CN112791101B - 一种多种维生素矿物质片剂及其制备方法 - Google Patents

一种多种维生素矿物质片剂及其制备方法 Download PDF

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CN112791101B
CN112791101B CN202010644188.9A CN202010644188A CN112791101B CN 112791101 B CN112791101 B CN 112791101B CN 202010644188 A CN202010644188 A CN 202010644188A CN 112791101 B CN112791101 B CN 112791101B
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vitamin
calculated
mug
tablet
mixture
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陈亚宁
陈平
田敏卿
徐希平
刘敏
白洁
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Fulette Shenzhen Precision Nutrition Food Group Co ltd
Shenzhen Ausa Pharmaceutical Co ltd
Shenzhen Fulaite Nutrition & Health Co ltd
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Shenzhen Fulaite Nutrition & Health Co ltd
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Abstract

本发明提供了一种多种维生素矿物质片剂及其制备方法，其由水溶性维生素、脂溶性维生素、矿物质和相应的辅料经适宜的工艺加工制备而成。本发明通过在制备过程中添加适量的助流剂制备所得片剂具有良好的可压性、含量均匀度及崩解性。

Description

一种多种维生素矿物质片剂及其制备方法
技术领域
本发明涉及医药健康技术领域，涉及一种多种维生素矿物质片剂及其制备方法。
背景技术
维生素是维护人体健康、促进生长发育和调节生理功能所必需的一类有机化合物。这些化合物都存在于天然食物中，一般在体内不能合成或合成量较少，不能满足人体的日常需要。维生素可构成多种辅酶，参与多种物质的代谢、利用和合成，促使骨骼生长，维持上皮组织的结构完整，保持正常的生长发育。微量元素是人体中酶、激素、维生素等活性物质的核心成分，对人体的正常代谢和健康起着重要作用，包括：参与酶的构成与激活；构成体内重要的载体及电子传递系统；参与激素及维生素的合成；调控自由基的水平。维生素和微量元素是维持人体正常生命活动所必需的重要物质，缺乏时可导致代谢障碍，引起多种疾病。现代研究证实，人体所含维生素、微量元素的多少与癌症、心血管疾病及人类的寿命有着密切的关系。
目前市场上复合维生素产品众多，一部分为非处方药品，各组分剂量均为药用剂量，需要有明确的临床指征，且必须在医师的指导下方可服用，因此并不适合大多数人群的日常保健补充；另一部分多为营养补充剂，各类人群皆可服用，但由于成分多、各组分含量差别较大，缺乏针对性，实际保健效果尚难预料。因此，本发明在对中国人群营养素水平分布状况研究的基础上开发一种更加适合中国人群营养素水平现状的产品，为各种营养素缺乏的人群多提供一种营养素补充剂选择。
本发明所涉及的多种维生素矿物质片成分复杂，铁、锌、镁、铜剂量高于同类型已上市的产品，可压性差，导致片剂的成型性差，硬度低；本发明中片剂所含维生素B2性质较粘，含有该成分的制剂在混合过程中容易粘附在混合罐壁，导致损耗较多且混合均匀度差；本发明片剂中水溶性差的铁、锌、镁、铜含量高，导致崩解时限较长，影响营养物质的吸收。
发明内容
本发明的一个目的在于提供一种含量均匀、可压性及崩解性好的多种维生素矿物质片剂。本发明的另一个目的是提供一种所述多种维生素矿物质片的制备方法，解决现有技术中含量均匀性、可压性、和崩解时限等存在的难题。
本发明是采用如下技术方案达到所述技术效果的：
