JPH02191223A - Iron-supplying preparation - Google Patents
Iron-supplying preparationInfo
- Publication number
- JPH02191223A JPH02191223A JP63306272A JP30627288A JPH02191223A JP H02191223 A JPH02191223 A JP H02191223A JP 63306272 A JP63306272 A JP 63306272A JP 30627288 A JP30627288 A JP 30627288A JP H02191223 A JPH02191223 A JP H02191223A
- Authority
- JP
- Japan
- Prior art keywords
- iron
- preparation
- present
- citrate
- sodium
- 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.)
- Granted
Links
- 238000002360 preparation method Methods 0.000 title claims description 35
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims abstract description 80
- 229910052742 iron Inorganic materials 0.000 claims abstract description 40
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims abstract description 24
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims abstract description 20
- 150000001875 compounds Chemical class 0.000 claims abstract description 14
- 235000017557 sodium bicarbonate Nutrition 0.000 claims abstract description 12
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims abstract description 12
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 11
- 230000003472 neutralizing effect Effects 0.000 claims abstract description 10
- 229910000029 sodium carbonate Inorganic materials 0.000 claims abstract description 10
- NPFOYSMITVOQOS-UHFFFAOYSA-K iron(III) citrate Chemical compound [Fe+3].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NPFOYSMITVOQOS-UHFFFAOYSA-K 0.000 claims abstract description 7
- JHYAVWJELFKHLM-UHFFFAOYSA-H tetrasodium;2-hydroxypropane-1,2,3-tricarboxylate;iron(2+) Chemical compound [Na+].[Na+].[Na+].[Na+].[Fe+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O JHYAVWJELFKHLM-UHFFFAOYSA-H 0.000 claims abstract description 7
- YWYZEGXAUVWDED-UHFFFAOYSA-N triammonium citrate Chemical compound [NH4+].[NH4+].[NH4+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O YWYZEGXAUVWDED-UHFFFAOYSA-N 0.000 claims abstract description 3
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- CWYNVVGOOAEACU-UHFFFAOYSA-N Fe2+ Chemical compound [Fe+2] CWYNVVGOOAEACU-UHFFFAOYSA-N 0.000 claims 1
- 235000017550 sodium carbonate Nutrition 0.000 abstract description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract description 7
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- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 abstract description 4
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 abstract description 4
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- PLKYGPRDCKGEJH-UHFFFAOYSA-N azane;2-hydroxypropane-1,2,3-tricarboxylic acid;iron Chemical compound N.[Fe].OC(=O)CC(O)(C(O)=O)CC(O)=O PLKYGPRDCKGEJH-UHFFFAOYSA-N 0.000 description 2
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- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 1
- VRIVJOXICYMTAG-IYEMJOQQSA-L iron(ii) gluconate Chemical compound [Fe+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O VRIVJOXICYMTAG-IYEMJOQQSA-L 0.000 description 1
- YOBAEOGBNPPUQV-UHFFFAOYSA-N iron;trihydrate Chemical compound O.O.O.[Fe].[Fe] YOBAEOGBNPPUQV-UHFFFAOYSA-N 0.000 description 1
- 229960000310 isoleucine Drugs 0.000 description 1
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 229960003136 leucine Drugs 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000000845 maltitol Substances 0.000 description 1
- 235000010449 maltitol Nutrition 0.000 description 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
- 229940035436 maltitol Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 229920001592 potato starch Polymers 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- HELXLJCILKEWJH-NCGAPWICSA-N rebaudioside A Chemical compound O([C@H]1[C@H](O)[C@@H](CO)O[C@H]([C@@H]1O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HELXLJCILKEWJH-NCGAPWICSA-N 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 229940081974 saccharin Drugs 0.000 description 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- WBXAXRUSCJTCGR-UHFFFAOYSA-K sodium hydrogen carbonate iron(2+) Chemical compound [Na+].[Fe+2].OC([O-])=O.OC([O-])=O.OC([O-])=O WBXAXRUSCJTCGR-UHFFFAOYSA-K 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000000153 supplemental effect Effects 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 229960004295 valine Drugs 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 229940100445 wheat starch Drugs 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/28—Compounds containing heavy metals
- A61K31/295—Iron group metal compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
Abstract
Description
【発明の詳細な説明】
星東上立五里匁1
本発明は鉄補給用製剤、より詳しくは鉄分の生体への補
給を行ない得る新しい製剤に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a preparation for iron supplementation, and more particularly to a new preparation capable of supplementing iron to living bodies.
