JPH03275626A - Sodium bicarbonate dialytic agent - Google Patents
Sodium bicarbonate dialytic agentInfo
- Publication number
- JPH03275626A JPH03275626A JP2075539A JP7553990A JPH03275626A JP H03275626 A JPH03275626 A JP H03275626A JP 2075539 A JP2075539 A JP 2075539A JP 7553990 A JP7553990 A JP 7553990A JP H03275626 A JPH03275626 A JP H03275626A
- Authority
- JP
- Japan
- Prior art keywords
- agent
- sodium bicarbonate
- sodium
- dialytic
- sodium acetate
- 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
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 title claims abstract description 104
- 239000003795 chemical substances by application Substances 0.000 title claims abstract description 88
- 235000017557 sodium bicarbonate Nutrition 0.000 title claims abstract description 52
- 229910000030 sodium bicarbonate Inorganic materials 0.000 title claims abstract description 52
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 34
- 238000004090 dissolution Methods 0.000 claims abstract description 26
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims abstract description 25
- 239000001632 sodium acetate Substances 0.000 claims abstract description 19
- 235000017281 sodium acetate Nutrition 0.000 claims abstract description 19
- 239000011780 sodium chloride Substances 0.000 claims abstract description 17
- 239000000203 mixture Substances 0.000 claims abstract description 12
- 229940040526 anhydrous sodium acetate Drugs 0.000 claims abstract description 6
- 238000000502 dialysis Methods 0.000 claims description 26
- 239000002245 particle Substances 0.000 claims description 21
- 239000003792 electrolyte Substances 0.000 claims description 11
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 8
- 239000008103 glucose Substances 0.000 claims description 8
- 230000005484 gravity Effects 0.000 claims description 6
- 239000011148 porous material Substances 0.000 claims description 6
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 23
- 229910001868 water Inorganic materials 0.000 abstract description 23
- 239000008187 granular material Substances 0.000 abstract description 12
- 239000000385 dialysis solution Substances 0.000 abstract description 5
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 abstract description 3
- 239000007864 aqueous solution Substances 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract description 2
- 239000003814 drug Substances 0.000 abstract description 2
- 239000004615 ingredient Substances 0.000 abstract 5
- 235000002639 sodium chloride Nutrition 0.000 description 14
- 239000000843 powder Substances 0.000 description 12
- 230000007423 decrease Effects 0.000 description 9
- 239000000047 product Substances 0.000 description 8
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 6
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 5
- 238000001035 drying Methods 0.000 description 5
- 238000005469 granulation Methods 0.000 description 5
- 230000003179 granulation Effects 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 239000000428 dust Substances 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 239000001569 carbon dioxide Substances 0.000 description 3
- 229910002092 carbon dioxide Inorganic materials 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 238000004448 titration Methods 0.000 description 3
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 229960000583 acetic acid Drugs 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000011777 magnesium Substances 0.000 description 2
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 2
- 229910052753 mercury Inorganic materials 0.000 description 2
- 239000011164 primary particle Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 239000011550 stock solution Substances 0.000 description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000003113 alkalizing effect Effects 0.000 description 1
- 238000003321 atomic absorption spectrophotometry Methods 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 229960005069 calcium Drugs 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 description 1
- 229940052299 calcium chloride dihydrate Drugs 0.000 description 1
- 239000013522 chelant Substances 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 239000012362 glacial acetic acid Substances 0.000 description 1
- 239000003979 granulating agent Substances 0.000 description 1
- 238000001631 haemodialysis Methods 0.000 description 1
- 230000000322 hemodialysis Effects 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 229940050906 magnesium chloride hexahydrate Drugs 0.000 description 1
- DHRRIBDTHFBPNG-UHFFFAOYSA-L magnesium dichloride hexahydrate Chemical compound O.O.O.O.O.O.[Mg+2].[Cl-].[Cl-] DHRRIBDTHFBPNG-UHFFFAOYSA-L 0.000 description 1
- 229940091250 magnesium supplement Drugs 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Landscapes
- External Artificial Organs (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
［産業上の利用分野〕
本発明は重曹透析用剤、特に使用時溶解する際に易溶性
である粒状化した重曹透析用剤に係るものである。[Industrial Field of Application] The present invention relates to a sodium bicarbonate dialysis agent, particularly a granulated sodium bicarbonate dialysis agent that is easily soluble when dissolved during use.
