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CN1212126C - 纳米羟基磷灰石补钙剂 - Google Patents

纳米羟基磷灰石补钙剂 Download PDF

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CN1212126C
CN1212126C CNB021239185A CN02123918A CN1212126C CN 1212126 C CN1212126 C CN 1212126C CN B021239185 A CNB021239185 A CN B021239185A CN 02123918 A CN02123918 A CN 02123918A CN 1212126 C CN1212126 C CN 1212126C
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李景虹
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Changchun Institute of Applied Chemistry of CAS
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Abstract

一种羟基磷灰石补钙剂,将羟基磷灰石制备成5-800nm的纳米级羟基磷灰石,其含量在5%-80%之间,其他成分可以包括有机酸、如柠檬酸、苹果酸,淀粉、糖、维生素D、维生素A、维生素B、维生素C、维生素E以及锶、氟、铁、锌、锰等微量元素,本发明产品可制成粉剂、片剂,包括包衣片剂、胶囊、冲剂等固体制剂和口服液、注射液、饮料等液体制剂以及离子导入型透皮吸收制剂等形式,或添加于其它食品中使用。产品包括通用型、儿童型、生育型、肝肾型和更年期型,以满足各种缺钙类群的需要。

Description

纳米羟基磷灰石补钙剂
技术领域
本发明涉及以纳米级羟基磷灰石作为补钙剂的保健品。
背景技术
钙是人体内含量最多,最重要的矿物元素之一,对维持人体的呼吸、神经、消化、内分泌、泌尿、免疫等正常功能均具有重要作用。当前医学研究表明无论第三世界,还是美、欧、日等发达国家,缺钙现象都比较严重。对于我国居民来讲,由于目前日常进食仍以植物来源的食物为主,植物性食物所含钙质不易为人体吸收,缺钙人群十分广泛,已成为一个很普遍的社会问题。我国已确诊骨质疏松患者达8000万人;全国9500万3岁以下儿童中,缺钙性佝偻病的发病率北方为49%,南方为24%;我国12亿人口中,不计青壮年缺钙者,老年人、儿童、婴儿、孕妇均需大量补钙,合计人口3.3亿。缺钙会诱发多种疾病:儿童缺钙会出现佝倭病,易患感冒,夜啼,烦躁,厌食、便秘,鸡胸,“O”型或“X”型腿等;孕妇缺钙会造成腰酸背痛,手足麻木,肌肉痉挛,严重患者可以引发产前高血压综合症,产后牙齿松动,并会对新生儿的健康带来影响;中、老年人与儿童一样容易缺钙,中、老年人的高血压,心律失常,糖尿病,溃疡病均与钙代谢失常有关。
虽然当前市场上的钙制剂已有几十种,比如中国发明专利申请号95 108344.9使用氧化钙,氢氧化钙,生物碳酸钙,其优点是制备方法简单。但是,粒度太粗,一般为μm量级,不利于人体对钙的吸收;中国发明专利98117505.8使用醋酸钙,乳酸钙,柠檬酸钙,葡萄糖酸钙,苏糖酸钙,及用于烃油的复合脱钙剂,其缺点是钙含量不足,达不到补钙的剂量;中国发明专利93106178.4利用海洋生物牡砺,贝壳为原料的钙提取物,虽然其生产工艺简单和成本低,但是其产品中含有海洋中的环境污染物,而且其钙含量不足和粒度太粗,满足不了人体对钙的吸收量。研究证明,国际市场上的各种活性钙的最高生物利用率只有30%;且成分复杂,并复合某些影响钙吸收的成分,如草酸等;特别是含大量钙盐而碱性过强,对胃刺激较大。所以,研制一种含钙量高、副作用小、人体容易吸收、并且满足不同人群需要的高效补钙制剂系列新产品是一个急需解决的问题。羟基磷灰石,Ca10(PO4)6(OH)2是构成脊椎动物和人体硬组织的无机成分,如成年人的骨骼是由65%的羟基磷灰石等无机物和35%的有机物组成的,而人牙齿珐琅质表面中的羟基磷灰石含量高达95%。
