CN1247199C - 一种营养补充剂 - Google Patents
一种营养补充剂 Download PDFInfo
- Publication number
- CN1247199C CN1247199C CNB2004100339182A CN200410033918A CN1247199C CN 1247199 C CN1247199 C CN 1247199C CN B2004100339182 A CNB2004100339182 A CN B2004100339182A CN 200410033918 A CN200410033918 A CN 200410033918A CN 1247199 C CN1247199 C CN 1247199C
- Authority
- CN
- China
- Prior art keywords
- vitamin
- calcium
- folic acid
- medicament
- calcium carbonate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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Abstract
本发明涉及一种营养补充剂,该补充剂由活性组分叶酸,维生素D,碳酸钙和辅料组成。
Description
技术领域:
本发明涉及一种营养补充剂,该补充剂由活性组分叶酸,维生素D,碳酸钙和辅料组成。
背景技术:
叶酸,是上世纪40年代中后期分离出来的B族维生素之一,排名顺次第九,由于开始是从菠菜的叶子中提取而得以冠名。实际上,叶酸是一组化学结构相似生物化学特性近似的化合物的统称,科学家给它的命名是“蝶酰多谷氨酸”,主要是由蝶啶、对氨基苯甲酸和谷氨酸三部分物质结合在一起的。
存在于自然的叶酸有二氢叶酸和四氢叶酸两种形式,而在人体中只有四氢叶酸才具有生理功能,四氢叶酸是一碳单位的传递体,而一碳单位是指在人体新陈代谢过程中含有一个碳原子的基因,例如甲基、羟甲基等,正是这些活跃的一碳单位四氢叶酸,参与了许多化合物的生成和代谢,例如生命物质中各种氨基酸的相互转换,遗传物质脱氧核糖核酸(DNA)的合成,以及血红蛋白、肾上腺素、肌酸、胆碱的合成等。
正常人体中含有5-6毫克叶酸,其中50%贮存在肝脏。血液中的叶酸含量受近期食物的影响可高可低,可血液中红细胞的叶酸含量比较恒定,可以反映出人体叶酸的营养状况。红细胞叶酸含量达到140微克/升以上时,说明人体叶酸营养适宜,即便膳食中没有叶酸的摄入,也可以维持2-3个月不出现叶酸的营养缺乏。
叶酸是各种酶中最活跃基因辅酶,营养不良妇女群体突出的生殖健康问题是胎儿无脑畸形和脊柱裂等中枢神经发育不良等出生缺陷疾病,甚至可以延续到婴儿出生后的智力发育障碍。此外,贫血还可导致孕妇胎盘早剥,先兆子痫等妊娠高危病症。
应该说,在一个以农业为主、农民居多的国家或地区里,叶酸的食物来源不应该是匮乏的,动物肝脏、酵母、蔬菜和水果中叶酸的含量都比较丰富。从前面的介绍中不难看出,叶酸的代谢是十分活跃的,它遇光遇热极易分解。它是一种水溶性的B族维生素,在食品清洗、切碎、烹调的过程中会大量丢失,而且天然植物中的生物因子也会妨碍人体对叶酸的家族的重要成员,所以从肉眼看不到的细菌、病毒,到人类及哺乳动物中的诚然大物,它几乎参与了所有生命的生化代谢过程。值得细说的是叶酸与蛋氨酸的代谢循环。这个典型的-碳单位传递体的运行过程是蛋氨酸在三磷酸腺甙(ATP)的作用下变为活性蛋氨酸,活性蛋氨酸提供出一个一碳单位甲基形成同型半胱氨酸。后者再与5-甲基四氨叶酸中的一碳单位甲基合成蛋氨酸,使5-甲基四氢叶酸转变为四氢叶酸。四氢叶酸再与其他生物化学代谢过程生成的一碳单位甲基结合,重新形成5-甲基四氢叶酸。