透析用剤は、透析液を作成するための薬剤である。透析
液は、人工腎臓、血液透析、腹膜透析などにより本来腎
臓が行なう機能に代わり、体液の老廃物を取り去り、更
には血液中に必要な成分を補うために用いるものであり
、アルカリ化剤として重Ｗを用いる重曹透析液が生理的
に好ましいものであるため注目されている１重曹透析液
としては、以下に示すような電解質イオン組成を有する
ものが用いられている。
Ｎａ” １２０〜１５０ ｍＥｑ／ＱＫ ”
０．５〜３．０〃
Ｃａ” １．５〜４．５ ｔｔ
Ｍｇ” Ｏ〜２．０〃
Ｃ１−９０〜１３５〃
ＣＨ，ＣＯＯ−５〜３５〃
ＨＣＯＲ−２０〜３５〃
ブドウ糖 ０〜２５０ ｇＩＱ
普通、重曹透析液は、重曹以外の必要電解質の約２．５
ｋｇ余に水を加えて溶解度の関係から約１０＋２の容積
の原液Ａとし、これとアルカリ剤としての重曹水溶液と
に分け、透析時に両者を混合して全量を３５０Ｑに希釈
して用いられる。重曹については粉末状にて保存あるい
は輸送して使用の直前に溶解することもある。
［発明の解決しようとする課題］
しかしながら、前記の如く重曹水溶液と他の電解質成分
溶液を予め調製しておく場合には、これを濃厚な原液と
したにしても、かなりの容積と重量になり、貯留や運搬
に不便を来たす欠点がある。
この欠点を避けるため、電解質成分を粉体として貯留や
運搬を行なう場合には、使用時に水に溶解する際に、電
解質成分のうち特に重曹の溶解速度が遅いという問題点
があった。
また重曹の粉末は、発塵しやすく、流動性が悪いため、
一般に取り扱いが困難である。しかし、取り扱いを容易
にするために造粒を行なうとさらに溶解速度が遅くなっ
てしまう。
本発明の目的は、貯留や搬送に有利であり、容易に重曹
透析液を得ることのできる、取り扱いが容易で溶解速度
が速い、粒状の重曹透析用剤を提供することである。
［課題を解決するための手段］
本発明は、電解質成分を、重曹を含まない群（Ａ剤）と
重曹を含む群（Ｂ剤）とに分け、使用時にＡ剤とＢ剤を
混合して用いる重曹透析用剤において、Ｂ剤が重曹と塩
化ナトリウムおよび／または酢酸ナトリウムとの混合造
粒物であることを特徴とする重曹透析用剤を提供するも
のである。
本発明においては、Ｂ剤が重曹と塩化ナトリウムおよび
／または酢酸ナトリウムとの混合造粒物であるので、水
に溶解する場合に、溶解速度の高い塩化ナトリウムまた
は酢酸ナトリウムが重曹より先に溶解し、重曹の１次粒
子が速やかに水中に分散するので、重曹の溶解も速やか
に起こる。ここで用いる酢酸ナトリウムとしては、無水
塩でも含水塩でも特に差異なく使用できる。
本発明のＢ剤は、造粒しているので流動性が良好で、発
塵性もほとんど無い。造粒しているのに６かかわらず、
上記の理由により溶解速度は、１次粒子単独にくらべて
も少し遅いだけである。
定量の固体を一定量の水に投入して撹拌するとき溶液が
透明になるまでの時間を溶解時間としてを比較する場合
、本発明のＢ剤は、重曹１次粒子の溶解時間の２倍以内
である。
Ｂ剤が重曹と塩化ナトリウムの混合物である場合、塩化
ナトリウムの含有量は、０．５〜７重量％であることが
好ましい。塩化ナトリウムの含有量が上記範囲に満たな
い場合は、水への溶解速度が低下するので好ましくない
。逆に上記範囲を越える場合にも、同様に水への溶解速
度が低下するので好ましくない。特に好ましい塩化ナト
リウムの含有量は、１〜５重量％である。
Ｂ剤が重曹と酢酸ナトリウムとの混合物である場合、酢
酸ナトリウムの含有量は無水酢酸ナトリウム換算で０．
３〜ｌＯ重量％であることが好ましい、酢酸ナトリウム
の含有量が上記範囲に満たない場合は、水への溶解速度
が低下するので好ましくない。逆に上記範囲を越える場
合に６、同様に水への溶解速度が低下するので好ましく
ない。特に好ましい酢酸ナトリウムの含有量は、無水酢
酸ナトリウム換算で０．５〜８重量％である。
Ｂ剤が重曹と塩化ナトリウムおよび酢酸ナトリウムとの
混合物である場合、塩化ナトリウムの含有量が０．５〜
７重量％で、酢酸ナトリウムの含有量が無水酢酸ナトリ
ウム換算で０．３〜ｌＯ重量％であることが好ましい。
それぞれの含有量が、上記範囲を逸脱する場合は、いず
れも水への溶解速度が低下するので好ましくない。
本発明のＢ剤において、重曹と配合する電解質が酢酸ナ
トリウム単独の場合は、水への溶解速度の点で最も好ま
しい。
また本発明においてＢ剤が、重曹とブドウ糖との混合造
粒物であってもＢ剤の溶解速度が増大する。ただし、ブ
ドウ糖を配合したＢ剤は細菌が増殖しやすいので注意が
必要である。
本発明のへ剤は、かくして透析用剤に必要な成分のうち
上記Ｂ剤に配合されない成分の混合物を用いる。透析剤
に必要な成分のうち重曹以外の成分は、比較的水に解け
やすいので、特にへ剤の性状は限定されないが、取り扱
い性が良好な点で、造粒されたものであることが好まし
い。
本発明において、Ｂ剤（またはＡ剤）の造粒物は、流動
性が良好で取り扱いが容易になるので安息角が５０度以
下であることが好ましい。造粒物の細孔容積は０．０５
〜０．２ｃｃ／ｇであることが好ましい。細孔容積が０
．０５ｃｃ／ｇに満たない場合は、溶解速度が遅くなる
恐れがあるので好ましくない。細孔容積が０．２ｃｃ／
ｇを越える場合は、造粒物の強度が低下して発塵性が現
われる可能性があるので好ましくない。また、造粒物の
見掛比重は、ゆるめで０．５〜０．９、かためで０．６
〜１．１であることが好ましい。見掛比重が上記範囲に
満たない場合は、造粒物の強度が低下して発塵性が現わ
