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第十五章 药物制剂的设计 PowerPoint PPT Presentation


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第十五章 药物制剂的设计. 复习. 举例说明流变学在药剂学(乳剂、混悬剂、软膏剂)中的应用? 剂型设计、处方组成及制备、质量控制 混悬剂:助悬剂的选择、稳定性、流动性 乳剂:粘度(处方组成) 软膏剂:附着性、铺展性、粘度. 内 容 提 要. 药物制剂的设计基础 药物制剂处方前的研究工作(包括有关药物的文献检索,药物的物理化学性质测定以及药物制剂的优化设计)。重点讲述药物的 多晶型、药物的分配系数。 介绍药物的分析方法与药物的配伍及相容性。 制剂处方的优化设计. 第一节 概 述. 新药研究与开发的起点:剂型设计 依据

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第十五章 药物制剂的设计

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  • 1. 2. 3.


  • 1.

  • 2.

  • 3.



1.


2.


3.


4.

5.


1

2

3

4

,


  • 1.

  • 2.


  • >60%

  • 30%<< 60%:

  • 30%< < 1%2%


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2

  • :

  • B


3

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    10~20


3.


>>>

  • 1.

  • pH



2.

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1.

2.



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1. IPA

(ASHP)1970750


2. Drug &pharmacology

  • ElsevierEMBASE

3. MEDLINE

  • MEDLARS 4000


4.

900

198950008001994

5.


1. RxList - The Internet Drug Index (http://www.rxlist.com)

RxListInternet4000

(1)


Keyword SearchSearch forSearch

(RxList-ID)

RxList-IDClick to Identify Imprint Code


(2)The Top200

200 979695The Top200 97200Brand NameManufacturerGeneral NameGeneral Name


2.PharmacokineticsPharmacodynamics and Biopharmaceutics homepage

http://griffin.vcu.edu/gkrishna/PK/pk.html

1Drug Metabolism Cytochrome P450s

2PK/PD Resources PKPD

3PK Equations PK Equations PK Solutions2.0


pKa


(o)(O)(w)(w)

  • (partition coefficients)

a(o) a(w)


C(o) ,C(w)



52000r/min10


  • P1:11:41:9

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()

1

()()


*2.

X

  • 30


1

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  • 1

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2

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  • dQ/dtDSC

  • DSC

    170.5


DSC

  • 358K(B)

  • 363K(A)358K


3

  • ()

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(Nujol)

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    1

  • 200

  • 180


2

() () pH(CPP)



  • 300MPaAB20%


4.

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-5-32120%4%1.4


2

-5-II


GB

3

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()


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:()


1.

  • 190nm~390nm



2.


3.

(ng)HPLC

4.


()

(TLC)


1205540DSCDTATLCHPLC

2552


1pH


2

3

4




(simplex optimization method)

  • nn+1


  • j


  • R(B)R(W)E




1


  • (orthogonal experiment design)


2(uniform design)


3


4central composite design)

  • 5

  • 12k2k1/2

    2

    3


  • 1985

  • 2002SFDA



  • 16234

    45 6


1

2

3

4

5

6

7

8

9



  • 32 123456


  • 789101112131415


  • 161718192021 22


  • 2324252627

  • 2829303132


  • 33


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