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软胶囊生产基本知识 PowerPoint PPT Presentation


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软胶囊生产基本知识. 培训的目的. 1 、加强大家对软胶囊产品及加工工艺过程的了解。 2 、帮助大家解决软胶囊生产过程中出现的问题,提高软胶囊产品的质量。. 内容. 1 、软胶囊定义 2 、软胶囊的特点 3 、软胶囊的发展史 4 、软胶囊的制备及工艺 4.1 、软胶囊的配方设计 4.2 、软胶囊的设备及应用 4.3 、软胶囊的生产工艺过程 4.4 、影响软胶囊的因素 4.5 、生产过程的控制及测定指标 5 、软胶囊存在的问题 6 、软胶囊的检测. 软胶囊定义.

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软胶囊生产基本知识

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1

2

3

4

4.1

4.2

4.3

4.4

4.5

5

6


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  • 1


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  • Mothesh DuBlanc

  • 1933Robert P.Scherer

  • RJNJ 2

  • 9040


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  • 1995BioprogressXXgelXXPVABioprogress32007XX20


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  • 1

  • 2


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1

  • 1

  • 2

  • 3

  • 4

  • 5 )

  • 6

  • 7

  • 8

  • 9 PH


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  • ,


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ABApH79BpH4.75.2ABAB356.67604.34.7mPa12.56018.520.5mPa


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  • 150250Bloom


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0.311.810.40.6111

0.30.510.40.610.6111.51


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515

D 2546

2030

510

1015

1320


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2530407%2530403

=100100


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1. 0.0150.2

2. 0.010.02

3. 0.020.5


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1N,NN200600

2

1.HLBHLB

HLB13

HLB36 W/O

HLB79

HLB818 O/W

HLB1518


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2025HLB10

2080

3530HLB10

206080Crodet04Cithrol 2MS

4HLBHLBHLB


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30.010.15

a) Butylated hydroxyanisoleBHA0.02

b) E 0.0010.05

c) Butylated hydroxytoluneBHT0.02

d) Propyl gallate0.010.1

4


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35

34

PH3.07.5


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1

Migylol812813

a) Migylol812813

b)

10

c)

Migylol 812


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d)

e)

f)

g)

h)

i)

j)

k)

l)


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a

b

c

d18C

e12C

2

PEG200~600

PG

99.5


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0525407

0.2ml300ml37,

37200rmp60100250nm1010


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A 6080

B

C 40751234

A 6080

B 4075


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1.5

20

pH2.57.5

0.0015


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2.PEGPEGPEG510PEGPEG400

3.80

4.80PEG400


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16PVP


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PEG400,PEG600,PEG3350,PEG8000,PVP,Carbomer9347580

1

/


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23


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<5L/61

<4L/24h

HSR-250


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a)

b)

c)

d)


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()


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GMP


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GMP


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HSZJHSZJ

HSZJGMP


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92~96


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30-3525%224-512-16


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1

2

3

1

2

3


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1

250L 175200kg

500L 350400kg

750L 500600kg

1000L 700800kg

250500L 3045min

7501000L 4560min


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6575

8570

2025

1045min

60


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pH


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2

122


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5

20421282

20342


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0.0062.54cm/

2

220

2

2


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1.82.2


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9511590115210

2

8


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NLT99.0100.5

94.0106.0

NMT2

97.0102


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8%

60

NLT20

11.513.5

3

NMT3.5

7.5

5.0

NMT30


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QC

300500QC

QC

A IR

B HPLC

7.5

5.0

530min

10.514.5

45min80%

(50rpm900ml370.1NHCl)


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95105

NMT0.1

NMT0.51.0

NMT1000/g

NMT100/g


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QC70

10110

2050kg5001000kg

250L500L750L1000L

rpm

253045


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rpm5rpm

rpm

A

B

C


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2545

3


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25kg500kg1000kg

kg rpm 15


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20kg

30403

15203

90180


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3015


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150um

2


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20202020307.55.0

/kg1020kg120kg6090901203490120


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42

20


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