CN116617189B - 一种盐酸度洛西汀缓释胶囊及其制备方法 - Google Patents
一种盐酸度洛西汀缓释胶囊及其制备方法 Download PDFInfo
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Abstract
本发明属于医药技术领域,公开了一种盐酸度洛西汀缓释胶囊及其制备方法,包含盐酸度洛西汀、乳糖、微晶纤维素和硬脂酸镁,盐酸度洛西汀采用干法制粒,制粒压力为140‑160bar,颗粒粒径在600‑800µm范围。该缓释胶囊无需缓释材料,满足一日一次给药方式,同时克服现有技术因采用缓释材料导致量差而影响药物质量的技术问题。
Description
技术领域
本发明属于医药制剂领域,涉及一种盐酸度洛西汀缓释胶囊及其制备方法。
背景技术
盐酸度洛西汀是一种具有选择性的5-羟色胺和去甲肾上腺素再摄取的抑制剂,其主要作用是抑制这两种神经递质的再摄取,它对两种神经递质都有一定的抑制作用,可用于治疗某些心境疾病如抑郁症和焦虑症以及缓解中枢性疼痛如糖尿病外周神经病性疼痛和妇女纤维肌痛等,对妇女应激性尿失禁症治疗也有效。
盐酸度洛西汀为白色或类白色结晶性粉末或粉末,微溶于水,在酸性条件下不稳定,易于降解,所以适宜制成肠溶制剂以抵御胃液对药物的破坏。但普通常释型的盐酸度洛西汀肠溶胶囊制剂,需每日多次服用。因此,提供一种具有肠溶缓释功能的盐酸度洛西汀缓释药物是十分必要的。如专利CN100525760C通过在处方中添加高分子骨架缓释材料(羟丙基纤维素),调节释放速度,实现一日一次服用。专利CN103637997B通过在处方中加入缓释材料海藻酸钠达到缓释效果。但羟丙基纤维素、海藻酸钠等缓释材料通常是由多分散性分子群组成,并非单一组分,不同生产批次其组成通常会有一定差异,由此带来的质量差异不可避免,进而影响药物释放。
发明内容
本发明提供一种盐酸度洛西汀缓释胶囊,采用干法制粒将盐酸度洛西汀原料制备成600-800µm的硬颗粒,通过减小原料的比表面积、提高颗粒硬度达到缓释效果。
本发明的一种盐酸度洛西汀缓释胶囊,包含盐酸度洛西汀、乳糖、微晶纤维素和硬脂酸镁,盐酸度洛西汀采用干法制粒,制粒压力为140-160bar,颗粒粒径在600-800µm范围。
优选的,上述本发明的盐酸度洛西汀缓释胶囊,包含重量份的盐酸度洛西汀20-40份、乳糖40-60份、微晶纤维素40-50份和硬脂酸镁1-1.5份。
优选的,上述本发明的盐酸度洛西汀缓释胶囊,包含重量份的盐酸度洛西汀30份、乳糖50份、微晶纤维素48.7份和硬脂酸镁1.3份。
优选的,上述本发明的盐酸度洛西汀缓释胶囊,单一剂量包含盐酸度洛西汀30mg、乳糖50mg、微晶纤维素48.7mg和硬脂酸镁1.3mg。
本发明还提供了一种本发明的盐酸度洛西汀缓释胶囊的制备方法,包括以下步骤:
1)称取处方量的盐酸度洛西汀,采用干法制粒机制粒,制粒压力为140-160bar,制备成粒径为600-800µm的颗粒;
2)步骤1)所得颗粒加入处方量的乳糖、微晶纤维素,混合;再加入处方量的硬脂酸镁,混合均匀;
3)装入肠溶胶囊即得。
优选的,上述本发明的方法,步骤2)中,加入乳糖、微晶纤维素的混合时间为10分钟。
优选的,上述本发明的方法,步骤2)中,加入硬脂酸镁的混合时间为5分钟。
有益效果:本发明的盐酸度洛西汀缓释胶囊,通过控制盐酸度洛西汀的制粒压力和颗粒粒径,在无需缓释材料的存在下,成功实现了盐酸度洛西汀缓释释放,达到一日一次的给药效果,克服了常规缓释制剂因加入缓释材料引起的质量差异而影响药物释放效果的缺点。
附图说明
图1为实施例1~2和比较例1~3的盐酸度洛西汀缓释胶囊样品在pH6.8的磷酸缓冲液中的溶出度试验结果曲线图。
具体实施方式
以下实施例为代表性的,用于进一步阐明和理解本发明的实质,但不以任何方式限制本发明的范围。
实施例1盐酸度洛西汀缓释胶囊
处方(10000粒):
盐酸度洛西汀300g
乳糖500g
微晶纤维素487g
硬脂酸镁13g
制备工艺:
(1)按处方量称取盐酸度洛西汀,采用干法制粒机制粒,制粒压力为140bar,制备成粒径为600-800µm的颗粒;
(2)步骤(1)所得颗粒加入处方量的乳糖、微晶纤维素,混合10分钟;再加入处方量的硬脂酸镁,混合5分钟;
(3)装入肠溶胶囊;
(4)包装,即得。
实施例2盐酸度洛西汀缓释胶囊
处方(10000粒):
盐酸度洛西汀300g
乳糖500g
微晶纤维素487g
硬脂酸镁13g
制备工艺:
(1)按处方量称取盐酸度洛西汀,采用干法制粒机制粒,制粒压力为160bar,制备成粒径为600-800µm的颗粒;
(2)步骤(1)所得颗粒加入处方量的乳糖、微晶纤维素,混合10分钟;再加入处方量的硬脂酸镁,混合5分钟;
(3)装入肠溶胶囊;
(4)包装,即得。
比较例1盐酸度洛西汀缓释胶囊
处方(10000粒):
盐酸度洛西汀300g
乳糖500g
微晶纤维素487g
硬脂酸镁13g
制备工艺:
(1)按处方量称取盐酸度洛西汀,采用干法制粒机制粒,制粒压力为140bar,制备成粒径为300-500µm的颗粒;
(2)步骤(1)所得颗粒加入处方量的乳糖、微晶纤维素,混合10分钟;再加入处方量的硬脂酸镁,混合5分钟;
(3)装入肠溶胶囊;
(4)包装,即得。
比较例2盐酸度洛西汀缓释胶囊
处方(10000粒):
盐酸度洛西汀300g
乳糖500g
微晶纤维素487g
硬脂酸镁13g
制备工艺:
(1)按处方量称取盐酸度洛西汀,采用干法制粒机制粒,制粒压力为140bar,制备成粒径为900-1200µm的颗粒;
(2)步骤(1)所得颗粒加入处方量的乳糖、微晶纤维素,混合10分钟;再加入处方量的硬脂酸镁,混合5分钟;
(3)装入肠溶胶囊;
(4)包装,即得。
比较例3盐酸度洛西汀缓释胶囊
处方(10000粒):
盐酸度洛西汀300g
乳糖500g
微晶纤维素487g
硬脂酸镁13g
制备工艺:
(1)按处方量称取盐酸度洛西汀,采用干法制粒机制粒,制粒压力为80bar,制备成粒径为600-800µm的颗粒;
(2)步骤(1)所得颗粒加入处方量的乳糖、微晶纤维素,混合10分钟;再加入处方量的硬脂酸镁,混合5分钟;
(3)装入肠溶胶囊;
(4)包装,即得。
实验例1溶出度试验
按《中国药典》2020版释放度试验浆法进行,测定各实施例1-2和比较例1-3的盐酸度洛西汀缓释胶囊样品在pH6.8的磷酸缓冲液中的溶出度,试验温度37±0.5℃。试验结果见表1和图1。
表1 实施例1~2和比较例1~3的样品在pH6.8的磷酸缓冲液中的溶出度
由溶出度试验结果可知,将原料盐酸度洛西汀采用干法制粒机制粒,制粒压力为140-160bar,制备成600-800µm的颗粒,再加入乳糖等辅料制备所得的样品,在pH6.8磷酸缓冲液中能够达到较满意的缓释效果;当原料盐酸度洛西汀制粒后的粒度较小(如300-500µm)时,制备所得的样品有一定缓释效果但缓释时间较短;当原料盐酸度洛西汀制粒后的粒度较大(如900-1200µm)时,制备所得的样品有缓释效果但样品难以溶出,在5h以后溶出缓慢,8h时仅溶出了约70%;当原料盐酸度洛西汀制粒时的制粒压力较小(如80bar)时,制备所得的样品有缓释效果但释放仍略快,未能达到较满意效果。
以上实施例是代表性的,任何在本发明的精神实质下进行的简单修饰和变通也属于本发明的保护范围。
Claims (7)
1.一种盐酸度洛西汀缓释胶囊,由盐酸度洛西汀、乳糖、微晶纤维素和硬脂酸镁组成,其特征在于:盐酸度洛西汀采用干法制粒,制粒压力为140-160bar,颗粒粒径在600-800µm范围。
2.如权利要求1所述的盐酸度洛西汀缓释胶囊,包含重量份的盐酸度洛西汀20-40份、乳糖40-60份、微晶纤维素40-50份和硬脂酸镁1-1.5份。
3.如权利要求2所述的盐酸度洛西汀缓释胶囊,包含重量份的盐酸度洛西汀30份、乳糖50份、微晶纤维素48.7份和硬脂酸镁1.3份。
4.如权利要求3所述的盐酸度洛西汀缓释胶囊,单一剂量包含盐酸度洛西汀30mg、乳糖50mg、微晶纤维素48.7mg和硬脂酸镁1.3mg。
5.一种权利要求1-4的任一盐酸度洛西汀缓释胶囊的制备方法,包括以下步骤:
1)称取处方量的盐酸度洛西汀,采用干法制粒机制粒,制粒压力为140-160bar,制备成粒径为600-800µm的颗粒;
2)步骤1)所得颗粒加入处方量的乳糖、微晶纤维素,混合;再加入处方量的硬脂酸镁,混合均匀;
3)装入肠溶胶囊即得。
6.如权利要求5所述的方法,步骤2)中,加入乳糖、微晶纤维素的混合时间为10分钟。
7.如权利要求5所述的方法,步骤2)中,加入硬脂酸镁的混合时间为5分钟。
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Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101939004A (zh) * | 2008-01-25 | 2011-01-05 | 阿尔法制药有限公司 | 度洛西汀的缓释药物组合物 |
CN102579403A (zh) * | 2011-12-26 | 2012-07-18 | 天津市嵩锐医药科技有限公司 | 盐酸度洛西汀药物组合物 |
CN103520131A (zh) * | 2013-10-12 | 2014-01-22 | 浙江华海药业股份有限公司 | 盐酸帕罗西汀半水合物胶囊的制备方法 |
CN104414993A (zh) * | 2013-08-20 | 2015-03-18 | 天津药物研究院 | 一种盐酸度洛西汀肠溶微丸胶囊及其制备方法 |
CN104856972A (zh) * | 2015-03-27 | 2015-08-26 | 华北制药股份有限公司 | 阿莫西林胶囊及其制备方法 |
CN107412198A (zh) * | 2017-03-27 | 2017-12-01 | 北京万全德众医药生物技术有限公司 | 盐酸度洛西汀肠溶缓释颗粒剂及其制备方法 |
