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1、Biopharmaceutics Biopharmacy Chapter 1 Introduction Branches of pharmaceutics uPhysical pharmaceutics uIndustry pharmaceutics uBiopharmaceutics uClinical pharmaceutics I Concept Study on the process of absorption distribution metabolism and excretion of drug and its dosage form in vivo to state a re
2、lationship between the factor of biology and dosage form and the pharmacologic effect of drug to provide scientific basis for evaluation of quality of the drug preparation and design and use of drug products rationally 1 Factors of dosage form Type of drug Physical and chemical properties of drug Do
3、sage form and administration of drug The nature of excipients and additives and the dose of drug The technological process and operation conditions of preparation Incompatibility and interaction between drugs Type of drug i e ester salt complex derivative and so on e g The solubility of sodium tolbu
4、tamide 甲磺丁脲钠 is better than that of tolbutamide The pharmacologic effect is either Physical and chemical properties of drug i e diameter of particle crystal form solubility dissolution rate and so on Dissolution is the process by which a chemical or drug becomes dissolved in a solvent Lots of facts
5、have proved that the dissolution rate of tablets influences the absorption and clinical therapeutic effect At the present the pharmacopeia of China and many other countries all have requirement of dissolution rate for solid preparations such as tablets or capsules e g convention tablets micronized t
6、ablets solid dispersion pills Griseofulvin 灰黄霉素 Dosage form and administration of drug i e tablets capsules injections transdermal therapeutic system TTS and so on e g the therapeutic effect of injections is faster than that of tablets Because the former was absorbed rapidly to the blood systemic ci
7、rculation The nature of excipients and additives and the dose of drug e g The fillers of phenytoin sodium 苯妥英钠钠 capsules calcium sulphate or lactose The technological process and operation conditions of preparation e g Preparation for chloramphenicol palmitate heating is effective and formulating in
8、 cold solvent is ineffective Incompatibility and interaction between drugs e g SMZ TMP antibacterial effect is enhanced Warfarin butazolidn bleeding side effect 2 Biological factor Differences in race sex and age Differences in physiologic and pathological conditions 3 Pharmacologic effect of drug T
9、herapeutic effect Side effect and Toxicity II Differences from relative subjects Pharmacology Study on the mode of action and mechanism of drugs in vivo Biochemistry Study on the biochemical process of drugs in vivo III History of biopharmaceutics the main action of a drug depends on its chemical st
10、ructure pharmacologic effect of a drug related not only to its chemical structure but also to dosage form and biologic factors Dissolution rate is a quality index in vitro Bioavailability is a quality index in vivo The founder in foreign country Kruger Thiemer E Nelson J G Wagner J Levy M Gibaldi T
11、L Loo 内藤俊一 村田敏 郎 野上寿 褂见喜一等 In our country China Pharmaceutical University conducted a training class of biopharmaceutics in 1978 IV Experiment design of biopharmaceutics Theory basis Experimental process Experiment Animal Theory basis Pharmacokinetics study on the transport law of drug in vivo by me
12、ans of the fundamentals of kinetics and mathematics Experimental process Analyze blood concentration urine concentration metabolite concentration concentration in tissue organ and fluid Determination of bioavailability Analysis methods Ultraviolet spectrometry UV Fluoro spectrophotometry Nuclear mag
13、netic resonance spectroscopy Flame photometer Thin layer chromatography TLC Isotope label method Experiment Animal Mammilla 哺乳动动物 includes rat mice rabbit dog pig row monkey and so on Human body V Research Work Dissolution rate and Bioavailability of solid dosage Design sustained release and controlled release preparations dependence of physiological function The fate of particles delivery system in systemic circulation New administration way and method Dissolution rate and Bioavailability of traditional Chinese medicine preparations Research method of biopharmaceutics
