摘要
目的:通过血塞通滴丸的长期试验,考察产品质量的稳定性,确定药品有效期。方法:以《中国药典》的相关规定为依据,以性状、三七总皂苷含量及溶散时限作为评价指标,采用长期试验方法,选择3批血塞通滴丸样品进行考察。结果:血塞通滴丸的性状、溶散时限均符合规定,而三七总皂苷含量下降较快,在24个月中,3批样品含量平均下降了15.93%;血塞通滴丸的制备工艺改进后的3批样品含量平均下降了9.55%,较工艺改进前明显提高,样品含量之间有高度统计意义(P<0.01)。结论:长期试验是考察药品质量非常重要的内容。
Objective： Research the stability of Xuesaitong dropping pills and supply the evidences to fix the useful-life, by the test of long-term stability of Xuesaitong dropping pills. Method： The experience of three batches of Xuesaitong dropping pills was held with the accordance of Chinese Pharmacopoeia, and tested the character, content and the time-limit dissolution as tile quality indexes. Result： The characters and the time-limit dissolutions of the 3 batches of the dropping pills are stable, And the content of Pannax notoginseng total saponin in these pills were descent 15.93% on average in the 24 months. The content of Pannax notoginseng total sapoifin in other 3 batches after we impruved the preparation technics descended 9.55% on average in the 24 months, h has a significant improve in the descent of content than before（P〈0.01）. Conclution： The long-term stability was the very important parts of drug quality tests.
出处
《中国医药导刊》
2008年第9期1438-1440,共3页
Chinese Journal of Medicinal Guide
关键词
血塞通滴丸
长期试验
有效期
方差分析
Xuesaitong dropping pills
the test of long-term Stabiliw
the useful-life
the analysis of variance
