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1、会计学1片剂的制备工业药剂片剂的制备工业药剂Purpose 1. To master the basic technological course of tablets through the preparation of aspirin tablets.2. To be familiar with the quality control of tablets.3. To be familiar with the basic structure and operation method of single-punch.Introduction Tablets are solid prepara
2、tions of various shapes, usually round, and obtained by compressing uniform volumes of particles containing one or more active ingredients with suitable excipients.Introduction - tablet typesSome of the pharmaceutical tablet types based on the way of administration or presentation to the patient are
3、 listed on the right:1. Simple uncoated tablets2. Coated tablets3. Effervescent tablets4. Buccal and sublingual tablets5. Chewable tablets6. Multilayered tablets7. Sugarcoated tablets8. Fast-disintegrating tablets9. Vaginal tablets10. Osmotic tablets11. Controlled-release tablets12. Multicomponent t
4、abletsIntroduction - tablet designTablet formulation design starts with a predetermined value, which is the dose size. Tablet design is based on the experience and knowledge of excipients, which are materials serving the purpose of making a good tablet when combined with a drug.1. Fillers/diluents2.
5、 Binders3. Disintegrants4. Lubricants5. Glidants6. Buffering agents7. Sweeteners8. Wetting agents9. Coating agents10. Matrix formers1 Premixing drug with other ingredients using a mixer. 2 Transferring the mixture into a traditional low shear granulator where a binder solution is added under a mecha
6、nical shear until a certain damp mass and a certain granule size are obtained.3 Wet sieving of granules through a desired screen size.4 Drying of granules in a tray-oven dryer.5 Dry sieving/milling of granules to a certain particle size distribution.6 Adding a lubricant to the dry granules.7 Compres
7、sing the granules into tablets. 混合压片填充剂黏合剂崩解剂API辅料粉碎和过筛制软材干燥整粒混合制湿粒润滑剂崩解剂湿法制粒压片工艺流程Introduction - manufacturing processes制软材制湿粒研磨混合干燥整粒压片混合制淀粉浆single-punch pressrotary tablet pressmanual driving wheel hopper feed shoe cam gearing core components die (模圈) lower punch (下冲) upper punch (上冲) WeightWeigh
8、t variationDisintegrationHardnessFriabilityDissolutionDrug content uniformityThicknessAverage weightWeight variation limitLess than 0.3 g 7.5%0.3 g or more 5%Purpose 1. To master the basic technological course of tablets through the preparation of aspirin tablets.2. To be familiar with the quality control of tablets.3. To be familiar with the basic structure and operation method of single-punch.1. Fillers/diluents2. Binders3. Disintegrants4. Lubrican
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