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阿仑尼乌斯方程在预测多种维生素片中维生素A稳定性方面的可靠性。

Reliability of Arrhenius Equation in predicting vitamin A stability in multivitamin tablets.

作者信息

Slater J G, Stone H A, Palermo B T, Duvall R N

出版信息

J Pharm Sci. 1979 Jan;68(1):49-52. doi: 10.1002/jps.2600680117.

Abstract

Shelflife predictions of vitamin A stability in multivitamin tablets were calculated based on data obtained from the analyses of six multivitamin tablet preparations by the classical Arrhenius treatment. This approach gave excessive variation in the predictions. The same data were treated by a modified Arrhenius method, which reduced the variation. Long-term room temperature data show that incorrect slopes were predicted in three of the six sets of data with the modified approach. The data indicate that erroneous predictions can result when applying the Arrhenius treatment to accelerated data and that this approach should be used with extreme caution in establishing the expiration date of a multivitamin tablet product, especially where the limiting ingredient for expiration dating is a preprocessed raw material and not a single-entity chemical.

摘要

基于通过经典阿累尼乌斯处理对六种多种维生素片剂制剂进行分析所获得的数据,计算了多种维生素片剂中维生素A稳定性的保质期预测。这种方法在预测中产生了过大的差异。相同的数据采用改进的阿累尼乌斯方法进行处理,从而减少了差异。长期室温数据表明,采用改进方法对六组数据中的三组预测出了错误的斜率。数据表明,将阿累尼乌斯处理应用于加速数据时可能会导致错误的预测,并且在确定多种维生素片剂产品的有效期时应极其谨慎地使用这种方法,特别是在有效期限制成分是预处理原料而非单一实体化学品的情况下。

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