生物制品（Biological product）.doc

生物制品（Biological product） 1. liver first pass effect: drug absorption through gastrointestinal membrane, the hepatic portal vein into the liver, the liver enzyme can produce drug biotransformation, the drug into the body before the cycle of degradation or inactivation of the first pass effect. 2.CMP: pharmaceutical production quality management, refers to the production of pharmaceuticals, scientific, rational, standardized conditions and methods to ensure the production of a set of system of good medicine, scientific management practices, is the basic principles for the production and quality of medicine, suitable for pharmaceutical production process. 3. validation: a series of activities to demonstrate whether the plant, facilities, raw materials, production processes, quality control, etc., which are used in the manufacture and inspection of drugs, have achieved the intended purpose. 4. air cleanliness: refers to the amount of air particles in a clean environment. 5. clean air level: it is determined by the maximum allowable particle size of particles in the unit volume of air containing more than 0.5 microns... 6. flow: gas at a speed greater than the solid particles and the settlement is less than the speed of airflow away upward flow through the solid bottom of special, so it is solid particles suspended in the air and gas driven part part. 7. channel: after the airflow into the fluidized bed in the body caused by uneven distribution in the fluidized bed partial pipeline, the material can not form a good fluidization state. 8.: air bubble in slugging fluidized bed mixed to grow with the fluidized bed layer diameter close to when the whole bed in the logistics such as piston top, when the bubble burst at a certain height of logistics by gravity as a rain 9. solvent: second kinds of material to form a complex, double or complex in drug dissolution, in order to increase the solubility and process of drugs in a solvent, adding in the process material called cosolv