術とその間 1、
生体において鉄はヘモグロビンの構成要素として重要な
役割を有しており、通常正常人においては食物からその
必要量が摂取され、これは全消化管、特に小腸(主に十
二指腸)から2価の形で吸収され、粘膜細胞内で3価に
酸化され、血流中に入ってそのキャリアプロティンであ
るトランスフェリン(β1−グロブリン)と結合し、貯
蔵臓器である肝臓、膵臓、貴簡等に運ばれる。また上記
鉄の正常人の1日の***量は約0.5〜’+moである
といわれており、この量が必要摂取量でもある。1. Iron plays an important role in living organisms as a component of hemoglobin, and normal people usually take in the required amount from food, which is distributed throughout the digestive tract, especially the small intestine (mainly the duodenum). It is absorbed in the divalent form from the bloodstream, oxidized to the trivalent form within the mucosal cells, enters the bloodstream, and binds to its carrier protein transferrin (β1-globulin), which is then transferred to the storage organs such as the liver, pancreas, and the kidneys. etc. Further, the daily excretion amount of iron in a normal person is said to be about 0.5 to +mo, and this amount is also the required intake amount.
しかしながら、一般に食物からの上記鉄の吸収率は数%
程度と低く、この吸収率の低さより、生体はしばはしば
鉄欠乏性貧血等の病理状態に陥る。However, the absorption rate of iron from food is generally only a few percent.
Due to this low absorption rate, living bodies often fall into pathological conditions such as iron deficiency anemia.
この鉄欠乏性貧血としては、例えば萎黄病、特発性低色
素性貧血、妊娠時の低色素性貧血、胃腸疾患における低
色素性貧血等が知られてお1す、現在之等の病理状態の
改善、即ち貧血の予防、治療を目的とした各種の鉄化合
物製剤(造血剤)が知られているが、公知の造血剤は、
その製剤形態での均−性、安定性、摂取や服用の容易性
(飲みヤすざ、味等)、充分な鉄分の安定補給性等にお
いて、尚改善されるべき余地がめる。Examples of iron deficiency anemia include chlorosis, idiopathic hypochromic anemia, hypochromic anemia during pregnancy, and hypochromic anemia associated with gastrointestinal diseases. Various iron compound preparations (hematopoietic agents) are known for the purpose of improving, that is, preventing and treating anemia.
There is still room for improvement in the uniformity and stability of the formulation, ease of ingestion and dosing (drinkability, taste, etc.), stable supply of sufficient iron content, etc.
明が解決しようとする口 1、
本発明の目的は、上記公知の鉄化合物製剤に代って、よ
り実用性が高く、殊に製剤形態での均一性、安定性に優
れており、摂取や服用が容易(飲みやすく、味等に優れ
ている)で、しかも充分な鉄分を安定して補給できる新
しい鉄補給用製剤を提供することにある。1. The purpose of the present invention is to provide a more practical alternative to the above-mentioned known iron compound preparations, which is particularly excellent in uniformity and stability in the form of a preparation, and which is easy to ingest and use. To provide a new iron supplementation preparation that is easy to take (easy to drink, has excellent taste, etc.) and can stably supply sufficient iron.
本発明者らは、上記目的より鋭意研究を重ねた結果、鉄
含有化合物の所定量と共に炭酸ナトリウム及び(又は)
炭酸水素ナトリウムと中和剤とを所定割合で必須成分と
して含有させた製剤が、上記目的に合致する新しい鉄補
給用製剤として有効であることを見出し、ここに本発明
を完成するに至った。As a result of intensive research for the above purpose, the present inventors discovered that sodium carbonate and/or
The present inventors have discovered that a preparation containing sodium bicarbonate and a neutralizing agent as essential components in a predetermined ratio is effective as a new iron supplement preparation that meets the above objectives, and has now completed the present invention.
問 1、を解決するための 段
本発明によれば鉄含有化合物を鉄として0.01〜3.
5重量%と共に、炭酸ナトリウム及び(又は)炭酸水素
ナトリウム10〜35重量%と中和剤20〜70重量%
とを必須成分として含有する鉄補給用製剤、殊に鉄含有
化合物がクエン酸鉄アンモニウム、クエン酸第一鉄ナト
リウム及びクエン酸鉄から選択され、錠剤、顆粒剤又は
カプセル剤の形態を有する上記鉄補給用製剤が提供され
る。In order to solve Question 1, according to the present invention, the iron-containing compound is 0.01 to 3.