れる可能性があるので好ましくない。見掛比重が上記範
囲を越える場合は、溶解速度が遅くなる恐れがあるので
好ましくない。
Ａ剤またはＢ剤を造粒する場合は、各成分を粉体のまま
適宜水と共に混合し、種々の造粒機を用いて造粒するこ
とができる。次のような手段を採用すると、溶解性、特
に重曹の溶解性をさらに改善し得ると共に、粒状体の取
り扱いも容易であり、また強度も充分で粉状化もし難く
、均質で組成安定性の良い造粒物が得られるので好まし
い。
電解質成分粉末を粒度調製し、水分が１〜２５重量％と
なるように水を加えて充分混合し、押出し造粒機等によ
り造粒後、乾燥することにより、顆粒状の製品とする。
用いられる原料としての電解質成分粉末の粒子径として
は２５０μｍ以下、好ましくは１８０μｍ以下、更に好
ましくは１００μｍ以下を採用するのが適当である。粒
子径が２５０μｍを超える場合には、最終品となる顆粒
の機械的強度が不十分となり、粉化しやすくなり、また
溶解速度が遅くなるので好ましくない。また、造粒に際
し水分が１重量％に満たない場合には、粒子強度が低く
なるため粉化し易くなり、逆に２５重量％を超える場合
には造粒が困難となる恐れがあるので何れも好ましくな
い。造粒される粒子の粒径は０．１〜１０ｍｍ程度にす
るのが適当である。粒状体の粒径が前記範囲に満たない
場合には流動性が阻害されたり、粉化して飛散したりし
て取扱いが困難となり、逆に前記範囲を超える場合には
粒子の機械的強度が低下したり、溶解に時間がががりす
ぎたりする恐れがあるので何れも好ましくない。
造粒物、特にＢ剤の乾燥に際しては、重曹の分解防止の
理由により、炭酸ガス雰囲気を用いるのが好ましい。炭
酸ガス濃度としては５％程度以上を採用するのが好まし
い。乾燥は３０〜９０’Ｃにおいて行なうのが適当であ
り、具体的乾燥手段としては例えば、バンド乾燥機、円
板乾燥機、通気乾燥機、回転乾燥機等を採用することに
より、高強度及び易溶性で均一で組成安定性の良好な顆
粒を得ることが可能となる。
本発明の透析用剤においては、溶解したあとのｐＨを調
整する目的で予め酢酸のようなｐｏ調整成分を含むもの
であってもよい。ｐＨ調整成分は溶解後の透析液に加え
てもよい。
［実施例コ
実施例１
それぞれ平均粒径５０μｍ程度に粉砕された塩化ナトリ
ウム、塩化カリウム、塩化カルシウム２水和物、塩化マ
グネシウム６水和物、酢酸ナトリウムおよびブドウ糖を
下記の比率で混合し、さらに乾燥基準で１．５重量％の
水を添加して混合した。
ＮａＣ１７４，７１１０重量％
ＫＣＩ １．７９４３ ／／ＣａＣ
１１２ＨｓＯ２，２８３９ｔｔ
ＭｇＣ１ｍ・６ＨｉＯ１，２４０８／／ＣＨ，ＣＯＯＮ
ａ ７．９２９６ ／／ブドウ糖
１２．０４０４ ／／該混合物を押し出し造粒機を用
いて造粒し、直径０．５ｍｍ 、長さ １〜１０ｍｍの
円柱状の粒子を１００ｋｇ得た０次に、温度５０℃に調
整された回分式箱型乾燥機に前記粒子を入れ３時間乾燥
した。その後さらに、氷酢酸を１．５重量％加えて、こ
れをＡ剤とした。
このＡ剤は顆粒状であり、水銀圧入式ポロシメーターに
より測定した細孔容積は、０．０８ｃｍ’／ｇであった
。１５℃の水１００ｃｃを容量１００ｃｃのビーカーに
とり、Ａ剤６ｇを投入しマグネチックスクーラーにて５
０Ｏｒｐｍで撹拌したとき、溶解時間（固形分がなくな
るまでの時間）は、２分１０秒であった。線用ミクロン
■製のパウダーテスターで測定した安息角は４０度であ
り、良好な流動性を持っていた。また、見掛比重は、ゆ
るめがＱ、 ７０７で、かためが０．７９０であった。
これとは別にＢ剤を次のようにして作製した。
まず、それぞれ平均粒径５０ＬＬｍ程度に粉砕された重
曹および塩化ナトリウムを下記の比率で混合し、次いで
乾燥基準で１４重置％の水を添加して混合した。
ＮａＨＣＯ，９７，６０重量％
ＮａＣ１２，４０ｕ
該混合物を押し出し造粒機を用いて造粒し、直径０．５
ｍｍ 、長さ０．５〜５ ｍｍの円柱状の粒子を５４ｋ
ｇ得た０次に、炭酸ガス濃度５５％、温度７５℃に調整
された回分式箱型乾燥機に前記粒子を入れ３時間乾燥し
、Ｂ剤を得た。
このＢ剤は顆粒状であり、水銀圧入式ポロシメーターに
より測定した細孔容積は、０．０８ｃｍ”７ｇであった
。１５℃の水１００ｃｃを容量１００ｃｃのビーカーに
とり、Ａ剤６． Ｉｇを投入しマグネチックスターラー
にて５０Ｏｒｐｍで撹拌したとき、溶解時間（固形分が
なくなるまでの時間）は、３分３５秒であった。線用ミ
クロン■製のパウダーテスターで測定した安息角は４２
度であり、良好な流動性を持っていた。また、見掛比重
は、ゆるめが０．７４２で、かためが０．９９７であっ
た。
このＡ剤２５ｇとＢ剤６．３８７ｇを、２５℃の水で溶
解して２．９６７２にしたときの、各成分の濃度を測定
した。ナトリウムおよびカリウムは原子吸光光度法によ
り、カルシウムおよびマグネシウムはキレート滴定法に
より、塩素はモール法による滴定により、総計酸および
ブドウ糖は液体クロマトグラフ法により、炭酸水素イオ
ンは酸・アルカリ滴定法によって定量分析した。結果を
表１に示す。
次に、Ａ剤とＢ剤の長期保存による経時変化を調べた。
Ａ剤およびＢ剤を密閉包装し、室温下に放置して、製造
直後および製造後１力月、３力月、６力月、１２力月に
おいて、Ａ剤１２Ｂ５４ｇとＢ斉０６７８ｇを２５℃の
水で溶解して３１５Ｑにした。得られた溶液について、
ｐＨおよび製造直後の各イオン濃度を１００としてこれ
