CN1132626A - 改良的钙的饮食增补剂 - Google Patents

改良的钙的饮食增补剂 Download PDF

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CN1132626A
CN1132626A CN95118698A CN95118698A CN1132626A CN 1132626 A CN1132626 A CN 1132626A CN 95118698 A CN95118698 A CN 95118698A CN 95118698 A CN95118698 A CN 95118698A CN 1132626 A CN1132626 A CN 1132626A
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L·艾伦波根
L·C·布昂诺
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Abstract

本发明公开了一种包含一种钙盐、维生素D和一种硼盐的饮食增补组合物。也可含有其他的矿物盐，如铜盐、镁盐、锰盐和锌盐。

Description

改良的钙的饮食增补剂
矿物质和维生素组合物通常被用作饮食增补剂，或者作为直接针对某种特殊的内科疾病的治疗剂，或作为一般的营养补充剂。
对于成年人和正在成长的儿童来说钙和微量矿物质的补充同等重要。为帮助防止随着正常年龄的增长而伴随的骨损失，成年人也需要补充钙。由于妇女绝经后激素状态的变化加速骨的损失率而导致骨质疏松，所以她们需要更多的钙。
骨质疏松是一种流行病，在美国有15000,000至20,000,000人患有此种疾病。在骨质疏松病中，骨质减少导致骨头变脆，这样骨头变得更容易骨折。据估计在美国至少有1,300,000人所患的骨折可归因于这种疾病(国家骨质疏松基金会，Stand up toOsteoporosis，Your Guide to Staying Healthy andIndependent Through Prevention and Treatment，Washing-ton D.C.1992)许多科学家认为导致骨质疏松的一个很重要的因素就是饮食中钙的慢性缺乏。成年人最佳钙的摄取量(1,000-1,500mg)可以通过饮食、富钙食品、钙的补充剂或其结合而获得。据研究表明美国成年妇女通常钙的摄取量为每天450-500mg。(美国健康与人服务部门，国家健康研究所公共卫生部门，Osteoporosis，Cause，Treatment Prevention，Maryland，国家健康研究所，1987)；这一剂量恰好低于美国推荐的每日允许量(U.S.RDA)。近来有报道认为除了钙外，矿物质硼，铜、镁、锰和锌，对骨的形成也具有很重要的作用(Strause L.，等：微量元素在骨的代谢中的作用，Nutritional Aspects of Osteoporosis，NewYork，Raven Press，P.223-233，1992和Nielsen，F.：有关硼的事实和错觉，Nutrition Today，27(3)：6-12，5/6 1992)。另外，我们已经知道在人体对钙的吸收中，维生素D起着关键的作用。对老年人来说，每日摄取维生素D的推荐量为400国际单位至800国际单位，下文把国际单位简写为I.U.。
本发明涉及一种钙、维生素D和多种矿物质的饮食增补组合物。多种矿物质可包括一种或多种硼盐，铜盐、镁盐、锰盐和锌盐。该组合物也包括药学上可接受的载体和赋形剂。
本发明涉及一种防止骨损失疾病的钙、维生素D和多种矿物质的饮食增补组合物。
众所周知，就生物利用率和吸收方面而言，并不是所有的钙源都是等同的。钙的优选形式是碳酸钙，它含有最高量的可吸收钙，即40％的元素钙。碳酸钙价廉易得，并且容易致密地形成一体含钙量较大的片剂。由于碳酸钙中元素钙含量较高，片剂就能做得较小并且还能含有较高浓度的可吸收的钙。片剂变小，就更容易吞咽，特别是对老年人。
可增补用的其它钙源有葡萄糖酸钙、乳酸钙、磷酸二钙和枸橼酸钙等。所提供的元素钙大约在400-1,000mg范围内。
增加在钙的吸收过程中起关键作用的维生素D的范围是50I.U-800IU.。优选范围是200I.U.-400I.U.。
多种矿物质是硼，铜、镁、锰和锌。矿物质的阴离子可以是磷酸根，氯离子，硫酸根和硝酸根等。
