CN1371688A - Vc－磷酸酯镁在医药中的应用 - Google Patents
Vc－磷酸酯镁在医药中的应用 Download PDFInfo
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- 239000011777 magnesium Substances 0.000 title claims abstract description 23
- 229910052749 magnesium Inorganic materials 0.000 title claims abstract description 19
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 title abstract 2
- 229910019142 PO4 Inorganic materials 0.000 title abstract 2
- 150000002148 esters Chemical class 0.000 title abstract 2
- 239000010452 phosphate Substances 0.000 title abstract 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 title 1
- 239000008187 granular material Substances 0.000 claims abstract description 12
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- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 17
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 6
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
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- PBSRSWFGYPZDAU-FFIPNUABSA-H trimagnesium;[(2r)-2-[(1s)-1,2-dihydroxyethyl]-3-oxido-5-oxo-2h-furan-4-yl] phosphate Chemical compound [Mg+2].[Mg+2].[Mg+2].OC[C@H](O)[C@H]1OC(=O)C(OP([O-])([O-])=O)=C1[O-].OC[C@H](O)[C@H]1OC(=O)C(OP([O-])([O-])=O)=C1[O-] PBSRSWFGYPZDAU-FFIPNUABSA-H 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
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Abstract
本发明涉及一种公知食品添加剂Vc－磷酸酯镁新的医药用途。以其为活性成分可与一种或多种赋形剂结合,经常规方法制成片剂、颗粒剂、散剂或糖浆剂、胶囊剂,用于人体缓泻作用。采用本发明制得的缓泻药无任何毒副反应且兼有保健作用。
Description
本发明涉及Vc-磷酸酯镁的新应用，特别是涉及在制备缓泻剂中的应用。
Vc-磷酸酯镁，英文名称为Ascorbyl phosphate magnesium，简称AP-Mg。
AP-Mg的分子式：C6H6O9PMg1.5·5H2O
分子量为：379.61
结构式为：
AP-Mg用途较广，通常作为食品添加剂，尚无作为缓泻剂应用的报导。
1、目前，治疗便秘的泻药种类很多，按其作用机理大致可分为三类：(1)刺激性泻药：如市售的果导片、轻泻片、通舒片、一轻松、麻仁润肠片(丸)等均属此类；(2)盐类泻药；如硫酸镁、硫酸钠等；(3)润滑性泻药；如甘油栓、开塞露等。这些泻药在临床应用中均可减轻便秘患者的痛苦，但不同程度地都存在一些副作用，长期使用还会造成习惯依赖性，甚至造成钙及维生素的丢失，引起维生素缺乏症，因此，便秘患者尤其中、老年患者及孕、产妇便秘者要慎重选择这些泻药。(引自～《家庭顾问》北京出版社，1980年2月第一版P335-336。)
本发明的目的在于利用AP-Mg所具有的新的药用用途，制成缓泻药。既可克服现有泻药存在的易造成患者维生素缺乏，甚至易引起结肠痉挛性便秘等不足，又可兼顾为人体补充人体所必需的维生素C及镁离子的作用。
本发明的目的是这样实现的：