に対する偏差を求めた結果を表２に示す。
表１および表２から、Ａ剤およびＢ剤とからなる本透析
用剤は、再現性良く透析Ｍを作製でき、しかも経時的に
も安定であり、長期保存後ら製造直後と実質的に変わら
ぬ透析液に復元できることが明らかである。第２表で、
各成分の含有量がしだいに減少しているのは、包装材料
を透過した水分の影響であると考えられる。
実施例２〜８ 比較例１．２
それぞれ、平均粒径５０μｍ程度に粉砕された塩化ナト
リウム、酢酸ナトリウム、ブドウ糖を用いて、実施例１
と同様な操作により、表３の条件にて配合、造粒、乾燥
して得られたＢ剤の性状についての測定結果を表３に示
す。比較例１は、重曹単独の造粒物であり、比較例２は
、造粒前の重曹１次粒子である。
［発明の効果］
本発明の透析用剤は容易に水に溶解して均質な水溶液に
なり簡単に透析液を得ることができる。
また、本透析用剤は、体積が小さくでき、貯留時に粉化
したりあるいは難溶性の化合物が生成したすせず保存あ
るいは輸送に有利である。さらに、流動性に優れるので
、取り扱いが容易である。A dialysis agent is a drug used to create a dialysate. Dialysate is used in artificial kidneys, hemodialysis, peritoneal dialysis, etc. to replace the functions normally performed by the kidneys, remove waste products from body fluids, and supplement necessary components in the blood, and is used as an alkalizing agent. Since the sodium bicarbonate dialysate using heavy W is physiologically preferable, a sodium bicarbonate dialysate having the following electrolyte ion composition is used. Na” 120-150 mEq/QK”
0.5~3.0〃 Ca" 1.5~4.5 tt Mg" O~2.0〃 C1-90~135〃 CH, COO-5~35〃 HCOR-20~35〃 Glucose 0~250 gIQ Normally, baking soda dialysate contains about 2.5 of the required electrolytes other than baking soda.
Water is added to more than 1 kg to make a stock solution A with a volume of about 10 + 2 due to solubility, and this is divided into an aqueous sodium bicarbonate solution as an alkaline agent, and the two are mixed during dialysis to dilute the total amount to 350Q for use. Baking soda may be stored or transported in powder form and dissolved immediately before use. [Problems to be Solved by the Invention] However, when the aqueous sodium bicarbonate solution and other electrolyte component solutions are prepared in advance as described above, even if they are made into concentrated stock solutions, they take up a considerable volume and weight. However, it has the disadvantage of being inconvenient for storage and transportation. In order to avoid this drawback, when electrolyte components are stored or transported in the form of powder, there is a problem in that the rate of dissolution of the electrolyte components, especially sodium bicarbonate, is slow when dissolved in water during use. In addition, baking soda powder easily generates dust and has poor fluidity.