发明内容
本发明的目的是提供一种纳米羟基磷灰石补钙剂的制备方法,采用5nm-800nm的羟基磷灰石作为补钙剂的新型保健品。它是生物活性钙的最佳载体,最容易被人体吸收,具有高生物利用度,不刺激胃肠,无毒副作用的特点。特别是本技术使用纳米高科技制备的羟基磷灰石是在纳米级范围内的钙剂,更利于人体对钙的吸收,吸收率比现有技术的钙剂高,提高了保健品的生物功效。
本发明采用羟基磷灰石粒度为5-800nm,重量百分比含量为5%-80%,其它成分包括重量百分比0-30%的有机酸、重量百分比4-50%的淀粉、重量百分比0-40%的糊精、重量百分比0-30%的糖、重量百分比0-10%的维生素,其中维生素选自维生素D、维生素A、维生素B、维生素C、维生素E中一种或多种混合以及重量百分比0-5%的微量元素。
本发明产品可制成粉剂、片剂,包括包衣片剂、胶囊、冲剂等固体制剂和口服液、注射液、饮料等液体制剂以及离子导入型透皮吸收制剂等形式,或添加于其它食品中使用。产品包括通用型、儿童型、生育型、肝肾型和更年期型,以满足各种缺钙类群的需要。本发明产品除了以羟基磷灰石为主成分外,还添加维生素A、B、C、D、E以及锌,铁等微量元素,能更加丰富其营养和保健作用。纳米级范围内的钙剂,更利于人体对钙的吸收,吸收率比现有技术的钙剂高,提高了保健品的生物功效。
纳米羟基磷灰石的制备方法包括物理方法,如机械粉碎法,包括球磨、振动球磨、振动磨、搅拌磨、胶体磨和纳米气流粉碎气流等;蒸发凝聚法包括烟粒子结晶法、流动油面上的真空蒸发沉积法、等离子体加热法、激光加热蒸发法、电子束加热蒸发法、电弧放电加热蒸发法、高频感应加热蒸发法、太阳炉加热蒸发法等;离子溅射法;冷冻干燥法;火花放电法;爆炸烧结法和化学方法,如气相化学反应法,包括气相分解法、气相合成法、气-固反应法;沉淀法包括共沉淀法、水解沉淀法、水热合成法;喷雾热解法;溶剂挥发分解法;溶胶-凝胶法;电化学合成法;辐射化学合成法。
本发明采用的羟基磷灰石对大部分人体蛋白质具有亲合性,因而具有良好的生物相容性,植入体内不仅安全、无毒、还能传导骨生长,被公认为医用生物陶瓷的明星,是生物材料中最重要的一大类。因为磷本身就是一切生物和人体的营养元素,所以它对软,硬组织均有良好的生物相容性和生物活性,安全可靠性好。因此,从生物学的观点看,羟基磷灰石是最适宜作生物体硬组织的替代材料,是一种新型的有效、易吸收的钙剂。
由于本发明制备纳米羟基磷灰石的方法为同行技术人员所熟悉的公知技术,因此在实施例中对其不作详细描述。
实施例1
将粒径为100±5纳米的羟基磷灰石60公斤加入容积为120升的混合器内,然后再加入柠檬酸3公斤,苹果酸4公斤,淀粉3公斤,糖3公斤,锶100克,氟165克,铁150克,锌170克,锰50克充分混合后,使用成片机压成片剂,片重0.5克,制得本发明的高营养高疗效纳米钙。人体对本发明的高营养高疗效纳米钙的吸收率为85%。
实施例2
将粒径为30+5纳米的羟基磷灰石65公斤加入容积为120升的混合器内,然后再加入柠檬酸2公斤,苹果酸3公斤,淀粉30公斤,锶100克,氟165克,铁150克,锌170克充分混合后,使用成片机压成片剂,片重0.5克,制得本发明的高营养高疗效纳米钙。人体对本发明的高营养高疗效纳米钙的吸收率为90%。
实施例3
将粒径为30±5纳米的羟基磷灰石70公斤加入容积为120升的混合器内,然后再加入柠檬酸2公斤,苹果酸2公斤,淀粉14公斤,200克维生素D,200克维生素B,200克维生素C,200克维生素E充分混合后,使用成片机压成片剂,片重0.5克,制得本发明的高营养高疗效纳米钙。人体对本发明的高营养高疗效纳米钙的吸收率为92%。
实施例4
