基因工程制药概述 基因工程制药的基本流程 重组蛋白分离纯化技术 基因工程药物的修饰改造 基因工程在制药工业中的应用 基因工程制药的优点 基因工程菌的构建与筛选 基因工程制药基本环节 选择宿主细胞的原则 凝胶过滤 (gel filtration chromatography) 特异结合亲和性-亲和层析 纯化后蛋白的质量检测与保存 修饰与改造的主要手段 基因工程药物的质量控制与应用 成品理化性质的检定

一、什么是生物技术制药 二、为什么我们要学习生物技术制药？ 三、生物技术制药的主要研究内容 基因工程制药 细胞发酵工程制药 酶工程制药 抗体工程制药 四、生物技术制药的特征 高技术 高投入 长周期 高风险 高收益 五、生物技术发展简史 六、医药生物技术新进展 七、我国的医药生物技术 八、医药生物技术发展展望

• 1. Introduction • 2.Topical Administration • 3.Oral Administration • 4.Vaginal Administration • 5.Ophthalmics • 6.Parenteral Administration • 7.Peglated Dosage Forms • 8.Fusion Protein • 9.Implants • 10.Other Novel Delivery Systems

1) orally, conveniently carried, readily identified, and easily taken 2) compared with equivalent doses of a liquid medication, accurate dosing, most tasteless when swallowed 3) readily identified 4) Prescribing flexibility (a variety of dosage strengths) 5) from a pharmaceutic standpoint, solid dosage forms are • efficiently and productively manufactured • packaged and shipped by manufacturers at lower cost and with less breakage than comparable liquid forms • more stable, have a longer shelf-life than their liquid counterparts

• Introduction • The characteristics of the biotech products • Techniques used to produce biotechnologic products • The pharmaceutical concerns of biotech drug • Products of Biotechnology • The future of the biotech products

I. Factors affecting percutaneous absorption II. Percutaneous absorption enhancer III. Design features of transdermal drug delivery system IV. Percutaneous absorption model V. Advantages and disadvantages of TDDSs VI. Examples of transdermal drug deliver systems VII. General clinical considerations in the use of TDDSs

1. Types of tablets 2. Compressed tablets 3. Chewable tablets 4. Molded tablets 5. Tablet coating 6. Impact of manufacturing changes on solid dosage forms 7. Official and commercially available tablets 8. Packaging and storing tablet

1. Drug discovery and drug design 2. Biological characterization 3. Early formulation studies 4. The investigational New Drug (IND) Application(研究性新药申请） 5. The New Drug Application (NDA)

Injections Small volume parenterals Large volume parenterals Special considerations associated with parenteral therapy Other injectable products-pellets or implants Irrigation and dialysis solutions

◼ Suspensions （混悬剂） ◼ Emulsions （乳剂） ◼ Gels and magmas （凝胶剂和乳浆剂） ◼ Proper administration and use of disperse systems （分散体系的正确给药和使用） ◼ Aerosols （气雾剂）