Generally difficult to handle. However, if granulation is performed to facilitate handling, the dissolution rate becomes even slower. An object of the present invention is to provide a granular sodium bicarbonate dialysis agent that is advantageous in storage and transportation, can easily yield a sodium bicarbonate dialysis solution, is easy to handle, and has a fast dissolution rate. [Means for Solving the Problems] The present invention divides electrolyte components into a group that does not contain baking soda (A agent) and a group that contains baking soda (A agent B), and mixes A agent and B agent at the time of use. The present invention provides a sodium bicarbonate dialysis agent to be used, characterized in that agent B is a mixed granulated product of sodium bicarbonate, sodium chloride, and/or sodium acetate. In the present invention, since Part B is a mixed granule of baking soda and sodium chloride and/or sodium acetate, when it is dissolved in water, sodium chloride or sodium acetate, which has a high dissolution rate, dissolves earlier than baking soda. Since the primary particles of baking soda are quickly dispersed in water, the dissolution of baking soda also occurs quickly. As the sodium acetate used here, either an anhydrous salt or a hydrated salt can be used without particular difference. Since the B agent of the present invention is granulated, it has good fluidity and almost no dust generation. Even though it is granulated,
For the above reasons, the dissolution rate is only slightly slower than that of primary particles alone. When comparing the dissolution time, which is the time required for the solution to become transparent when a fixed amount of solid is added to a fixed amount of water and stirred, the B agent of the present invention has a dissolution time that is within twice the dissolution time of primary baking soda particles. It is. When the B agent is a mixture of sodium bicarbonate and sodium chloride, the content of sodium chloride is preferably 0.5 to 7% by weight. If the content of sodium chloride is less than the above range, the rate of dissolution in water will decrease, which is not preferable. Conversely, if it exceeds the above range, the dissolution rate in water similarly decreases, which is not preferable. A particularly preferred content of sodium chloride is 1 to 5% by weight. When the B agent is a mixture of baking soda and sodium acetate, the content of sodium acetate is 0.0% in terms of anhydrous sodium acetate.
