JP6216777B2 - 腹膜透析液 - Google Patents
腹膜透析液 Download PDFInfo
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- JP6216777B2 JP6216777B2 JP2015509768A JP2015509768A JP6216777B2 JP 6216777 B2 JP6216777 B2 JP 6216777B2 JP 2015509768 A JP2015509768 A JP 2015509768A JP 2015509768 A JP2015509768 A JP 2015509768A JP 6216777 B2 JP6216777 B2 JP 6216777B2
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- JP
- Japan
- Prior art keywords
- solution
- peritoneal dialysis
- liquid
- icodextrin
- lactate
- 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.)
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- 239000007788 liquid Substances 0.000 claims description 46
- 239000000243 solution Substances 0.000 claims description 43
- 239000000385 dialysis solution Substances 0.000 claims description 40
- 229920002177 Icodextrin Polymers 0.000 claims description 32
- 229940016836 icodextrin Drugs 0.000 claims description 32
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 21
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 21
- 230000001954 sterilising effect Effects 0.000 claims description 18
- 238000004659 sterilization and disinfection Methods 0.000 claims description 18
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 16
- 239000003330 peritoneal dialysis fluid Substances 0.000 claims description 16
- 239000004310 lactic acid Substances 0.000 claims description 11
- 235000014655 lactic acid Nutrition 0.000 claims description 11
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims description 10
- 229940001447 lactate Drugs 0.000 claims description 10
- 239000001540 sodium lactate Substances 0.000 claims description 10
- 229940005581 sodium lactate Drugs 0.000 claims description 10
- 235000011088 sodium lactate Nutrition 0.000 claims description 10
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 9
- 239000011780 sodium chloride Substances 0.000 claims description 8
- 235000002639 sodium chloride Nutrition 0.000 claims description 8
- 239000003002 pH adjusting agent Substances 0.000 claims description 7
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 6
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 6
- 239000012530 fluid Substances 0.000 claims description 6
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 claims description 4
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 claims description 4
- 229910001424 calcium ion Inorganic materials 0.000 claims description 4
- 229910001425 magnesium ion Inorganic materials 0.000 claims description 4
- 238000000638 solvent extraction Methods 0.000 claims description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 3
- 230000002378 acidificating effect Effects 0.000 claims description 3
- 239000001110 calcium chloride Substances 0.000 claims description 3
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 3
- 235000011148 calcium chloride Nutrition 0.000 claims description 3
- 229910001629 magnesium chloride Inorganic materials 0.000 claims description 3
- 235000011147 magnesium chloride Nutrition 0.000 claims description 3
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 3
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 3
- 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 description 15
- 239000008103 glucose Substances 0.000 description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- -1 lactate ion Chemical class 0.000 description 10
- 239000008215 water for injection Substances 0.000 description 9
