CN114680329A - 一种增加骨密度的鹿骨氨糖软骨素钙片配方及其制备方法 - Google Patents
一种增加骨密度的鹿骨氨糖软骨素钙片配方及其制备方法 Download PDFInfo
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Abstract
本发明属于健康产品领域,是一种涉及增加骨密度的鹿骨氨糖软骨素钙片及其制备方法,其组成与配比:原料:鹿骨粉,杜仲提取物,骨碎补提取物,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽等成分制备得到,其中鹿骨粉,杜仲提取物,骨碎补提取物,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽的重量比为180~540:75~225:30~90:70~210:80~240:103~309:88~264,其中杜仲、骨碎补经提取、浓缩、干燥得到浸膏粉,加入鹿骨粉,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽原料及微晶纤维素、交联聚维酮,硬脂酸镁,薄膜包衣预混剂辅料混合、制粒、干燥、整粒、压片、包装即得。得到具有增加骨密度活性功能的健康保健产品。
Description
技术领域
本发明属于健康产品领域,具体涉及增加骨密度的鹿骨氨糖软骨素钙片配方及其制备方法
背景技术
骨密度指骨单位面积所含的骨矿物量,是骨质量的一个重要标志,反映骨质疏松程度,预测骨折危险性的重要依据。中国健康促进基金会骨质疏松基金筹委会发布的《中国办公室人群骨密度情况调研分析报告》显示:35~40岁以后骨矿含量出现下降趋势,女性尤为显著。到了50岁以上,骨质疏松发病率则高达50%,为家庭和社会带来极沉重的负担。60岁以上骨质疏松患者约9000万,占老年人口比例的68%。这类群患者一旦经历了第一次骨质疏松性骨折,继发性骨折的危险明显加大。在中国逐步进入老龄化社会之际,关爱中老年人健康,防治骨质疏松,已成为国内外学者普遍关注的问题。2003年至2006年一次全国性大规模流行病学调查显示,50岁以上人群以椎体和股骨颈骨密度值为基础的骨质疏松症总患病率女性为20.7%,男性为14.4%。60岁以上人群中骨质疏松症的患病率明显增高,女性尤为突出。按调查估算全国2006年在50岁以上人群中约有6944万人患有骨质疏松症,约2亿1千万人存在低骨量。预计到2050年,达到1.5亿人,该病已成为对人类健康构成巨大威胁的严重问题,加紧开展药物防治研究已到了刻不容缓的地步。
本发明配方原料选择均符合保健食品的配方要求,是以中医理论为指导,结合现代医学理论进行组方,鹿骨性温,味甘,微热,无毒,归肾经。中医《伤寒杂记》中记载“虎难捕,可用鹿骨代之。虎肉食,其骨效迅急而猛烈;鹿草食,其骨性温良而悠长”。老虎吃肉,药效较激烈;而鹿性温良,鹿骨可以更温和地补充骨骼所需要的营养。本配方中杜仲提取物性甘,温。具有补肝肾,强筋骨,安胎。用于肝肾不足,腰膝酸痛,筋骨无力,头晕目眩,妊娠漏血,胎动不安。骨碎补具有疗伤止痛,补肾强骨。外用消风祛斑。用于跌扑闪挫,筋骨折伤,肾虚腰痛,筋骨痿软,耳鸣耳聋,牙齿松动;外治斑秃,白癜风的功效。加上鹿骨粉共奏增强骨密度的吸收功效。综上所述,目前其他同类保健食品普遍只强调了营养的供给,而忽略了循环、吸收。
本产品具有一定的综合优势,是专为适宜人群设计的安全、有效、服用方便的保健食品。
发明内容
本发明克服了背景作用的单一的营养供给效果,增加产品的吸收及功效。
本发明涉及增加骨密度的鹿骨氨糖软骨素钙片配方及其制备方法。
