CN1303989C - 葡萄糖酸锌口腔崩解片及其制备工艺 - Google Patents
葡萄糖酸锌口腔崩解片及其制备工艺 Download PDFInfo
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- CN1303989C CN1303989C CNB2004100863197A CN200410086319A CN1303989C CN 1303989 C CN1303989 C CN 1303989C CN B2004100863197 A CNB2004100863197 A CN B2004100863197A CN 200410086319 A CN200410086319 A CN 200410086319A CN 1303989 C CN1303989 C CN 1303989C
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- zinc gluconate
- disintegrating tablet
- zinc
- gram
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Abstract
本发明涉及一种用于预防和治疗小儿、老年人、妊娠妇女因缺锌引起的生长发育迟缓、营养不良、厌食症、复发性口腔溃疡、皮肤痤疮等症的葡萄糖酸锌口腔崩解片及其制备工艺。以葡萄糖酸锌为原料，填充剂、崩解剂、矫味剂、助流剂、润滑剂等为辅料，根据不同情况可使用粘合剂或包衣材料，也可酌情加入适量泡腾剂，再经过特定的制备方法制备，采用压片机压片即得。本发明的口腔崩解片脆碎度良好，崩解迅速，口感好，无砂砾感，不需要特殊的生产条件；具有生产成本低，携带、储藏、运输和服用方便等特点；特别之处是可以在无水条件下服用并快速起效，从而改善患者的依从性，提高药物的疗效。
Description
技术领域
本发明涉及一种用于预防和治疗小儿、老年人、妊娠妇女因缺锌引起的生长发育迟缓、营养不良、厌食症、复发性口腔溃疡、皮肤痤疮等症的葡萄糖酸锌口腔崩解片及其制备工艺。
背景技术
锌参与多种酶的合成与激活，对蛋白质和核酸合成、肠道蛋白质的吸收和消化发挥重要的生理功能，促进生长发育；通过参与味蕾中味觉素的合成及防止颊黏膜上皮细胞角化不全，维持正常的食欲及味觉；增强吞噬细胞的吞噬能力，激化其活力及杀菌功能；而且通过超氧歧化酶保持吞噬细胞内自由基水平，自由基能破坏微生物的细胞膜，发挥杀菌作用，加速创伤、烧伤、遗疡的愈合；对维生素A的代谢及视觉起重要作用；促进及维持性机能；稳定细胞膜，改善组织能量代谢及组织呼吸；能改善下肢的血流灌注，减少乳酸积蓄，是治疗间歇性破行的生化基础。
现有的葡萄糖酸锌制剂的剂型有：普通片剂、硬胶囊、软胶囊、颗粒剂、口服液和糖浆剂。
由于剂型的原因，普通片硬胶囊、软胶囊和颗粒剂在服用时需要大量的水送下，这使得许多老年人、婴幼儿或者吞咽困难、取水不便的患者难以服用，而老年人和婴幼儿又是最需补锌的人群。口服液和糖浆剂携带不便，制造成本相对较高，患者经济负担重的缺点。因此，有必要制备服用更加方便的剂型以满足临床治疗和家庭使用的多种需要。
发明内容
本发明的目的在于改进现有的葡萄糖酸锌在口服剂型方面的不足，向广大患者和医务工作者提供一种服用方便、吸收起效快、生物利用度高的葡萄糖酸锌口腔崩解片制剂。本发明涉及服用时不必饮水、在口腔中仅需几十秒即可迅速崩解或溶解、随唾液下咽即可完成服药的葡萄糖酸锌口腔崩解片及其制备方法。
一、处方
本发明所述及的葡萄糖酸锌口腔崩解片，包括原料药物葡萄糖酸锌，共需要以下9类原、辅材料，其中：不作包衣处理时，则不使用包衣材料，泡腾剂为酌情可选用辅料，也可不用。
葡萄糖酸锌(5-60)％，粘合剂(0-5)％，填充剂(10-80)％，崩解剂(2-35)％，矫味剂(1-40)％，包衣材料(0-40)％，泡腾剂(0-30)％，助流剂(0.01-5)％，润滑剂(0.3-3)％。
其中：
粘合剂包括但不仅限于淀粉、预胶化淀粉、糊精、麦芽糖糊精、蔗糖、阿拉伯胶、明胶、甲基纤维素、羧甲基纤维素、乙基纤维素、聚乙烯醇、聚乙二醇、聚乙烯吡咯烷酮(PVP)、海藻酸及海藻酸盐、黄原胶、羟丙基纤维素和羟丙基甲基纤维素(HPMC)，可单独使用，也可组合使用。
