论文总字数：22730字

摘 要

目的：盐酸齐拉西酮为苯并异噻唑取代哌嗪类非典型抗精神病药物，通过对5-羟色胺多巴胺（如5-HT₂a/D₂）的作用起效。与传统抗精神病药物相比 , 本品除可改善阳性症状外,还可改善阴性症状,提高认知功能，不良反应特别是锥体外系列症状大大减轻，耐受性明显提高，提高认知功能。不良反应特别是锥体外系症状大大减轻,耐受性明显提高。本品对阴性的疗效相当甚至更好，且不引起体重增加和血清泌乳素水平升高,不良反应较小。本论文对其工艺进行研究，通过对其处方进行筛选，制成盐酸齐拉西酮分散片。

方法：根据处方组成的理化性质，设计了制备工艺路线。实验以崩解时限等为指标，筛选处方中崩解剂、助悬剂、填充剂等最佳辅料种类；通过正交实验，确定最佳处方并制备盐酸齐拉西酮分散片；并对样品的外观、性状、硬度、脆碎度、崩解时限、分散均匀性、含量测定、溶出度等质量指标进行了研究。

结果:通过筛选的优化处方为: 盐酸齐拉西酮,MCC 30%,PVPP 5%,微粉硅胶1%,乳糖适量,3%PVP _{K 30},水溶液适量。

关键词：盐酸齐拉西酮；分散片；制备工艺。

Ziprasidone Hydrochloride Dispersible tablets

ABSTRACT

Objective: Ziprasidone Hydrochloride for different benzo thiazole replace piperazine kind of atypical antipsychotics, Dopamine in serotonin (5 - HT2a/D2) the role of the work. Compared with the traditional antipsychotic drugs, besides can improve positive symptoms, but also improve the negative symptoms, improve cognitive function, adverse reactions, especially in series of extrapyramidal symptoms significantly reducing, tolerance, improve cognitive function. Adverse reactions, especially in extrapyramidal symptoms significantly reducing, obviously improve the tolerance. This product quite even better with negative effect, and does not cause weight gain and serum prolactin levels, less adverse reaction. This thesis study of the process, through the prescription screening, made from ziprasidone hydrochloric dispersible tablets.Methods: According to the physicochemical properties of prescription composition, preparation process route design. Experiment with disintegration time as index, screening of disintegrants,filler, the suspending agent is the best accessories category; through orthogonal experiment, the best prescription and preparation of ziprasidone hydrochloride dispersible tablets; and the appearance, properties, hardness, friability, disintegration time, dispersible uniformity content determination, stripping of the quality index is studied.Results: The formulation was optimized by screening for: Ziprasidone Hydrochloride,MCC 30%,PVPP 5%, Micro powder silica gel 1%,Lactose,3%PVP _{K 30}，Double steaming water.

Key words: Ziprasidone Hydrochloride; dispersible tablets; preparation process.

目录

摘 要..............................................................................................................I

Abstract.............................................................................................................II

1. 文献综述...........................................................................................2

1.1 研究背景...................................................................................................2

1.2 盐酸齐拉西概述.......................................................................................3

1.2.1 盐酸齐拉西酮的理化性质................................................................4

1.2.2 盐酸齐拉西酮的药理作用................................................................4

1.2.3 盐酸齐拉西酮的药动学....................................................................4

1.2.3 盐酸齐拉西酮的临床应用................................................................4

1.2.5 盐酸齐拉西酮的副作用....................................................................4

1.3 分散片概述...............................................................................................5

1.3.1 制备分散片的意义............................................................................5

1.3.2 分散片的处方研究............................................................................5

1.3.2.1 药物...............................................................................................5

1.3.2.2 辅料...............................................................................................5

1.3.3 新技术在分散片研制中的应用........................................................7

1.3.4 分散片小结........................................................................................7

第二章 实验部分........................................................................................8

2.1 实验仪器与试剂.......................................................................................8

2.2 实验方法...................................................................................................8

2.2.1制备工艺的初步确定.........................................................................8

2.2.2基本处方.............................................................................................9

2.2.3制剂处方单因素筛选.........................................................................9

2.2.4制剂处方的优化.................................................................................11

2.2.5制剂工艺的优化考察.........................................................................12

2.3 小结...........................................................................................................14

第三章 结论与展望....................................................................................15

3.1 结论...........................................................................................................15

3.2 展望...........................................................................................................15

参考文献.........................................................................................................17

致谢..................................................................................................................19

文献综述

1.1 研究背景

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