叶酸在这个代谢循环过程中的重要性在于,如果叶酸缺乏,5-甲基四氢叶酸合成不足,那么同型半胱氨酸向蛋氨酸的转换就会发生障碍,相继引发出一系列病现变化:同型半胱氨酸堆积,导致一碳单位甲基生成减少,这就直接影响50多种重要物质的合成。高浓度的同型半胱氨酸能损害血管的内皮细胞,成为重要的心脑血管致病因素,同型半胱氨酸作用于敏感的胚胎神经细胞,可造成无脑畸形和脊柱裂等不可逆损害,同型半胱氨酸溶解性小,易形成结合堵塞泌尿系统……叶酸的营养缺乏问题由此而引起广泛的关注。
叶酸缺乏较早为人们所熟知的临床表现是贫血,它与一般缺铁性贫血不同,首当其冲危害的是孕妇和胎儿。在受精卵发育,细胞分裂生长十分旺盛时,新陈代谢活跃,蛋白质合成加速,叶酸的需要量陡然剧增。如果孕妇体内红细胞叶酸贮存量不足,胎盘发育不良就会自发流产。胚胎发育不良最早受损的部位就是中枢神经。80年代以来,各国科学家发现吸收,实验证实,不同方式的摄入,叶酸吸收率差别很大,随食品摄入的叶酸吸收率通常只有服用单纯叶酸片剂的一半左右。所以,尽管叶酸在各种食品中分布比较广泛,但人体对叶酸的吸收利用会受到多种因素的制约。越来越多的国家推荐居民(特别是育龄妇女)要注意根据需要及时增补叶酸,以防治疾病、保护健康、提高生活质量。
维生素D的发现是人们与佝偻症抗争的结果。早在1824年,就有人发现鱼肝油可在治疗佝偻病中起重要作用。1918年,英国的梅兰比爵士证实佝偻病是一种营养缺乏症。但他误认为是缺乏维生素A所致。直到20年代末、30年代初,人们才确认维生素D缺乏是引起佝偻病的原因,并分离提纯了维生素D。
维生素D能使钙和磷有效地被利用,制造强健的骨骼和牙齿;和维生素A、C同时服用可预防感冒;有助于对结膜炎的治疗;帮助吸收维生素A。
维生素D大部分是在体内合成,仅少部分维生素D3是来自食物。人体皮下固醇类物质经紫外线照射后即可形成。晒大阳和食物中摄取都是不可缺少的。
维生素D的主要生理功能是:调节钙、磷代谢,促进钙、磷吸收。缺乏时,儿童可引起佝偻病,全身代谢障碍,发育不良;成人可引起骨软化症,孕妇和哺乳期妇女更为明显。
婴儿是维生素D缺乏的危险人群,因为在身体快速生长发育期间需要相对大量的维生素D。出生时,婴儿已从母体获得并储存了一定量维生素D,能满足生后最初几个月的需要。法国近年来对新生儿的调查结果显示,有64%的婴儿25-(OH)D3值<30nmol/L此值已为正常范围的低限(Zeghund等,1997年).由于母乳中维生素D含量较低,故母乳喂养的婴儿更易出现维生素D缺乏(Specker等,1985年)但是母乳喂养儿的营养性佝偻病还是很少见的,病例往往发生在缺乏阳光照射的母乳喂养婴儿(Pettifor 和Daniels,1997年;Binet 和Kooh,1996年;Brunvand和Nordshus,1996年;Gessner等,1997年)。在我国北方地区秋季出生的婴儿,要在室内度过6个月的时间,即使抱婴儿到户外,也将婴儿包裹的非常严实,使他们的皮肤很少有合成维生素D的机会,这样的孩子更易发生维生素D缺乏(阎怀成等,1986年,1989年)
在我国南方地区婴幼儿每日提供8.75μg(350IU)维生素D可预防佝偻病的生化变化,而在北方地区的婴幼儿就需要13.75μg(550IU)维生素D(吴光弛,1989年;李同等,1990年)。尽管维生素D缺乏在发达国家中已少见,但在北方城市仍有散发佝偻病的报道,往往总是母乳喂养的婴儿。儿童佝偻病的病因除日照不足,从食物中摄取的维生素D不够,钙磷比例不当,过早地给婴儿添加谷类食物等原因外,还与妊娠期母体的维生素D营养不良有密切关系。在婴儿配方食品中需要添加0.2-0.6μg/100kj(9.6-23.9IU/100KJ)的维生素D。充足维生素D,可预防婴幼儿佝偻病的发生。