The content of sodium acetate is preferably 3 to 10% by weight. If the content is less than the above range, the rate of dissolution in water will decrease, which is not preferable. On the other hand, if it exceeds the above range, the dissolution rate in water similarly decreases, which is not preferable. A particularly preferable content of sodium acetate is 0.5 to 8% by weight in terms of anhydrous sodium acetate. When agent B is a mixture of baking soda, sodium chloride, and sodium acetate, the content of sodium chloride is 0.5 to
7% by weight, and the content of sodium acetate is preferably 0.3 to 10% by weight in terms of anhydrous sodium acetate. If the respective contents deviate from the above ranges, the rate of dissolution in water will decrease, which is not preferable. In the B agent of the present invention, when the electrolyte to be mixed with sodium acetate is solely sodium acetate, it is most preferable from the viewpoint of dissolution rate in water. Further, in the present invention, even if the B agent is a mixed granulated product of sodium bicarbonate and glucose, the dissolution rate of the B agent increases. However, care must be taken as agent B, which contains glucose, is susceptible to bacterial growth. The preparation of the present invention thus uses a mixture of components necessary for a dialysis agent that are not included in the agent B. Among the components necessary for the dialysis agent, the components other than baking soda are relatively easily dissolved in water, so the properties of the hemolytide are not particularly limited, but granulated ones are preferable for ease of handling. . In the present invention, the granulated material of agent B (or agent A) preferably has an angle of repose of 50 degrees or less because it has good fluidity and is easy to handle. The pore volume of the granules is 0.05
It is preferable that it is 0.2 cc/g. Pore volume is 0
．． If it is less than 0.05 cc/g, the dissolution rate may become slow, which is not preferable. Pore volume is 0.2cc/
If it exceeds g, the strength of the granulated product may decrease and dust generation may occur, which is not preferable. In addition, the apparent specific gravity of the granules is 0.5 to 0.9 for loose and 0.6 for hard.
It is preferable that it is 1.1. If the apparent specific gravity is less than the above range, the strength of the granulated product may decrease and dust generation may occur, which is not preferable. If the apparent specific gravity exceeds the above range, the dissolution rate may become slow, which is not preferable. When granulating Agent A or Agent B, each component can be mixed as a powder with appropriate water and granulated using various granulators. By adopting the following measures, the solubility, especially the solubility of baking soda, can be further improved, the granules are easy to handle, have sufficient strength, are difficult to powder, are homogeneous, and have a stable composition. This is preferred because good granules can be obtained. The particle size of the electrolyte component powder is adjusted, water is added so that the moisture content becomes 1 to 25% by weight, and the mixture is thoroughly mixed. After granulation using an extrusion granulator or the like, the powder is dried to form a granular product. The particle size of the electrolyte component powder used as a raw material is suitably 250 μm or less, preferably 180 μm or less, and more preferably 100 μm or less. If the particle size exceeds 250 μm, the final product granules will have insufficient mechanical strength, will easily become powder, and will have a slow dissolution rate, which is not preferable. Additionally, if the moisture content is less than 1% by weight during granulation, the particle strength will be low and it will be easier to powder, while if it exceeds 25% by weight, granulation may become difficult. Undesirable. It is appropriate that the particle size of the particles to be granulated is about 0.1 to 10 mm. If the particle size of the granules is less than the above range, the fluidity may be inhibited or the particles may become powdered and scattered, making them difficult to handle.On the other hand, if the particle size exceeds the above range, the mechanical strength of the particles decreases. Both are undesirable because they may cause the dissolution to take too long. When drying the granulated product, especially the B agent, it is preferable to use a carbon dioxide gas atmosphere in order to prevent the decomposition of the baking soda. It is preferable to adopt a carbon dioxide concentration of about 5% or more. It is appropriate to carry out drying at 30 to 90'C, and specific drying means such as a band dryer, disc dryer, ventilation dryer, rotary dryer, etc. can be used to achieve high strength and easy drying. It becomes possible to obtain granules that are soluble, uniform, and have good compositional stability. The dialysis agent of the present invention may contain a po adjusting component such as acetic acid in advance for the purpose of adjusting the pH after dissolution. A pH adjusting component may be added to the dialysate after dissolution. [Example Example 1 Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate and glucose, each pulverized to an average particle size of about 50 μm, were mixed in the following ratio, and 1.5% by weight of water on a dry basis was added and mixed. NaC174,7110% by weight KCI 1.7943 //CaC
112HsO2,2839tt MgC1m・6HiO1,2408//CH,COON
a 7.9296 // glucose
12.0404 //The mixture was granulated using an extrusion granulator to obtain 100 kg of cylindrical particles with a diameter of 0.5 mm and a length of 1 to 10 mm.Next, the batch was adjusted to a temperature of 50°C. The particles were placed in a box dryer and dried for 3 hours. Thereafter, 1.5% by weight of glacial acetic acid was further added, and this was used as agent A. This agent A was in the form of granules, and the pore volume measured by a mercury intrusion porosimeter was 0.08 cm'/g. Put 100cc of water at 15°C in a 100cc beaker, add 6g of agent A, and mix with a magnetic cooler for 5 minutes.
