胃复片的稳定性考察

目的考察胃复片的稳定性。方法按2010年版《中国药典》(二部)附录原料药与药物制剂稳定性试验指导原则,以胃复片重点考察项目性状、鉴别、崩解时限、微生物限度检查、含量为评价指标,进行影响因素试验、加速试验和长期试验。结果除影响因素试验中的090426批样品的含量略有下降外,其余指标均未见明显变化;3批样品(批号:090426,090427,090428)经过6个月的加速试验和24个月的长期试验,各项指标均符合质量标准规定。结论胃复片药物性质稳定,其有效期可确定为24个月。

Investigation on stability of Weifu Tablet

Objective To investigate the stability of Weifu Tablet. Methods According to the stability test of guiding principles of crade drugs and pharmaceutical preparations in the appendix of Chinese Pharmacopoeia （2005 edition, Vol Ⅱ ）, with the major investigation items of character, identification, disintegration time, microbial limit test and content as the evaluation index, the influencing factors test, accelerated testing and long-term test were performed. Results Except the contents of 090426 batch samples had a little decrease in influencing factors test, other index had no marked change. All index in three batches of samples （ batch number： 090426,090427,090428 ） after 6 - month accelerated testing and 24 - month long-term test met the quality standard requirements. Conclusion The character of Weifu Tablet were stable, and the expiration date can be defined to 24 months.