CN103652939B - 多种维生素c胶囊 - Google Patents
多种维生素c胶囊 Download PDFInfo
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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- A—HUMAN NECESSITIES
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Abstract
本发明提供了一种多种维生素C胶囊,可用于人体日常进行营养素强化补充的多种维生素C胶囊,采用了维生素C亚铁、维生素C钙、维生素C钠、维生素C等三种以上(含三种)的维生素C及其衍生物为主要原料,经粉碎,过筛,混合的方法制得,并装入胶囊。由于多种维生素C胶囊的产品性能稳定,其内容物在水中溶解性好、人体吸收率高,pH值在7.2~7.8之间、安全性能好;能同时补充维生素C、铁、钙等,能替代目前单一或复方维生素C类口服制剂的应用,多种维生素C胶囊将成为新的维生素C类补充剂消费热点。
Description
技术领域
本发明涉及一种日常补充维生素C与矿物质的营养强化剂类产品,尤其是一种多种维生素C胶囊。
背景技术
维生素C类衍生物是国内外广泛使用的维生素C强化剂,已经逐步替代维生素C使用。但除了美国、意大利、瑞士和日本外,我国尚未有多种维生素C的制剂供人们使用;据国外有关临床报道,维生素C与其衍生物的混合物可提高人体的维生素C生理饱和水平值,提升人体内血液与细胞内维生素C的浓度与储量,有助于满足人体对维生素C的吸收利用与代谢平衡等生理需求;单一或复合维生素C类制剂是临床基本用药或日常保健营养强化剂,广泛应用于日常保健或多种疾病的预防与治疗上。由于维生素C酸性较强(4%水溶液pH值约为2.4),日常营养补充或临床应用上面临众多胃肠道、肾功能不好等人群不宜长期使用,有促进胃酸分泌增多、尿频等不良作用;另酸性的维生素C不宜与众多药物(碱性药物或含苷类的中药)同时使用;单方或复方维生素C钠制剂,只能单一补充维生素C,不能同时增加补充人体其它必需元素;单方维生素C钙制剂的生物利用度与水溶性欠佳,可影响人体的吸收传输,代谢物为草酸钙等,长期大剂量使用可能引起结石;另目前尚无人体补充维生素C钾、维生素C磷酸脂镁与维生素C亚铁的维生素C营养强化保健产品或药品制剂在我国生产应用的报道。
随着我国全民慢病、未病防治及养生保健意识的提升,人们对补充维生素C与矿物质类产品的需求量、使用量在逐年的增大,使用时间不断延长;为了扩大维生素C类产品的使用范围,保证营养补充均衡与安全,急需开发一种pH值在7.2~7.8之间,并能同时补充人体生理必需元素铁、钙的多种维生素C胶囊,以替代单方或复方维生素C类产品在日常保健、预防与治疗疾病中的应用。
本发明的目的是提供一种产品性能稳定,其内容物在水中溶解性好、人体吸收率高,pH值介于7.2~7.8之间,安全性能好,适用人群与使用范围较广;可同时补充铁、钙等其它人体必需元素,并能替代单方或复方维生素C类口服制剂产品进行补充维生素C的多种维生素C胶囊。
多种维生素C胶囊因维生素C类衍生物原料不稳定,因此配方组成、制备要求都要有所突破,稳定性研究就要做得更为细致严谨,围绕技术难点,本发明采用了新的配方组成、制剂包装选择与酸碱度调节的应用办法,并在研制、调配、工艺上进行新的改进。
发明内容
本发明的技术方案。包括:
1、原料重量配比组成:
维生素C亚铁:87.26份
维生素C钙: 107.00份
维生素C钠: 39.00份
维生素C: 1.74份
据文献报道:维生素C能将人体内的三价铁还原为二价铁,有助于人体对铁质的吸收利用;维生素C亚铁作为临床药品、维C补充剂、补铁剂也在国外广泛使用多年;钙离子在维生素C存在的情况下更易于吸收,维生素C钙作为补钙营养强化剂、维C补充剂也在国内外的日常保健与临床应用中使用多年;人体维生素C主要通过钠离子依赖性维生素C传输通道(SVCT)进行吸收传输,在钠离子存在情况下吸收利用最佳,维生素C钠有助于人体安全、高效吸收维生素C;另在人体的金属阳离子的代谢排泄中,首先排出的是钠盐,其次才是钾、钙、镁等;在维生素C代谢中,钠离子能替代钙离子优先与草酸结合,形成水溶性草酸钠盐,降低人体因同时补充维生素C与钙时,可能形成草酸钙结石的风险;维生素C具有良好的抗氧化性,可保护制剂中各组合物的稳定性,同时具有较强的酸性可有效调节本组合物的酸碱度。
维生素C及其衍生物易受金属离子影响,过筛时宜选用尼龙筛。为了减少湿度、氧气、金属离子、温度、其它赋形剂对多种维生素C补充剂的影响,不采用制粒工艺。