5% by weight, together with 10-35% by weight of sodium carbonate and/or sodium bicarbonate and 20-70% by weight of a neutralizing agent.
and, in particular, the iron-containing compound is selected from iron ammonium citrate, ferrous sodium citrate, and iron citrate, and the iron supplement is in the form of tablets, granules, or capsules. Supplemental formulations are provided.
本発明の鉄補給用製剤、殊に錠剤等の形態を有する本発
明製剤は、その製剤形態で保存安定性に優れており、且
つ溶解性、分散性も良好で、用時水中に投入するだけで
中和による炭酸ガスの発生を伴って、製剤中に含有され
る鉄含有化合物を水中に容易につ均一に溶解、分散させ
得、この溶液は服用(経口投与)が非常に容易且つ美味
しい特徴を有すると共に、該服用によって生体に充分な
鉄分を補給、吸収させることができる。従ってその利用
によれば、例えば貧血等の治癒効果が期待できる。The preparation for iron supplementation of the present invention, especially the preparation of the present invention in the form of a tablet, etc., has excellent storage stability in its form, and also has good solubility and dispersibility, so that it can be simply added to water at the time of use. With the generation of carbon dioxide gas through neutralization, the iron-containing compound contained in the preparation can be easily and uniformly dissolved and dispersed in water, and this solution is very easy and delicious to take (oral administration). In addition, by taking the drug, sufficient iron can be supplied and absorbed by the living body. Therefore, its use can be expected to have a therapeutic effect on, for example, anemia.
本発明製剤を構成する鉄含有化合物としては、例えばク
エン酸鉄アンモニウム、クエン酸第一鉄ナトリウム、ク
エン酸鉄、グルコン酸第一鉄、ピロリン酸第一鉄、ピロ
リン酸第二鉄、乳酸鉄、硫酸第一鉄、塩化第二鉄、三二
酸化鉄、鉄クロロフィンナトリウム、フマル酸第一鉄、
スレオニン鉄、オロチン酸第一鉄、含糖酸化鉄、グルコ
ン酸第二鉄等を例示でき、之等の内では特にクエン酸鉄
アンモニウム、クエン酸第一鉄ナトリウム及びクエン酸
鉄が好ましい。之等の鉄含有化合物はそれぞれ入手され
る形態、通常粒度が200μm以下の粉末形態で本発明
に有利に利用できる。また之等は単独で本発明製剤に配
合されてもよく、2種以上を混合して配合されてもよい
。その配合量は鉄としてO,O’l〜3.5%(重量%
、以下同じ)、好ましくは0.06〜0.6%の範囲か
ら選択されるのがよく、この範囲内での配合によって、
本発明製剤に所期の優れた鉄補給効果をもたらす。Examples of iron-containing compounds constituting the preparation of the present invention include ammonium citrate, sodium ferrous citrate, iron citrate, ferrous gluconate, ferrous pyrophosphate, ferric pyrophosphate, iron lactate, Ferrous sulfate, ferric chloride, iron sesquioxide, sodium iron chlorophyne, ferrous fumarate,
Examples include iron threonine, ferrous orotate, sugar-containing iron oxide, and ferric gluconate, among which ammonium iron citrate, sodium ferrous citrate, and iron citrate are particularly preferred. These iron-containing compounds can be advantageously utilized in the present invention in the form in which they are obtained, usually in powder form with a particle size of 200 μm or less. Further, these may be blended alone in the preparation of the present invention, or two or more of them may be blended. The blending amount is O, O'l ~ 3.5% (wt%) as iron.
, hereinafter the same), preferably from the range of 0.06 to 0.6%, and by blending within this range,
The preparation of the present invention provides the expected excellent iron supplementation effect.
特に好ましい上−2鉄含有化合物の配合量としては、ク
エン酸鉄アンモニウムでは0.6〜1.8%、クエン酸
第一鉄ナトリウムでは0.6〜3.0%、クエン酸鉄で
は0.4〜168%とするのがよい。Particularly preferred amounts of di-ferrous compounds are 0.6 to 1.8% for ammonium iron citrate, 0.6 to 3.0% for sodium ferrous citrate, and 0.6 to 1.8% for iron citrate. It is preferable to set it to 4 to 168%.
