CN106420643A - 一种含维生素c钠的咀嚼片及其制备方法 - Google Patents

一种含维生素c钠的咀嚼片及其制备方法 Download PDF

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CN106420643A
CN106420643A CN201610964478.5A CN201610964478A CN106420643A CN 106420643 A CN106420643 A CN 106420643A CN 201610964478 A CN201610964478 A CN 201610964478A CN 106420643 A CN106420643 A CN 106420643A
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sodium
parts
vitamine
chewable tablets
item
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CN106420643B (zh
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黄爱强
钟文
黄爱毅
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Guangxi Shengbaotang Health Industry Co Ltd
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Abstract

本发明公开了一种含维生素C钠的咀嚼片，该咀嚼片包括以下重量份的组分：维生素C钠20‑100份、淀粉100‑500份、甜味剂10‑30份、甘露醇5‑20份、微晶纤维素30‑100份、聚维酮K‑30 5‑20份、羧甲基淀粉钠20‑60份、十二烷基硫酸钠5‑20份、硬脂酸镁1‑5份、薄荷香精0.1‑0.5份。本发明针对现有维生素C咀嚼片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用，及存储过程中维生素C容易氧化失效、咀嚼片易受潮吸湿等问题，提供一种含维生素C钠的咀嚼片，制剂简便，口感香甜，质量稳定。

