程序升温法研究药物稳定性的试验误差  

ACCURACY AND PRECISION OF NONISOTHERMAL AND ISOTHERMAL DRUG STABILITY EXPERIMENT

作　　者：詹先成[1] 殷恭宽[1] 王丽华[1] 马宝忠[1] 

机构地区：[1]华西医科大学药学院

出　　处：《药学学报》1997年第3期213-218,共6页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金

摘　　要：通过电子计算机模拟程序升温加速试验数据，从理论上探讨了各种程序升温法的试验误差，并与恒温法作了对比。结果表明，药物降解程度越大，试验温度差越大，平均温度越接近室温，抽样频率越高，试验结果误差就越小。在药物降解程度和加热温度相同的条件下，指数程序升温法的试验误差明显小于线性升温、倒数升温和对数升温法。恒温法的试验结果误差小于指数升温法，但所需的加热时间约为指数升温法的５倍。By a theoretical investigation of simulated nonisothermal data, the estimates for shelf life and activation energy obtained by exponential and other nonisothermal heating models were statistically evaluated and were compared with those obtained by the isothermal method under various conditions. Results indicated that under the same experimental conditions, the estimates obtained by the exponential heating model were significantly more accurate and precise than those obtained by the linear, reciprocal, and logarithmic heating model. The estimates obtained by the isothermal method were somewhat more accurate and precise than those obtained by the exponential heating model. However, the experimental period needed by the isothermal method was about 5 times longer than that needed by the exponential heating model. Results also showed that in each of the heating models, the estimates would be more accurate and precise by increasing the final degradation of drugs, changes in temperature range, or sampling frequency, or by having the mean temperature closer to room temperature.

关 键 词：药物检验 药物稳定性 试验误差 程序升温法 

分 类 号：R927.11[医药卫生—药学]