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指纹图谱评价复方丹参片的稳定性 被引量:6

A fingerprint-based evaluation method for the stability of Compound Danshen tablets
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摘要 目的利用指纹图谱的研究思路,建立多组分综合考察复方丹参片稳定性的方法。方法采用HPLC法,将加速试验1、2、3、6月的结果与0月进行比较,考察复方丹参片中10个共有峰对应成分在加速试验中的相对含量变化情况。结果经过6个月的加速试验,复方丹参片中某些成分相对含量变化较大。结论这种利用指纹图谱研究思路的多组分衡量方法比仅用单一或少数几个成分作指标来评价稳定性可能更加合理。 OBJECTIVE Based on chromatographic fingerprint,a stability evaluation method for Compound Danshen tablets was established by detecting multiple components.METHODS Relative content changes of ten components in Compound Danshen tablets were determined by accelerated stability test and the results of 1,2,3 and 6 months were compared with 0 month by HPLC method.RESULTS After six months accelerated testing,the relative contents of some components in Compound Danshen tablets changed greatly.CONCLUSION This multi-components stability evaluation method based on fingerprint is possibly more reliable than most of current methods,which use merely single or few components to evaluate the stability of traditional Chinese medicine preparation.
出处 《华西药学杂志》 CAS CSCD 北大核心 2009年第4期377-378,共2页 West China Journal of Pharmaceutical Sciences
关键词 稳定性 复方丹参片 指纹图谱 Stability Compound Danshen tablets Fingerprint
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参考文献4

  • 1刘莉,鲁丽.复方丹参片药理及临床应用[J].黑龙江医药,2005,18(1):59-60. 被引量:7
  • 2中华人民共和国国家药典委员会.中国药典[S].一部.北京:化学工业出版社,2005.598-599.
  • 3中药、天然药物稳定性研究技术指导原则[M].国食药监注[2006]678号.
  • 4中药注射剂指纹图谱研究的技术要求(暂行)[M].国药管注[2000]348号.

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