Description

一种含维生素C钠的咀嚼片及其制备方法
技术领域
本发明属于药品、保健食品、食品领域，涉及一种组合物制剂及其制备方法，特别是涉及一种含维生素C钠的咀嚼片及其制备方法。
背景技术
维生素C是临床基本常用药物或营养补充剂，是抗氧化维生素当中的一种，它参与体内羟化反应，为形成骨骼、牙齿、结缔组织及非上皮组织细胞间粘物所必需，可维持牙齿、骨骼、血管的正常功能，增加对疾病的抵抗能力，为人体必需的营养元素之一，广泛应用于多种疾病预防和治疗。
片剂质量稳定、服用方便，是一种最基本、最常用的制剂形式。然而，对于儿童、老人以及吞咽困难的患者，普通片剂往往服用困难，长期服药甚至会使其产生心理上的拒药现象，咀嚼片则可弥补这种不足。咀嚼片是一类可在口腔内嚼碎后咽下的片剂，大小一般与普通片剂相同，可根据需要制成不同形状的异形片。药片经嚼碎后便于吞服，药片表面积增大，可促进药物在体内的溶解、吸收。对于难崩解的药物，制成咀嚼片可加速其崩解，提高药效。咀嚼片服用方便，即使在缺水的条件下也可以按时用药，特别适用于小儿、老人、吞咽困难或胃肠功能较差的患者，可减少药物对胃肠道的负担。因此，咀嚼片剂应用逐渐广泛起来。
由于维生素C是维持人体正常生理功能所必需的重要营养素之一，近年来维生素C咀嚼片受到了人们的青睐，然而，由于维生素C易氧化失效等问题，导致维生素C咀嚼片的使用效果及保质期受到很大影响。且维生素C咀嚼片溶解后酸性较大，对口腔、咽喉食道以及胃粘膜刺激较大，不宜长期服用，也不适合与酸性药物同时服用，在日常作为营养剂的使用或作为临床疾病的治疗或预防应用均受到一定限制。
维生素C钠是维生素C的钠盐，水溶液pH值接近中性，它的作用与维生素C相同，但由于是钠盐，所以性能更稳定，同时不再有维生素C的强酸性，可以长期与多种药物同时服用，更优于维生素C。维生素C钠属于国内外广泛使用的维生素C强化剂，已逐步替代维生素C使用。本发明直接将维生素C钠制成咀嚼片，经临床试用，制剂安全有效，且制剂简便，口感香甜适口，质量稳定。
发明内容
本发明针对现有维生素C咀嚼片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用，及生产、存储过程中维生素C容易氧化失效等问题，提供一种含维生素C钠的咀嚼片及其制备方法，解决了临床上应用维生素C存在的质量不稳定、不易长期服用的问题。本发明含维生素C钠的咀嚼片，香甜适口，生物利用度高，制剂简便，质量稳定，可长期用于治疗坏血病、传染性疾病、紫癜兼有肌肉无力、瘫痪、心律失常或肾功能障碍疾病，或用于恶性肿瘤、心脑血管疾病、感染性疾病或自身免疫性疾病等的防治和辅助治疗；或作为营养补充剂长期服用。
为解决上述技术问题，本发明是通过以下技术方案实现的：
一种含维生素C钠的咀嚼片，包括以下重量份的组分：维生素C钠20-100份、淀粉200-500份、甘露醇5-20份、微晶纤维素30-100份、聚维酮K-30 5-20份、羧甲基淀粉钠10-60份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、甜味剂10-30份、薄荷香精0.1-0.5份。
以上所述的含维生素C钠的咀嚼片，最佳优选包括以下重量份的组分：维生素C钠30份、淀粉361.75份、甘露醇10份、微晶纤维素60份、聚维酮K-30 10份、羧甲基淀粉钠40份、十二烷基硫酸钠10份、硬脂酸镁3份、甜味剂20份、薄荷香精0.25份。
以上所述含维生素C钠的咀嚼片，所述甜味剂优选为阿斯巴甜、纽甜、罗汉果甜苷。
一种以上所述含维生素C钠的咀嚼片的制备方法，包括如下步骤：
S1.分别取维生素C钠、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、甜味剂，粉碎，过100目筛，备用；
S2.分别按配方量称取S1项下各原辅料，以等量递增法混合均匀，得混合粉；
S3.取S2项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、制粒、过筛，干燥4小时，控制水分为2-4％，整粒，得颗粒；
S4.按配方量称取硬脂酸镁、薄荷香精，与S3项下颗粒混合均匀，压片，即得。
进一步的，步骤S3项下所述的干燥的温度为60-65℃，这样得到的颗粒硬度适中，更有利于压片；所述的过筛步骤所用的筛网优选为14-30目。
本发明的有益效果是：
1.本发明克服现有维生素C咀嚼片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用，及生产、存储过程中维生素C容易氧化失效等问题，使产品稳定性更好，疗效更确切，适用于消费者或患者长期服用，无副作用。
2.本发明可用于治疗坏血病、传染性疾病、紫癜等兼有肌肉无力、瘫痪、心律失常或肾功能障碍等疾病，也可用于恶性肿瘤、心脑血管疾病、感染性疾病、自身免疫性疾病等重大疑难病症防治和辅助治疗；或作为营养补充剂长期服用。
3.本发明含维生素C钠的咀嚼片，制剂简便，颗粒流动性好，压片不粘冲，所制得的片剂外观光洁、色泽均匀，硬度适中，香甜适口，质量稳定，利地携带，方便食用，尤其适用于儿童、老年人，生物利用度高，使用更安全有效。
具体实施方式
虽然本说明书通过特别指出并清楚要求保护本发明的权利要求书作出结论，但应该相信下列说明将更好地理解本发明。
如本文所用，单词“优选”及变体是指在特定环境下能够提供特定有益效果的本发明的实施方案。然而，其它的实施方案在相同或其它的环境下也可以是优选的。此外，一个或多个优选实施方案的详述并不表示其它实施方案是无用的，并且不旨在从本发明的范畴排除其它的实施方案。
一、制剂条件筛选
1.润湿剂选择
