摘要
目的:研究氯霉素亚砜涂剂(氯霉素-二甲基亚砜)的热降解动力学过程,并预测其有效期。方法:采用高效液相色谱法测定氯霉素亚砜涂剂在75、80、85、95℃恒温水浴中放置0、8、16、20、24 h的氯霉素含量;采用经典恒温法和多元线性模型两种方法预测制剂的有效期,同时比较两种方法的特点。结果:经典恒温法取20个数据经5次拟合可得回归方程为lg K=-4 825.3×(1/T)+11.349(r=0.999 0),K25℃为1.470 88×10-5h-1,t0.9为7 165.76 h,活化能为92.46 k J/mol。多元线性模型取8个数据经1次拟合可得回归方程为lnt=1.016 1ln(lnc0-lnc)+11 026.550 1×1/T-25.866 3(r=0.994 2),t0.9为6 794.18 h,活化能为91.73 k J/mol。氯霉素亚砜涂剂降解符合一级动力学方程。用经典恒温法和多元线性模型预测氯霉素亚砜涂剂的有效期分别为9.8、9.3个月。结论:氯霉素亚砜涂剂的有效期约为9.5个月;采用多元线性模型法预测有效期更简便。
OBJECTIVE： To study the thermal degradation kinetic process of Chloramphenicol sulfoxide paint （chlorampheni- col-dimethyl sulfoxide） and predict its expiration date. METHODS： HPLC was conducted to determine the chloramphenicol content of Chloramphenicol sulfoxide paint with the constant temperature bath of 75, 80, 85, 95 ℃ for 0, 8, 16, 20, 24 h. Classical con- stant temperature acceleration and multivariate linear model were used to calculate the expiration date and the characteristics of 2 methods were compared. RESULTS： The regression equation was obtained through 5 fittings with 20 experiment data by classical constant temperature acceleration; it was lgK= - 4 825.3 × （1/T） ＋ 11.349 （r=0.999 0）, K25℃ was 1.470 88 × 10 ^-5 h^-1, t0.9 was 7 165.76 h and the activation energy was 92.46 kJ/mol. The regression equation was obtained through 1 fitting with 8 experiment da- ta by multivariate linear model; it was lnt=1.016 lln（lnC0-lnc）＋11 026.550 1×1/T-25.866 3（r=0.994 2）, t0.9 was 6 794.18 h and the activation energy was 91.73 kJ/mol. The degradation of Chloramphenicol sulfoxide paint was in line with the first-class ki- netics reaction. The expiration dates of Chloramphenicol sulfoxide paint predicted by classical constant temperature acceleration and multivariate linear model were 9.8 and 9.3 months, respectively. CONCLUSIONS： The expiration date of chloramphenicol sulfox- ide paint is about 9.5 months. Multiple linear model is more convenient for the prediction of expiration date.
出处
《中国药房》
CAS
北大核心
2015年第16期2202-2204,共3页
China Pharmacy
关键词
氯霉素亚砜涂剂
经典恒温法
多元线性模型
氯霉素
有效期
Chloramphenicol sulfoxide paint
Classical constant temperature acceleration
Multivariate linear model
Chloram-phenicol
Expiration date