青春期是身体快速发育的另一个阶段。在这个阶段,青少年对维生素D的需要增加。青少年与婴儿不一样,他们常常在户外活动,因此可得到充足紫外线照射来合成维生素D满足自身的需要。夏季和早秋时节体内过多的维生素D主要储存在脂肪组织中,这将有利于在接下来的冬季维持身体正常的生长速度。在这个时期,如果身体维生素D储存不足将可能会导致维生素D缺乏。
在过去20年,对维生素D的生化机制进行了较多的临床研究。结果表明,维生素D的许多关键功能都与衰老有关(Holick,1994年)。包括皮肤合成速率、形成具有活性激素形式的转化速率化及靶组织的反应(如骨),还有皮肤暴露的减少(Shearer,1997年)。老年人维生素D缺乏的问题,以血中低25-(OH)D3伴随血浆甲状旁腺激素和碱性磷酸酶海活性的升高为其特征(Gloth等,1995年;Chapuy等,1997年)。维生素D缺乏可降低老年人的骨质,增加髋骨骨折发生率(Dawson-Hughes等,1997年)。几个研究小组已发现适当增加维生素D摄入量(10-20μg/d)可降低骨质丢失及骨折发生率(Shearer,1997年;Chapuy和Meunier,1997年;Lips等,1996年)。适当增加老年人维生素D的推荐摄入量,增加到能维持老年人正常的25-(OH)D3水平(Russell,1997年;Goulding,1999年)这分别可使中年人和老年人(>70岁)的骨质丢失率小到10-15μg/(kg·d)(Report on Dietary Reference Intakes,1997年)。近来的多项研究都建议增加老年人的维生素D摄入量,从5μg/d或15μg/d(RNI)。
在妇女怀孕和哺乳期间,体内性激素的水平发生了变化。孕期补充维生素D对孕妇可产生一定的作用,而对哺乳期可能没有作用。尽管孕期维生素D的代谢也有所变化,即母亲血浆中1.25-(OH)2D3的水平增加,公认的原因是胎盘激素合成的作用(Delvin等,1985年),似乎不会对母体维生素D推荐量产生多大的影响。关于孕期补充维生素D可能对胎儿有害的看法还有待证实,鉴于维生素D从母体转运至胎儿后,对决定新生儿的生长速度很重要,因此还不能反对给孕妇补充适量的维生素D。在我国,通过给怀孕28周妇女一次性补充维生素D10万IU或20万IU并无副作用(阎怀成,1986年)。这个剂量可明显改善孕妇的维生素D营养状况(包括升高产妇血和脐血25-(OH)D3的水平,减少孕后期血钙的降低和孕妇腿抽筋等妊娠合并症的发生),并且有助于预防婴儿先天性佝偻病(吴光驰,1992年)。
对哺乳期妇女来讲,维生素D没有直接的作用。钙需要量增加是受分娩前后特殊激素的调节,并且近年来的研究没有发现哺乳期间维生素D代谢有何变化(Prentice,1998年,Jones等1999年)。母乳中维生素D水平较低(Specker等,1985年),哺乳期间母体的维生素D不会有较多的消耗。并且也没有证据表明,给哺乳的母亲补充钙或维生素D可增加钙或维生素D转运到新生儿体内的量(Prentice,1998年)。目前的意见是哺乳期间没有必要额外补充维生素D,在新生儿出生前后,只要能够保持母体良好的营养,有充足的阳光暴露,就能保证正常的维生素D营养状况。
因缺钙引起的人体不良症状,已经得到证实。在食品中强化补钙,是最科学、简洁、有效的措施。我们通过大面积人群调查,发现钙缺乏与叶酸缺乏在人体内并存,两者的缺乏严重影响了人们的健康,而目前市场上仅有单纯的补钙药物,如:碳酸钙制剂,也有维生素D和碳酸钙的复合制剂作为钙剂的补充,但没有即补充叶酸,又同时补充钙的药剂,为此,本发明提供了这样一种药剂,即有利于人们健康,也服用方便,显示出了优良的效果。
发明内容:
本发明提供一种补充营养的药剂,由具有营养作用的活性组分和药剂学上可接受的辅料组成,其特征在于,所述具有营养作用的活性组分是叶酸,维生素D类物质和含钙物质的结合。
本发明的药剂,是以单位剂量存在的,每一剂量单位含有的活性组分叶酸0.1-1.5mg,维生素D类物质40-180IU,含钙物质中的可利用钙100-800mg,其余为药剂学上可接受的辅料。优选的组成为:叶酸0.2-0.8mg,维生素D类物质60-120IU,含钙物质中的可利用钙300-400mg,最优选的组成为:叶酸0.2mg,维生素D类物质80IU,含钙物质中的可利用钙386mg,其中维生素D类物质优选为维生素D3,含钙物质选自碳酸钙、葡萄糖酸钙、枸橼酸钙、乳酸钙或苏糖酸钙。
该药剂中还包括药物或食品所能够接受的辅料,本发明的药剂是以单位剂量形式存在的,所述单位剂量形式是指制剂的单位,如片剂的每片,胶囊的每粒胶囊,注射剂的每支等,在最优选的组成中,每一单位剂量的药剂中含有:
可利用钙 100-800mg
叶酸 0.1-1.5mg
维生素D3 40-180IU
优选的是
可利用钙 300-400mg
叶酸 0.2-0.8mg
维生素D3 60-120IU
最优选的是
可利用钙 386mg
叶酸 0.2mg
维生素D3 80IU
其中,可利用钙是指钙离子的量,对于不同的钙盐,可加入不同的钙盐量,但其中的钙离子的量为以上处方量,例如碳酸钙1000g,其中钙离子占碳酸钙重量的百分比为小于等于40%,一般商品碳酸钙中钙离子的量为300-400g(当碳酸钙为纯品时,碳酸钙中的钙离子的量40%,在不纯时则低于40%)。维生素D3采用国际单位计算,每1ug分析纯的维生素D3等于40国际单位IU,而市场上销售的食品级维生素D3不是纯的,因此以国际单位和可利用钙计算可以避免摄取量的变化。
原料来源:
碳酸钙 产地 山东烟台
叶酸 产地 江苏
维生素D3 产地 进口食品添加剂为江苏分装
本发明的配方依据
本产品是钙与叶酸及维生素D3的营养补充剂.
钙是构成人体的重要成份,是人体内含量最多的无机元素,约占人体重的1.5%-2.0%。钙是构成人体完整性的不可缺少的组成部分,对维持生命起着重要的作用。然而,大量的科学调查证明我国各人群钙的摄取普遍偏低,仅达RDA的50%左右,尤其是儿童、乳母、钙的摄取量严重不足,由缺钙引起的各种疾患不断发生。经过几年来政府对初级保健工作的重视和普及,人们用营养补充剂来调整体内钙的缺乏已成时尚。另外,我们还从大量的调查中发现人体内钙缺乏与叶酸缺乏的现象并存。美国食品与营养委员会(FNB)1998年提出叶酸膳食摄入量应以膳食叶酸当量(DFE)=[膳食叶酸ug+(1.7=叶酸补充剂ug)]。
叶酸在体内的活性形式为四氢叶酸,作为一碳单位(如甲基CH3,亚基CH2)转移酶系的辅酶,是氨基酸代谢及核甘酸代谢中不可缺少的重要物质。细胞增殖,组织生长和机体发育均需要足够的叶酸。流行病学调查表明,由于人体内叶酸缺乏导致孕妇可产生畸形儿,中青年心脑血管疾病增加。据有关文献报道老年痴呆症的发生也与叶酸缺乏有关,因而本产品集碳酸钙,微量叶酸和微量维生素D3为一体做为营养补充剂,是一种金属原素,二种维生素类的混合补充剂,而且配伍合理,三种成份在体内互补,能为平衡体内生化环境起到一定作用,因而是一种配方合理、食用方便的理想营养补充剂。
大剂量的叶酸为5mg产品,国内作为药物治疗贫血,由于剂量大,长期服用对维生素B12的摄取有影响,也存在激发其他疾患的可能,而本发明的药剂中叶酸的含量是微量的,适合每日服用。
本发明的药剂可以是任何可服用用的剂型,这些剂型包括:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、糖浆剂、口含剂、颗粒剂、冲剂、丸剂、散剂、膏剂、丹剂、混悬剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂、缓释制剂、控释制剂。
