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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 To establish a multi-component method for the comprehensive study of the stability of compound Danshen tablets by using the fingerprinting research ideas. Methods HPLC method was used to compare the results of accelerated test 1, 2, 3, and 6 months with that of month 0. The relative content changes of 10 common peak components in compound Danshen tablets in accelerated test were investigated. Results After 6 months accelerated test, the relative content of certain components in the compound Danshen Tablets changed greatly. Conclusion This method of multi-component measurement using the fingerprinting approach may be more reasonable than evaluating the stability using only a single or a few components as indicators.