclusion: The quality of this variety basically meets the requirements of current statutory standards, but there is great difference among different manufacturers in terms of dissolution rate. This product prompts prescriptions and production processes need to be improved, the current test standards are yet to be revised.