填充剂包括但不仅限于甘露醇(粒状或粉状)、木糖醇、山梨醇、麦芽糖、赤蘚醇、微晶纤维素、PROSOLVSMCC、聚合糖(EMDEX)、偶合糖、葡萄糖、乳糖、蔗糖、糊精和淀粉等，可以单独使用，也可以组合应用，用量通常为(10-80)％。
崩解剂包括但不仅限于交联聚乙烯吡咯烷酮(PVPP)、羧甲基淀粉钠(CMS-Na)、低取代羟丙基甲基纤维素(L-HPC)、交联羧甲基纤维素钠(CCNa)和大豆多糖(EMCOSOY)等，可单独使用，也可组合使用。
矫味剂包括但不仅限于甘露醇、木糖醇、甜菊甙、乳糖、果糖、蔗糖、蛋白糖、麦芽糖醇、甘草甜素、环己氨基磺酸钠、明胶、阿斯巴甜、香蕉香精、菠萝香精、香兰素、香橙香精、桔子香精、薄荷香精、人参香精、草莓香精、枸橼酸、柠檬酸等，可单独使用，也可组合使用。
包衣材料包括但不仅限于明胶、阿拉伯胶、海藻酸盐、壳聚糖、羧甲基纤维素盐、醋酸纤维素酞酸酯、乙基纤维素、甲基纤维素、羟丙甲纤维素、丙烯酸树脂类(国产丙烯酸树脂I、II、III、IV，Eudragit系列)、聚乙烯醇、聚乙烯吡咯烷酮、聚乙二醇等，可单独使用，也可组合使用。
助流剂包括但不仅限于微粉硅胶、滑石粉、Cab-O-sil、Arosil、水合硅铝酸钠等，可单独使用，也可组合使用。
润滑剂包括但不仅限于硬脂酸镁、硬脂酸锌、硬脂酸锌、单硬脂酸甘油脂、聚乙二醇、氢化植物油、硬脂富马酸钠、聚氧乙烯单硬脂酸酯、单月桂蔗糖酸酯、月桂醇硫酸钠、月桂醇硫酸镁、十二烷基硫酸镁和滑石粉等，可单独使用，也可组合使用。
泡腾剂包括但不仅限于苹果酸、柠檬酸或枸橼酸与碳酸氢钠或碳酸钠的混合物。
二、制备方法
本发明所述及的葡萄糖酸锌口腔崩解片，其制备方法为直接压片法，具有制备常规片剂的生产厂家均可采用。
葡萄糖酸锌无臭，味微涩。本发明可以采用不同方法进行矫味或掩味：①采用矫味剂直接矫味；②预先将葡萄糖酸锌进行粉末包衣以掩味。
具体制备方法如下：
第一步 葡萄糖酸锌的预处理方法：
①直接矫味法——本法对葡萄糖酸锌原料进行制粒或不作处理，直接进入第二步；
②粉末包衣掩味——取所选定的包衣材料，用与之相适应的溶媒溶解并稀释至适当浓度备用，再取葡萄糖酸锌置于沸腾床中使沸腾，然后以适当速度喷入上述溶液进行粉末包衣，得葡萄糖酸锌粉末包衣颗粒，干燥后过筛备用；
第二步 将矫味剂与葡萄糖酸锌或经第一步掩味处理后的原料颗粒按量称取，并混合均匀备用；
第三步 将填充剂、崩解剂、泡腾剂、助流剂按量称取并混合均匀，再与经第二步所得之物料混合使均匀，加入润滑剂混匀备用；
第四步 所得物料经中间体检测，确定片重后，送入压片机压片即得。
有益效果
片剂是一种传统剂型，因其质量稳定、剂量准确、服用、携带方便、机械化程度高、生产成本低而成为目前最常用的剂型之一，但因片剂加压成型，崩解较慢、生物利用度较低，且部分患者吞服较为困难，因而片剂的推广使用在一定程度上受到限制。为此口服固体速释制剂成为近年新药研发的一个热点，特别是口腔崩解片，因其服用方便、起效快、生物利用度高、口感好而成为片剂开发的重点。
口腔崩解片是指不需用水或只需少量水，无需咀嚼，片剂置于舌面，遇唾液后迅速崩解，或借吞咽动力，药物即可入胃起效的片剂。口腔崩解片的特点是吸收快、生物利用度高，肠道残留少，副作用低，避免肝脏首过效应等。
据《口腔崩解片的剂型特点和质量控制会议纪要》的要求，口腔崩解片比滴丸和普通片的崩解速度有本质的飞跃，口腔崩解片的崩解一般在30秒以内，最多不超过1分钟。
具体实施例
实施例一
(一)处方
1.原 料——葡萄糖酸锌 25.0g；
2.粘合剂——聚乙烯吡咯烷酮K-30 0.5g；
3.填充剂——甘露醇 45.5g；
乳糖 15.0g；
4.矫味剂——阿斯巴甜 1.0g；
香橙香精 5.0g；
5.崩解剂——交联聚乙烯吡咯烷酮 3.0g；
交联羧甲基纤维素 3.0g；
6.助流剂——微粉硅胶 1.0g；
7.润滑剂——硬脂酸镁 1.0g。
总重100.0g，共制成1000片。
(二)制备方法
1)取聚乙烯吡咯烷酮K-30用50％乙醇溶解并稀释至一定浓度备用；
2)取葡萄糖酸锌和乳糖用高速混合搅拌制粒机制粒，以步骤1)的溶液为粘合剂，干燥后备用；
3)将甘露醇、微粉硅胶、交联聚乙烯吡咯烷酮、交联羧甲基纤维素、阿斯巴甜、和香橙香精混合均匀，再和步骤2)的颗粒混和均匀，备用；
