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Evaluation of Photostability of Drugs and Design for Photostabilization of the Drugs

药物光稳定性评价及药物光稳定性设计

基本信息

批准号：
11672154
负责人：
MATSUDA Yoshihisa
金额：
$ 1.79万
依托单位：
Kobe Pharmaceutical University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
1998
资助国家：
日本
起止时间：
1998 至 2000
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-11672154/
关键词：
Photostability Photostabilization Tretinoin tocoferil ICH Nifedipine 熱安定性トコレチナート

项目摘要

(1)Effect of the particle size on the photostability of nifedipine powder and its tablet was investingated using HPLC method and Fourier-transformed infrared reflection-absorption spectroscopy (FT-IR-RAS) under the non-destructive condition.The nifedipine content on the surface of the tablet was determined based on the absorption at 1682 cm^<-1> attributable to the C=O stretch vibration in FT-IR-RAS spectra before and after irradiation by fluorescent lamp. The apparent photodegradation constant of nifedipine powder increased with decrease of the particle size, while that of its tablet was approximately constant irrespective of particle size.(2)The photostability of tretinoin tocoferil was investigated under irradiation with three kinds of lamps, i.e., a cool white fluorescent lamp, a UV-A fluorescent lamp and a D65 fluorescent lamp. A combination of the cool white fluorescent lamp and the UV-A fluorescent lamp, and the D65 lamp having relative spectral power distribution similar to that of direct daylight, correspond to options 2 and 1 in ICH Guidelines, respectively. The photodegradation apparently followed second-order kinetics under these light sources and the degradation rate constant under exposure by the D65 lamp was larger than that by the cool white fluorescent lamp. The drug was susceptible to degradation by visible light below 480 nm and was degraded most remarkably at around 420 nm, showing a wavelength- dependency.The rate of oxidative degradation was slightly accelerated with the rise of temperature. The degradation rate constant rapidly increased in proportion to partial pressure of oxygen below 20kPa.

(1)在无损条件下，采用高效液相色谱法和傅里叶变换红外反射吸收光谱法（FT-IR-RAS）考察了颗粒大小对硝苯地平粉剂及其片剂光稳定性的影响。利用荧光灯照射前后FT-IR-RAS光谱中C=O拉伸振动在1682 cm^<-1>处的吸收来测定片剂表面硝苯地平的含量。硝苯地平粉末的表观光降解常数随粒径的减小而增大，而片剂的表观光降解常数与粒径无关。(2)在冷白荧光灯、UV-A荧光灯和D65荧光灯三种灯的照射下，考察了维a酸对黄芪油的光稳定性。冷白荧光灯与UV-A荧光灯的组合，以及相对光谱功率分布与日光直射相似的D65灯，分别对应ICH指南中的选项2和选项1。在这些光源下，降解明显遵循二级动力学，且D65灯照射下的降解速率常数大于冷白光下的降解速率常数。该药物在480 nm以下的可见光下易降解，在420 nm左右的可见光下降解最显著，表现出波长依赖性。随着温度的升高，氧化降解速率略有加快。在20kPa以下，降解速率常数随氧气分压的增大而迅速增大。