本发明涉及【原料】鹿骨粉、盐酸氨基葡萄糖、硫酸软骨素钠、酪蛋白磷酸肽、碳酸钙、杜仲提取物、骨碎补提取物。
本发明涉及【辅料】微晶纤维素、交联聚维酮、薄膜包衣预混剂(羟丙基甲基纤维素、聚乙二醇)、硬脂酸镁。
本发明原料配比:鹿骨粉,杜仲提取物,骨碎补提取物,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽等成分制备得到,其中鹿骨粉,杜仲提取物,骨碎补提取物,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽的重量比为180~540:75~225:30~90:70~210:80~240:103~309:88~264。
本发明涉及制备方法:杜仲、骨碎补经提取、浓缩、干燥得到浸膏粉,加入鹿骨粉,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽原料及微晶纤维素、交联聚维酮,硬脂酸镁,薄膜包衣预混剂辅料混合、制粒、干燥、整粒、压片、包装。得到具有增加骨密度活性功能的健康保健产品。
【生产工艺】本品原辅料经灭菌(6kGy,60Co辐照)、过筛、混合、制粒、干燥(温度55-65℃,水分4-6%)、总混、压片、包衣、包装等主要工艺加工制成。
【直接接触产品包装材料的种类、名称及标准】口服固体药用高密度聚乙烯瓶符合《口服固体药用高密度聚乙烯瓶》(YBB 00122002)的规定。
【感官要求】应符合表1的规定。
表1感官要求
【鉴别】无。
【理化指标】应符合表2的规定。
表2理化指标
【微生物指标】应符合表3的规定。
表3微生物指标
项目 | 指标 | 检测方法 |
菌落总数,CFU/g≤ | 3×10<sup>4</sup> | GB 4789.2 |
大肠菌群,MPN/g≤ | 0.92 | GB 4789.3MPN计数法 |
霉菌和酵母,CFU/g≤ | 50 | GB 4789.15 |
金黄色葡萄球菌≤ | 0/25g | GB 4789.10 |
沙门氏菌≤ | 0/25g | GB 4789.4 |
【标志性成分指标】应符合表4的规定。
表4标志性成分指标
【重量差异指标】
重量差异指标应符合《中华人民共和国药典》中“制剂通则”项下片剂的规定。
【原辅料质量要求】
1鹿骨粉
鹿骨粉应符合表6的规定。
表6鹿骨粉应符合的质量要求
项目 | 标准 |
原料来源 | 梅花鹿或马鹿的骨头(不带肉) |
制法 | 前处理、蒸煮、干燥、粉碎、过筛等 |
感官要求 | 黄色至浅棕色粉末 |
钙(以Ca计),g/100g≥ | 15 |
水分,%≤ | 8 |
粒度 | 80目 |
铅(Pb),mg/kg≤ | 2.0 |
总砷(As),mg/kg≤ | 1.0 |
总汞(Hg),mg/kg≤ | 0.3 |
2盐酸氨基葡萄糖
盐酸氨基葡萄糖应符合WS1-XG-028-2001《盐酸氨基葡萄糖》的要求。
硫酸软骨素钠
硫酸软骨素钠,猪软骨来源应符合《中华人民共和国药典》的规定。
酪蛋白磷酸肽
酪蛋白磷酸肽应符合GB31617《食品安全国家标准食品营养强化剂酪蛋白磷酸肽》的规定。
5碳酸钙
碳酸钙应符合GB 1898《食品安全国家标准食品添加剂碳酸钙》的规定。
6杜仲提取物
杜仲提取物应符合表7的规定。
表7杜仲提取物应符合的质量要求
7骨碎补提取物
骨碎补提取物应符合表8的规定。
表8骨碎补提取物应符合的质量要求
8微晶纤维素
微晶纤维素应符合《中华人民共和国药典》的规定。
交联聚维酮
交联聚维酮应符合《中华人民共和国药典》的规定。
10硬脂酸镁
硬脂酸镁应符合《中华人民共和国药典》的规定。
11薄膜包衣预混剂