本发明的药剂是将上述配方的活性成分与药学上或食品上可接受的载体(辅料)混合在一起,制备而成的。
本发明的药剂,其口服给药的片剂和胶囊通常为一种单位剂量,并含有常用的赋形剂,诸如粘合剂、填充剂、稀释剂、压片剂、润滑剂、崩解剂、着色剂、调味剂和湿润剂,可对片剂进行包衣。
适用的填充剂包括纤维素、甘露糖醇、乳糖和其它类似的填充剂。适宜的崩解剂包括淀粉、聚乙烯吡咯烷酮和淀粉衍生物,例如羟基乙酸淀粉钠。适宜的润滑剂包括,例如硬脂酸镁。适宜的药物可接受的湿润剂包括十二烷基硫酸钠。
可通过混合,填充,压片等常用的方法制备固体口服组合物。进行反复混合可使活性成分分布在整个使用大量填充剂的那些组合物中。
口服液体制剂的形式例如可以是水性或油性悬浮液、溶液、乳剂、糖浆剂或酏剂,或者可以是一种在使用前可用水或其它适宜的载体复配的干燥产品。这种液体制剂可含有常规的添加剂,诸如悬浮剂,例如山梨醇、糖浆、甲基纤维素、明胶、羟乙基纤维素、羧甲基纤维素、硬脂酸铝凝胶或氢化食用脂肪,乳化剂,例如卵磷脂、脱水山梨醇一油酸酯或阿拉伯胶;非水性载体(它们可以包括食用油),例如杏仁油、分馏椰子油、诸如甘油的酯的油性酯、丙二醇或乙醇;防腐剂,例如对羟基苯甲酯或对羟基苯甲酸丙酯或山梨酸,并且如果需要,可含有常规的香味剂或着色剂。
对于注射剂,制备的液体单位剂型含有本发明的活性成分配方和无菌载体。根据载体和浓度,可以将此化合物悬浮或者溶解。溶液的制备通常是通过将活性成分溶解在一种载体中,在将其装入一种适宜的小瓶或安瓿前过滤消毒,然后密封。辅料例如一种局部麻醉剂、防腐剂和缓冲剂也可以溶解在这种载体中。为了提高其稳定性,可在装入小瓶以后将这种组合物冰冻,并在真空下将水除去。
用基本相同的方式制备胃肠外悬浮液,除了是将活性化合物悬浮在载体而不是将其溶解,而且在将其悬浮于无菌载体之前,用环氧乙烷对其进行消毒。表面活性剂或湿润剂可包括在此组合物中,以利于这种活性化合物的均匀分布。
本发明的药剂,在制备成药剂时可选择性的加入适合的药物可接受的载体,所述药物可接受的载体选自:甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、预胶化淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等。
本发明的药物制剂的制备方法可以采用以下方法:
如片剂:碳酸钙和医用淀粉混合,制软材,制湿颗粒,在80-100度干燥4小时,冷却后加入叶酸,维生素D3,硬脂酸镁,预胶化淀粉混合,整粒,压片,包薄膜衣,包装,即得片剂。
在制备本发明的药剂时应注意以下几个技术问题:
1、原辅料使用前必须经过质检部门化验合格方可使用。碳酸钙,粒度<10μ。
2、将辅料、淀粉、预胶化淀粉过100目筛。
3、将碳酸钙与淀粉,置于混合器中,充分混合,加入15%的淀粉浆,混合至均匀。用12目尼龙筛网制粒。
4、将上述颗粒置于干燥箱内,80℃-100℃干燥4小时左右,同时达到消毒作用。
5、将干燥的颗粒,均匀地加入叶酸、维生素D3加入硬脂酸镁、预胶化淀粉进行总混,达到均匀后用14目筛网整粒。
6、检验颗粒含量,计算片重,进行压片,挂薄膜衣。
7、检验合格后分装,装箱,入库。
本发明的药剂,可以每天服用1-6次,优选是3次,每次服用1-6个制剂单位,如1-6片或1-6粒胶囊,儿童可以根据情况减少服用的剂量。
本发明的药剂对于缺乏钙和叶酸引起的疾病或营养不良或身体不适具有良好的调节,治疗和预防作用,还可用于高血压,冠心病,糖尿病,精神不振,容易疲劳,面色苍白,健忘,失眠,生长发育不良等具有治疗和预防作用,本发明的药剂易于吸收,制剂方法简单,作用优良,相互配方,相辅相成,获得了良好的效果,对有关人群使用后的反馈表明,深受人们的欢迎。