- 239000004743 Polypropylene Substances 0.000 description 7
- 229920001155 polypropylene Polymers 0.000 description 7
- 238000003860 storage Methods 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 6
- 238000000502 dialysis Methods 0.000 description 6
- 239000011259 mixed solution Substances 0.000 description 6
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 description 5
- 229940052299 calcium chloride dihydrate Drugs 0.000 description 5
- 238000000354 decomposition reaction Methods 0.000 description 5
- 239000007857 degradation product Substances 0.000 description 5
- 229940050906 magnesium chloride hexahydrate Drugs 0.000 description 5
- DHRRIBDTHFBPNG-UHFFFAOYSA-L magnesium dichloride hexahydrate Chemical compound O.O.O.O.O.O.[Mg+2].[Cl-].[Cl-] DHRRIBDTHFBPNG-UHFFFAOYSA-L 0.000 description 5
- 230000003204 osmotic effect Effects 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 238000002835 absorbance Methods 0.000 description 4
- 238000004040 coloring Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 3
- 229960000448 lactic acid Drugs 0.000 description 3
- NOEGNKMFWQHSLB-UHFFFAOYSA-N 5-hydroxymethylfurfural Chemical compound OCC1=CC=C(C=O)O1 NOEGNKMFWQHSLB-UHFFFAOYSA-N 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 2
- 229960002713 calcium chloride Drugs 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- RJGBSYZFOCAGQY-UHFFFAOYSA-N hydroxymethylfurfural Natural products COC1=CC=C(C=O)O1 RJGBSYZFOCAGQY-UHFFFAOYSA-N 0.000 description 2
- 230000007124 immune defense Effects 0.000 description 2
- 229960002337 magnesium chloride Drugs 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 210000003245 peritoneal mesothelial cell Anatomy 0.000 description 2
- 210000004303 peritoneum Anatomy 0.000 description 2
- 229960002668 sodium chloride Drugs 0.000 description 2
- 229910001415 sodium ion Inorganic materials 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000003113 alkalizing effect Effects 0.000 description 1
- 230000008952 bacterial invasion Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 229940003871 calcium ion Drugs 0.000 description 1
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 description 1
- 239000001527 calcium lactate Substances 0.000 description 1
- 235000011086 calcium lactate Nutrition 0.000 description 1
- 229960002401 calcium lactate Drugs 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 230000002016 colloidosmotic effect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 210000002540 macrophage Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000003024 peritoneal macrophage Anatomy 0.000 description 1
- 206010034674 peritonitis Diseases 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- PHZLMBHDXVLRIX-UHFFFAOYSA-M potassium lactate Chemical compound [K+].CC(O)C([O-])=O PHZLMBHDXVLRIX-UHFFFAOYSA-M 0.000 description 1
- 239000001521 potassium lactate Substances 0.000 description 1
- 235000011085 potassium lactate Nutrition 0.000 description 1
- 229960001304 potassium lactate Drugs 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000002636 symptomatic treatment Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 238000000108 ultra-filtration Methods 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/287—Dialysates therefor
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Urology & Nephrology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- External Artificial Organs (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
