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本文报告了用经典恒温法,以丹参素为指标测定丹参注射液贮存期的试验,采用薄层分离,扫描定量,数据统计处理,最后确定丹参素分解反应的活化能E=28.399,室温下的速度常数K_(25·σ)=1.361×10~(-5),有效期t_(0.9)~(25·σ)=0.88年。本文还提出了中药注射剂有效期预测的新建议。
This article reports the use of classical constant-temperature method to determine the shelf-life of Danshen injection with Danshensu as an indicator. Thin-layer separation, quantitative scans, and statistical data processing are used to determine the activation energy for the decomposition reaction of Danshensu, E=28.399, at room temperature. The speed constant K_(25·σ)=1.361×10~(-5), and the effective period t_(0.9)~(25·σ)=0.88 years. This article also proposes new recommendations for the prediction of the effective period of traditional Chinese medicine injections.