JP5876042B2 - 透析前駆体組成物 - Google Patents
透析前駆体組成物 Download PDFInfo
- Publication number
- JP5876042B2 JP5876042B2 JP2013515839A JP2013515839A JP5876042B2 JP 5876042 B2 JP5876042 B2 JP 5876042B2 JP 2013515839 A JP2013515839 A JP 2013515839A JP 2013515839 A JP2013515839 A JP 2013515839A JP 5876042 B2 JP5876042 B2 JP 5876042B2
- Authority
- JP
- Japan
- Prior art keywords
- precursor composition
- dialysis
- acid
- solution
- calcium
- 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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Links
- 239000000203 mixture Substances 0.000 title claims description 89
- 239000002243 precursor Substances 0.000 title claims description 79
- 238000000502 dialysis Methods 0.000 title claims description 71
- 239000002253 acid Substances 0.000 claims description 76
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 52
- 239000000243 solution Substances 0.000 claims description 42
- 239000012141 concentrate Substances 0.000 claims description 39
- 239000000385 dialysis solution Substances 0.000 claims description 34
- 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 28
- 239000008103 glucose Substances 0.000 claims description 28
- 159000000003 magnesium salts Chemical class 0.000 claims description 26
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 21
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 20
- 159000000007 calcium salts Chemical class 0.000 claims description 17
- 230000005540 biological transmission Effects 0.000 claims description 16
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 14
- 239000000843 powder Substances 0.000 claims description 14
- 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 claims description 13
- 239000011734 sodium Substances 0.000 claims description 13
- 229910052708 sodium Inorganic materials 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 12
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 claims description 8
- 238000002360 preparation method Methods 0.000 claims description 8
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 7
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 6
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 6
- PLSARIKBYIPYPF-UHFFFAOYSA-H trimagnesium dicitrate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O PLSARIKBYIPYPF-UHFFFAOYSA-H 0.000 claims description 6
- PHOQVHQSTUBQQK-SQOUGZDYSA-N D-glucono-1,5-lactone Chemical compound OC[C@H]1OC(=O)[C@H](O)[C@@H](O)[C@@H]1O PHOQVHQSTUBQQK-SQOUGZDYSA-N 0.000 claims description 5
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 5
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 claims description 5
- 229940052299 calcium chloride dihydrate Drugs 0.000 claims description 5
- FNAQSUUGMSOBHW-UHFFFAOYSA-H calcium citrate Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O FNAQSUUGMSOBHW-UHFFFAOYSA-H 0.000 claims description 5
- 239000001354 calcium citrate Substances 0.000 claims description 5
- 229960004256 calcium citrate Drugs 0.000 claims description 5
- 239000004227 calcium gluconate Substances 0.000 claims description 5
- 235000013927 calcium gluconate Nutrition 0.000 claims description 5
- 229960004494 calcium gluconate Drugs 0.000 claims description 5
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 claims description 5
- 239000001527 calcium lactate Substances 0.000 claims description 5
- 235000011086 calcium lactate Nutrition 0.000 claims description 5
- 229960002401 calcium lactate Drugs 0.000 claims description 5
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims description 5
- 229960004106 citric acid Drugs 0.000 claims description 5
- 235000012209 glucono delta-lactone Nutrition 0.000 claims description 5