以AP-Mg作为活性成份，与一种或多种赋形剂结合，按片剂、颗粒剂、散剂、糖浆剂等工艺操作制成片剂、颗粒剂、散剂或糖浆剂，也可直接将活性成份装入胶囊制成胶囊剂，用于缓泻作用，其中AP-Mg的用量占总剂量的0.6-100％。
AP-Mg人体吸收后可分解为Vc和镁离子。Vc为人体需要量最大的维生素，可增强人体免疫功能，防治坏血病及多种疾病的发生。镁离子也具有多种保健功能，是人体必需的第四位阳离子，与许多酶的功能活动有着重要关系，可催化或激活机体300多种酶系，因此镁离子是体内所有能量代谢的关键元素。在采用AP-Mg进行的动物实验中发现，它具有促进胃肠运动，增加对胃肠道水份的吸收作用，进而软化排泄物，达到缓泻、防止便秘的作用。AP-Mg对小白鼠胃肠运动的影响、对小白鼠肠道吸收水分的影响及其泻下作用结果分别见表1、表2、表3。
1、AP-Mg对小鼠胃肠运动的影响
(1)方法：选取健康体重18-23g的昆明种小白鼠50只，雌性12只，雄性38只，均分为5组，每组10只，空白组给常水，阳性药组分别给予80，2835Mg.kg-1的硫酸镁，给药组分别给予80，2835Mg.kg-1的AP-Mg，均按0.6ml/20g容积灌胃，15分钟后均以10％炭末灌胃，再过15分钟将小白鼠脱颈处死，取出胃肠道，以幽门为起点测量小肠全长和炭末移动距离，计算炭末移动距离占小肠全长的百分率。用组间对比t检验方法计算组间小肠运动有无差异。
(2)结论；结果见表1，AP-Mg2835Mg.kg-1剂量组对小肠运动有促进作用，其推进距离和推进率与空白组比较差异显著(p＜0.01)，优于阳性药组，此试验表明AP-Mg在一定剂量下对胃肠运动有促进作用。
2、AP-Mg对小白鼠肠道吸收水份的作用
(1)方法：取健康小鼠60只，体重18-23克，均分为4组，每组15只，空白组给常水，阳性药组给予5000Mg.kg-1MgSO4，给药组分别给予2500、5000Mg.kg-1AP-Mg，均按0.6ml/20g容积灌胃给与，药后1小时将小白鼠脱颈处死，分别称量全肠重量，用t检验进行组间比较。
(2)结论：结果见表2，AP-Mg具有增加肠道水分吸收的作用，2500Mg.kg-1剂量组增加肠道水份的作用与MgSO45000 Mg.kg-1剂量相当。
3、AP-Mg的泻下作用
(1)方法：将健康小鼠72只均分6组，每组12只，空白组给常水，其余各组给50％硫糖铝，均按1ml/只/天给予，连续两天后饥饿过夜，第三天以上述半量灌胃一次，半小时后空白组给常水，阳性药组给5000Mg.kg-1MgSO4，模型组给50％硫糖铝，给药组分别给予2500、5000、7500Mg.kg-1AP-Mg，均按0.6mL/20g容积灌胃。药后1小时开始分别记录各组30、60、120、180、360分钟各时间段内小鼠累计排便粒数，用组间比较t检验方法计算组间差异。
(2)结论：结果见表3，阳性药和AP-Mg5000Mg.kg-1剂量组与模型组比较差异显著，(P＜0.05-0.001之间)，AP-Mg2500Mg.kg-1即有泻下作用，AP-Mg5000Mg.kg-1与MgSO45000Mg.kg-1的泻下作用接近，表明AP-Mg5000Mg.kg-1的剂量具有与MgSO4相同的泻下作用。
发明优点：从上述动物实验结果不难看出，AP-Mg泻下作用与泻下作用快而强的阳性药硫酸镁效果相当。另外使用AP-Mg作为泻药具有一药多用、安全无毒的特点，既可避免现有泻药的副作用，又可为人体增加必要的营养，同时也拓宽了AP-Mg的应用范围。其主要优点是；(1)AP-Mg无毒性作用，使用安全。(2)AP-Mg无嗅、无味，不刺激胃肠道，易于被接受。(3)AP-Mg泻下作用缓和。(4)AP-Mg性质稳定，不易氧化，不怕碱，不受铁等离子影响，易贮存。(5)耐高温，在218℃烘烤25分钟不被破坏。(6)价格便宜，制造容易，不产生环境污染。
在AP-Mg进行动物试验的基础上，用与动物试验等效剂量供数例习惯便秘患者服用，每次200Mg(AP-Mg)(胶囊剂)，一日给药三次，也取得了满意的缓泻效果。
本发明中赋形剂通常包括淀粉、乳糖、蔗糖、香精等。以下通过实施例进一步说明本发明制剂的制备方法。
实施例1
巡下列配方制得AP-Mg片剂(所用含量均为重量百分含量)
AP-Mg 50％
乳糖 25％
淀粉 24％
硬脂酸 1％
(1)将AP-Mg、乳糖分别粉碎，过100目筛，淀粉直接过100目筛备用；
(2)取适量淀粉配制成10％淀粉糊，备作黏合剂；
(3)将AP-Mg、乳糖及剩余量淀粉混匀，加入黏合剂制软才，过16目筛制颗粒；
(4)将湿颗粒置于约50℃干燥箱内，鼓风干燥约3小时；
(5)干颗粒经16目筛整粒后，加入硬脂酸镁，混合均匀；
(6)以直径90mm平冲压片，即得。
实施例2
按下列配方制得AP-Mg胶囊(所用含量均为重量百分含量)
AP-Mg 48％
淀粉 52％
(1)将AP-Mg、淀粉分别通过100目筛，进行预处理；
(2)将已经处理的AP-Mg、淀粉充分混合均匀；