When stirring at 0 rpm, the dissolution time (time until the solid content disappeared) was 2 minutes and 10 seconds. The angle of repose measured with a powder tester made by Micron ■ for wires was 40 degrees, and it had good fluidity. In addition, the apparent specific gravity was Q, 707 for the loose material, and 0.790 for the hard material. Separately, Agent B was prepared as follows. First, baking soda and sodium chloride, each pulverized to an average particle size of about 50 LLm, were mixed in the following ratio, and then 14% water on a dry basis was added and mixed. NaHCO, 97.60% by weight NaC12.40u The mixture was granulated using an extrusion granulator to form particles with a diameter of 0.5
mm, 54k cylindrical particles with a length of 0.5 to 5 mm
Next, the particles were placed in a batch type box dryer adjusted to a carbon dioxide concentration of 55% and a temperature of 75° C. and dried for 3 hours to obtain a B agent. This B agent was in the form of granules, and the pore volume measured using a mercury intrusion porosimeter was 0.08 cm" and 7 g. 100 cc of water at 15°C was placed in a 100 cc beaker, and 6. Ig of A agent was added. When stirred at 50 rpm with a magnetic stirrer, the dissolution time (time until the solid content disappeared) was 3 minutes and 35 seconds.The angle of repose measured with a powder tester manufactured by Micron ■ for wires was 42
It had good fluidity. Moreover, the apparent specific gravity was 0.742 for the loose material and 0.997 for the hard material. 25 g of agent A and 6.387 g of agent B were dissolved in water at 25° C. to give a concentration of 2.9672, and the concentration of each component was measured. Sodium and potassium were quantitatively analyzed by atomic absorption spectrophotometry, calcium and magnesium by chelate titration, chlorine by Mohr's titration, total acid and glucose by liquid chromatography, and hydrogen carbonate ions by acid-alkali titration. did. The results are shown in Table 1. Next, changes over time due to long-term storage of Agents A and B were investigated. Agents A and B were sealed and left at room temperature, and 54 g of agent A 12B and 0678 g of agent B were placed at 25°C immediately after manufacture and at 1st month, 3rd month, 6th month, and 12th month after manufacture. It was dissolved with water to make 315Q. Regarding the obtained solution,
The pH and the concentration of each ion immediately after production were set as 100, and the deviations from this were determined and the results are shown in Table 2. From Tables 1 and 2, this dialysis agent consisting of Agent A and Agent B can produce dialysis M with good reproducibility, and is also stable over time, with substantially no difference after long-term storage compared to immediately after manufacture. It is clear that the dialysis fluid can be reconstituted. In table 2,
The gradual decrease in the content of each component is thought to be due to the influence of moisture permeating through the packaging material. Examples 2 to 8 Comparative Example 1.2 Example 1 was prepared using sodium chloride, sodium acetate, and glucose, each of which was pulverized to an average particle size of about 50 μm.
Table 3 shows the measurement results for the properties of agent B obtained by blending, granulating, and drying under the conditions shown in Table 3 by the same operation as above. Comparative Example 1 is a granulated product of sodium bicarbonate alone, and Comparative Example 2 is a primary sodium bicarbonate particle before granulation. [Effects of the Invention] The dialysis agent of the present invention is easily dissolved in water to form a homogeneous aqueous solution, and a dialysate can be easily obtained. In addition, the present dialysis agent can be made small in volume, which is advantageous for storage or transportation without pulverization or formation of poorly soluble compounds during storage. Furthermore, since it has excellent fluidity, it is easy to handle.