在骨的形成和代谢中，铜、镁和锌是必需的。它们是机体骨基质合成中所包括的几种酶的必要辅助因子。人类研究的结果表明了形成和养护健康骨骼代谢的必要性(Strause，L.等；微量元素在骨代谢中的作用，Nutritional Aspects of Osteoporosis，New York，Raven Press，P.223-233，1992)。锰的缺乏本身就表明骨已处于损害性生长和骨骼畸形的状态中。此外，镁是所有软组织的骨的基本成份。身体中的大多数镁是与骨中的钙和磷酸盐结合在一起的(Avioli，L.钙和骨质疏松，Ann. Rev.Nutr.，4：471-491，1984)。硼的缺乏会影响骨的组成、结构和强度。硼对骨代谢的影响可能会反应在它对大量矿物质(macromineral)代谢的已知作用。对人体的研究有力证实了硼对钙的代谢和吸收都是有益的(Nielsen，F.：有关硼的事实和错觉，Nutrition Today，27(3)：6-12，5/6 1992)。
增补矿物质的优选量为硼盐  50-3,000微克；铜盐  0.10-5.0mg；镁盐  10-150mg；锰盐  3-10mg；和锌盐3-25mg一般认为，剂型的总重量应少于大约3.0g。剂型的优选例大约等于或少于2.0g。
本配方也可以包括防腐剂，如苯甲酸及其盐，丁基化羟基苯甲醚，2，6-二叔丁基对甲酚和二氧化硫等；食品级的乳化剂，如卵磷酯，长链脂肪酸的甘油单酯和甘油双酯，以及丙二醇酯；和本领域普通技术人员所熟知的药学上可接受的载体及赋形剂。
本文所用的药学上可接受的是指一种适合人体使用的成分，它没有如刺激性、毒性和变态反应之类的不良副作用。
本配方可采用口服的固体剂型，如片剂，胶囊，锭剂，可咀嚼的片剂或大体积的粉剂。片剂、胶囊或锭剂可包括本领域普通技术人员所熟知的适当的粘合剂，润滑剂，稀释剂，崩解剂，着色剂，调味剂，流动诱导剂和溶解剂。
本配方也可采用液体剂型，包括乳剂和悬浮剂。液体剂型也可包含本领域普通技术人员所熟知的适当的溶剂，防腐剂，乳化剂，悬浮剂，稀释剂，甜味剂，溶解剂以及着色剂和调味剂。
片剂是服用本发明组合物的优选形式，尽管如此，口服的任何剂型也都是可以采用的。
为了使有效成份避免受潮，氧化或光照，和掩盖任何不良的味道和外观，固体剂型可以有一层膜包衣。适合的包衣剂包括纤维素，羟丙基甲基纤维素，邻苯二甲酸纤维素，α-甲基丙烯共聚物和虫胶。也可以使用肠包衣或便于识别的着色剂，如需要的话，固体剂型还可以用一种蜡组合物如巴西棕榈蜡进行磨光。
下面的实施例是举例说明本发明目的，而不应认为是对本发明的限定。除非另有说明，各部分都按重量计算。实施例1
如下列图示，将一种由药品级碳酸钙与麦芽糖糊精BTH颗粒；冷水溶解的100,000I.U/g维生素D3 CSW；氧化铜，氧化镁，硫酸锰，硼酸钠·10H2O和月桂基硫酸钠组成的混合物混合5分钟(预混合物A)。
用氧化锌和剩余的碳酸钙将预混合物A包紧并混合10分钟(最后的混合物)。
混合粉红色膜(土灰色胶的玫瑰红)的包衣预混物，矿物油和月桂醇硫酸钠制成一种15％的固体悬浮液包衣(包衣溶液制剂)。
把最后的混合物压成所需的剂量形式。
将包衣溶液配方塗复到固体剂型上。
下面所列出的是钙，维生素D和多种矿物质的饮食增补制剂中优选成分的各自用量。
                    标签所要求       单位剂量的原料                    的单位剂量含量   原料含量(克)1.药品级W的碳酸钙       600mg Ca++       1.690000/麦芽糖糊精BTH颗粒2.维生素D3 CWS          200I.U./D        0.002800100,000I.U./g3.氧化锌                7.5mg Zn         0.0093354.氧化铜                1.0mg Cu         0.0012525.氧化镁                40mg Mg          0.0663136.硫酸锰                1.8mg Mn         0.0055407.硼酸钠·10H2O        250mcg B         0.0022308.粉红色膜(土灰色般的玫瑰红)             0.025900的包衣预混合物9.矿物油                                 0.00735010.月桂基硫酸钠                          0.001750
总片重                               1.812470
下面图解所示的数字与上述原料数字一致。
制剂的图解
Figure A9511869800101

Claims (20)