具体实施方式:
以下通过实施例进一步说明本发明。
实施例1:
片剂的制备
碳酸钙 1000kg
叶酸 202g
维生素D3 880g(10万IU/g)
医用淀粉 100kg
硬脂酸镁 10kg
预胶化淀粉 10kg
碳酸钙和医用淀粉混合,制软材,制湿颗粒,在80-100度干燥4小时,冷却后加入叶酸,维生素D3,硬脂酸镁,预胶化淀粉混合,整粒,压片,包薄膜衣,包装,即得片剂100万片。
实施例2:
胶囊剂的制备
碳酸钙 1000kg
叶酸 202g
维生素D3 880g(10万IU/g)
医用淀粉 100kg
硬脂酸镁 10kg
预胶化淀粉 10kg
碳酸钙和医用淀粉混合,制软材,制湿颗粒,在80-100度干燥4小时,冷却后加入叶酸,维生素D3,硬脂酸镁,预胶化淀粉混合,整粒,装胶囊得到100万粒胶囊。
实施例3:
颗粒剂的制备
碳酸钙 1000kg
叶酸 202g
维生素D3 880g(10万IU/g)
蔗糖 200kg
预胶化淀粉 10kg
糊精 100kg
碳酸钙和蔗糖,叶酸,维生素D3,预胶化淀粉,糊精混合,淀粉糊润湿,制粒,整粒,包装,得到50万袋口服颗粒剂。
实施例4:
片剂的制备
葡萄糖酸钙(折合成钙离子) 386kg
叶酸 202g
维生素D3 880g(10万IU/g)
医用淀粉 100kg
硬脂酸镁 10kg
预胶化淀粉 10kg
葡萄糖酸钙和医用淀粉混合,制软材,制湿颗粒,在80-100度干燥4小时,冷却后加入叶酸,维生素D3,硬脂酸镁,预胶化淀粉混合,整粒,压片,包薄膜衣,包装,即得片剂100万片。
实施例5:
片剂的制备
枸橼酸钙(折合成钙离子) 386kg
叶酸 202g
维生素D3 880g(10万IU/g)
医用淀粉 100kg
硬脂酸镁 10kg
预胶化淀粉 10kg
枸橼酸钙和医用淀粉混合,制软材,制湿颗粒,在80-100度干燥4小时,冷却后加入叶酸,维生素D3,硬脂酸镁,预胶化淀粉混合,整粒,压片,包薄膜衣,包装,即得片剂100万片。
Claims (7)
1.一种补充营养的药剂,由具有营养作用的活性组分和药剂学上可接受的辅料组成,其特征在于,所述具有营养作用的活性组分是叶酸,维生素D3和碳酸钙的结合;每一剂量单位含有的活性组分叶酸0.1-1.5mg,维生素D340-180IU,可利用钙100-800mg,所述可利用钙是碳酸钙中钙离子的量,其余为药剂学上可接受的辅料。
2.权利要求1的药剂,每一剂量单位含有的活性组分叶酸0.2-0.8mg,维生素D3 60-120IU,碳酸钙中可利用钙的量为300-400mg,其余为药剂学上可接受的辅料。
3.权利要求1的药剂,每一剂量单位含有的活性组分叶酸0.2mg,维生素D3 80IU,碳酸钙中可利用钙的量为386mg,其余为药剂学上可接受的辅料。
4.权利要求1的药剂,是适合口服的剂型。
5.权利要求1的药剂,是片剂、胶囊剂、颗粒剂或口服液。
6.权利要求1的药剂,是片剂。
7.权利要求6的药剂,每一剂量单位含有的活性组分叶酸0.2mg,维生素D3 80IU,碳酸钙中可利用钙的量为386mg,其余为药剂学上可接受的辅料。
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CN104958316A (zh) * | 2015-07-21 | 2015-10-07 | 陈�峰 | 一种高密度复合碳酸钙片及其制备方法 |
CN106109490A (zh) * | 2016-08-02 | 2016-11-16 | 辽宁康辰药业有限公司 | 一种增加骨密度、防治骨质疏松的片剂及其制备方法 |
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