(3)将混匀的药粉填充到2号空胶囊即得。
取已粉碎，并过100目筛的AP-Mg100g，分别填充到2号空胶囊内，即得纯AP-Mg胶囊。
实施例3
按下列配方制得AP-Mg散剂(所用含量均为重量百分含量)
AP-Mg 10％
糖粉 90％
将AP-Mg与糖粉分别粉碎，过100目筛，采用等量递加的方法将二者混合均匀，分包即得。
实施例4
按下列配方制得AP-Mg颗粒剂(所用含量均为重量百分含量)
AP-Mg 6％
蔗糖粉 94％
将AP-Mg粉碎后，过100目筛，与适量糖粉混合均匀，另取蔗糖适量配置成50％糖浆，加入到上述混匀的物料中，制软材，通过12目筛制粒，烘干，再过12目筛整粒，装袋即可。
实施例5
按下列配方制得AP-Mg干糖浆(所用含量均为重量百分含量)
AP-Mg 5％
蔗糖粉 93％
柠檬酸 1.745％
桔味香精 0.125％
橙味香精 0.125％
(1)将AP-Mg、蔗糖、柠檬酸分别粉碎，过100目筛：
(2)取AP-Mg、柠檬酸与适量糖粉混匀；
(3)另取适量蔗糖配成50％糖浆并将色素融入其中备作黏合剂；
(4)将步骤(3)制得的黏合剂加入到步骤(2)混匀的物料中，制软材，过12目筛制粒，干燥，整粒后即得。
Claims (7)
1、Vc-磷酸酯镁在医药中的应用，其特征是采用Vc-磷酸酯镁作为活性成分，制成治疗便秘病的缓泻剂。
2、根据权利要求1所述的Vc-磷酸酯镁在医药中的应用，其特征在于采用Vc-磷酸酯镁作为活性成份与一种或多种赋形剂相结合，按片剂、颗粒剂、糖浆剂等工艺操作制成片剂、颗粒剂、糖浆剂，也可将活性成份装入胶囊制成胶囊剂，活性成分用量按重量百分比计为整个制剂量的0.6-100％。
3、根据权利要求1或2所述的Vc-磷酸酯镁在医药中的应用，其特征是Vc-磷酸酯镁活性成份用量按重量百分比计为50％，剂型为片剂。
4、根据权利要求1或2所述的Vc-磷酸酯镁在医药中的应用，其特征是Vc-磷酸酯镁活性成分用量按重量百分比计为48％或100％，剂型为囊剂。
5、根据权利要求1或2所述的Vc-磷酸酯镁在医药中的应用，其特征是Vc-磷酸酯镁活性成分含量按重量百分比计为10％，剂型为散剂。
6、根据权利要求1或2所述的Vc-磷酸酯镁其特征是Vc-磷酸酯镁活性成分含量按重量百分比计为6％，剂型为颗粒剂。
7、根据权利要求1或2所述的Vc-磷酸酯镁在医药中的应用，其特征是Vc-磷酸酯镁活性成分含量按重量百分比计为5％，剂型为干糖浆。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
-
2001
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
| US10646512B2 (en) | 2011-03-11 | 2020-05-12 | Norgine Bv | Colonoscopy - preparation |
| US10780112B2 (en) | 2011-03-11 | 2020-09-22 | Norgine Bv | Colonoscopy-preparation |
| US10792306B2 (en) | 2011-03-11 | 2020-10-06 | Norgine Bv | Colonoscopy—preparation |
| US11529368B2 (en) | 2011-03-11 | 2022-12-20 | Norgine Bv | Colonoscopy—preparation |
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US9326969B2 (en) | 2012-09-11 | 2016-05-03 | Norgine Bv | Compositions |
| US9707297B2 (en) | 2012-09-11 | 2017-07-18 | Norgine Bv | Compositions |
| US10016504B2 (en) | 2012-09-11 | 2018-07-10 | Norgine Bv | Compositions |
| US10918723B2 (en) | 2012-09-11 | 2021-02-16 | Norgine Bv | Colon cleansing compositions and methods of use |
| US12083179B2 (en) | 2012-09-11 | 2024-09-10 | Norgine Bv | Colon cleansing compositions and method of use |
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