药物剂型的分类(双语).doc

药物剂型的分类The classification of drug dosage forms一. 按物态分类According to the material classification将剂型分为固体、半固体、液体和气体等类。固体剂型入散剂、颗粒剂（冲剂）、丸剂、片剂、胶剂等；半固体剂型如内服膏滋、外用膏剂、糊剂；液体剂型如汤剂、合剂（含口服液剂）、糖浆剂、酒剂、酊剂、露剂、注射液等；气体剂型如气雾剂、烟剂等。The dosage forms are divided into solid, semi solid, liquid and gas. Solid dosage forms into powder, granule (granule), pills, tablets, adhesive agent; semi solid dosage forms such as oral soft extract, ointment, paste; liquid dosage forms such as decoction, Decoction (including oral liquid agent), syrup, wine, tincture, lotions, injection; gas dosage forms such as aerosol, smoke agent etc.由于物态相同，其制备特点和医疗效果亦有相同之处。例如固体剂型多需经粉碎和混合；半固体剂型多需要熔化和研匀；液体剂型多需经提取。疗效方面以液体、气体剂型为最快，固体剂型较慢。Due to the same state, its preparation and medical effect is similar. For example, solid dosage forms more crushing and mixing; semi solid dosage forms need to melt and research smoothing; liquid dosage forms by extraction. Effect in liquid, gas dosage form for the fastest, solid dosage forms slowly.这种分类法在制备、贮藏和运输上较有意义，但是过于简单，缺少剂型间的内在联系，实用价值不大。This classification method in the preparation, storage and transportation is significant, but is too simple, the lack of internal connection forms, of little practical value.二、按制法分类According to the classification system of law将主要工序采用同样方法制备的剂型列为一类。例如浸出药剂是将用浸出方法制备的汤剂、合剂、酒剂、酊剂、流浸膏剂与浸膏剂等归纳为一类。无菌制剂是将用灭菌方法或无菌操作法制备的注射剂、滴眼剂等列为一类。这种分类法有利于研究制备的共同规律，但归纳不全，而且某些剂型随着科学的发展会改变其制法，故有一定局限性。The main process adopts the form of column similarly prepared for a class. Such as leaching agent is made by leaching method for preparation of decoction, mixture, wine, tincture, liquid extract and extract agent into a class. Sterile preparation is injection, will use the sterilization method or aseptic preparation of eye drops as a class. This classification is conducive to the common law of preparation, but the sum is not complete, and some dosage forms with the development of science will change its preparation method, it has certain limitations.三、按分散系统分类According to the classification of dispersed system此法按剂型分散特性分类，便于应用物理化学原理说明各类剂型的特点。分类如下。The method according to the dosage form dispersion characteristics of classification, facilitate the application of physical chemistry principle explains the characteristics of various dosage. Classified as follows.1. 真溶液类剂型：如芳香水剂、溶液剂、醑剂、甘油剂及部分注射剂等；2. 胶体溶液类剂型：如胶浆剂、火棉胶剂、涂膜剂等；3. 乳浊液类剂型：如乳剂、静脉乳剂、部分搽剂等；4. 混悬液类剂型：如合剂、洗剂、混悬剂等；5. 气体分散体剂型：如气雾剂等；6. 固体分散体剂型：如散剂、丸剂、片剂等；1 true solution dosage forms: such as aromatic fragrance agent, solution, spirit, glycerol and injection;2. 胶体溶液类剂型：如胶浆剂、火棉胶剂、涂膜剂等；2 colloidal solution dosage forms: such as mucilage, collodion, plastics etc.;3. 乳浊液类剂型：如乳剂、静脉乳剂、部分搽剂等；3 emulsion dosage forms: such as emulsion, emulsion, etc. some liniment;4. 混悬液类剂型：如合剂、洗剂、混悬剂等；4 suspension dosage forms: such as agent, lotion, suspension agent etc.;5. 气体分散体剂型：如气雾剂等；5 gas dispersion forms: such as aerosol;6. 固体分散体剂型：如散剂、丸剂、片剂等；6 solid dispersion formulation: such as powder, pills, tablets, etc.;这类分类法最大的缺点是不能反映用药部位与方法对剂型的要求，甚至一种剂型由于辅料和制法的不同而必须分到几个分散系统中去，因而无法保持剂型的完整性，如注射剂中有溶液型、混悬型、乳浊型及粉针型等，合剂、软膏剂也有类似情况。此外，中药汤剂可同时包含有真溶液、胶体溶液、乳浊液和混悬液。