薄膜包衣预混剂应符合的质量要求见表9。
表9薄膜包衣预混剂应符合的质量要求表
项目 | 标准 |
组成 | 羟丙基甲基纤维素、聚乙二醇 |
制法 | 配料、干燥、粉碎、过筛、混合、包装 |
性状 | 白色粉末 |
外观均一性 | 颜色均匀,无杂质 |
粒度 | 通过50目筛不得少于99% |
水分,%≤ | 8 |
灰分,%≤ | 45 |
菌落总数,CFU/g≤ | 3×10<sup>4</sup> |
大肠菌群,MPN/g≤ | 0.92 |
霉菌和酵母菌,CFU/g≤ | 50 |
金黄色葡萄球菌≤ | 0/25g |
沙门氏菌≤ | 0/25g |
附图说明
图1是制备流程图。
Claims (15)
1.一种增加骨密度的鹿骨氨糖软骨素钙片配方。
2.一种增加骨密度的鹿骨氨糖软骨素钙片制备方法。
3.根据权利要求1增加骨密度的鹿骨氨糖软骨素钙片配方原料:鹿骨粉,杜仲提取物,骨碎补提取物,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽。
4.根据权利要求1增加骨密度的鹿骨氨糖软骨素钙片配方辅料:微晶纤维素、交联聚维酮、薄膜包衣预混剂(羟丙基甲基纤维素、聚乙二醇)、硬脂酸镁。
5.根据权利要求2增加骨密度的鹿骨氨糖软骨素钙片制备方法原料重量比,鹿骨粉,杜仲提取物,骨碎补提取物,碳酸钙,盐酸氨基葡萄糖,硫酸软骨素钠,酪蛋白磷酸肽的重量比为180~540:75~225:30~90:70~210:80~240:103~309:88~264。
6.根据权利要求1所有原料辅料,均应符合企业标准规定;加工助剂乙醇应符合GB10343食用酒精的规定,加工助剂水应符合《中华人民共和国药典》“纯化水”的规定。
7.根据权利要求1包装材料口服固体药用高密度聚乙烯瓶符合《口服固体药用高密度聚乙烯瓶》(YBB 00122002)的规定。
8.根据权利要求3、根据权利要求4,原辅料和加工助剂应经质量检查合格后用于生产。
9.根据权利要求2制备方法:根据权利要求5配方重量比取原料辅料,将鹿骨粉灭菌(6kGy,60Co辐照),按配方比例称取鹿骨粉、杜仲提取物、骨碎补提取物、碳酸钙、盐酸氨基葡萄糖、硫酸软骨素钠、酪蛋白磷酸肽、微晶纤维素、交联聚维酮、硬脂酸镁。
10.根据权利要求9原辅料过筛:取鹿骨粉、杜仲提取物、骨碎补提取物、碳酸钙、盐酸氨基葡萄糖、硫酸软骨素钠、酪蛋白磷酸肽、微晶纤维素、交联聚维酮、硬脂酸镁过80目筛。
11.根据权利要求10原辅料混合:将过筛后的鹿骨粉、杜仲提取物、骨碎补提取物、碳酸钙、盐酸氨基葡萄糖、硫酸软骨素钠、酪蛋白磷酸肽、微晶纤维素、交联聚维酮混合30min,混合均匀,得混合粉。
12.根据权利要求11将混合粉制粒、干燥、整粒:加入70 %乙醇,制成软材,过20目筛制粒,干燥(温度55-65℃,水分4-6%),20目筛整粒。
13.根据权利要求12整粒总混:将制得的颗粒与硬脂酸镁混合5min,混合均匀,得总混颗粒。
14.根据权利要求13将总混颗粒压片、包衣:将总混颗粒进行压片,得素片;素片包衣(将素片放入包衣锅内,开启包衣锅,速转2-5转/min,调整进风口温度75℃-80℃,出风口温度45℃左右,开启喷枪,观察包衣情况,逐渐加快转速和喷液量,待片芯成膜后,提高包衣锅转速至6-20转/min,加快喷液量,继续包衣,关闭喷枪,干燥5-10分钟,取出包衣片,晾至室温),包衣增重2.5%,0.9g/片,得半成品。
15.根据权利要求14将半成品包装、检测:取片装瓶,60片/瓶,经检验合格后外包装,检测合格即得成品。
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