一种多种维生素矿物质片由水溶性维生素、脂溶性维生素、矿物质和相应的辅料组成：
所述的水溶性维生素包括叶酸、维生素B12、维生素B1、维生素B2、烟酸、泛酸、维生素B6、生物素和维生素C；
所述的脂溶性维生素包括维生素A、维生素D和维生素E；
所述的矿物质包括铁、锌、硒、镁和铜中的一种或几种。
所述的多种维生素矿物质片剂，其特征在于，单位制剂中含有叶酸30-500μg、维生素B12(以钴胺素计)0.2-10μg、维生素B1(以硫胺素计)0.1-20mg、维生素B2(以核黄素计)0.1-20mg、烟酸1.0-15mg、泛酸0.4-20mg、维生素B6(以吡哆醇计)0.1-10mg、生物素3-100μg、维生素C(以L-抗坏血酸计)6-300mg、维生素A(以视黄醇计)50-1200μg、维生素E(以d-α-生育酚计)1.5-150μg、维生素D(以胆钙化醇计)2.0-15μg、铁0-20mg、锌0-15mg、硒5-100μg、镁30-400mg、铜0.1-1.5mg及相应辅料。
所述的多种维生素矿物质片剂，其特征在于，单位制剂中优选各组分含量叶酸133-500μg、维生素B12(以钴胺素计)2.5-10μg、维生素B1(以硫胺素计)1.20-19.80mg、维生素B2(以核黄素计)1.20-19.80mg、烟酸4.0-15mg、泛酸4.0-15mg、维生素B6(以吡哆醇计)1.2-10mg、生物素26.4-100μg、维生素C(以L-抗坏血酸计)32-100mg、维生素A(以视黄醇计)200-660μg、维生素E(以d-α-生育酚计)6.4-25μg、维生素D(以胆钙化醇计)4.0-15μg、铁0-15mg、锌0-10mg、硒15-56.3μg、镁65-120mg、铜0.3-0.6mg及相应辅料。
所述辅料包括填充剂、崩解剂、粘合剂、助流剂、润滑剂等。其中助流剂选自凝胶法二氧化硅，凝胶法二氧化硅用量占片剂质量分数为0.5％-5％。
本发明的片剂制备方法包括如下步骤：
(1)将烟酸、D-泛酸钙、葡萄糖酸锌、富硒酵母、碳酸镁、麦芽糊精、1/2配方量的交联聚维酮、1/3配方量的微晶纤维素混合，1/2配方量凝胶法二氧化硅得混合物Ⅰ，备用。
(2)将余下量的微晶纤维素过80目筛网，筛上物和筛下物分别装袋备用。
(3)将维生素B1、维生素B2、维生素B6、叶酸、葡萄糖酸铜、富马酸亚铁、余下配方量的凝胶法二氧化硅、过80目筛的微晶纤维素筛下物置混合机中进行混合，得混合物Ⅱ。
(4)将批投料量的维生素C、混合物Ⅱ置混合机中进行混合，混合物过65目筛网1次，得混合物Ⅲ。
(5)将维生素E、D-生物素原料、维生素B12原料、维生素A醋酸酯、维生素D3原料、余下配方量的交联聚维酮、过80目的微晶纤维素筛上物、混合物Ⅲ同置混合机中，得混合物Ⅳ。
(6)将混合物Ⅰ制粒，55±5℃干燥，24目整粒。
(7)将干颗粒、混合物Ⅳ同置混合机中混合。
(8)加入硬脂酸镁混合。
(9)压片。
(10)包衣。
本发明所用的二氧化硅广泛用于药剂，化妆品和食品中，见因其小粒径和大比表面积而具有良好的流动性，这一特点在混合、压片过程中用来改善干粉的流动性，通常多作为助流剂、抗粘剂使用。而在本发明中意外地发现通过选用添加片剂质量分数0.5％-5％的凝胶法二氧化硅，显著改善了本发明多种维生素矿物质片含量均匀性、可压性、和崩解时限等性状。
具体实施方式
实施例1：
配方：
制备方法：
(1)将烟酸、D-泛酸钙、葡萄糖酸锌、富硒酵母、碳酸镁、麦芽糊精、1/2配方量的交联聚维酮、1/3配方量的微晶纤维素混合，得混合物Ⅰ，备用。
(2)将余下量的微晶纤维素过80目筛网，筛上物和筛下物分别装袋备用。
(3)将维生素B1、维生素B2、维生素B6、叶酸、葡萄糖酸铜、富马酸亚铁、过80目筛的微晶纤维素筛下物置混合机中进行混合，得混合物Ⅱ。
(4)将批投料量的维生素C、混合物Ⅱ置混合机中进行混合，混合物过65目筛网1次，得混合物Ⅲ。
(5)将维生素E、D-生物素原料、维生素B12原料、维生素A醋酸酯、维生素D3原料、余下配方量的交联聚维酮、过80目的微晶纤维素筛上物、混合物Ⅲ同置混合机中，得混合物Ⅳ。
(6)将混合物Ⅰ制粒，55±5℃干燥，24目整粒。
(7)将干颗粒、混合物Ⅳ同置混合机中混合。
(8)加入硬脂酸镁混合。
(9)压片。
(10)包衣。
实施例2：
配方：
制备方法：
