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Pharmaceutics Introduction Chapter 1
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I. Concepts and tasks A.concepts (1)pharmaceutics basic theory formulation design drug product preparation techniques quality evaluation correct application
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(2)dosage forms forms of administration e.g. tablet, capsule, injection, granule… (abstract) (3)pharmaceutical preparations drug+form e.g. aspirin tablets, 0.5%glucose infusion… (objective)
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(4)pharmaceutical manufacturing the process of research and preparation of drug product (verb.) (5)drug delivery systems (DDS) modern dosage forms e.g. sustained or controlled; targeting; transdermal; solid dispersion; liposomes; microencapsulation…
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B.Tasks to prepare safe, effective, stable and convenient pharmaceutical preparations (1)basic theory (2) dosage forms(esp. Chinese traditional medicine and biomedicine) new preparation techniques excipients equipment(sealed, effective, multifunction, automation and continuity)
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II. Branches industrial P.—essential physical P. biopharmaceutics basic P. pharmacokinetics polymers in P. clinical P. hospital P. dispensing P.
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III. Dosage forms A.Importance (1)Change the applicative properties of drug (2)Adjust effective time (3)Decrease the side effects of drug (4)Improve targeting ability (5)Affect effectiveness
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B. Types (1)According to administration routes gastrointestinal tract (GIT): oral injection (IM, IV, SC…) inhale parenteral transdermal transmucous membrane (buccal, sublingual…) cavity (rectal, ear, nose, vaginal…)
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(2)according to dispersion systems solution(molecule or ion) colloid(D:1~100nm) emulsion(insoluble liquids) suspension(insoluble solid and liquid) gas dispersion(aerosol) solid dispersion(solid preparations) microparticle dispersion
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(3)according to drug states liquid gas solid semi-solid
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C. Development 1 st generation: traditional 2 nd generation: sustained or prolonged 3 rd generation: controlled 4 th generation: targeting
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IV. Related statutes A.Pharmacopoeia: standard of medicine Chp 2005 edition(three parts) B. Prescription drug: prescripted by doctors Nonprescription drug (over-the-counter, OTC): mainly chosen and bought by patients themselves
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C. Seven “G”s GMP (good manufacturing practice) --enterprise GLP (good laboratory practice) --research institute GCP (good clinical practice) --hospital GSP (good supply practice) --pharmaceutical company GPP (good preparation practice) --hospital GAP (good agricultural practice) --Chinese traditional medicine GUP (good using practice) --using process in hospital (pharmacy, storeroom)
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V. Gap between domestic and abroad A.basic theory B.new preparation and technique C.promising excipients D.advanced equipment challenge but a lot of room for improvement!
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VI. References 《药剂学》第五版教材 《药剂学》第四版教材 美国《 Modern Pharmaceutics 》 3 rd edition 陆彬《药物新制剂新技术》第一版 中国药科大学《药剂学》第三版
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