装胶囊前的混合物应控制水份在1%以下,应使用水含量较低、密闭性好的空心胶囊。
制剂内容物的pH值控制在7.2~7.8之间。
2、配方依据
本发明的原料配比确定了本胶囊剂的规格为235mg/粒;相当于维生素C200mg、亚铁12mg、钙10mg。多种维生素C混合物在避光、干燥情况下稳定,但易受到光照、湿度、氧气、温度、pH值等因素影响而缓慢氧化,因此避光、防潮甚为重要。采用水含量低及密闭性好的胶囊剂,可有效防氧化、防潮湿及避免光的直接照射;采用高密度聚乙烯瓶包装能提升保持其内容物的温度恒定,并方便使用与携带,若另行内置干燥剂保证在正常使用中不易吸湿,效果更佳。在试制过程中,发现随着湿度的加大,pH值的影响也会加大,pH值控制在7.2~7.8之间,实验结果较为理想。
3、工艺流程
将维生素C亚铁、维生素C钙、维生素C钠、维生素C分别粉碎,过80目尼龙筛;将各原料置混合机中,充分混匀,装入胶囊,经高密度聚乙烯瓶包装即可。
发明的优点及积极效果
在国内,维生素C、维生素C钠、维生素C钙作为临床药品、膳食补充剂、食品添加剂、营养强化剂和抗氧化剂而广泛使用多年;在国外,维生素C亚铁作为临床药品、维C强化补充剂、补铁剂也广泛使用多年。整体组成配方中的各成分,经多年人体广泛使用在国家相关日摄入补充标准剂量以内安全、可靠;各配方组分混合后,能提升人体对其所含的各种元素的吸收、利用,形成协同增效的作用。据国外资讯报道,美国可能有相关多元维生素C类相拟产品,但具体组合配方不同,查新表明国内尚无相关制剂;多种维生素C胶囊的成功开发,将填补我国国内空白,同时由于多种维生素C胶囊的产品性能稳定,抗湿性好,能高效补充维生素C、铁、钙,pH值介于7.2~7.8之间,人体长期使用安全,能替代目前单一或复方维生素C类的口服制剂的应用,多种维生素C胶囊将成为新的维生素C补充剂消费热点。
产品的用途
维生素C、亚铁、钙补充剂。
1、有助于骨胶原的生物合成,有助于组织创伤口的愈合。
2、有助于人体氨基酸中酪氨酸和色氨酸的代谢,有助于改善色素沉着,延长肌体寿命。
3、有助于改善缺铁性贫血,促进人体对维生素C、铁、钙等的利用。
4、有助于脂肪和类脂特别是胆固醇的代谢,有助于预防心血管病。
5、有助于牙齿和骨骼的生长,防止牙床出血,防止关节痛、腰腿痛。
6、有助于增强肌体对外界环境的抗应激能力和免疫力。
7、有助于坚固结缔组织。
8、有助于胶原蛋白的合成,防止牙龈出血。
使用方法
口服,每次1粒,每日1~3粒。
具体实施方式
分别称取:维生素C亚铁872.6g、维生素C钙1070g、维生素C钠390g、维生素C17.4g。
将维生素C亚铁、维生素C钙、维生素C钠、维生素C分别粉碎,过80目尼龙筛;按等量递增法混合均匀,然后置于混合机中充分混匀20分钟,送检合格后填充胶囊,装入合格的1号胶囊,经检验合格后,装入高密度聚乙烯瓶中,包装即得。
共制成10000粒胶囊,每粒含多种维生素C235mg[约相当于200mg维生素C、12mg铁、10mg钙、4.5mg钠、8.5mg化合水]。
Claims (3)
1.一种多种维生素C胶囊,其特征在于其组成配方及重量配比如下:
2.根据权利要求1所述的多种维生素C胶囊,其特征在于生产工艺为:
将维生素C亚铁、维生素C钙、维生素C钠、维生素C分别粉碎,过80目尼龙筛;将各原料置混合机中,充分混匀,装入胶囊,经高密度聚乙烯瓶包装即可。
3.根据权利要求1所述的多种维生素C胶囊,其特征在于:多种维生素C胶囊内容物的pH值在7.2~7.8之间。
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CN1047450A (zh) * | 1990-03-12 | 1990-12-05 | 河南省淅川制药厂 | 防氧化的二价铁剂和维生素c复合剂 |
CN1546061A (zh) * | 2003-12-12 | 2004-11-17 | 黄爱强 | 维生素c钠胶囊 |
CN101700236A (zh) * | 2009-09-14 | 2010-05-05 | 蔡晓东 | 维生素c软胶囊 |
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CN1546061A (zh) * | 2003-12-12 | 2004-11-17 | 黄爱强 | 维生素c钠胶囊 |
CN101700236A (zh) * | 2009-09-14 | 2010-05-05 | 蔡晓东 | 维生素c软胶囊 |
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