(1)将烟酸、D-泛酸钙、葡萄糖酸锌、富硒酵母、碳酸镁、麦芽糊精、1/2配方量的崩解剂、1/3配方量的微晶纤维素，1/2凝胶法二氧化硅混合，得混合物Ⅰ，备用。
(2)将余下量的微晶纤维素过80目筛网，筛上物和筛下物分别装袋备用。
(3)将维生素B1、维生素B2、维生素B6、叶酸、葡萄糖酸铜、富马酸亚铁、余下配方量的凝胶法二氧化硅、过80目筛的微晶纤维素筛下物置混合机中进行混合，得混合物Ⅱ。
(4)将批投料量的维生素C、混合物Ⅱ置混合机中进行混合，混合物过65目筛网1次，得混合物Ⅲ。
(5)将维生素E、D-生物素原料、维生素B12原料、维生素A醋酸酯、维生素D3原料、余下配方量的崩解剂、过80目的微晶纤维素筛上物、混合物Ⅲ同置混合机中，得混合物Ⅳ。
(6)将混合物Ⅰ制粒，55±5℃干燥，24目整粒。
(7)将干颗粒、混合物Ⅳ同置混合机中混合。
(8)加入硬脂酸镁混合。
(9)压片。
(10)包衣。
实施例3：
配方：
制备方法：
(1)将烟酸、D-泛酸钙、葡萄糖酸锌、富硒酵母、碳酸镁、麦芽糊精、1/2配方量的崩解剂、1/3配方量的微晶纤维素，1/2胶态二氧化硅混合，得混合物Ⅰ，备用。
(2)将余下量的微晶纤维素过80目筛网，筛上物和筛下物分别装袋备用。
(3)将维生素B1、维生素B2、维生素B6、叶酸、葡萄糖酸铜、富马酸亚铁、余下配方量的胶态二氧化硅、过80目筛的微晶纤维素筛下物置混合机中进行混合，得混合物Ⅱ。
(4)将批投料量的维生素C、混合物Ⅱ置混合机中进行混合，混合物过65目筛网1次，得混合物Ⅲ。
(5)将维生素E、D-生物素原料、维生素B12原料、维生素A醋酸酯、维生素D3原料、余下配方量的崩解剂、过80目的微晶纤维素筛上物、混合物Ⅲ同置混合机中，得混合物Ⅳ。
(6)将混合物Ⅰ制粒，55±5℃干燥，24目整粒。
(7)将干颗粒、混合物Ⅳ同置混合机中混合。
(8)加入硬脂酸镁混合。
(9)压片。
(10)包衣。
实施例4
配方：
制备方法：同实施例2。
实施例5：
配方：
制备方法：
(1)将烟酸、D-泛酸钙、富硒酵母、碳酸镁、麦芽糊精、1/2配方量的崩解剂、1/3配方量的微晶纤维素，1/2凝胶法二氧化硅混合，得混合物Ⅰ，备用。
(2)将余下量的微晶纤维素过80目筛网，筛上物和筛下物分别装袋备用。
(3)将维生素B1、维生素B2、维生素B6、叶酸、葡萄糖酸铜、余下配方量的凝胶法二氧化硅、过80目筛的微晶纤维素筛下物置混合机中进行混合，得混合物Ⅱ。
(4)将批投料量的维生素C、混合物Ⅱ置混合机中进行混合，混合物过65目筛网1次，得混合物Ⅲ。
(5)将维生素E、D-生物素原料、维生素B12原料、维生素A醋酸酯、维生素D3原料、余下配方量的崩解剂、过80目的微晶纤维素筛上物、混合物Ⅲ同置混合机中，得混合物Ⅳ。
(6)将混合物Ⅰ制粒，55±5℃干燥，24目整粒。
(7)将干颗粒、混合物Ⅳ同置混合机中混合。
(8)加入硬脂酸镁混合。
(9)压片。
(10)包衣。
实施例样品崩解时限检测结果
表1崩解时限对比表
结果：
(1)实施例1崩解时间最长(不添加二氧化硅)。
(2)实施例4(5％凝胶法二氧化硅)短于实施例3(5％胶态二氧化硅)。
(3)实施例4(5％凝胶法二氧化硅)短于实施例2(0.5％凝胶法二氧化硅)。
通过对比，在不添加助流剂的情况下，该片剂的崩解时限有所超标，添加相同用量的凝胶法二氧化硅或胶态二氧化硅，前者较后者能显著降低崩解时限，实现更好的崩解性能。
实施例样品含量均匀度检测结果
表2含量均匀度对比表(n＝10)
通过对比，添加0.5％-5％凝胶法胶态二氧化硅，与不添加助流剂相比，含量均匀度提高显著；相同添加用量的凝胶法胶态二氧化硅与胶态二氧化硅相比，前者含量均匀度提高显著。
实施例样品可压性检测结果
表3片剂可压性对比表
压片机主压力(KN) 片硬度(N) 脆碎度(％)
实施例1 18.1 150.5 0.5％
实施例2 17.9 185.1 0.4％
实施例3 18.2 200.2 0.3％
实施例4 18.0 250.3 0.05％
实施例5 18.1 280.1 0.01％
结果：
(1)实施例1硬度最低(不添加凝胶法胶态二氧化硅)。
(2)实施例4(5％凝胶法二氧化硅)硬度显著高于实施例3(5％胶态二氧化硅)。
(3)实施例4(5％凝胶法二氧化硅)硬度显著高于实施例2(0.5％凝胶法二氧化硅)。
在压片机主压力一致的情况下，凝胶法胶态二氧化硅能显著提升片剂的可压性，增加片硬度，降低片剂脆碎度。