润湿剂能使粉粒润湿，呈现粘性，以利于制备颗粒，压成片剂。本发明对比了干法压片、湿法制粒再压片，干法压片采用普通压片机效果不好，对设备要求高，故本发明采用湿法制粒再压片。试验中对比了20％麦芽糊精、30％淀粉浆、40％蔗糖糖浆、5％羟丙甲纤维素水溶液、80％乙醇做润湿剂，结果见表1。
表1润湿剂考察结果表
从表1中的试验结果可知:本发明使用80％乙醇制粒情况效果最好，故本发明润湿剂选择乙醇。为进一步优化乙醇浓度，本发明继续优化乙醇浓度，试验结果见表2。
表2乙醇浓度考察结果表
序号 湿润剂 制粒情况 颗粒外观
1 50％乙醇 成团，制粒困难 颗粒紧
2 60％乙醇 成团，制粒困难 颗粒紧
3 70％乙醇 成团，制粒不结块 颗粒松紧合适
4 80％乙醇 成团，制粒不结块 颗粒松紧合适
5 90％乙醇 不成团，制粒困难 颗粒松
从表2中的试验结果可知:本发明使用70％-80％乙醇制粒情况效果较好，浓度低太紧，浓度高太松，均影响制粒，故本发明润湿剂选择70％-80％乙醇。
2.润滑剂的选择
压片时为增加颗粒的流动性，使填充良好、片剂密度分布均匀，需加入一定的润滑剂，以解决压片时出现颗粒流动性差、易粘冲等现象。本发明试验中对比了硬脂酸镁、微粉硅胶、滑石粉、十二烷基硫酸钠、甘露醇做润滑剂时的压片情况，结果见表3。
表3润滑剂试用结果表
从表3中的试验结果可知:加入硬脂酸镁、十二烷基硫酸钠、甘露醇，流动性均较好，且压片不粘冲，压出来的片硬度合适，片面光滑美观，加入微粉硅胶，流动性好，压片时不粘冲，但压出来的片硬度低，加入滑石粉，流动性不好，压片时粘冲，压出来的片硬度大。故本发明选用硬脂酸镁、十二烷基硫酸钠、甘露醇作为润滑剂。为了调节咀嚼片的口感以及基于对生产成本的考虑，本发明试验中还对比了硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例，结果表明：硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例为3:3:1或者4:4:1其口感达到最佳。
4.矫味剂的选择
只有具有良好口感的咀嚼片才易被人们接受，因此，风味、口感非常重要，而此往往通过甜味剂、香精等矫味剂的选择来实现。本发明试验中对比如下甜味剂：蔗糖、乳糖、葡萄糖、甜菊糖、甘草酸二钠、阿斯巴甜、糖精钠、环己基氨基磺酸钠、罗汉果甜苷、纽甜、阿力甜，结果表明：上述甜味剂中阿斯巴甜、罗汉果甜苷、纽甜，在组分中比例为“甜味剂10-30份”的范围内与薄荷香精配合使用，口感风味好，甜度适中，没有不适感，其中阿斯巴甜口感最佳。故本发明选用阿斯巴甜、罗汉果甜苷、纽甜为甜味剂，并规定其加入量为10-30份。
二、含维生素C钠的咀嚼片的制备方法
实施例1
含维生素C钠的咀嚼片的制备方法，包括如下步骤：
S1.分别取维生素C钠、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、纽甜，粉碎，过100目筛，备用；
S2.分别按以下重量份称取S1项下各原辅料：维生素C钠30kg、淀粉361.75kg、甘露醇10kg、微晶纤维素60kg、聚维酮K-30 10kg、羧甲基淀粉钠40kg、十二烷基硫酸钠10kg、纽甜20kg，以等量递增法混合均匀，得混合粉；
S3.取S2项下的混合粉，一边搅拌一边加80％乙醇溶液制软材、过20目筛制粒，62℃干燥4小时，控制水分为2-4％，过20目筛整粒，得颗粒；
S4.按以下重量份称取：硬脂酸镁3kg、薄荷香精0.25kg，与S3项下颗粒混合均匀，压片，即得。
实施例2
含维生素C钠的咀嚼片的制备方法，包括如下步骤：
S1.分别取维生素C钠、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、阿斯巴甜，粉碎，过100目筛，备用；
S2.分别按以下重量份称取S1项下各原辅料：维生素C钠20kg、淀粉200kg、甘露醇5kg、微晶纤维素30kg、聚维酮K-30 5kg、羧甲基淀粉钠10kg、十二烷基硫酸钠5kg、阿斯巴甜10kg，以等量递增法混合均匀，得混合粉；
S3.取S2项下的混合粉，一边搅拌一边加70％乙醇溶液制软材、过30目筛制粒，60℃干燥4小时，控制水分为2-4％，过30目筛整粒，得颗粒；
S4.按以下重量份称取：硬脂酸镁1kg、薄荷香精0.1kg，与S3项下颗粒混合均匀，压片，即得。
实施例3
含维生素C钠的咀嚼片的制备方法，包括如下步骤：
S1.分别取维生素C钠、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、罗汉果甜苷，粉碎，过100目筛，备用；
S2.分别按以下重量份称取S1项下各原辅料：维生素C钠100kg、淀粉500kg、甘露醇20kg、微晶纤维素100kg、聚维酮K-30 20kg、羧甲基淀粉钠60kg、十二烷基硫酸钠20kg、罗汉果甜苷30kg，以等量递增法混合均匀，得混合粉；
S3.取S2项下的混合粉，一边搅拌一边加75％乙醇溶液制软材、过14目筛制粒，65℃干燥4小时，控制水分为2-4％，过14目筛整粒，得颗粒；
S4.按以下重量份称取：硬脂酸镁5kg、薄荷香精0.5kg，与S3项下颗粒混合均匀，压片，即得。
三、稳定性试验
将上述实施例1-3样品分别用铝塑复合膜包装好，置稳定性加速试验箱内试验:温度：40±2℃，相对湿度：75±5％，加速试验3个月，结果实施例1-3样品的外观性状、口感、硬度、脆碎度、主要成分含量等稳定性重点考察指标与0时样品测定结果比较，均无明显变化，口感风味也没有变化，说明本发明实施例1-3样品质量较为稳定，可满足贮存、运输、使用的稳定性要求。试验结果见表4。
表4维生素C钠的咀嚼片稳定性试验结果表

