CN106727401A - 一种药用辅料薄膜包衣材料及其制备方法 - Google Patents
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Abstract
本发明公开了一种药用辅料薄膜包衣材料及其制备方法,由以下质量份数配方成分组成:羟丙甲纤维素5‑7份、填充剂1‑3份、聚丙烯3‑5份、聚乙二醇2‑4份、纤维素醚1‑3份、白水泥2‑4份、聚乙二醇3‑5份、滑石粉11‑13份、氧化铁8‑12份、果胶16‑18份、吐温6‑10份、白土4‑6份、自来水10‑20份,本发明可增加喷雾速度,降低片床温度,降低膜内应力,减少衣膜开裂的发生率,而且不会发生基片粘连现象,用水做载体易发生基片粘连现象。
Description
技术领域
本发明涉及薄膜材料领域,具体而言涉及一种药用辅料薄膜包衣材料及其制备方法。
背景技术
薄膜包衣是近年来制剂高尖技术发展的重大成果之一,被认为是技术强、难度大、对产品质量影响大的技术,这种技术必须有可靠的检测手段为依据,并经得起实践和时间的考验,薄膜包衣是将聚合物包裹在固体剂型外的薄膜,膜厚通常为20-100微米.包衣材料按类型分为胃溶型、肠溶型、缓控释型。处方通常由下列组成:①成膜剂②增塑剂③色料/遮光剂④溶剂,该配方制成的药用辅料薄膜包衣材料容易开裂,使用不方便。
发明内容
本发明提供了一种药用辅料薄膜包衣材料及其制备方法,本发明可增加喷雾速度,降低片床温度,降低膜内应力,减少衣膜开裂的发生率,而且不会发生基片粘连现象,用水做载体易发生基片粘连现象。
为实现上述目的,本发明提供如下技术方案:
一种药用辅料薄膜包衣材料及其制备方法,由以下质量份数配方成分组成:羟丙甲纤维素5-7份、填充剂1-3份、聚丙烯3-5份、聚乙二醇2-4份、纤维素醚1-3份、白水泥2-4份、聚乙二醇3-5份、滑石粉11-13份、氧化铁8-12份、果胶16-18份、吐温6-10份、白土4-6份、自来水10-20份。
进一步:由以下质量份数配方成分组成:羟丙甲纤维素5份、填充剂1份、聚丙烯3份、聚乙二醇2份、纤维素醚1份、白水泥2份、聚乙二醇3份、滑石粉11份、氧化铁8份、果胶16份、吐温6份、白土4份、自来水10份。
进一步:由以下质量份数配方成分组成:羟丙甲纤维素6份、填充剂2份、聚丙烯4份、聚乙二醇3份、纤维素醚2份、白水泥3份、聚乙二醇4份、滑石粉12份、氧化铁10份、果胶17份、吐温8份、白土5份、自来水15份。
进一步:由以下质量份数配方成分组成:羟丙甲纤维素7份、填充剂3份、聚丙烯5份、聚乙二醇4份、纤维素醚3份、白水泥4份、聚乙二醇5份、滑石粉13份、氧化铁12份、果胶18份、吐温10份、白土6份、自来水20份。
进一步:本发明制备方法具有如下步骤:
步骤一、在常温下,将动力粘度为5mpa.s的羟丙甲纤维素、动力粘度为15mpa.s的羟丙甲纤维素、动力粘度为50mpa.s的羟丙甲纤维素、聚乙二醇4000,白水泥、滑石粉、白土过80目加厚振动筛;
步骤二、在常温下,将上述原料按配方称取所需用量,投入V型混合机,拧紧盖后,开启搅拌20-40分钟,搅拌后均匀投入正在搅拌的质量分数为80%乙醇溶剂中,搅拌30-50分钟后即可形成药用辅料薄膜包衣材料。
本发明的有益效果是:
1、本发明可增加喷雾速度,降低片床温度,降低膜内应力;
2、减少衣膜开裂的发生率,而且不会发生基片粘连现象;
3、用水做载体易发生基片粘连现象。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例一:
一种药用辅料薄膜包衣材料由以下质量份数配方成分组成:羟丙甲纤维素5-7份、填充剂1-3份、聚丙烯3-5份、聚乙二醇2-4份、纤维素醚1-3份、白水泥2-4份、聚乙二醇3-5份、滑石粉11-13份、氧化铁8-12份、果胶16-18份、吐温6-10份、白土4-6份、自来水10-20份。
实施例二:
一种药用辅料薄膜包衣材料由以下质量份数配方成分组成:羟丙甲纤维素5份、填充剂1份、聚丙烯3份、聚乙二醇2份、纤维素醚1份、白水泥2份、聚乙二醇3份、滑石粉11份、氧化铁8份、果胶16份、吐温6份、白土4份、自来水10份。
实施例三:
一种药用辅料薄膜包衣材料由以下质量份数配方成分组成:羟丙甲纤维素6份、填充剂2份、聚丙烯4份、聚乙二醇3份、纤维素醚2份、白水泥3份、聚乙二醇4份、滑石粉12份、氧化铁10份、果胶17份、吐温8份、白土5份、自来水15份。
实施例四:
一种药用辅料薄膜包衣材料由以下质量份数配方成分组成:羟丙甲纤维素7份、填充剂3份、聚丙烯5份、聚乙二醇4份、纤维素醚3份、白水泥4份、聚乙二醇5份、滑石粉13份、氧化铁12份、果胶18份、吐温10份、白土6份、自来水20份。
实施例五:
一种药用辅料薄膜包衣材料的制备方法制备方法包括如下步骤:
步骤一、在常温下,将动力粘度为5mpa.s的羟丙甲纤维素、动力粘度为15mpa.s的羟丙甲纤维素、动力粘度为50mpa.s的羟丙甲纤维素、聚乙二醇4000,白水泥、滑石粉、白土过80目加厚振动筛;
