阿奇霉素分散片的处方设计和质量研究.docx
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阿奇霉素分散片的处方设计和质量研究.docx
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阿奇霉素分散片的处方设计和质量研究
一、前言..............................................................................................................................4
1.1抗生素概述..................................................................................................................4
1.1.1抗生素的发现.........................................................................................................4
1.1.2抗生素的发展........................................................................................................4
1.2.阿奇霉素概述............................................................................................................6
1.2分散片的优缺点............................................................................................................7
1.2.1阿奇霉素的发现及发展..........................................................................................8
1.2.2阿奇霉素的相关剂型...............................................................................................9
1.3、分散片简介...............................................................................................................10
1.3.1分散片的定义及发展............................................................................................10
1.3.2分散片的优缺点.....................................................................................................10
1.3.3工艺设计的要求及注意点....................................................................................11
二、阿奇霉素的理化性质及合成..................................................................................11
2.1.阿奇霉素的理化性质..............................................................................................11
2.2.阿奇霉素的合成......................................................................................................12
2.2.1仪器..........................................................................................................................12
2.2.2药品...........................................................................................................................12
2.2.3制备过程..................................................................................................................12
三、阿奇霉素分散片的处方设计方案和质量研究........................................................13
3.1实验仪器...................................................................................................................13
3.2实验药品...................................................................................................................13
3.3处方设计...................................................................................................................14
3.4阿奇霉素分散片的制备...........................................................................................14
3.5相关辅料的选择…………………………………………………………………...14
3.5.1润滑剂的选择........................................................................................................15
3.5.2稀释剂的选择.........................................................................................................15
3.5.3矫味剂的选择..........................................................................................................16
3.6分散片的检查...........................................................................................................16
3.6.1外观检查..................................................................................................................16
3.6.2重量差异限度的检查..............................................................................................16
3.6.3硬度检查..................................................................................................................17
3.6.4溶出度检测..............................................................................................................17
3.6.5脆碎度检查..............................................................................................................19
3.6.6崩解时限检查..........................................................................................................20
四、结论............................................................................................................................21
参考文献...........................................................................................................................22
致谢.............................................................................................................................24
阿奇霉素分散片的处方设计和质量研究
[摘要]阿奇霉素是一种常用的大环内酯类抗生素,本文以红霉素为原料经贝克曼(Beck-man)重排反应、还原、水解、N-甲基化还原反应制得到备大环内酯类药物阿奇霉素。
采用湿法制粒压片法制备阿奇霉素分散片,并进行了阿奇霉素分散片的处方设计和质量研究,主要通过控制变量法来对阿奇霉素的种类、用量以及配伍组合进行研究探讨,从而得出最适宜的处方为:
主药:
32.5g、PVPP(交联羟甲基吡咯烷酮)6g、CCNA(交联羧甲基纤维素)6g、CMS-Na(羧甲基淀粉钠)1.5g、MCC(羟甲基纤维素)15g,各种崩解剂的混合使用。
这样所得的阿奇霉素分散片的外观光洁美观、硬度检查、崩解时限等指标最好。
[关键词]阿奇霉素分散片处方设计质量研究
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- 关 键 词:
- 霉素 分散 处方 设计 质量 研究