- 239000000182 glucono-delta-lactone Substances 0.000 claims description 5
- 229960003681 gluconolactone Drugs 0.000 claims description 5
- 239000007924 injection Substances 0.000 claims description 5
- 238000002347 injection Methods 0.000 claims description 5
- 229960005336 magnesium citrate Drugs 0.000 claims description 5
- 239000004337 magnesium citrate Substances 0.000 claims description 5
- 235000002538 magnesium citrate Nutrition 0.000 claims description 5
- 239000001755 magnesium gluconate Substances 0.000 claims description 5
- 235000015778 magnesium gluconate Nutrition 0.000 claims description 5
- 229960003035 magnesium gluconate Drugs 0.000 claims description 5
- IAKLPCRFBAZVRW-XRDLMGPZSA-L magnesium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate;hydrate Chemical compound O.[Mg+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 IAKLPCRFBAZVRW-XRDLMGPZSA-L 0.000 claims description 5
- 239000011591 potassium Substances 0.000 claims description 5
- 229910052700 potassium Inorganic materials 0.000 claims description 5
- 235000013337 tricalcium citrate Nutrition 0.000 claims description 5
- AGBQKNBQESQNJD-SSDOTTSWSA-N (R)-lipoic acid Chemical compound OC(=O)CCCC[C@@H]1CCSS1 AGBQKNBQESQNJD-SSDOTTSWSA-N 0.000 claims description 4
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 claims description 4
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims description 4
- 229960004308 acetylcysteine Drugs 0.000 claims description 4
- AGBQKNBQESQNJD-UHFFFAOYSA-N alpha-Lipoic acid Natural products OC(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-N 0.000 claims description 4
- 239000000174 gluconic acid Substances 0.000 claims description 4
- 235000012208 gluconic acid Nutrition 0.000 claims description 4
- 229950006191 gluconic acid Drugs 0.000 claims description 4
- 235000019136 lipoic acid Nutrition 0.000 claims description 4
- OVGXLJDWSLQDRT-UHFFFAOYSA-L magnesium lactate Chemical compound [Mg+2].CC(O)C([O-])=O.CC(O)C([O-])=O OVGXLJDWSLQDRT-UHFFFAOYSA-L 0.000 claims description 4
- 239000000626 magnesium lactate Substances 0.000 claims description 4
- 235000015229 magnesium lactate Nutrition 0.000 claims description 4
- 229960004658 magnesium lactate Drugs 0.000 claims description 4
- 230000035699 permeability Effects 0.000 claims description 4
- 229960002663 thioctic acid Drugs 0.000 claims description 4
- LADYPAWUSNPKJF-UHFFFAOYSA-L calcium;2-oxopentanedioate Chemical compound [Ca+2].[O-]C(=O)CCC(=O)C([O-])=O LADYPAWUSNPKJF-UHFFFAOYSA-L 0.000 claims description 3
- YMIFCOGYMQTQBP-UHFFFAOYSA-L calcium;dichloride;hydrate Chemical compound O.[Cl-].[Cl-].[Ca+2] YMIFCOGYMQTQBP-UHFFFAOYSA-L 0.000 claims description 3
- 235000015165 citric acid Nutrition 0.000 claims description 3
- 239000004310 lactic acid Substances 0.000 claims description 3
- 235000014655 lactic acid Nutrition 0.000 claims description 3
- 229960000448 lactic acid Drugs 0.000 claims description 3
- WSKWESCCQFXQKT-UHFFFAOYSA-L magnesium;2-oxopentanedioate Chemical compound [Mg+2].[O-]C(=O)CCC(=O)C([O-])=O WSKWESCCQFXQKT-UHFFFAOYSA-L 0.000 claims description 3
- 238000007865 diluting Methods 0.000 claims description 2
- 230000037452 priming Effects 0.000 claims description 2
- 238000006073 displacement reaction Methods 0.000 claims 1
- 235000008504 concentrate Nutrition 0.000 description 34
- 229960001031 glucose Drugs 0.000 description 28
- 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 description 27
- 239000008280 blood Substances 0.000 description 18
- 210000004369 blood Anatomy 0.000 description 18
- 238000011282 treatment Methods 0.000 description 13