4)进行中间体含量检测，确定片重；
5)加入硬脂酸镁，混匀，送入压片机压片即得。
实施例二
(一)处方
1.原 料——葡萄糖酸锌 50.0g；
2.包衣材料——EudragitE100 10.0g；
3.填充剂——聚合糖 71.0g；
4.矫味剂——阿斯巴甜 1.0g；
桔子香精 2.0g；
5.崩解剂——交联聚乙烯吡咯烷酮 7.0g；
低取代羟丙基甲基纤维素 5.0g；
6.助流剂——微粉硅胶 2.5g；
7.润滑剂——硬脂酸镁 1.5g。
总重150.0g，共制成1000片。
(二)制备方法
1)取EudragitE100用95％的乙醇溶解并稀释至一定浓度备用；
2)取葡萄糖酸锌置于流化床中沸腾，按一定速度喷入上述溶液进行粉末包衣，制得葡萄糖酸锌粉末包衣颗粒，干燥后备用；
3)将聚合糖、微粉硅胶、交联聚乙烯吡咯烷酮、低取代羟丙基甲基纤维素、阿斯巴甜、和桔子香精混合均匀，再和包衣颗粒混匀备用；
4)中间体含量检测，确定片重；
5)加入硬脂酸镁，混匀，送入压片机压片即得。
实施例三
(一)处方
1.原 料——葡萄糖酸锌 70.0g；
2.粘合剂——聚乙烯吡咯烷酮K-30 1.0g；
3.泡腾剂——枸橼酸 25.0g；
碳酸氢钠 20.0g；
4.填充剂——甘露醇 102.5g；
PROSOLVSMCC 10.0g；
5.矫味剂——阿斯巴甜 1.5g；
香橙香精 4.0g；
6.崩解剂——交联聚乙烯吡咯烷酮 8.0g；
交流羧甲基纤维素 4.0g；
7.助流剂——微粉硅胶 2.0g；
8.润滑剂——硬脂富马酸钠 2.0g。
总重250g，共制成1000片。
(二)制备方法
1)取葡萄糖酸锌和枸橼酸原料混合后粉碎，用聚乙烯吡咯烷酮K-30制粒，过26目筛，备用；
2)取碳酸氢钠粉碎，用聚乙烯吡咯烷酮K-30制粒，过26目筛，备用；
3)将除硬脂酸镁外其余所有的辅料分别过40目筛后混合均匀，再加入已制粒的颗粒1)和2)，混合均匀，备用；
4)中间体含量检测，确定片重后；
5)加入硬脂酸镁，混匀，送入压片机压片即得。
Claims (3)
1、一种用于预防和治疗锌缺乏症的葡萄糖酸锌口腔崩解片，葡萄糖酸锌25克，甘露醇45.5克，乳糖15克，交联聚乙烯吡咯烷酮3克，交联羧甲基纤维素3克，聚乙烯吡咯烷酮K-30 0.5克，阿斯巴甜1克，香橙香精5克，微粉硅胶1克，硬脂酸镁1克，将葡萄糖酸锌和乳糖混匀后用聚乙烯吡咯烷酮K-30作为粘合剂进行制粒，干燥后与其余组分混匀，压制成片。
2、一种用于预防和治疗锌缺乏症的葡萄糖酸锌口腔崩解片，葡萄糖酸锌70克，甘露醇102.5克，PROSOLV SMCC 10克，枸橼酸25克，碳酸氢钠20克，交联聚乙烯吡咯烷酮8克，交联羧甲基纤维素4克，聚乙烯吡咯烷酮K-30 1克，阿斯巴甜1.5克，香橙香精4克，微粉硅胶2克，硬脂富马酸钠2克，将葡萄糖酸锌和枸橼酸的混合物和碳酸氢钠分别用聚乙烯吡咯烷酮K-30制粒后，与其余组分混匀，压制成片。
3、一种用于预防和治疗锌缺乏症的葡萄糖酸锌口腔崩解片，葡萄糖酸锌50克，EudragitE100 10克，聚合糖71克，交联聚乙烯吡咯烷酮7克，低取代羟丙基甲基纤维素5克，阿斯巴甜1克，桔子香精2克，微粉硅胶2.5克，硬脂酸镁1.5克，将葡萄糖酸锌置于流化床中沸腾，用Eudragit E100作为包衣材料进行粉末包衣，制得的葡萄糖酸锌粉末包衣颗粒干燥后与其余组分混匀，压制成片。
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| Publication number | Priority date | Publication date | Assignee | Title |
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| RU2779129C1 (ru) * | 2019-02-04 | 2022-09-01 | Афлофарм Фармацья Польска Сп З О О | Твердая дозированная лекарственная форма, содержащая глюконат цинка и инозина пранобекс, способ ее получения и применения |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| ITBO20090070A1 (it) * | 2009-02-12 | 2010-08-12 | Monica Bonucci | Farmaco per la stomatite aftosa |