本発明製剤は上記鉄含有化合物と共に、炭酸ナトリウム
及び(又は)炭酸水素ナトリウムと中和剤との所定量を
発泡成分として配合することを必須とする。ここで用い
られる中和剤とは、上記炭酸ナトリウム及び炭酸水素ナ
トリウムを中和させて炭酸ガスを発生させ得る酸性化合
物をいう。該化合物には、例えば代表的にはL−酒石酸
、クエン酸、フマル酸、アスコルビン酸等の有機酸が包
含される。The formulation of the present invention requires that a predetermined amount of sodium carbonate and/or sodium bicarbonate and a neutralizing agent be blended together with the above-mentioned iron-containing compound as foaming ingredients. The neutralizing agent used here refers to an acidic compound capable of neutralizing the above-mentioned sodium carbonate and sodium hydrogen carbonate to generate carbon dioxide gas. Such compounds typically include organic acids such as L-tartaric acid, citric acid, fumaric acid, and ascorbic acid.
上記発泡成分の本発明製剤中への配合割合は、得られる
本発明製剤を水に溶解ざぜた場合に、溶液が酸性、特に
pH約3.5〜4.6程度の酸性を呈するものとなる割
合とするのがよ。より具体的には上記割合は炭酸ナトリ
ウム及び(又は)炭酸水素ナトリウム10〜35%及び
中和剤20〜70%の範囲から選択されるのがよい。特
に炭酸ナトリウムは11〜31%、好ましくは22〜2
6%、炭酸水素ナトリウムは10〜35%、好ましくは
20〜30%の範囲から選ばれるのがよく、その内でも
炭酸水素ナトリウムを単独で20〜25%の範囲で用い
るのが最も好ましい。また中和剤は、20〜70%、好
ましくは30〜40%の範囲から選択され、特にL−酒
石酸を20〜25%及びアスコルビン酸を8〜15%の
範囲内で使用するのが最も好ましい。上記発泡成分の配
合により本発明所期の優れた効果が達成される。The blending ratio of the foaming component in the formulation of the present invention is such that when the resulting formulation of the present invention is dissolved in water, the solution exhibits acidity, particularly acidity with a pH of about 3.5 to 4.6. It's best to use it as a percentage. More specifically, the above proportions are preferably selected from the range of 10-35% of sodium carbonate and/or sodium bicarbonate and 20-70% of the neutralizing agent. In particular, sodium carbonate is 11 to 31%, preferably 22 to 2%.
6%, sodium hydrogen carbonate is preferably selected from the range of 10 to 35%, preferably 20 to 30%, and among these, it is most preferable to use sodium hydrogen carbonate alone in the range of 20 to 25%. The neutralizing agent is selected from the range of 20 to 70%, preferably 30 to 40%, and most preferably L-tartaric acid is used in the range of 20 to 25% and ascorbic acid is used in the range of 8 to 15%. . By blending the above-mentioned foaming components, the excellent effects desired by the present invention can be achieved.
また、本発明製剤は、上記鉄含有化合物及び発泡成分を
必須成分として、他に通常知られている各種の添加剤成
分、例えば賦形剤、結合剤、崩壊剤、滑沢剤、増粘剤、
表面活性剤、浸透圧調節剤、電解質、甘味料、香料、色
素、p目調節剤等を必要に応じて適宜添加配合すること
ができる。上記添加剤としては、例えば小麦澱粉、馬鈴
薯澱粉、コーンスターチ、デキストリン等の澱粉類、シ
ョ糖、ブドウ糖、果糖、麦芽糖、キシロース、乳糖等の
糖類、ソルビトール、マンニトール、マルチトール、キ
シリトール等の糖アルコール類、カップリングシュガー
、パラチノース等の糖転位配糖体、リン酸カルシウム、
硫酸カルシウム等の賦形剤、澱粉、糖類、ゼラチン、ア
ラビアガム、デキストリン、メチルチセルロース、ポリ
ビニルピロリドン、ポリビニルアルコール、ヒドロキシ
プロピルセルロース、キサンタンガム、ペクチン、トラ
ガントガム、カゼイン、アルギン酸等の結合剤乃至増粘
剤、ロイシン、イソロイシン、L−バリン、シュガーエ
ステル、硬化油、ステアリン酸、ステアリン酸マグネシ
ウム、タルク、マクロゴール等の滑沢剤、アビセル、C
MC,CMC−Na。In addition, the preparation of the present invention contains the above iron-containing compound and foaming component as essential components, and various other commonly known additive components, such as excipients, binders, disintegrants, lubricants, and thickeners. ,
Surfactants, osmotic pressure regulators, electrolytes, sweeteners, fragrances, pigments, p-eye regulators, and the like can be added and blended as appropriate. Examples of the above additives include starches such as wheat starch, potato starch, corn starch, and dextrin; sugars such as sucrose, glucose, fructose, maltose, xylose, and lactose; and sugar alcohols such as sorbitol, mannitol, maltitol, and xylitol. , coupling sugar, sugar transfer glycosides such as palatinose, calcium phosphate,
Excipients such as calcium sulfate, binders and thickeners such as starch, sugars, gelatin, gum arabic, dextrin, methylthicellulose, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropylcellulose, xanthan gum, pectin, gum tragacanth, casein, alginic acid, etc. , leucine, isoleucine, L-valine, sugar ester, hydrogenated oil, stearic acid, magnesium stearate, talc, lubricant such as macrogol, Avicel, C
MC, CMC-Na.
