片剂的制备工业药剂 (2).ppt

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1、片剂的制备工业药剂现在学习的是第1页，共34页PurposeIntroductionEquipments and MaterialsProceduresExperimental InstructionsQuestionsTest report 现在学习的是第2页，共34页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 b

2、e familiar with the basic structure and operation method of single-punch.现在学习的是第3页，共34页Introduction Tablets are solid preparations of various shapes,usually round,and obtained by compressing uniform volumes of particles containing one or more active ingredients with suitable excipients.现在学习的是第4页，共34

3、页Introduction-tablet typesSome of the pharmaceutical tablet types based on the way of administration or presentation to the patient are listed on the right:1.Simple uncoated tablets2.Coated tablets3.Effervescent tablets4.Buccal and sublingual tablets5.Chewable tablets6.Multilayered tablets7.Sugarcoa

4、ted tablets8.Fast-disintegrating tablets9.Vaginal tablets10.Osmotic tablets11.Controlled-release tablets12.Multicomponent tablets现在学习的是第5页，共34页Introduction-tablet designTablet formulation design starts with a predetermined value,which is the dose size.Tablet design is based on the experience and kno

5、wledge of excipients,which are materials serving the purpose of making a good tablet when combined with a drug.现在学习的是第6页，共34页Introduction-tablet designTablet excipients can be classified on the basis of their functionality as listed below:1.Fillers/diluents2.Binders3.Disintegrants4.Lubricants5.Glida

6、nts6.Buffering agents7.Sweeteners8.Wetting agents9.Coating agents10.Matrix formers现在学习的是第7页，共34页Introduction-manufacturing processesDeciding on a manufacturing method is a complex task that requires time,equipment,and formulation optimization,as well as a close collaboration between formulation scie

7、ntists and process engineers.In general terms,there are three manufacturing processes for tablets:wet granulation,dry granulation,and direct compression.现在学习的是第8页，共34页Introduction-manufacturing processesThe purpose of wet granulation is to convert the drug and excipient mixture into granules that fl

8、ow well into dies,and which are compressible into mechanically strong and acceptable tablets.1.flowability pressibilityWet granulation compression method has been widely used in tablets production,especially for drugs resistant to wet and heat.现在学习的是第9页，共34页Introduction-manufacturing processesThe st

9、eps of wet granulation1Premixing drug with other ingredients using a mixer.2Transferring the mixture into a traditional low shear granulator where a binder solution is added under a mechanical shear until a certain damp mass and a certain granule size are obtained.3Wet sieving of granules through a

10、desired screen size.4Drying of granules in a tray-oven dryer.5Dry sieving/milling of granules to a certain particle size distribution.6Adding a lubricant to the dry granules.7Compressing the granules into tablets.现在学习的是第10页，共34页Introduction-manufacturing processesThe steps of wet granulation现在学习的是第1

11、1页，共34页 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现在学习的是第12页，共34页Equipments and MaterialsEquipments:electronic balance,single-punch press,nylon sieve(16 and 18 mesh),punch(9.5mm shallow concave punch),etc.Materials:aspirin(in granule crystal),tartaric aci

12、d,talcum powder,starch,concentrated hydrochloric acid,sodium hydroxide,distilled water,etc.现在学习的是第13页，共34页Procedure1.Preparation of aspirin tablets(1)Formulation(weight in 100 tablets)Aspirin30 gStarch 2 gTartaric acid 0.2 g10%starch paste qsStarch 1 gTalcum powder 1.5 g现在学习的是第14页，共34页(2)Preparing p

13、rocessesPreparing 10%starch paste:Heating the aqueous dispersion of starch(2 g starch and 0.2g tartaric acid in 20mL water)at 80 for 15 min.Grinding aspirin to pass the sieve of 80 meshes.Mixing aspirin powder with starch.Adding 10%starch paste to prepare a damp mass.Screening the damp mass through

14、a nylon sieve of 18 meshes into granules.Drying of the wet granules at 60 for 15 min.Dry sieving of granules through 16 meshes.Adding starch and talcum powder to dry granules with blending uniformly.Compressing the granules into tablets.制软材制湿粒研磨混合干燥整粒压片混合制淀粉浆现在学习的是第15页，共34页single-punch pressrotary t