- 210000004379 membrane Anatomy 0.000 description 12
- 239000012528 membrane Substances 0.000 description 12
- 238000001631 haemodialysis Methods 0.000 description 9
- 230000000322 hemodialysis Effects 0.000 description 9
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 8
- 210000001124 body fluid Anatomy 0.000 description 7
- 239000012611 container material Substances 0.000 description 7
- 239000002699 waste material Substances 0.000 description 7
- 239000010839 body fluid Substances 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- 230000015572 biosynthetic process Effects 0.000 description 5
- 238000002845 discoloration Methods 0.000 description 5
- 239000003792 electrolyte Substances 0.000 description 5
- 238000001802 infusion Methods 0.000 description 5
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 4
- 239000000872 buffer Substances 0.000 description 4
- 238000010790 dilution Methods 0.000 description 4
- 239000012895 dilution Substances 0.000 description 4
- 238000002615 hemofiltration Methods 0.000 description 4
- 239000001103 potassium chloride Substances 0.000 description 4
- 235000011164 potassium chloride Nutrition 0.000 description 4
- 238000007711 solidification Methods 0.000 description 4
- 230000008023 solidification Effects 0.000 description 4
- PXRKCOCTEMYUEG-UHFFFAOYSA-N 5-aminoisoindole-1,3-dione Chemical compound NC1=CC=C2C(=O)NC(=O)C2=C1 PXRKCOCTEMYUEG-UHFFFAOYSA-N 0.000 description 3
- 229960004543 anhydrous citric acid Drugs 0.000 description 3
- 238000009792 diffusion process Methods 0.000 description 3
- 230000007613 environmental effect Effects 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- 229960002337 magnesium chloride Drugs 0.000 description 3
- 229910001629 magnesium chloride Inorganic materials 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 238000001556 precipitation Methods 0.000 description 3
- 208000037157 Azotemia Diseases 0.000 description 2
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 2
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 150000007513 acids Chemical class 0.000 description 2
- 230000003078 antioxidant effect Effects 0.000 description 2
- 239000002585 base Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 description 2
- 239000001110 calcium chloride Substances 0.000 description 2
- 229960002713 calcium chloride Drugs 0.000 description 2
- 229910001628 calcium chloride Inorganic materials 0.000 description 2
- 229910001424 calcium ion Inorganic materials 0.000 description 2
- 239000001569 carbon dioxide Substances 0.000 description 2
- 229910002092 carbon dioxide Inorganic materials 0.000 description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-N carbonic acid Chemical class OC(O)=O BVKZGUZCCUSVTD-UHFFFAOYSA-N 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 239000007857 degradation product Substances 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 description 2
- 239000001095 magnesium carbonate Substances 0.000 description 2
- 229910000021 magnesium carbonate Inorganic materials 0.000 description 2
- 229910001425 magnesium ion Inorganic materials 0.000 description 2
- 229910001414 potassium ion Inorganic materials 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000012959 renal replacement therapy Methods 0.000 description 2
- 238000002834 transmittance Methods 0.000 description 2
- 208000009852 uremia Diseases 0.000 description 2
- 208000009304 Acute Kidney Injury Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 208000033626 Renal failure acute Diseases 0.000 description 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 1