CMC−〇a等の崩壊剤、ポリソルベート、レシチン等
の表面活性剤、糖類、糖アルコール類、アスパラテーム
、アリテーム等のジペプチド、その他ステビア、サッカ
リン等の甘味料等を例示でき、之等は必須成分との関係
や製剤の性質、製造法等を考慮してその適当量を適宜選
択して用いることができる。Examples include disintegrants such as CMC-○a, surfactants such as polysorbate and lecithin, sugars, sugar alcohols, dipeptides such as aspartame and alitame, and other sweeteners such as stevia and saccharin, which are essential ingredients. An appropriate amount can be appropriately selected and used in consideration of the relationship with the drug, the properties of the preparation, the manufacturing method, etc.
更に、本発明製剤にはビタミン類、特にジアノコバラミ
ンやアスコルビン酸(ビタミンC)等の適当量を添加配
合することができ、上記ビタミンCは抗酸化剤として機
能する他、必須成分とする鉄含有化合物の生体への吸収
性を一層高めて、本発明製剤の鉄補給効果を助長でき、
更に本発明製剤によるビタミン類の補給をも可能とする
。上記ビタミン類の配合割合は、特に限定はないが、通
常ビタミンCでは30%までの量、好ましくは約5〜2
5%の範囲から選ばれるのが好ましい。Furthermore, appropriate amounts of vitamins, particularly dianocobalamin and ascorbic acid (vitamin C), can be added to the preparation of the present invention, and the vitamin C functions as an antioxidant and also contains iron, which is an essential component. It is possible to further enhance the absorbability of the contained compounds into the living body and promote the iron replenishment effect of the preparation of the present invention,
Furthermore, it is also possible to supplement vitamins with the preparation of the present invention. The blending ratio of the above vitamins is not particularly limited, but the amount of vitamin C is usually up to 30%, preferably about 5 to 2%.
It is preferably selected from a range of 5%.
本発明製剤の製造法は、基本的には通常のこの種製剤、
例えば発泡錠剤の製造法と同様のものとすることができ
る。即ち、発泡錠剤形態の本発明製剤は、所定量の各成
分を秤量、混合し、直接粉末圧縮法、乾式又は湿式顆粒
圧縮法等に従って実施できる。The method for producing the preparation of the present invention is basically a conventional preparation of this kind,
For example, it can be similar to the method for manufacturing effervescent tablets. That is, the preparation of the present invention in the form of an effervescent tablet can be prepared by weighing and mixing predetermined amounts of each component, and then performing direct powder compression, dry or wet granule compression, or the like.
かくして得られる本発明製剤(発泡錠剤等)は、これを
水中に投入するだけで、経口投与に適した飲料形態とな
り、これは経口投与される。The preparation of the present invention (effervescent tablet, etc.) thus obtained becomes a drink form suitable for oral administration simply by adding it to water, and is administered orally.
その投与量は、これを適用すべき生体の年齢、性別、体
重や疾患の程度等に応じて適宜決定され、特に限定され
るものではないが、一般には1錠約1.5〜6.0CI
に調製された本発明錠剤の1〜2錠剤を1回に水100
〜300mGに溶かして服用させればよい。The dosage is appropriately determined depending on the age, sex, weight, degree of disease, etc. of the organism to which it is applied, and is not particularly limited, but generally one tablet is approximately 1.5 to 6.0 CI.
