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等温及非等温短期试验以及长期试验中药物水溶液稳定性的比较研究。第2部分:非等温短期试验中丁卡因水溶液的稳定性(作者译)

[Comparative studies on the stability of aqueous drug solutions in the isothermal and the non-isothermal short-time test as well as in the long-time test. Part 2: The stability of aqueous tetracaine solutions in the non-isothermal short-time test (author's transl)].

作者信息

Göber B, Timm U, Pfeifer S, Hübel S

出版信息

Pharmazie. 1979 Apr;34(4):237-40.

PMID:482330
Abstract

A study of the hydrolytic degradation of tetracaine solutions at various pH values demonstrates that the results from non-isothermal stability testing with logarithmic rise in temperature are in good agreement with the activation energies determined, under analogous conditions, by means of the isothermal short-time test and long-time test. The range of the maximum of stability is more clearly evinced by the non-isothermal short-time test than by the isothermal stability test. The comparison of the two methods reveals that the deviation of the reaction rate constants is greater in the non-isothermal test, which is due to the calculation required for the logarithmic rise in temperature. The results obtained with tetracaine evidence that the non-isothermal stability test is an appropriate method for the rapid determination of stability parameters (e.g. stability maximum, hydrolysis velocities) in the frame-work of testing potential drugs for stability and in the optimization of prescriptions.

摘要

一项关于不同pH值下丁卡因溶液水解降解的研究表明,温度呈对数上升的非等温稳定性测试结果与在类似条件下通过等温短期测试和长期测试确定的活化能高度一致。非等温短期测试比等温稳定性测试更清晰地显示出稳定性最大值的范围。两种方法的比较表明,非等温测试中反应速率常数的偏差更大,这是由于温度对数上升所需的计算所致。丁卡因的测试结果证明,在测试潜在药物的稳定性以及优化处方的框架内,非等温稳定性测试是快速确定稳定性参数(如最大稳定性、水解速度)的合适方法。

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