口服药物制剂的开发设计与评估

Design and evaluation of oral drug preparations development

关键词:  口服药物制剂  开发  设计  评估

Key words:  oral drug preparations  development  design  evaluation

摘要:

口服药物开发设计时要考虑药物本身的特性、靶动物胃肠道生理特性和药物制剂剂型；药物本身的特性常常可参考药物的生物药剂学分类特性进行差异化的药物制剂设计；另外哺乳动物不同物种之间消化道基本结构相似，但是胃肠道的整体形态会被食物性质、食物摄入频率、需要存储的食物以及身体的大小形状影响，胃肠道的形态以及粘膜区面积有很大不同；不同物种肠道长度及pH值也存在很大差异，口服药物设计时要充分给予考虑，另外本文介绍了口服药物的评估模型人工生物膜模型、细胞模型和动物模型。

Abstract:

While developing and designing oral drugs, the characteristics of the drug itself, the gastrointestinal physiological characteristics of the target animals and pharmaceutical preparation formulations should be taken into consideration; the characteristics of the drug itself often refer to the biopharmaceutic classification features to process the designing of differentiated pharmaceutical preparations; furthermore, the basic structure of the digestive tract between different species of mammals is similar, however the entire morphology of the gastrointestinal tract will be affected by the nature of food, the frequency of food intake, the required food storage and the size and the shape of the body，and the morphology and the mucous membrane area of gastrointestinal tract are quite different; the intestinal length and the pH value of different species are also quite different, which should be fully considered when designing the oral drugs. The evaluation models of oral drugs such as artificial biological membrane models, cell models and animal models are also introduced in this text.