1 to 2 tablets of the present invention prepared in 100 g of water at a time.
It may be dissolved in ~300mG and administered.
本発明製剤は、特に上述した発泡錠剤に限定されるもの
ではなく、前記組成範囲を有する限り、水に溶解、分散
させて服用される適宜の形態、例えば顆粒剤、散剤、カ
プセル剤等の形態であってもよく、更にかかる水に溶解
、分散させて服用される形態に限らず、例えば水溶液等
の液状形態であってもよい。The preparation of the present invention is not particularly limited to the above-mentioned effervescent tablets, but may be in any suitable form, such as granules, powders, capsules, etc., which can be dissolved or dispersed in water and taken. Furthermore, it is not limited to the form in which the drug is taken by dissolving or dispersing it in water, but may be in a liquid form such as an aqueous solution.
本発明製剤の特に好ましい配合組成の具体例としては以
下のもの(単位二重量%)を例示できる。As specific examples of particularly preferable compositions of the formulation of the present invention, the following (unit: double weight %) can be exemplified.
クエン酸鉄アンモニウム、クエン
酸第一鉄ナトリウム及びクエン@ 0.6〜1.5%
鉄から選ばれる鉄含有化合物
炭酸水素ナトリウム 20 〜25 %
L−酒石酸等の有機酸系中和剤・ 20 〜25 %
アスコルビン!! 8〜15 %
及−旦−五−ヱー1
本発明によれば、新しい鉄補給用製剤が提供される。該
製剤は安定であり、保存性に優れており、しかも溶けや
すく、服用も容易である利点があり、その服用によって
充分な鉄分を安全に生体に供給、吸収させることができ
、貧血治療等の効果を奏し得、また低カロリーである特
徴も有している。更に、本発明製剤は総じて味がよく、
鉄の味をマスクして清涼感のあるおだやかな味を有する
特徴がある。Ammonium ferrous citrate, sodium ferrous citrate and citric acid @ 0.6-1.5%
Iron-containing compound selected from iron Sodium hydrogen carbonate 20-25%
Organic acid neutralizing agent such as L-tartaric acid・20 to 25%
Ascorbine! ! 8-15%
A-D-5-E-1 According to the present invention, a new iron supplementation formulation is provided. This preparation is stable, has excellent storage stability, and has the advantage of being easily soluble and easy to take. By taking it, sufficient iron can be safely supplied and absorbed by the body, and it can be used for anemia treatment, etc. It is effective and also has the characteristic of being low in calories. Furthermore, the preparation of the present invention has good taste overall;
It has a characteristic that it masks the taste of iron and has a refreshing and mild taste.
!−−1−−1
以下、本発明を更に詳しく説明するため実施例を挙げる
。尚、各例中部及び%は特記しない限り重量部及び重量
%を示す。! --1--1 Examples will be given below to explain the present invention in more detail. Incidentally, in each example, parts and percentages indicate parts by weight and percentages by weight unless otherwise specified.
実施例 1〜18
下記第1表に示す組成となる各成分を混合し、混合物を
直接粉末圧縮法により製錠して本発明製剤(発泡錠剤)
を調製した。Examples 1 to 18 The ingredients having the composition shown in Table 1 below are mixed, and the mixture is directly made into tablets by powder compression method to obtain the preparation of the present invention (expandable tablet).
was prepared.
上記で得られた本発明製剤(実施例1〜18の発泡錠剤
)は、鉄の補給食品として、美味(清涼感等)を有して
おり、手軽に鉄の補給が可能な新しい食品として有効で
ある。また之等の製剤は、乾燥状態で提供されるもので
あり、水溶液状態と比べて、内容物の安定性に優れてお
り、味及び栄養効果の点でも優れたものである。更に之
等の製剤はこれを水中に投入すると速やかに溶解、分散
し、溶液が総じて透明となり、この溶解後の液性より呈
色等による不快感もなく、また色素等を添加された本発
明製剤は、その飲用時の液の色を任意に調節されており
、その外観も好ましいものである。加えて、上記本発明
製剤は軽量で安定性に富んでおり、運搬等にも便利であ
り、市場流通に好ましい製品である。The above-obtained preparations of the present invention (the effervescent tablets of Examples 1 to 18) have a delicious taste (cooling sensation, etc.) as an iron supplement food, and are effective as a new food that can easily supplement iron. It is. In addition, these preparations are provided in a dry state, and are superior in terms of stability of contents and taste and nutritional effects compared to aqueous solutions. Furthermore, when these preparations are put into water, they are quickly dissolved and dispersed, and the solution becomes generally transparent, and the liquid properties after dissolution do not cause discomfort due to coloration, and the present invention, which has added pigments, etc. The color of the liquid when drinking the preparation is arbitrarily controlled, and its appearance is also desirable. In addition, the above-mentioned formulation of the present invention is lightweight, highly stable, and convenient for transportation, making it a product preferred for market distribution.