Claims (6)

1.一种含维生素C钠的咀嚼片，其特征在于，包括以下重量份的组分：维生素C钠20-100份、淀粉200-500份、甘露醇5-20份、微晶纤维素30-100份、聚维酮K-30 5-20份、羧甲基淀粉钠10-60份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、甜味剂10-30份、薄荷香精0.1-0.5份。
2.如权利要求1所述的含维生素C钠的咀嚼片，其特征在于，包括以下重量份的组分：维生素C钠30份、淀粉361.75份、甘露醇10份、微晶纤维素60份、聚维酮K-30 10份、羧甲基淀粉钠40份、十二烷基硫酸钠10份、硬脂酸镁3份、甜味剂20份、薄荷香精0.25份。
3.一种如权利要求1-2中任一所述含维生素C钠的咀嚼片的制备方法，其特征在于，包括如下步骤：
S1.分别取维生素C钠、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、甜味剂，粉碎，过100目筛，备用；
S2.分别按配方量称取S1项下各原辅料，以等量递增法混合均匀，得混合粉；
S3.取S2项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、制粒、过筛，干燥4小时，控制水分为2-4％，整粒，得颗粒；
S4.按配方量称取硬脂酸镁、薄荷香精，与S3项下颗粒混合均匀，压片，即得。
4.如权利要求3所述含维生素C钠的咀嚼片的制备方法，其特征在于，步骤S3项下所述的干燥的温度为60-65℃。
5.如权利要求3所述含维生素C钠的咀嚼片的制备方法，其特征在于，步骤S3项下所述的过筛步骤所用的筛网为14-30目。
6.如权利要求1-3中任一所述的含维生素C钠的咀嚼片，其特征在于，所述甜味剂为阿斯巴甜、纽甜、罗汉果甜苷。
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