Claims (10)
を含む群（Ｂ剤）とに分け、使用時にＡ剤とＢ剤を混合
して用いる重曹透析用剤において、Ｂ剤が重曹と塩化ナ
トリウムおよび／または酢酸ナトリウムとの混合造粒物
であることを特徴とする重曹透析用剤。(1) The electrolyte component is divided into a group that does not contain baking soda (A agent) and a group that contains baking soda (A agent B), and in a sodium bicarbonate dialysis agent that is used by mixing A agent and B agent at the time of use, B agent is A sodium bicarbonate dialysis agent characterized in that it is a mixed granulated product of baking soda and sodium chloride and/or sodium acetate.
ものである請求項１の重曹透析用剤。(2) The sodium bicarbonate dialysis agent according to claim 1, wherein agent B contains 0.5 to 7% by weight of sodium chloride.
算で０．３〜１０重量％含むものである請求項１の重曹
透析用剤。(3) The sodium bicarbonate dialysis agent according to claim 1, wherein agent B contains 0.3 to 10% by weight of sodium acetate in terms of anhydrous sodium acetate.
び酢酸ナトリウムを無水酢酸ナトリウム換算で０．３〜
１０重量％含むものである請求項１の重曹透析用剤。(4) Agent B contains 0.5 to 7% by weight of sodium chloride and 0.3 to 7% of sodium acetate in terms of anhydrous sodium acetate.
The sodium bicarbonate dialysis agent according to claim 1, which contains 10% by weight.
請求項１〜４いずれか１の重曹透析用剤。(5) The sodium bicarbonate dialysis agent according to any one of claims 1 to 4, wherein the dissolution time of agent B is at most twice that of the primary sodium bicarbonate particles.
れか１の重曹透析用剤。(6) The sodium bicarbonate dialysis agent according to any one of claims 1 to 5, wherein agent A is granulated.
６〜１．１である請求項６の透析用剤。(8) Apparent specific gravity is loose 0.5-0.9 and hard 0.
The dialysis agent according to claim 6, which has a molecular weight of 6 to 1.1.
項６の透析用剤。(9) The dialysis agent according to claim 6, which has a pore volume of 0.05 to 0.2 cc/g.
曹を含む群（Ｂ剤）とに分け、使用時にＡ剤とＢ剤を混
合して用いる重曹透析用剤において、Ｂ剤が重曹とブド
ウ糖との混合造粒物であることを特徴とする重曹透析用
剤。(10) In a sodium bicarbonate dialysis agent in which the electrolyte components are divided into a group that does not contain baking soda (A agent) and a group that contains baking soda (A agent B), and the A agent and B agent are mixed at the time of use, the B agent is A sodium bicarbonate dialysis agent characterized by being a granulated mixture of sodium bicarbonate and glucose.
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP02075539A JP3076051B2 (en) | 1990-03-27 | 1990-03-27 | Baking soda dialysis agent |
| US07/564,159 US5071558A (en) | 1989-08-11 | 1990-08-08 | Sodium bicarbonate dialysate |
| DE69018172T DE69018172T3 (en) | 1989-08-11 | 1990-08-09 | Composition containing sodium bicarbonate for the preparation of a dialysis solution. |
| EP90115320A EP0417478B2 (en) | 1989-08-11 | 1990-08-09 | Sodium bicarbonate containing mixture for producing a dialysis solution |
| CA002023075A CA2023075C (en) | 1989-08-11 | 1990-08-10 | Sodium bicarbonate dialysate |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP02075539A JP3076051B2 (en) | 1990-03-27 | 1990-03-27 | Baking soda dialysis agent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH03275626A true JPH03275626A (en) | 1991-12-06 |
| JP3076051B2 JP3076051B2 (en) | 2000-08-14 |
Family
ID=13579112
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP02075539A Expired - Fee Related JP3076051B2 (en) | 1989-08-11 | 1990-03-27 | Baking soda dialysis agent |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3076051B2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06178802A (en) * | 1992-12-14 | 1994-06-28 | Tomita Seiyaku Kk | Production of agent for artificial kidney perfusion for bicarbonate dialysis and the agent |
| JPWO2006115067A1 (en) * | 2005-04-20 | 2008-12-18 | 株式会社林原生物化学研究所 | Peritoneal dialysate |
-
1990
- 1990-03-27 JP JP02075539A patent/JP3076051B2/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06178802A (en) * | 1992-12-14 | 1994-06-28 | Tomita Seiyaku Kk | Production of agent for artificial kidney perfusion for bicarbonate dialysis and the agent |
| JPWO2006115067A1 (en) * | 2005-04-20 | 2008-12-18 | 株式会社林原生物化学研究所 | Peritoneal dialysate |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3076051B2 (en) | 2000-08-14 |
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