75gのイコデキストリンを200mLの注射用水に溶解し、第1液を調製した。また、5.35gの塩化ナトリウム、4.48gの乳酸ナトリウム、0.257gの塩化カルシウム・二水塩、および0.051gの塩化マグネシウム・六水塩を800mLの注射用水に溶解し、水酸化ナトリウムでpHを調整し、第2液を調製した。第1液200mL、第2液800mLを、それぞれポリプロピレン製複室容器(ミッドペリック(登録商標)(テルモ株式会社製)の容器)に充填した後、ポリプロピレン/ナイロン/ポリプロピレン製の三方袋に入れて脱気包装した。その後、オートクレーブを用いて加熱滅菌(121℃、10分)を行った後、第1液、第2液、および混合液(腹膜透析液)のpHを測定した。第1液のpHは4.8、第2液のpHは6.9、混合液のpHは6.7であった。
75gのイコデキストリンを160mLの注射用水に溶解し、第1液を調製した。また、5.35gの塩化ナトリウム、4.48gの乳酸ナトリウム、0.257gの塩化カルシウム・二水塩、および0.051gの塩化マグネシウム・六水塩を840mLの注射用水に溶解し、水酸化ナトリウムでpHを調整し、第2液を調製した。第1液160mL、第2液840mLを、実施例1と同様の条件で、充填、加熱滅菌した後、第1液、第2液、および混合液(腹膜透析液)のpHを測定した。第1液のpHは4.7、第2液のpHは7.0、混合液のpHは6.6であった。
75gのイコデキストリン、0.257gの塩化カルシウム・二水塩、および0.051gの塩化マグネシウム・六水塩を200mLの注射用水に溶解し、第1液を調製した。また、5.35gの塩化ナトリウムおよび4.48gの乳酸ナトリウムを800mLの注射用水に溶解し、水酸化ナトリウムでpHを調整し、第2液を調製した。第1液200mL、第2液800mLを、実施例1と同様の条件で、充填、加熱滅菌した後、第1液、第2液、および混合液(腹膜透析液)のpHを測定した。第1液のpHは5.0、第2液のpHは6.8、混合液のpHは6.6であった。
50gのイコデキストリン、0.257gの塩化カルシウム・二水塩、0.051gの塩化マグネシウム・六水塩、および5.35gの塩化ナトリウムを200mLの注射用水に溶解し、第1液を調製した。また、4.48gの乳酸ナトリウムを800mLの注射用水に溶解し、水酸化ナトリウムでpHを調整し、第2液を調製した。第1液200mL、第2液800mLを、実施例1と同様の条件で、充填、加熱滅菌した後、第1液、第2液、および混合液(腹膜透析液)のpHを測定した。第1液のpHは4.9、第2液のpHは6.8、混合液のpHは6.6であった。
75gのイコデキストリン、0.257gの塩化カルシウム・二水塩、0.051gの塩化マグネシウム・六水塩、5.35gの塩化ナトリウム、および4.48gの乳酸ナトリウムを注射用水に溶解し、塩酸でpHを調整し、1000mLの溶液を調製した。調製液1000mLを、ポリプロピレン製単室容器に充填した後、ポリプロピレン/ナイロン/ポリプロピレン製の三方袋に入れて脱気包装した。その後、オートクレーブを用いて加熱滅菌(121℃、10分)を行った後、得られた腹膜透析液のpHを測定した。pHは、5.5であった。
実施例1、2、および比較例1〜4の腹膜透析液について、ブドウ糖の主たる分解生成物である5−ヒドロキシメチルフルフラールの指標である284nmの吸光度の経時的な変化を測定した。結果を表1及び表2に示す。なお、実施例1、2、および比較例1〜4の腹膜透析液の保管は60℃の恒温槽中で行い、第1液と第2液の混合(比較例3は除く)は、吸光度の測定直前に行った。
Claims (5)
- 375.0〜468.8g/Lのイコデキストリンを含有し、乳酸、乳酸塩、カルシウムイオン、マグネシウムイオンのいずれも含まず、かつ、酸性である第1液と、アルカリ性pH調整剤を含有するアルカリ性の第2液とからなる滅菌された腹膜透析液であって、滅菌後の前記第1液のpHが4.5〜5.5、滅菌後の前記第2液のpHが6.5〜7.5、滅菌後に前記第1液と前記第2液を混合した後のpHが6.0〜7.5となることを特徴とする腹膜透析液。
- 前記第2液は、イコデキストリンを含まず、乳酸または乳酸塩を含む請求項1に記載の腹膜透析液。
- 前記第2液のアルカリ性pH調整剤が、水酸化ナトリウムおよび炭酸水素ナトリウムの少なくとも一つを含む請求項1に記載の腹膜透析液。
- 前記第2液が、塩化ナトリウム、乳酸、乳酸ナトリウム、塩化カルシウムおよび塩化マグネシウムの少なくとも一つを含む請求項1に記載の腹膜透析液。
- 医療用袋体に収納された請求項1に記載の腹膜透析液であって、前記袋体は、その内部を開放可能な仕切手段によって分離されることにより形成される第1室と第2室とを有し、前記第2室は前記袋体の内外を連通する排出ポートを有するものであって、前記第1液は前記第1室に、前記第2液は前記第2室に収納されている腹膜透析液。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/JP2013/060075 WO2014162515A1 (ja) | 2013-04-02 | 2013-04-02 | 腹膜透析液 |
Publications (2)
Publication Number | Publication Date |
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JPWO2014162515A1 JPWO2014162515A1 (ja) | 2017-02-16 |
JP6216777B2 true JP6216777B2 (ja) | 2017-10-18 |
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JP2015509768A Active JP6216777B2 (ja) | 2013-04-02 | 2013-04-02 | 腹膜透析液 |
Country Status (2)
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JP (1) | JP6216777B2 (ja) |
WO (1) | WO2014162515A1 (ja) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP6313653B2 (ja) * | 2014-05-19 | 2018-04-18 | テルモ株式会社 | 腹膜透析液 |
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JPH08131542A (ja) * | 1994-11-11 | 1996-05-28 | Baxter Kk | 腹膜透析液調製用溶液セット |
US20040121982A1 (en) * | 2002-12-20 | 2004-06-24 | Leo Martis | Biocompatible dialysis fluids containing icodextrins |
-
2013
- 2013-04-02 JP JP2015509768A patent/JP6216777B2/ja active Active
- 2013-04-02 WO PCT/JP2013/060075 patent/WO2014162515A1/ja active Application Filing
Also Published As
Publication number | Publication date |
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WO2014162515A1 (ja) | 2014-10-09 |
JPWO2014162515A1 (ja) | 2017-02-16 |
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