健脾固肾颗粒的制备工艺和质量标准研究.docxVIP

健脾固肾颗粒的制备工艺和质量标准研究

目录

一、内容描述................................................2

1.1研究背景与意义.......................................3

1.2研究目的与内容概述...................................4

二、材料与方法..............................................4

2.1原料选择与鉴定.......................................5

2.1.1原料来源与采收...................................6

2.1.2原料质量标准.....................................8

2.2制备工艺路线设计.....................................8

2.2.1制备方法的选择..................................10

2.2.2工艺流程优化....................................11

2.3验证方法与质量控制..................................12

2.3.1验证试验设计....................................14

2.3.2质量标准制定....................................15

三、健脾固肾颗粒的制备工艺.................................16

3.1原料处理与提取......................................16

3.1.1原料预处理......................................18

3.1.2提取方法与条件..................................19

3.2制剂制备与工艺控制..................................20

3.2.1制剂制备方法....................................22

3.2.2关键工艺参数确定................................23

3.3中间体检验与控制....................................24

3.3.1中间体检测方法..................................26

3.3.2中间体质量标准..................................27

四、健脾固肾颗粒的质量标准研究.............................28

4.1性状鉴别............................................28

4.1.1外观性状描述....................................29

4.1.2显微鉴别方法....................................30

4.2定量分析方法........................................31

4.2.1高效液相色谱法..................................32

4.2.2薄层色谱法......................................33

4.3稳定性研究..........................................35

4.3.1长期稳定性考察..................................36

4.3.2加速稳定性考察..................................37

五、结论与展望.............................................38

5.1研究成果总结........................................39

5.2存在问题与改进方向..................................40

5.3未来展望.........................