盐酸帕罗西汀肠溶缓释胶囊的制备工艺及质量标准研究

盐酸帕罗西汀肠溶缓释胶囊的制备工艺及质量标准研究

摘  要

    本课题是运用现代制药技术将药物制成微丸，再填装在胶囊中，使药物缓慢的释放。经含药微丸粘合剂的筛选、缓释层处方筛选以及肠溶层处方筛选，确定了最佳生产工艺路线，并着重研究了缓释包衣处方、肠溶层处方工艺.结果表明，该工艺合理、稳定、可行。研究并制定了该制剂的质量标准，分别建立了鉴别、释放度的测定方法，采用高效液相色谱法测定盐酸帕罗西汀肠溶缓释胶囊中盐酸帕罗西汀的含量，本标准具有专属性强和重现性好的特点。经加速试验6个月及长期试验24个月稳定性考察结果表明:制剂基本稳定。因此，本制剂的处方工艺可用于工业大批量生产，产品质量能够保证临床用药的安全有效。

关键词: 盐酸帕罗西汀肠溶缓释胶囊，制备工艺，质量标准，稳定性

Abstract

This topic is makes using the modern drugs manufacture technology the medicine the micro pill, fills again in the capsule, causes the medicine slow release. After contains medicine micro pill bond screening, slow release level prescription screening as well as the intestines dissolves level prescription screening, had determined the best technique of production route, and studied the slow release coating prescription, the intestines to dissolve the level prescription craft emphatically. The result indicated that this craft reasonable, is stable, is feasible. Studied and has formulated this preparation quality specification, has established the distinction, release's determination method separately, used the highly effective liquid phase chromatography determination hydrochloric acid handkerchief Rowsey sandbank intestines to dissolve in the slow release capsule the hydrochloric acid handkerchief Rowsey sandbank content, this standard gauge has the specificity to be strong and reproduction quality good characteristic. After the acceleration test 6 months and the long-term test 24 month stability inspection result indicated: Preparation basic stable. 

Key words: Paroxetine Hydrochloride enteric sustained-release capsules ，PreParation Proeedure ，Quality  standard ， Preliminary stability ，Stability

目   录

1   引言  ………………………………………………………………………1

1.1  盐酸帕罗西汀缓释胶囊的特点…………………………………………………………1

1.2  盐酸帕罗西汀缓释胶囊与现有剂型比较………………………………………………1

2   处方及工艺研究  …………………………………………………………2

2.1  处方及其依据  …………………………………………………………………………2

2.2  处方筛选  ………………………………………………………………………………3

2.3  制备工艺研究  …………………………………………………………………………5

2.4  工艺总结  ………………………………………………………………………………7

3   质量研究…………………………………………………………………… 8

3.1   性状 ……………………………………………………………………………………8

3.2  鉴别 ……………………………………………………………………………………8

3.3   释放度  ………………………………………………………………………………8

3.4   含量 …………………………………………………………………………………16

4   稳定性试验数据及产品有效期的确定…………………………………18

4.1  稳定性试验 ………………………………………………………………………… 18

4.2  有效期确定 ………………………………………………………………………… 19

5  实验结果的总结及评价………………………………………………… 20

5.1  处方筛选与工艺研究过程 ………………………………………………………… 20

5.2  质量研究 …………………………………………………………………………… 21

5.3  稳定性试验 ………………………………………………………………………… 21

参考文献 …………………………………………………………………… 22

致谢 ………………………………………………………………………… 23