CN110123836A - 钙锌维生素d泛酸片的应用 - Google Patents
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- 229930003316 Vitamin D Natural products 0.000 title claims abstract description 17
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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Abstract
钙锌维生素D泛酸片系采用昆明朗盛生物科技有限公司《一种显著促进钙源高效吸收利用的营养素组合物及制备》专利(申请号：201910385236.4)所制备的组合物为原料，添加聚维酮K30、羧甲基淀粉钠、硬脂酸镁，经混合、制粒、压片制成的片剂。本发明以钙锌维生素D泛酸片为研究对象，选用快速生长期4周龄SD大鼠为试验动物，设低钙高磷饲料、碳酸钙、柠檬酸钙、葡萄糖酸钙、复合维生素电子螯合钙对照组，通过血生化及股骨钙磷测定，评价本品对血清及骨骼钙磷平衡影响。结果显示：本品能快速提高血钙水平并促进其转化为骨钙，同时抑制磷的吸收及骨磷转化，从而实现改善和维持血液、骨骼钙磷平衡。
Description
技术领域
本发明涉及钙锌维生素D泛酸片的应用。具体是作为改善和维持机体血液、骨骼钙磷平衡的外源性营养素补充剂。属于生物医药大健康应用技术领域。
技术背景
钙、磷均为人体不可或缺的常量元素，二者在人体摄入、吸收、分布、代谢、排泄过程相似且相互耦联。从钙磷代谢动力学角度体现的中国人缺钙、补钙现状如下：
摄入：人体摄入的钙磷主要源自膳食结构。根据中国营养学会制定的《中国居民膳食营养素参考摄入量》，钙的推荐摄入量为800-1200mg/日，磷的推荐摄入量为350-700mg/日。由于中国居民膳食结构的特殊性，钙的平均摄入量仅为400mg/日(缺口达400-800mg/日)，而磷的平均摄入量却高达1058mg/日(过剩达350-700mg/日)。由此可见：中国人钙的摄入严重不足而磷的摄入严重过剩，通过外源性钙产品补充钙源(即“补钙”)的同时，需尽可能抑制膳食磷源吸收，方可达到钙磷平衡。
吸收、分布：人体通过膳食及补钙产品摄入的外源性钙源、磷源，需通过胃酸/酶的离解后在小肠/空肠被吸收入血，然后通过碱性磷酸酶、骨钙素等调节沉积到骨骼和牙齿中，成为人体骨骼、牙齿的主要成分。被人体吸收利用的钙，99％以骨钙形式分布在骨骼和牙齿中，1％以血钙形式分布在血液、细胞间液和软组织中；被人体吸收利用的磷，86％左右以骨磷形式分布在骨骼和牙齿中，14％左右以血磷的形式分布在血液、细胞间液及软组织中。构成人体骨骼/牙齿的成分除水分、有机质及微量矿物质外，主要就是钙磷无机质，其占比高达70％。而这70％的钙、磷无机质，其钙：磷比例应为1～2:1方可促进/维持生长期骨骼生长发育和定型期骨骼硬度和韧性。由于中国人膳食结构摄入的钙严重不足而磷严重过剩，导致机体吸收入血并转化沉积至骨骼的骨钙严重不足、骨磷严重过剩、骨钙磷比例倒挂为1:2～2.5，这是中国人佝偻病、腰腿关节疼痛、牙齿出血松动脱落、骨质疏松易骨折等缺钙症状和疾病高发的主要原因。鉴于机体对钙磷吸收利用相互耦联的关系，我们在补钙的同时，会显著促进磷的吸收利用，骨磷水平会进一步提高，不仅达不到钙磷平衡，还可能会加剧骨钙磷比例倒挂，使缺钙症状和疾病更加严重。由此可见：“补钙”主要是补充骨钙，补钙的同时需充分考虑抑制磷的吸收，尽可能改善和维持血液、骨骼钙磷平衡，方可达到改善缺钙症状和疾病之目的。
