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固体制剂- Ⅰ (散剂、颗粒剂、片剂、片剂的包衣). 张娜. 目的要求. 1 .了解散剂、颗粒剂的制备方法,常用设备、质量标准、包装与贮存;掌握基本理论、常用术语及剂型特点。 2 .了解片剂的特点、分类、质量要求、常用设备、包装材料与贮存等。 3 .掌握片剂常用的辅料的特点与应用;片剂制备工艺过程;包衣过程、种类、目的;片剂制备的基本理论和常用术语。. 第一节 概述. 固体制剂的制备工艺. 图 4 - 1 固体剂型的制备工艺流程图. 固体剂型的体内吸收. - PowerPoint PPT Presentation
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Noyes-Whiney
Noyes-Whiney
K D V SCsCt
Noyes-Whiney
Powders
1D1D2n
3
1
2
1
2
100100100100
123
4V
1. (1) 5,,,, 2 3 4 ,,
(CRH)(CRH)CRHCRHCRHAB = CRHA CRHBCRH1CRH23CRH
0.1~0.01g1090.01~0.001g1000.001g1000
Granules
105500um
12345
5131(2000m4250m82.0
10g200ml5
tablets1
tablets
2
(compressed tablets)(coated tablets)(multilayer tablets)(chewable tablets)(buccal tablets)(sublingual tablets)(solution tablets)(vaginal tablets)(effervescent tablets)(implant tablets)(hyperdemic tablets)
excipients
1234
diluentsfillers5mm50mg
1.starch 2. sucrose 3. dextrin 4. lactose 5. pregelatinized starch
6. (microcrystalline celluloseMCC) 7. 8. mannitol
1. 2. 30%70%
1 8%15%10%
2
1MC2HPC3HPMC 550cPas2%5%4CMC-Na 2%10%5EC EC
3 PVP
10%
PVPPVPK152500PVPK306000PVPK90300000
PVPK303%15%
4. 10%20%5PEGPEG4000PEG6000PEG6. 50%70%g/g
1
2300
3 4
1.
2CMS-Na 300
3.L-HPC 4.CCNa
5. PVPP
6.
7.
80
1
2
350%75%25%50%
25%50%50%75%
1
2
3
4
5PEG PEG4000PEG6000
6
3.13.23.33.43.5
25mg
3.1
()
1 2 3 50%60%
YK60
2025mm
1.
MCCHPMCPVPMCC
2.
1 2 3
1. 2. 3.
V
HZD
1
2
()
1
2
3 4 5
1 2 3
CJY300B
78X-2
40.3g7.5%0.3g5%202111/3
5
15min30min2h1h
6
701985
7
10mg5%
1.
Eudragit E100HPMCHPC
2.
151865%75%g/g1002030min40551518
3.
401015
4.
815
5.
2%
5.2 HPMCHPCECPEGPVP PEG
1
HPMCHPCCMC-NaHPMC
PVPPEG
,Eudragit
Eudragit E100Eudragit E
Eudragit LEudragit SEudragit L30D
Eudragit L100Eudragit S100
Eudragit RSEudragit RL
2
Eudragit RSEudragit RL
ECHPMCPEG
3pH
CAP
Eudragit LEudragit SEudragit L30DEudragit L100Eudragit S100
HPMCPCAP
HPMCAS CAPHPMCP
2 PEG300PEG400
3 PEG
6.1 6.2 6.3 6.4 6.5 6.6 6.7
6.1 1000 268g 136g 33.4g 266g(17%) q.s 15g 0.25g
6.1 1/312
6.2 100mgVB2(1000 5g 50% Q.S. 26g 0.7g 42g
6.3
6.4 E1000 E 5g 38.5g 95% 4g 10g 30g 15% 35g 41g 1g
6.5
6.5 1000 262g 40g 60g 7g 60g 20g
6.6 CO2
6.6 1000 20 325g 2050g 305g 520g
6.7 1000 30g 10g 25g 1g 23g 1g