15、ablet press现在学习的是第16页，共34页2.Single-punch pressmanual driving wheel hopper feed shoe cam gearing core components die(模圈)lower punch(下冲)upper punch(上冲)现在学习的是第17页，共34页现在学习的是第18页，共34页现在学习的是第19页，共34页现在学习的是第20页，共34页3.Installing of single-punch press(1)Installing of core componentsInstalling of the lower p

16、unch安装下冲：旋松下冲固定螺钉，转动大皮带轮使下冲芯杆升到最高位置，将下冲插入下冲芯杆的孔中（注意使下冲杆的缺口斜面对准下冲紧固螺钉，并要插到底）最后旋紧下冲固定螺钉。现在学习的是第21页，共34页Installing of the lower punch安装上冲：旋松上冲紧固螺母，将上冲插入上冲芯杆的孔中，要插到底，旋紧上冲紧固螺母。Installing of the mould安装中模：旋松中模固定螺钉，将中模拿平放入中模台板的孔中，旋紧中模固定螺钉。缓缓转动大皮带轮，调整中模台板的位置，使上冲进入中模孔中，旋紧中模台板固定螺钉。现在学习的是第22页，共34页(2)Adjustment

17、 of out-of-tablets 出片调整转动大皮带轮使下冲升到最高位置，观察下冲口面是否与中模平面相齐（或高或低都将影响出片），若不齐则旋松蝶形螺丝，松开齿轮压板转动上调节齿轮，使下冲口面与中模平面相齐，然后将压板按上，旋紧蝶形螺丝。用手转动大皮带轮，空车运转若正常，则可加料试压，进行下一步调整。现在学习的是第23页，共34页(3)Adjustment of tablet weight片重调节旋松蝶形螺丝，松开齿轮压板。转动下调节齿轮向左转使下冲芯杆上升，则充填深度减少（药片重量减轻）。调节好后将轮齿压板按上，旋紧蝶形螺丝。(4)Adjustment of tablet hardness

18、硬度调节旋松连杆锁紧螺母、转动上冲芯杆，向左转使上冲芯杆向下移动，则压力加大，压出的药片硬度增加；反之，硬度降低。调节好后用扳手卡住上冲芯杆下部的六方，将连杆锁紧螺母锁紧。现在学习的是第24页，共34页4.Tablet compression压片冲模的安装、调试完成后，即可启动电机试压，检查片重、硬度和表面光洁度等，质量如合格，即可投料批量生产。在生产过程中仍须随时检查药片质量，及时调整。现在学习的是第25页，共34页5.Quality control of tabletsAfter manufacturing tablets,a series of tests are carried out

19、 to assure that they meet the specifications of pharmacopoeia or industry standards.These tests are as listed on the right:WeightWeight variationDisintegrationHardnessFriabilityDissolutionDrug content uniformityThickness现在学习的是第26页，共34页(1)Tablet weight and weight variationThe quantity of fill placed

20、in the die cavity of a tablet press determines the weight of the resulting tablet.Weight variation:sample amount 20 tablets.Tablets should comply with the following requirements stated in the table below.Average weightWeight variation limitLess than 0.3 g 7.5%0.3 g or more 5%现在学习的是第27页，共34页(2)Tablet

21、 hardnessIn general,tablets should be sufficiently hard to resist breaking during normal handling,packaging and shipping,and yet soft enough to disintegrate properly after swallowing.Hardness of the tablet is controlled by(or is affected by)the degree of the pressure applied during the compression s

22、tage.现在学习的是第28页，共34页(2)Tablet hardnessSample amount 4 tablets.现在学习的是第29页，共34页(3)Tablet disintegration testTablets must be tested to ensure disintegration.The CP,BP,USP and EP have official standards,including descriptions of the apparatus type dimensions and test conditions.现在学习的是第30页，共34页(3)Tablet

23、disintegration testSample amount 6 tablets.现在学习的是第31页，共34页(4)Tablet friabilityThis test shows the strength of tablets against mechanical attrition.Method:allowing the tablets to roll and fall within the rotating apparatus(friabilator);determine the loss in weight;Requirement:weight loss 1%现在学习的是第32页

24、，共34页(4)Tablet friability现在学习的是第33页，共34页Experimental Instructions1.Aspirin acid should be milled and forced through screen(80 mesh),then mix with excipients,usually we use the method that mass increased as others increased,screen and mix several times to insure uniformly mixed.2.The dosage of adhesives should be aptitude to make the soft material be conglomeration in hand and when fingers press it slightly,it should disperse but does not turn into powders.现在学习的是第34页，共34页