步骤二、在常温下,将上述原料按配方称取所需用量,投入V型混合机,拧紧盖后,开启搅拌20-40分钟,搅拌后均匀投入正在搅拌的质量分数为80%乙醇溶剂中,搅拌30-50分钟后即可形成药用辅料薄膜包衣材料。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (5)
1.一种药用辅料薄膜包衣材料,其特征在于:由以下质量份数配方成分组成:
羟丙甲纤维素5-7份、填充剂1-3份、聚丙烯3-5份、聚乙二醇2-4份、纤维素醚1-3份、白水泥2-4份、聚乙二醇3-5份、滑石粉11-13份、氧化铁8-12份、果胶16-18份、吐温6-10份、白土4-6份、自来水10-20份。
2.根据权利要求1所述的一种药用辅料薄膜包衣材料,其特征在于:由以下质量份数配方成分组成:
羟丙甲纤维素5份、填充剂1份、聚丙烯3份、聚乙二醇2份、纤维素醚1份、白水泥2份、聚乙二醇3份、滑石粉11份、氧化铁8份、果胶16份、吐温6份、白土4份、自来水10份。
3.根据权利要求1所述的一种药用辅料薄膜包衣材料,其特征在于:由以下质量份数配方成分组成:
羟丙甲纤维素6份、填充剂2份、聚丙烯4份、聚乙二醇3份、纤维素醚2份、白水泥3份、聚乙二醇4份、滑石粉12份、氧化铁10份、果胶17份、吐温8份、白土5份、自来水15份。
4.根据权利要求1所述的一种药用辅料薄膜包衣材料,其特征在于:由以下质量份数配方成分组成:
羟丙甲纤维素7份、填充剂3份、聚丙烯5份、聚乙二醇4份、纤维素醚3份、白水泥4份、聚乙二醇5份、滑石粉13份、氧化铁12份、果胶18份、吐温10份、白土6份、自来水20份。
5.一种根据权利要求1所述的一种药用辅料薄膜包衣材料的制备方法,其特征在于:包括如下步骤:
步骤一、在常温下,将动力粘度为5mpa.s的羟丙甲纤维素、动力粘度为15mpa.s的羟丙甲纤维素、动力粘度为50mpa.s的羟丙甲纤维素、聚乙二醇4000,白水泥、滑石粉、白土过80目加厚振动筛;
步骤二、在常温下,将上述原料按配方称取所需用量,投入V型混合机,拧紧盖后,开启搅拌20-40分钟,搅拌后均匀投入正在搅拌的质量分数为80%乙醇溶剂中,搅拌30-50分钟后即可形成药用辅料薄膜包衣材料。
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CN113388162A (zh) * | 2020-03-13 | 2021-09-14 | 信越化学工业株式会社 | 成膜组合物和膜 |
EP4026542A4 (en) * | 2019-09-04 | 2023-09-27 | Shin-Etsu Chemical Co., Ltd. | FILM-FORMING COMPOSITION AND FILM |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101120953A (zh) * | 2006-08-10 | 2008-02-13 | 上海新菲尔生物制药工程技术有限公司 | 中药片剂全水型薄膜包衣预混剂 |
CN101612136A (zh) * | 2008-06-23 | 2009-12-30 | 株洲千金药业股份有限公司 | 一种中药片剂薄膜包衣材料及其制备方法 |
CN101927003A (zh) * | 2010-08-06 | 2010-12-29 | 安徽山河药用辅料股份有限公司 | 药用辅料薄膜包衣材料的制备方法 |
CN102813934A (zh) * | 2012-09-18 | 2012-12-12 | 天津市普乐新药用辅料有限公司 | 中药片剂防潮型薄膜包衣剂及其制备方法 |
-
2016
- 2016-12-05 CN CN201611100955.XA patent/CN106727401A/zh active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101120953A (zh) * | 2006-08-10 | 2008-02-13 | 上海新菲尔生物制药工程技术有限公司 | 中药片剂全水型薄膜包衣预混剂 |
CN101612136A (zh) * | 2008-06-23 | 2009-12-30 | 株洲千金药业股份有限公司 | 一种中药片剂薄膜包衣材料及其制备方法 |
CN101927003A (zh) * | 2010-08-06 | 2010-12-29 | 安徽山河药用辅料股份有限公司 | 药用辅料薄膜包衣材料的制备方法 |
CN102813934A (zh) * | 2012-09-18 | 2012-12-12 | 天津市普乐新药用辅料有限公司 | 中药片剂防潮型薄膜包衣剂及其制备方法 |
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CN113388162A (zh) * | 2020-03-13 | 2021-09-14 | 信越化学工业株式会社 | 成膜组合物和膜 |
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