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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)%
()(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
[]