双黄连口服液稳定性考察

Stability Observation of Shuanghuanglian Oral Liquid

目的:考察双黄连口服液2005版药典新增连翘苷含量、绿原酸含量控制标准后,二年有效期内双黄连口服液质量稳定性。方法:采用大生产三批样品长期留样观察。结果:二年实际有效期内各项指标符合中国药典2005版质量标准要求。结论:双黄连口服液有效期二年其质量是有保证的。

Objective:To observe the quality stability of Shuanghuanglian Oral Liquid in its 2 years validity time, since the 2005 Pharmacopoeia now adds the content control level of phillyrin and chlorogenic acid.Methods:adopt obser- vation of long time remained samples of three batch number.Results:Each index is accorded with the quality level re- quest in Chinese Pharmacopoeia 2005 in the 2 years validity time.Conclusion:The quality of Shuanghuanglian Oral Liquid is guaranteed in its validity time.