Claims (2)

1.一种多种维生素矿物质片剂，其特征在于，所述片剂由水溶性维生素、脂溶性维生素、矿物质和相应的辅料组成；所述辅料包含填充剂、崩解剂、粘合剂、助流剂、润滑剂，其中所述助流剂是凝胶法二氧化硅，凝胶法二氧化硅用量占片剂质量百分比0.5%-5%；其中，每制剂单位中水溶性维生素、脂溶性维生素、矿物质组成如下：叶酸30-500μg、维生素B12 以钴胺素计 0.2-10μg、维生素B1 以硫胺素计 0.1-20mg、维生素 B2 以核黄素计 0.1-20mg、烟酸1.0-15mg、泛酸0.4-20mg、维生素B6 以吡哆醇计 0.1-10mg、生物素3-100μg、维生素C 以L-抗坏血酸计 6-300mg、维生素A 以视黄醇计 50-1200μg、维生素E 以d-α-生育酚计 1.5-150μg、维生素D 以胆钙化醇计 2.0-15μg、铁0-20mg、锌0-15mg、硒5-100μg、镁30-400mg、铜0.1-1.5mg。
2.根据权利要求1所述的片剂，其特征在于，每制剂单位中水溶性维生素、脂溶性维生素和矿物质组成：叶酸133-500μg、维生素B12 以钴胺素计 2.5-10μg、维生素B1 以硫胺素计1.20-19.80mg、维生素 B2 以核黄素计 1.20-19.80mg、烟酸4.0-15mg、泛酸4.0-15mg、维生素B6 以吡哆醇计 1.2-10mg、生物素26.4-100μg、维生素C 以L-抗坏血酸计 32-100mg、维生素A 以视黄醇计 200-660μg、维生素E 以d-α-生育酚计 6.4-25μg、维生素D 以胆钙化醇计 4.0-15μg、铁0-15mg、锌0-10mg、硒15-56.3μg、镁65-120mg、铜0.3-0.6mg。
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