代谢、排泄：人体通过膳食及外源性补钙产品摄入的钙磷，被吸收利用后的剩余部分，主要通过消化系统、泌尿系统代谢，并经粪便、尿排出体外。如果因“缺钙”而盲目补钙，不考虑摄入钙源的吸收利用率，通过机体摄入未被吸收利用的钙源会加剧代谢、排泄负担。长期使用吸收利用率低的补钙产品，除大量消耗胃酸/酶导致胃部不适外，未被正常代谢、排泄的钙源积蓄在消化和泌尿系统，引起便秘、消化和泌尿系统结石等严重不良症状。由此可见：我们在“补钙”提高钙摄入量的同时，应充分考虑钙的吸收入血并快速转化为“骨钙”的量，方可达到补钙之目的。
昆明朗盛生物科技有限公司《一种显著促进钙源高效吸收利用的营养素组合物及制备》专利(申请号：201910385236.4)公开了一种显著促进钙源高效吸收利用的营养素组合物及制备方法，并通过钙表观吸收率、钙储存率验证了其技术效果。作为该专利的发明人，在实施该专利的过程中，针对国内外缺钙、补钙现状及存在的问题，开展不断的探索和研究，发现以该营养素组合物为原料制备的片剂(命名为钙锌维生素D泛酸片)，口服后不仅可显著提高血钙水平并快速转化为骨钙，还能抑制磷的吸收利用，可用于改善和维持血液、骨骼钙磷平衡。本发明权利要求保护的内容未被《一种显著促进钙源高效吸收利用的营养素组合物及制备》专利(申请号：201910385236.4)覆盖和公开，对于弥补因“缺钙”而盲目补钙可能进一步加剧缺钙症状具有重要意义。
发明内容
本发明的目的在于开辟《一种显著促进钙源高效吸收利用的营养素组合物及制备》专利(申请号：201910385236.4)的新用途。
本发明的目的是采用以下技术方案来实现的。
本发明以所述钙锌维生素D泛酸片为研究对象，选用快速生长期4周龄SD大鼠为试验动物，设低钙高磷饲料、碳酸钙、柠檬酸钙、葡萄糖酸钙、复合维生素电子螯合钙为对照开展喂养试验。通过不同时间段血清钙、磷、碱性磷酸酶、骨钙素生化指标检测及股骨钙磷测定，评价本品对血液及骨骼钙磷平衡影响。结果显示：本品能快速提高血钙水平并促进其转化为骨钙，同时抑制磷的吸收及骨磷转化，从而实现改善和维持血液、骨骼钙磷平衡。
具体实施方式：
下面通过具体实施例对本发明作进一步说明，但不以任何方式对本发明限制，基于本发明教导所作的任何变化或替换，均属本发明保护范围。
实施例1：复合维生素电子螯合钙、显著促进钙源高效吸收利用营养素组合物制备
复合维生素电子螯合钙：按昆明朗盛生物科技有限公司《一种显著促进钙源高效吸收利用的营养素组合物及制备》(申请号：201910385236.4)制备。经检测：钙含量为16.67％。
显著促进钙源高效吸收利用营养素组合物：按昆明朗盛生物科技有限公司《一种显著促进钙源高效吸收利用的营养素组合物及制备》(申请号：201910385236.4)制备。经检测：钙含量为16.54％。
实施例2：钙锌维生素D泛酸片制备
取实施例1制备的显著促进钙源高效吸收利用营养素组合物457.5g，添加聚维酮K30 25g、羧甲基淀粉钠15g、硬脂酸镁2.5g，混合均匀，经湿法制粒、50℃以下干燥，压片制成1000片0.5g规格的片剂。经检测：钙含量为15.00％。
钙锌维生素D泛酸片对SD大鼠钙磷平衡的影响实验
1、实验动物、材料及仪器
SD大鼠(Sprague—Dawley)：雄性，4周龄(快速生长期)、体重70-80g，清洁级，饲养环境：温度(22±2)℃、湿度60％±5％，上海西普尔-必凯实验动物有限公司提供；
低钙高磷饲料：市售。钙含量为0.1％，磷含量为0.6％；
碳酸钙(食品级)：市售。碳酸钙含量为99.8％(相当于钙含量为39.96％)；
葡萄糖酸钙口服液：市售。含葡萄糖酸钙100mg/ml(相当于钙9mg/ml)；
柠檬酸钙(食品级)：含柠檬酸钙97.84％(相当于钙23.60％)；
复合维生素电子螯合钙：实施例1制得，钙含量为16.67％；
钙锌维生素D泛酸片：实施例2制得，钙含量为15.00％；
血清钙、磷、碱性磷酸酶、骨钙素检测试剂盒；石墨炉消化炉；MARS6微波消解仪；原子吸收分光光度仪；BS-200全自动生化分析仪；游标卡尺等。
2、实验方法
(1)造模、分组、剂量设计及喂养
造模：取4周龄快速生长期雄性SD大鼠，经适应性喂养1周(自由进食低钙高磷饲料、去离子水)，造低钙高磷摄入动物模型。