| ES2713349T3 (es) * | 2009-04-15 | 2019-05-21 | Bmg Pharma S P A | Composiciones de sal mineral-ácido sulfónico y procedimientos de uso |
| CN103284964A (zh) * | 2012-02-28 | 2013-09-11 | 海南卫康制药(潜山)有限公司 | 小儿葡萄糖酸锌奶组合物冻干口腔崩解片及其制备方法 |
| CN103271900B (zh) * | 2013-05-31 | 2014-12-17 | 河南创新药业有限公司 | 一种枸橼酸锌片及其制备方法 |
| CN103719869A (zh) * | 2013-11-22 | 2014-04-16 | 镇江市丹徒区南山溪园茶叶专业合作社 | 一种葛根黄酮咀嚼片的加工工艺 |
| CN103734697A (zh) * | 2013-11-22 | 2014-04-23 | 镇江市丹徒区南山溪园茶叶专业合作社 | 一种缓解口腔溃疡症状的咀嚼片 |
| CN108451913B (zh) * | 2018-05-07 | 2020-12-15 | 北京聚源康生物科技有限公司 | 一种葡萄糖酸锌糖片及其制备方法和用途 |
| CN112336711B (zh) * | 2020-11-13 | 2021-09-14 | 迪沙药业集团有限公司 | 一种赖氨葡锌口腔崩解片 |
| CN115517366B (zh) * | 2022-11-02 | 2024-04-02 | 宝健（北京）生物技术有限公司 | 一种缩短崩解时限和减缓β-胡萝卜素衰减的螺旋藻片剂及其制备方法 |
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| CN1473560A (zh) * | 2003-06-27 | 2004-02-11 | 辉 刘 | 中药或天然来源药用物质口腔速崩片及其制备方法 |
| CN1154476C (zh) * | 1998-11-06 | 2004-06-23 | 爱的发 | 改进的迅速崩解片剂 |
| CN1531921A (zh) * | 2003-03-21 | 2004-09-29 | 上海兴康医药研究开发有限公司 | 经粉末包衣的药物口腔速崩片及其制备方法 |
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| CN1154476C (zh) * | 1998-11-06 | 2004-06-23 | 爱的发 | 改进的迅速崩解片剂 |
| CN1531921A (zh) * | 2003-03-21 | 2004-09-29 | 上海兴康医药研究开发有限公司 | 经粉末包衣的药物口腔速崩片及其制备方法 |
| CN1473560A (zh) * | 2003-06-27 | 2004-02-11 | 辉 刘 | 中药或天然来源药用物质口腔速崩片及其制备方法 |
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| RU2779129C1 (ru) * | 2019-02-04 | 2022-09-01 | Афлофарм Фармацья Польска Сп З О О | Твердая дозированная лекарственная форма, содержащая глюконат цинка и инозина пранобекс, способ ее получения и применения |
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