论文总字数：20342字

摘 要

本文以右兰索拉唑作为治疗GERD的药物，研究该药以双相缓控释技术制备的处方和工艺。在处方前研究中建立了测定溶出度的紫外分光光度法，建立了测定含量和耐酸力的高效液相色谱法。两种测定方法线性均良好。

采用挤出-滚圆法制备本品中含药丸芯，用两种不同的处方包衣得到不同的两种微丸，按一定比例装入胶囊中，得到成品。在处方筛选和工艺优化过程中，采用单因素考察各参数。最后筛选出最佳处方和工艺，参数条件为，挤出机挤出速度20Hz，孔板孔径0.5mm，黏合剂的浓度3%，崩解剂的比例5%，稀释剂微晶纤维素和甘露醇的比例为5：2；流化床包衣抛丸机转盘频率55Hz，风机频率30Hz；包衣喷雾气压0.18Mpa，风机30Hz，进风温度50℃，供液速度3 rpm→13 rpm；F丸和S丸最佳隔离层增重为15%，最佳肠溶层增重为50%。按以上参数和条件，制出了外观圆整、粒径均一度高、脆碎度、含水量都符合要求的微丸。含量、溶出度和耐酸力与原研比较，符合要求。

最后进行稳定性研究：自制样品，在基本考察项目合格后进行质量研究。以外观形状、溶出度、含量、有关物质等指标对右兰索拉唑缓释胶囊的稳定性进行了评价。

关键词： 右兰索拉唑 双相控制释放 肠溶微丸 单因素考察

Prescription Screening And process research of Dexlansoprazole Sustained - release Capsules

Abstract

In this paper, Dexlansoprazole as a drug for the treatment of GERD, the study of the drug prepared by the two-phase slow release technology prescription and technology. In the prescription study, an ultraviolet spectrophotometric method for the determination of dissolution was established, and a high performance liquid chromatography method was established for the determination of content and acid resistance. Both methods were linearly good.

Using the extrusion - roll round preparation of the product containing pellets core, with two different prescription coating to get two different pellets, according to a certain percentage into the capsule, the finished product. In the prescription screening and process optimization process, the use of single factors to study the parameters. Finally, the best prescription and process were selected. The parameters were as follows: extruder extrusion speed 20Hz, orifice plate diameter 0.5mm, adhesive concentration 3%, disintegrant ratio 5%, diluent microcrystalline cellulose and mannose The ratio of the alcohol is 5: 2; the fluidized bed coating shot blasting machine frequency is 55Hz, the fan frequency is 30Hz; the coating spray pressure is 0.18Mpa, the fan is 30Hz, the air inlet temperature is 50 ℃, the liquid supply speed is 3rpm → 13rr; Pills and S pill best isolation layer weight gain of 15%, the best enteric layer weight gain of 50%. According to the above parameters and conditions, made the appearance of round, the average particle size is high, crisp, water content are in line with the requirements of the pellets. Content, dissolution and acid resistance compared with the original study, meet the requirements.

Finally, the stability study: homemade samples, after the basic inspection project qualified for quality research. The stability of dexlansoprazole sustained-release capsules was evaluated by the indexes such as appearance shape, dissolution, content and related substances.

KEYWORDS：Dexlansoprazole；Biphasic controlled release；Enteric-coated pellets；Single factor study

目 录

摘 要 I

Abstract II

第一章 前言 1

1.1右兰索拉唑研究背景 1

1.1.1疾病研究背景 1

1.1.2治疗GERD的药物分类 2

1.1.3右兰索拉唑概述 2

1.2 双相释药缓控释制剂概述进展 3

1.3本论文的立题依据和主要研究内容 4

1.3.1立题依据 4

1.3.2主要研究内容 4

第二章 右兰索拉唑缓释胶囊处方筛选与优化 6

2.1体外分析方法的建立 6

2.2.1高效液相色谱法测定含量方法建立 6

2.2.2释放度测定方法及耐酸力分析方法的建立 6

2.3处方筛选 7

2.3.1试验仪器 7

2.3.2试验材料 8

2.3.3评价指标 8

2.3.4处方及工艺的初步拟定 9

2.3.5 F丸处方筛选和工艺摸索 10

2.3.6 S丸处方筛选和工艺研究 13

2.4结果与讨论 13

2.4.1高效液相色谱法测定含量方法建立 13

2.4.2释放度测定方法及耐酸力分析方法的建立 14

2.4.3处方筛选与工艺研究的评价指标 15

2.4.4 F丸处方筛选和工艺摸索 17

2.4.5隔离层包衣 19

2.4.6 S丸处方筛选和工艺研究 20

2.5本章小结 22

第三章 右兰索拉唑缓释胶囊质量研究及稳定性考察 23

3.1质量研究 23

3.1.1试验仪器 23

3.1.2试验材料 24

3.1.3含药微丸 24

3.1.4隔离层微丸 25

3.1.5肠溶衣包衣 26

3.1.6混合样品测定 27

3.1.7确定的处方与工艺 30

3.2稳定性实验 33

3.3本章小结 33

第四章 结论与展望 34

参考文献 35

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