分组：挑选造模后体重无显著性差异的大鼠60只，随机分为6组：低钙高磷饲料组(①)、碳酸钙组(②)、柠檬酸钙组(③)、葡萄糖酸钙组(④)、复合维生素电子螯合钙组(⑤)、钙锌维生素D泛酸片组(⑥)，每组10只。
剂量设计：本发明所述钙锌维生素D泛酸片成人每天服用量3g(相当于摄入钙量450mg/天)，据此折算⑥组钙锌维生素D泛酸片给样剂量为0.31g/(kg·d)。依据等剂量给样可比原则(每日钙摄入量相同)，换算②组碳酸钙给样剂量为0.12g/(kg·d)，③组柠檬酸钙给样剂量为0.20g/(kg·d)，④组葡萄糖酸钙口服液给样剂量为5.21ml/(kg·d)，⑤组复合维生素电子螯合钙给样剂量为0.28g/(kg·d)。
喂养：经适应性喂养1周并分组的SD大鼠，至第2周起，②～⑥组大鼠于每日清晨灌胃给样1次对应的试验及对照样品(剂量参见剂量设计)，之后①～⑥组自由进低钙高磷饲料及去离子水，连续喂养5周。
(2)血生化指标测定及评价
连续喂养的①～⑥组SD大鼠，于1周末，3周末，5周末分别采集血标本，分离血清于4℃保存。利用生化自动分析仪测定其钙、磷、碱性磷酸酶、骨钙素含量，结果见表1、2、3。
表1 1周末各组大鼠血清中生化指标水平(n＝10)
表2 3周末各组大鼠血清中生化指标水平(n＝10)
表3 5周末各组大鼠血清中生化指标水平(n＝10)
由表1、2、3得出如下结论：
1、①组1周末血清钙磷水平倒挂，碱性磷酸酶、骨钙素水平较高，表明低钙高磷动物模型造模成功；3周末、5周末一直处于低钙、高磷、高碱性磷酸酶和骨钙素水平，表明动物处于钙吸收不足、磷吸收过剩、骨钙流失严重。
2、相较于①组，②～⑥组因补充外源性钙，1周末血清钙水平均出现不同程度升高，而碱性磷酸酶、骨钙素水平出现不同程度降低，3周末和5周末血清钙、碱性磷酸酶、骨钙素均降低并维持在稳态水平，说明外源性钙产品提高了钙的摄入、吸收及骨钙转化水平；⑥组相较于②～⑤组而言，其1周末、3周末、5周末血清钙、碱性磷酸酶、骨钙素变化差异具有显著性(相较②～④组P<0.01、相较⑤组P<0.05)，表明钙锌维生素D泛酸片能快速提高血钙水平并促进其转化为骨钙，减少骨钙流失。
3、相较于①组，②～⑤组在补钙的同时，1周末血清磷同步提高，3周末和5周末维持在较高水平；而⑥组1周末血清磷极显著降低(相较于②～⑤组P<0.01)并于3周末和5周末维持在较低的稳态水平。说明②～⑤组在补钙的同时促进磷的吸收和转化，而⑥组补钙的同时显著抑制磷的吸收和转化，可改善和维持骨钙磷水平。
(3)、股骨生长及钙磷检测、评价
①～⑥组大鼠于喂养5周后处死，取右股骨，用游标卡尺测定长度，烘干恒重后称取股骨干重。烘干恒重的股骨磨成细粉，采用火焰原子吸收法测定其钙含量，钼酸铵分光光度法测定磷含量，结果见表4。
表4 5周末各组大鼠股骨生长及钙磷检测结果(n＝10)
表4看出：饲养5周后，⑥组大鼠股骨干重、股骨长、钙含量显著高于①～⑤组(P<0.05)，而磷含量显著低于①～⑤组(P<0.05)，股骨钙磷比例约为1.2:1。说明本发明所述钙锌维生素D泛酸片能显著促进骨骼生长，提升骨钙含量，改善并维持骨钙磷平衡。
通过加载低钙高磷饲料，比较5种不同钙源物质对大鼠体内血清钙、磷、碱性磷酸酶、骨钙素及股骨干重、股骨长、骨钙和骨磷含量影响，确认钙锌维生素D泛酸片能快速提高血钙水平并促进其转化为骨钙，同时抑制磷的吸收及骨磷转化，可用于改善和维持血液、骨骼钙磷平衡。
以上所述仅为本发明的较佳实施例，并不用于限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (1)
1.钙锌维生素D泛酸片的应用，其特征在于：本品能快速提高血钙水平并促进其转化为骨钙、同时抑制血磷的吸收及骨磷转化，用于改善和维持机体血液、骨骼钙磷平衡。
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