片 剂 ( tablets )

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1 片 片Tablets

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片 剂 ( Tablets ). 主要讲解内容. 片剂的概念、特点; 片剂的分类; 片剂的辅料; 片剂的制备 片剂的质量检查 片剂的包衣 举例说明不同类型药物的片剂制备. 一、片剂的基本概念. (一)、片剂的定义 指药物与适宜辅料均匀混合,通过制剂技术压制而成的圆片状或异形片状的固体制剂,可供内服、外用,目前临床应用最广泛的剂型之一。. (二)、片剂的特点. 1. 片剂的优点 种类多,用途广,能适应多种临床用药需求 剂量准确,携带贮存运输和使用方便 质量稳定,保存时间长。 适应机械化大生产,产量高,成本低 易于识别,可压印名称含量标记. - PowerPoint PPT Presentation

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  • Tablets

  • 1.

  • 2.

  • () 2005

  • 1.(Compressed tablets)0.1g0.5gB1 (Coated tablets)(sugar coated tablets)(film coated tablets)(enteric coated tablets) (Multilayer tablets)(Tablets by dry coating) (Model tablets)

  • 2.

    (Buccal tablets, Toroches) (Buccal patch) (Chewable tablets)(Sublingual tablets)(Vaginal tabets)(Implant tabets)(Hypodermic tablets)

  • 3.

    (Immediate release tablets) (Sustained release tablets)(Controlled release tablets)(Dispersible tablets )(Effervescent tablets)#/CO2 (Solution tablets)

  • 4.

  • AdjuvantsAdditivesExcipients() ()

  • ()(Fillers)(Diluents)(Absorbents)5mm100mg (50mg)

  • (Starch)#200-980MW 104-105 20%1.

  • -Pregelatinized starch

    (Lactose)# -

  • (Dextrin)MW 102-10480%

    (Sugar)

  • MannitolSorbitol

  • 2.

    (Microcrystalline cellulose, MCC)# 101102

    (Powdered cellulose)1500MW 2.43105,

  • (Calcium sulphate) 70C

  • ()Moistening agents

    (Distilled water)

    (Ethanol)()

  • ()Adhesives)

    1.#hydroxypropylmethylcellulose,HPMC 2%5%550cPas hydroxypropylcellulose,HPC(MCC)methylcellulose,MC (carboxymethylcellulose ,CMC-Na ethylcellulose,EC

  • 2polyvinylpyrrolidine,PVP#K15K30K90 10% PVP K30 3.(Starch slurry) 70C520% (Dextrin) (Sugar and Syrup) 1070g/g

  • 4.(Mucilage)5101025

  • ()(Disintegrants)

    +>> >>

  • 1. croscarmellose sodium,CCNa Ac-Di-Sol 0.5%5%

    2. crospovidone, PVPP0.5%5% 3. carboxymethyl starch sodium, CMS-Na#2

  • 4.L-HPC#500%700% 25

    5. 5%20%

    6. 80SDS

  • ()(Lubricants)

    1.(glidants)(anti-adherents)(lubricants)

    ()200

  • 2. 60

  • 3.(Magnesium stearate)0.3%1% (Talc) 5%(Hydronated plant oil)

  • PEG PEG4000600050um

    Sodium dodecyl sulphate,SDS

  • Colloidal silicon dioxide, aerosil100-350m2/g 0.15%3% Aerosil

    Talc

  • ()

    Color additives, Colorants, Coloring agents

    Aromatizing agents,

    Sweetening agents

  • wet granulation

  • 2.12345 3.

  • ()Granulation

  • 1.# (Extrusion) (1).1) 801001202) 3)

  • (2). 12-20

  • 2#(Wheeling)+2-3mm

  • 3.#(Fluid bed) 30-80

  • 4.#(Spray dry) 50%60%()

  • 5.#(High-velocity shearing)

    ()()()

  • 6.#(Compound device)++

  • 7.Spherical crystallization in liquids

  • (Drying)

  • (Re-granulation)

  • ()(Tableting) 1.

    1() ()%+=100 mg /50%=200mg7.5%185-215mg

  • 2.

  • # (Single punch tablet press)

  • 12

    123

  • 123456

  • ()

  • #(Rotary tablet press)()()(////) 161927335575

  • Dry granulation and press tablets 12.

  • 31pressure roll process

    2double compressionslugging method19mm5-20g

  • (press tablets directly)

  • 1

    C

  • 212123(MCC)()

  • /

  • (Capping, Laminating)#/

    (Cracking, Chipping)

  • Sticking, Binding

    (Delay of disintegration)

  • 5.(Variance of tablet weight beyond the limit)

    6.(Color changes or spots)

  • 7.(Disqualification of content uniformity)

    8.

  • (Tablet coating)1.

  • 2.

  • 3.

  • 1. 2. 3.

  • 1.#(Pan coating)+3040 2040/min

  • ( fluidized bed coating)

    compression coating123

  • ()(Film coating) 25

  • ()(Solvents)30%E30D ()(Plasticizers) ()

  • (Sugar coating) 1 // 30-35%10-15%65%:

  • +40C-50C3-5 +40C 55C15-1840C15-1840C(Glassing)2%24

  • ()(Apperance) 10075W60cm30cm30s

  • ()(Hardness)#

  • ()(Friability)#% 2000

  • Roche25r/min100(4min)1%()RH%40%

  • ()(Variance of tablet weight)%

  • ()(Content uniformity)
  • ()(Limit for disintegration time)2mm

  • 61000ml371C3032

  • ()(Dissolution)#

    ?

  • ()1000ml37C 0.5C50200

  • ()(Limit for microbes)

    1000/g100/g

  • ()( ) ()+()

  • (Examples)

  • () [] 400g 800g HPMC3% 180200g 80g 3g 1000

  • []+80HPMC141670C80C14

  • ()

  • [] 268g 136g 33.4g (17%) 15g 266g 0.25g 1000

  • []+1001/31470C12[]1. 100C105C2.

  • ()
  • [] 5g 50% 60g 0.7g 18g 1.5g 1000[] 50%

  • []+501655C16[] B2

  • [] 88.8g 38.0g 17% 10% (0.6g) 1.0g 1000(0.5mg/)

  • []301040C50-60 []

  • [] 1 57.5g 10% 10g 3.6g 1000

    Eudragit L100 28g 85% 560ml 80 5.6g 16.8g 5.6g 16.8g

  • []1080-90C5g12Eudragit85%80

    []