肾炎宁片稳定性考察

Stability study on shenyanning tablets

目的考察肾炎宁片的稳定性。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,以片剂重点考察项目性状、鉴别、崩解时限、微生物限度检查、含量测定为评价指标,进行影响因素试验、加速试验和长期试验。结果该制剂在影响因素试验中各项指标未出现明显变化;在长期试验和加速试验中,除大黄总蒽醌含量略有升高,其他各项指标均未出现明显变化。结论肾炎宁片在一年有效期内质量稳定,符合质量标准要求。

Objective To investgate the stability of shenyanning tablets. Methods According to the stability testing of pharmaceutical preparations and guiding principles in the appendix of Chinese Pharmacopeia（2010 edition, Vol. II）, with the major investigation items of character,identification, disintergration time, microbial limit test, content determination as the evaluation indexes, the influencing factors test, accelerated test and long - term test were performed. Results The indexs in＂ the sample showed no significant changes in the influ- encing factors test ; except a little increase of anthraquinones content, and the other indexs in the sample showed no significant changes in the accelerated test and long-term test. Conclusion The drug properties of shenyanning tablets are stable in a year and in line with the quality standard requirements.