常见的动植物微生物来源的化学药品质量控制.ppt

动植物、微生物来源的化学药品质量控制中生物测定法与理化测定法的合理应用Reasonably apply biological and physical-chemical assay and test for the drugs, which extracted from animal and plant and microbes 摘 要 ABSTRACT 科学合理地应用生物测定法、理化测定法，制订能够有效控制药品质量的药品标准，不断提高药品的有效性和安全性是药品标准工作永恒的目标。 Work out drug standard ， that is able to control quality of drugs effectively, to improve safety and effectiveness of drug substances and drug product, is eternal goal for drug standard work. 控制药品质量的实质就是要控制原料药和制剂中的药物活性成分分子在其有效期内符合临床需要的药物构效关系并保持其物理稳定性、化学稳定性、治疗学稳定性、微生物学稳定性和毒理学稳定性。 Control molecular of activity pharmaceutical ingredient in the drug substances and products, in essence of control quality， conform to structure-activity relationship and maintain its physical stability, chemical stability, therapeutic stability, microbiological stability and toxicology stability, before term of validity. 因此，我们认为在方法学研究中应该注意以下3点： 1、生物测定法是不可替代的方法。 2、理化测定法检测结果必须体现药物的真实活性或效价。 3、科学合理地综合运用生物测定法和理化测定法，才能有效控制药品质量。 Therefore we must be attention to following 3 problems，when study and design for methodology: 1. Biological assay and test is the irreplaceable method. 2. Determination results of physical and chemical assay must be indicating true activity or potency of drug. 3. Only scientifically and reasonably apply biological and physical and chemical test methods, drug quality is controlled effectively. 一、生物测定法是无可替代的药品检测方法。 Biological assay is the irreplaceable method of drug test. 药物的分子结构及其构型、构象决定着药物的生物学特性和理化特性，（特别是药物制剂中药物分子的结构是否稳定？其构型、构象对于治疗或预防疾病是否有利？其降解产物、可能的外来物质会对人体产生何种危害？），而检测与 评价其特性所导致的生物效应（包括对疾病的治疗作用与可能发生的不良反应）最直接的方法就是生物测定法。 The molecular structure of API in the drug product and its configuration and conformation decided its biological, physical and chemical characteristics, (especially must be attention for that, the structure and its configuratio