CN107432871A (zh) * | 2016-05-26 | 2017-12-05 | 天津市汉康医药生物技术有限公司 | 一种盐酸度洛西汀肠溶胶囊及其制备方法 |
JP2018008917A (ja) * | 2016-07-15 | 2018-01-18 | 富士化学工業株式会社 | 腸放出粒子組成物 |
CN108014087A (zh) * | 2017-12-27 | 2018-05-11 | 江苏联环药业股份有限公司 | 一种盐酸舍曲林胶囊的制备方法 |
CN108210475A (zh) * | 2016-12-13 | 2018-06-29 | 河南后羿实业集团有限公司 | 一种阿莫西林胶囊及其制备方法 |
CN112274490A (zh) * | 2020-11-19 | 2021-01-29 | 四川尚锐生物医药有限公司 | 一种氨氯地平氯沙坦钾复方组合物的制备方法 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100040680A1 (en) * | 2008-08-15 | 2010-02-18 | Felix Lai | Multiparticulate selective serotonin and norepinephrine reuptake inhibitor formulation |
WO2011077451A2 (en) * | 2009-12-22 | 2011-06-30 | Abbott Healthcare Private Limited | Controlled release pharmaceutical composition |
-
2023
- 2023-07-26 CN CN202310922891.5A patent/CN116617189B/zh active Active
Patent Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101939004A (zh) * | 2008-01-25 | 2011-01-05 | 阿尔法制药有限公司 | 度洛西汀的缓释药物组合物 |
CN102579403A (zh) * | 2011-12-26 | 2012-07-18 | 天津市嵩锐医药科技有限公司 | 盐酸度洛西汀药物组合物 |
CN104414993A (zh) * | 2013-08-20 | 2015-03-18 | 天津药物研究院 | 一种盐酸度洛西汀肠溶微丸胶囊及其制备方法 |
CN103520131A (zh) * | 2013-10-12 | 2014-01-22 | 浙江华海药业股份有限公司 | 盐酸帕罗西汀半水合物胶囊的制备方法 |
CN104856972A (zh) * | 2015-03-27 | 2015-08-26 | 华北制药股份有限公司 | 阿莫西林胶囊及其制备方法 |
CN107432871A (zh) * | 2016-05-26 | 2017-12-05 | 天津市汉康医药生物技术有限公司 | 一种盐酸度洛西汀肠溶胶囊及其制备方法 |
JP2018008917A (ja) * | 2016-07-15 | 2018-01-18 | 富士化学工業株式会社 | 腸放出粒子組成物 |
CN108210475A (zh) * | 2016-12-13 | 2018-06-29 | 河南后羿实业集团有限公司 | 一种阿莫西林胶囊及其制备方法 |
CN107412198A (zh) * | 2017-03-27 | 2017-12-01 | 北京万全德众医药生物技术有限公司 | 盐酸度洛西汀肠溶缓释颗粒剂及其制备方法 |
CN108014087A (zh) * | 2017-12-27 | 2018-05-11 | 江苏联环药业股份有限公司 | 一种盐酸舍曲林胶囊的制备方法 |
CN112274490A (zh) * | 2020-11-19 | 2021-01-29 | 四川尚锐生物医药有限公司 | 一种氨氯地平氯沙坦钾复方组合物的制备方法 |
Non-Patent Citations (2)
Title |
---|
Preparation and evaluation of duloxetine hydrochloride enteric-coated pellets with different enteric polymers;Chen Kuang,等;Asian Journal of Pharmaceutical Science;第12卷;216-226 * |
盐酸度洛西汀肠溶胶囊的研究;冯佳;中国优秀硕士学位论文全文数据库 工程科技Ⅰ辑(第1期);B016-1486 * |
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