| 400g／L抗坏血酸注射剂变色降解规律及稳定性预测方法的探讨 |
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| 引用本文： | 郭英喜,黄建忠,汪捷,李琳丽.400g／L抗坏血酸注射剂变色降解规律及稳定性预测方法的探讨[J].中国药学杂志,1996(4). |
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| 作者姓名： | 郭英喜 黄建忠 汪捷 李琳丽 |
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| 作者单位： | 华西医科大学药学院 |
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| 摘 要： | 目的：由４００ｇ／Ｌ抗坏血酸注射剂的变色规律确定注射液稳定性的预测方法。方法：用正交设计法筛选注射剂的两个新处方，其变色曲线和贮存期由经典恒温法和威布尔概率法进行探讨。结果：各加热温度的变色降解曲线的规律基本相同，曲线第Ⅰ段称为变色诱导期。实验数据表明注射剂的变色速率可用回归方程Ｔ＝Ａ＋Ｂｔ￣ｎ表示，由此可求得新处方的活化能和室温贮存期。结论：注射剂的变色规律与药物水溶液存在明显差异，因此初均速法不能用于具有变色诱导期的注射剂。同时，单测点法的应用也应受到一定限制。
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| 关 键 词： | 变色及降解 抗坏血酸 稳定性预测 贮存期 |
The rule of discoloration and prediction of stability for 400 g/L ascorbic acid injection |
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| Guo Yingxi.The rule of discoloration and prediction of stability for 400 g/L ascorbic acid injection[J].Chinese Pharmaceutical Journal,1996(4). |
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| Authors: | Guo Yingxi |
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| Abstract: | OBJECTIVE:To predicte the stability of the rule of discoloration of 400 g/L ascorbic acid injection. METHODS:The formulation of two new injections was selected by screening with the method of orthogonal de- sign. The curves of discoloration of injections was studied by classical isothermal method and Weibull probabilitypaper method. RESULTS: The rule of discoloration of injection at four temperatures appeared to be the same. Thefirst stage of the curve was termed the inducing period of discoloration. Experimental data indicate that the rule ofdiscoloration of the injection may be represented by the regression equation:T=A Btn,the activation energy andthe shelf-life of the injection may be calculated. CONCLUSION : The rule of discoloration of injections is differentfrom that of the aqueous solutiOn of ascorbic acid. Consequently,"initiial average rate method" is not useful to pre- dict the shelf-life of the injection. Moreover,the application of"One-point determinate method" must be restricted. |
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| Keywords: | discoloration and degradation ascorbic acid stability predicate shelf-life |
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