将粒径为300±5纳米的羟基磷灰石70公斤加入通用的容积为200升的混合器内,然后再加入柠檬酸15公斤,苹果酸17公斤,淀粉5公斤,糖2公斤,100克维生素D,100克维生素A,100克维生素B,100克维生素C混合后,制得本发明的高营养高疗效纳米钙粉剂。人体对本发明的高营养高疗效纳米钙的吸收率为82%。
实施例5
将粒径为100±5纳米的羟基磷灰石3公斤加入通用的容积为200升的混合器内,然后再加入柠檬酸8公斤,苹果酸8公斤,淀粉20公斤,糖19公斤,100克维生素D,100克维生素A,100克维生素B,100克维生素C和100克维生素E充分,锶100克,氟165克,铁150克,锌170克混合后,制得本发明的高营养高疗效纳米钙粉剂。人体对本发明的高营养高疗效纳米钙的吸收率为90%。
实施例6
将粒径为100±5纳米的羟基磷灰石100公斤加入通用的容积为200升的混合器内,然后再加入柠檬酸10公斤,淀粉5公斤,5公斤维生素D,5公斤维生素A,5公斤维生素C和铁150克,锌170克,锰100克充分混合后,制得本发明的高营养高疗效纳米钙粉剂。人体对本发明的高营养高疗效纳米钙的吸收率为90%。
实施例7
将粒径为200±5纳米的羟基磷灰石70公斤加入容积为120升的混合器内,然后再加入苹果酸10公斤,淀粉8公斤,200克维生素D,200克维生素A,200克维生素B,200克维生素C,200克维生素E充分混合后,使用成片机压成片剂,片重0.5克,制得本发明的高营养高疗效纳米钙。人体对本发明的高营养高疗效纳米钙的吸收率为85%。
实施例8
将粒径为150±5纳米的羟基磷灰石80公斤加入通用的容积为200升的混合器内,然后再加入淀粉15公斤,糖6公斤,100克维生素D,100克维生素A,100克维生素B,100克维生素C和100克维生素E,锶1.5公斤,氟1公斤,铁1.5公斤,锌1.5公斤,锰1.5公斤充分混合后,制得本发明的高营养高疗效纳米钙粉剂。人体对本发明的高营养高疗效纳米钙的吸收率为90%。
实施例9
通用型高效补钙胶囊的制造工艺之一,取200±5纳米羟基磷灰石6公斤,加600克的淀粉和2.4公斤的糊精粘合剂制成软材,制粒,100℃干燥8小时,过60目筛整粒,加60克柠檬酸,在避光防潮条件下,即温度小于28℃,湿度小于40%,加0.03克维生素D3按等量递加法反复过筛混合,用高速混合制粒器混合均匀,装胶囊,铝箔片密封或装瓶加干燥剂后密封,避光贮存。人体对本发明的高营养高疗效纳米钙的吸收率为85%。
实施例10
通用型高效补钙胶囊的制造工艺之一,取100±5纳米羟基磷灰石6公斤,加900克的淀粉和1公斤的糊精粘合剂制成软材,制粒,100℃干燥8小时,加60克苹果酸,在避光防潮条件下,温度小于28℃和湿度小于40%,加0.3克维生素C按等量递加法反复过筛混合,用高速混合制粒器混合均匀,装胶囊,铝箔片密封或装瓶加干燥剂后密封,避光贮存。人体对本发明的高营养高疗效纳米钙的吸收率为90%。
实施例11
称取2公斤250±10纳米的羟基磷灰石,置于盛50升蒸馏水的容器中,加人800克柠檬酸搅拌,使之全部溶解,再加淀粉200克,葡萄糖酸锌500克,乳酸亚铁8克,搅拌均匀,装10毫升瓶,密封,消毒后保存,制备成纳米补钙口服液。人体对本发明的高营养高疗效纳米钙的吸收率为90%。
实施例12
称取2公斤100±5纳米的羟基磷灰石,置于盛50升蒸馏水的容器中,加人300克苹果酸搅拌,使之全部溶解,再加淀粉100克,葡萄糖酸锌500克,乳酸亚铁50克,搅拌均匀,装10毫升瓶,密封,消毒后保存,制备成纳米补钙口服液。人体对本发明的高营养高疗效纳米钙的吸收率为90%。

Claims (1)

1、一种补钙剂,其特征在于,羟基磷灰石粒度为5-800nm,重量百分比含量为5%-80%,其它成分包括重量百分比0-30%的有机酸、重量百分比4-50%的淀粉、重量百分比0-40%的糊精、重量百分比0-30%的糖、重量百分比0-10%的维生素,其中维生素选自维生素D、维生素A、维生素B、维生素C、维生素E中一种或多种混合以及重量百分比0-5%的微量元素。
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