特に鉄化合物としてクエン酸鉄アンモニウムを使用した
本発明製剤(実施例1〜7.10〜18)は、鉄の溶解
性がより一層優れており、充分な看の鉄を容易に補給さ
せることができる。In particular, the preparations of the present invention (Examples 1 to 7 and 10 to 18) using iron ammonium citrate as the iron compound have even better iron solubility and can easily supply sufficient iron. can.
また、実施例1に記載の本発明製剤は、殊に惨めで味が
よく、鉄の味をマスクして、清涼感のあるおだやかな味
を有するものであった。Furthermore, the preparation of the present invention described in Example 1 had a particularly pleasant taste, masked the iron taste, and had a refreshing and mild taste.
(以 上)(that's all)
Claims (2)
と共に、炭酸ナトリウム及び(又は)炭酸水素ナトリウ
ム10〜35重量%と中和剤20〜70重量%とを必須
成分として含有することを特徴とする鉄補給用製剤。(1) 0.01 to 3.5% by weight of iron-containing compound as iron
An iron supplement preparation characterized by containing 10 to 35% by weight of sodium carbonate and/or sodium bicarbonate and 20 to 70% by weight of a neutralizing agent as essential components.
酸第一鉄ナトリウム及びクエン酸鉄から選択され、錠剤
、顆粒剤又はカプセル剤の形態を有する請求項1記載の
製剤。2. A formulation according to claim 1, wherein the iron-containing compound is selected from ferrous ammonium citrate, ferrous sodium citrate and iron citrate, and is in the form of tablets, granules or capsules.
Priority Applications (16)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP63306272A JPH02191223A (en) | 1988-10-04 | 1988-12-02 | Iron-supplying preparation |
NL8902439A NL194959C (en) | 1988-10-04 | 1989-10-02 | Preparation for administering iron. |
GB8922219A GB2223405B (en) | 1988-10-04 | 1989-10-03 | Effervescent iron preparation |
SE8903232A SE509650C2 (en) | 1988-10-04 | 1989-10-03 | Iron supply compositions comprising an iron-containing compound, an alkali metal carbonate and / or alkali metal hydrogen carbonate and a neutralizing agent |
CH2559/91A CH680569A5 (en) | 1988-10-04 | 1989-10-03 | |
CH3602/89A CH681138A5 (en) | 1988-10-04 | 1989-10-03 | |
FR898912919A FR2640505B1 (en) | 1988-10-04 | 1989-10-03 | PREPARATION FOR THE SUPPLY OF IRON, PREPARATION FOR THE SUPPLY OF VITAMINS AND METHOD FOR STABILIZING AN EFFERVESCENT PREPARATION |
DE3943807A DE3943807B4 (en) | 1988-10-04 | 1989-10-04 | Effervescent vitamin or iron compsn. - contg. sodium carbonate or sodium bi:carbonate, neutralising agent and potassium carbonate as stabilising agent |
DE3933164A DE3933164B4 (en) | 1988-10-04 | 1989-10-04 | Prepn. for iron supply - comprises specified amts. of specified iron contg. cpd., sodium carbonate or bi:carbonate and a neutralising agent |
US07/417,111 US5087442A (en) | 1988-10-04 | 1989-10-04 | Preparation for iron supply, preparation for vitamin supply and method for stabilizing a foam preparation |
KR1019890014192A KR0143232B1 (en) | 1988-10-04 | 1989-10-04 | Preparation for iron supply, preparation for vitamin supply and method for stabilizing a foam preparation |
FR909000352A FR2640506B1 (en) | 1988-10-04 | 1990-01-12 | PREPARATION FOR THE SUPPLY OF IRON, PREPARATION FOR THE SUPPLY OF VITAMINS AND METHOD FOR STABILIZING AN EFFERVESCENT PREPARATION |
GB9005119A GB2230699B (en) | 1988-10-04 | 1990-03-07 | Preparation for vitamin supply and method for stabilising a foam preparation |
US07/540,532 US5160728A (en) | 1988-10-04 | 1990-06-19 | Preparation for iron supply, preparation for vitamin supply and method for stabilizing a foam preparation |
SE9803394A SE519516C2 (en) | 1988-10-04 | 1998-10-06 | Foam preparation and method of stabilizing a foam preparation |
