摘要
许多药物在光线的作用下会分解、变质,药物效价降低甚至失效,有的还会分解成为对人体有剧毒的物质。为此研制人员必须对新药进行光稳定性试验,研究光对药物内在质量的影响,探究光引起的降解程度与途径,从而指定处方选择、生产工艺,包装储藏的策略。文中介绍了光强化试验的必要性,应该采用的光源与适宜的光照度,并就光稳定性试验的设备、试验的方法、置样方式、试验结果的判断及目前还存在的问题进行了研讨。
A lot of drugs will be decomposed and deteriorated by light, and their potency may be cut down or the effectiveness may be lost, and some of them even can be decomposed into the severe poisonous substances to human. Therefore the photo-stability testing on new drugs must be done. The necessity of strength photo-stability testing are described, and the discussions are made on the light source, intensity of illumination, apparatus, testing method, sample setting style, the result judgement and the problems.
出处
《中国药事》
CAS
2000年第1期17-18,共2页
Chinese Pharmaceutical Affairs