The biggest disadvantage of classification method is unable to reflect the application site and method of dosage forms, and even a dosage form as excipients and preparation method is different and must be divided into several decentralized system, integrity and cannot maintain dosage forms, such as injection in the solution, suspension, emulsion and powder type, agent, ointment had a similar situation. In addition, traditional Chinese medicine decoction can also contain the true solution, colloidal solution, emulsion and suspension.四、按给药途径与方法分类According to the classification administration route and method将采用同一给药途径和方法的剂型列为一类。分类如下。Will use the same route of administration and dosage forms as a class method. Classified as follows.1. 经胃肠道给药的剂型：有汤剂、合剂（口服液）、糖浆剂、煎膏剂、酒剂、流浸膏剂、散剂、颗粒剂（冲剂）、丸剂、片剂、胶囊剂等。经直肠给药的有灌肠剂、栓剂等。2. 不经胃肠道给药的剂型：a、注射给药的，有注射剂（包括肌内注射、静脉注射、皮下注射、皮内注射及穴位注射）；b皮肤给药的，有软膏剂、膏药、橡胶膏剂、糊剂、搽剂、洗剂、涂膜剂、离子透入剂等；c粘膜给药的，有滴眼剂、滴鼻剂、含漱剂、舌下片、吹入剂、栓剂、膜剂及含化丸等；d呼吸道给药的，有气雾剂、吸入剂、烟剂等。1 administered via the gastrointestinal tract preparation: decoction, Decoction (oral liquid), syrup, electuary, wine, liquid extract, powder, granule (granule), pill, tablet, capsule etc. Rectal administration of enemas, suppository.2. 不经胃肠道给药的剂型：a、注射给药的，有注射剂（包括肌内注射、静脉注射、皮下注射、皮内注射及穴位注射）；b皮肤给药的，有软膏剂、膏药、橡胶膏剂、糊剂、搽剂、洗剂、涂膜剂、离子透入剂等；c粘膜给药的，有滴眼剂、滴鼻剂、含漱剂、舌下片、吹入剂、栓剂、膜剂及含化丸等；d呼吸道给药的，有气雾剂、吸入剂、烟剂等。2 no gastrointestinal drugs: A, given by injection, with injection (including intramuscular injection, intravenous injection, subcutaneous injection, intradermal injection and acupuncture point injection); B skin dose, with ointment, plaster, rubber paste, paste, liniment, lotion, liniment, iontophoresis agent; C mucosal administration, there are eye drops, nasal drops, gargle, sublingual tablets, suppositories, blowing agent, film forming agent and containing pills; D respiratory drug delivery, with aerosol inhalation, smoke agent, etc.这类分类方法与临床用药结合得比较紧密，并能反映给药途径与方法对剂型制备的特殊要求。缺点是一种剂型，由于给药途径或方法的不同，可能多次出现，使剂型分类复杂化，同时这种分类方法亦不能反映剂型的内在特性。This kind of classification method and clinical medication combination of more closely, special requirements and can reflect the administration route and method of preparation. The weakness is a kind of form, the route of administration or the different methods, may appear many times, the dosage form classification is complicated, at the same time, this method also can not reflect the inherent characteristics of dosage form.四、浸出制剂的分类Classification of leaching agent1、水浸出剂型：汤剂、合剂等2、含醇浸出剂型：药酒、酊剂、流浸膏等3、含糖浸出剂型：煎膏剂、糖浆剂等4、无菌浸出剂型：注射剂等5、其他浸出剂型：片剂、胶囊剂等1, water leaching dosage: decoction, mixture2、含醇浸出剂型：药酒、酊剂、流浸膏等2, alcohol leaching dosage: wine, tincture, extract etc.3、含糖浸出剂型：煎膏剂、糖浆剂等3, sugar leaching dosage: electuary, syrup etc.4、无菌浸出剂型：注射剂等4, sterile dosage forms: injection of leaching5、其他浸出剂型：片剂、胶囊剂等5, other leaching dosage: tablet, capsule etc.五、无菌制剂的分类Classification of sterile preparations按给药途径：规定无菌制剂和非规定无菌制剂(即限菌制剂)等； 按除去活微生物的制备工艺：无菌制剂分为灭菌制剂和无菌制剂等； According to route of administration: the provisions prescribed aseptic preparation and non sterile preparations (which limit the bacteria);按除去活微生物的制备工艺：无菌制剂分为灭菌制剂和无菌制剂等；According to the preparation of living microorganisms removal: aseptic preparation for sterilization and aseptic preparation and other preparations;广义上，无菌制剂和非无菌制剂都规定有染菌的