NL9900032A NL195070C (en) | 1988-10-04 | 2003-04-03 | Preparation for administering vitamins. |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP25066388 | 1988-10-04 | ||
JP63-250663 | 1988-10-04 | ||
JP63306272A JPH02191223A (en) | 1988-10-04 | 1988-12-02 | Iron-supplying preparation |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH02191223A true JPH02191223A (en) | 1990-07-27 |
JPH0559090B2 JPH0559090B2 (en) | 1993-08-30 |
Family
ID=17211197
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP63306272A Granted JPH02191223A (en) | 1988-10-04 | 1988-12-02 | Iron-supplying preparation |
Country Status (2)
Country | Link |
---|---|
JP (1) | JPH02191223A (en) |
KR (1) | KR0143232B1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002080347A (en) * | 2000-09-04 | 2002-03-19 | Taisho Pharmaceut Co Ltd | Oral liquid medicine formulated with iron compound |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IL152486A0 (en) | 2002-10-25 | 2003-05-29 | Meir Eini | Alcohol-free cosmetic and pharmaceutical foam carrier |
MXPA05004278A (en) | 2002-10-25 | 2005-10-05 | Foamix Ltd | Cosmetic and pharmaceutical foam. |
US9265725B2 (en) | 2002-10-25 | 2016-02-23 | Foamix Pharmaceuticals Ltd. | Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof |
US7704518B2 (en) | 2003-08-04 | 2010-04-27 | Foamix, Ltd. | Foamable vehicle and pharmaceutical compositions thereof |
US9668972B2 (en) | 2002-10-25 | 2017-06-06 | Foamix Pharmaceuticals Ltd. | Nonsteroidal immunomodulating kit and composition and uses thereof |
US10117812B2 (en) | 2002-10-25 | 2018-11-06 | Foamix Pharmaceuticals Ltd. | Foamable composition combining a polar solvent and a hydrophobic carrier |
US20080260655A1 (en) | 2006-11-14 | 2008-10-23 | Dov Tamarkin | Substantially non-aqueous foamable petrolatum based pharmaceutical and cosmetic compositions and their uses |
US8636982B2 (en) | 2007-08-07 | 2014-01-28 | Foamix Ltd. | Wax foamable vehicle and pharmaceutical compositions thereof |
WO2009072007A2 (en) | 2007-12-07 | 2009-06-11 | Foamix Ltd. | Carriers, formulations, methods for formulating unstable active agents for external application and uses thereof |
CA2760186C (en) | 2009-04-28 | 2019-10-29 | Foamix Ltd. | Foamable vehicle and pharmaceutical compositions comprising aprotic polar solvents and uses thereof |
WO2011013009A2 (en) | 2009-07-29 | 2011-02-03 | Foamix Ltd. | Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses |
WO2011039638A2 (en) | 2009-10-02 | 2011-04-07 | Foamix Ltd. | Topical tetracycline compositions |
US9849142B2 (en) | 2009-10-02 | 2017-12-26 | Foamix Pharmaceuticals Ltd. | Methods for accelerated return of skin integrity and for the treatment of impetigo |
US10398641B2 (en) | 2016-09-08 | 2019-09-03 | Foamix Pharmaceuticals Ltd. | Compositions and methods for treating rosacea and acne |
-
1988
- 1988-12-02 JP JP63306272A patent/JPH02191223A/en active Granted
-
1989
- 1989-10-04 KR KR1019890014192A patent/KR0143232B1/en not_active IP Right Cessation
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002080347A (en) * | 2000-09-04 | 2002-03-19 | Taisho Pharmaceut Co Ltd | Oral liquid medicine formulated with iron compound |
Also Published As
Publication number | Publication date |
---|---|
KR900005963A (en) | 1990-05-07 |
KR0143232B1 (en) | 1998-07-15 |
JPH0559090B2 (en) | 1993-08-30 |
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