1.一种防止骨损失疾病的饮食增补组合物，它包括一种钙盐、维生素D和至少一种矿物质。
2.根据权利要求1所述的组合物，其特征在于钙盐选自于碳酸钙，葡萄糖酸钙，乳酸钙、磷酸二钙和枸橼酸钙。
3.根据权利要求2所述的组合物，其特征在于钙盐为碳酸钙。
4.根据权利要求1所述的组合物，其特征在于钙盐的含量约为1000mg-2500mg。
5.根据权利要求4所述的组合物，其特征在于钙盐的含量约为1500mg-2000mg。
6.根据权利要求1所述的组合物，其特征在于维生素D的含量约为50-800I.U.。
7.根据权利要求6所述的组合物，其特征在于维生素D的含量约为100-300I.U.。
8.根据权利要求1所述的组合物，其特征在于至少一种矿物质是选自于硼盐，铜盐，镁盐，锰盐和锌盐。
9.根据权利要求8所述的组合物，其特征在于硼盐、铜盐、镁盐、锰盐和锌盐有一个阴离子选自于磷酸根、氯离子、硫酸根、硝酸根及其混合的组中。
10.根据权利要求8所述的组合物，其特征在于硼盐含量为50-3000微克。
11.根据权利要求8所述的组合物，其特征在于铜盐含量约为0.1-3.0mg。
12.根据权利要求8所述的组合物，其特征在于镁盐含量约为10-150mg。
13.根据权利要求8所述的组合物，其特征在于锰盐含量约为3-10mg。
14.根据权利要求8所述的组合物，其特征在于锌盐的含量约为3-25mg。
15.根据权利要求1所述的组合物，其特征在于是口服的固体剂型。
16.防止骨损失的饮食增补组合物，包括一种钙盐，维生素D和至少一种含硼盐的矿物质。
17.根据权利要求16所述的组合物，其特征在于钙盐为碳酸钙。
18.根据权利要求17所述的组合物，其特征在于钙盐含量约为1500-2000mg。
19.一种防止骨损失的饮食增补组合物，包括：含量约为1000-2500mg的钙盐；含量约为50-800I.U.的维生素D；含量约为50-3,000微克的一种硼盐；含量约为0.1-5.0mg的一种铜盐；含量约为10-150mg的一种镁盐；含量约为3-10mg的一种锰盐；和含量约为3-25mg的一种锌盐。
20.根据权利要求19所述的组合物，其特征在于它是选自于片剂、胶囊、锭剂、可咀嚼的片剂和大体积的粉剂中的一种口服剂型。
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CN101797385A (zh) * 2010-04-12 2010-08-11 戴立忠 一种口服钙药物组合物
CN105012340A (zh) * 2015-08-21 2015-11-04 上海华源安徽锦辉制药有限公司 一种含有枸橼酸钙的药物组合物及其制备方法
CN106723065A (zh) * 2017-01-12 2017-05-31 浙江格蕾斯生物科技有限公司 一种维生素d和硼复合营养补充剂
CN111870584A (zh) * 2020-08-25 2020-11-03 无限极（中国）有限公司 一种有助于促进骨健康的组合物及其应用

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100452992C (zh) * 2002-08-22 2009-01-21 张昌华 水溶性钙复合营养强化剂的配制
CN101797385A (zh) * 2010-04-12 2010-08-11 戴立忠 一种口服钙药物组合物
CN101797385B (zh) * 2010-04-12 2011-02-16 戴立忠 一种口服钙药物组合物
CN105012340A (zh) * 2015-08-21 2015-11-04 上海华源安徽锦辉制药有限公司 一种含有枸橼酸钙的药物组合物及其制备方法
CN105012340B (zh) * 2015-08-21 2018-07-06 上海华源安徽锦辉制药有限公司 一种含有枸橼酸钙的药物组合物及其制备方法
CN106723065A (zh) * 2017-01-12 2017-05-31 浙江格蕾斯生物科技有限公司 一种维生素d和硼复合营养补充剂
CN111870584A (zh) * 2020-08-25 2020-11-03 无限极（中国）有限公司 一种有助于促进骨健康的组合物及其应用

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CA2158811A1 (en) 1996-03-27
PT702954E (pt) 2003-03-31
US5879698A (en) 1999-03-09
DK0702954T3 (da) 2003-03-03
EP0702954A3 (en) 1996-08-21
SI0702954T1 (en) 2003-02-28
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NZ280069A (en) 1997-11-24
AU689307B2 (en) 1998-03-26
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JPH08208490A (ja) 1996-08-13
HU9502798D0 (en) 1995-11-28
DE69528801T2 (de) 2003-10-02
EP0702954A2 (en) 1996-03-27
MY112929A (en) 2001-10-31
EP0702954B1 (en) 2002-11-13
KR960010009A (ko) 1996-04-20
AU3284495A (en) 1996-04-04
HUT73330A (en) 1996-07-29
SK282310B6 (sk) 2002-01-07
UA27971C2 (uk) 2000-10-16
IL115241A (en) 2000-08-31
ZA958001B (en) 1997-03-24
CZ292213B6 (cs) 2003-08-13

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