- 230000002429 anti-coagulating effect Effects 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 229960005069 calcium Drugs 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 238000002144 chemical decomposition reaction Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000002274 desiccant Substances 0.000 description 1
- 230000003467 diminishing effect Effects 0.000 description 1
- 238000005755 formation reaction Methods 0.000 description 1
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 235000014666 liquid concentrate Nutrition 0.000 description 1
- 239000011777 magnesium Substances 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
- 235000015097 nutrients Nutrition 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000005192 partition Methods 0.000 description 1
- 210000003200 peritoneal cavity Anatomy 0.000 description 1
- 210000004303 peritoneum Anatomy 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 229960003975 potassium Drugs 0.000 description 1
- 229960002816 potassium chloride Drugs 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 229960002668 sodium chloride Drugs 0.000 description 1
- 229910001415 sodium ion Inorganic materials 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 108700012359 toxins Proteins 0.000 description 1
- 238000011277 treatment modality Methods 0.000 description 1
Classifications
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
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- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- 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
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- 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
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Description
(a)グルコースと、少なくとも1つの乾燥した酸と、少なくとも1つのマグネシウム塩と、任意にカリウム塩およびカルシウム塩とを含む透析前駆体組成物であって、前記グルコースおよび前記少なくとも1つのマグネシウム塩が、前記透析酸前駆体組成物中に無水成分として存在する透析前駆体組成物を用意することと、
(b)前記透析前駆体組成物を、38℃/90%RHで水蒸気透過率が0.3g/m2/d未満である密封した耐湿性容器で提供することと、
(c)所定の体積の水を前記容器中の前記透析前駆体組成物に加えて混合し、それにより、溶液として前記透析酸濃縮物を得ることと
を含む。
例としてであって限定するものではないが、以下の例は、本発明の実施形態に従ってさまざまな透析酸前駆体組成物を確認するものである。
本発明の実施形態によるものと比較用のものの両方について、異なる乾燥粉末組成物の安定性を試験するためにテストを実施した。固化、塊形成(lumping)、および変色などのパラメーターを評価した。
プラスチックフィルムを溶接して、1区画の袋にした。
230Lの透析液を作製するのに必要な量の粉末成分(塩化カリウム、無水塩化マグネシウム、塩化カルシウム二水和物、無水グルコース、およびクエン酸)を、38℃/90%RHで0.11g/m2/dの水蒸気透過率でプラスチック袋に充填した。袋を密封し、それぞれ、30℃、65%RH、および40℃、75%RHでインキュベートした。
230Lの透析液を作製するのに必要な量の粉末成分(塩化カリウム、無水塩化マグネシウム、無水塩化カルシウム、無水グルコース、およびクエン酸)を、38℃/90%RHで0.11g/m2/dの水蒸気透過率でプラスチック袋に充填した。袋を密封し、それぞれ、30℃、65%RH、および40℃、75%RHでインキュベートした。
230Lの透析液を作製するのに必要な量の粉末成分(塩化カリウム、無水塩化マグネシウム、塩化カルシウム二水和物、無水グルコース、およびクエン酸)を、38℃/90%RHで2.7g/m2/dの水蒸気透過率でプラスチック袋に充填した。袋を密封し、それぞれ、30℃、65%RH、および40℃、75%RHでインキュベートした。
組成物1および2は、少なくとも6カ月間は安定なままでいることが証明されたが、比較組成物3は、1カ月未満の後に茶色の塊が形成されたことにより失敗した。
[付記]以下に、出願当初の特許請求の範囲に記載された発明を付記する。
[項1] 透析酸濃縮溶液の調製中に使用し、水、ナトリウム含有濃縮物、および炭酸水素塩含有濃縮物と混合して即時使用可能な透析溶液にするための透析酸前駆体組成物であって、グルコースと、少なくとも1つの乾燥した酸と、少なくとも1つのマグネシウム塩と、任意にカリウム塩およびカルシウム塩とを含む粉末成分からなり、前記グルコースおよび前記少なくとも1つのマグネシウム塩は前記透析酸前駆体組成物中に無水成分として存在し、38℃/90%RHで水蒸気透過率が0.3g/m 2 /d未満である耐湿性容器中に密封されている透析酸前駆体組成物。
[項2] 前記少なくとも1つの乾燥した酸が、乳酸、クエン酸、グルコン酸、グルコノ−δ−ラクトン、N−アセチルシステインおよびα−リポ酸を含む群から選択される、項1に記載の透析前駆体組成物。
[項3] 前記透析酸前駆体組成物中の前記少なくとも1つのマグネシウム塩が、無水塩化マグネシウム、グルコン酸マグネシウム、クエン酸マグネシウム、乳酸マグネシウム、およびα−ケトグルタル酸マグネシウムを含む群から選択される、項1または項2に記載の透析前駆体組成物。
[項4] 前記透析酸前駆体組成物中の前記カルシウム塩が、塩化カルシウム二水和物、塩化カルシウム一水和物、無水塩化カルシウム、グルコン酸カルシウム、クエン酸カルシウム、乳酸カルシウム、およびα−ケトグルタル酸カルシウムを含む群から選択される少なくとも1つである、項1〜3のいずれか一項に記載の透析前駆体組成物。
[項5] 前記耐湿性容器の水蒸気透過率が、38℃/90%RHで0.2g/m 2 /d未満である、項1〜4のいずれか一項に記載の透析前駆体組成物。
[項6] 前記耐湿性容器の水蒸気透過率が、38℃/90%RHで0.1g/m 2 /dを超える、項1〜5のいずれか一項に記載の透析前駆体組成物。
[項7] 前記耐湿性容器内で所定の体積の水と混合して透析酸濃縮溶液を得るように構成される、項1〜6のいずれか一項に記載の透析前駆体組成物。
[項8] 水、ナトリウム含有濃縮物、および炭酸水素塩含有濃縮物で希釈して即時使用可能な透析溶液を作製するための透析酸濃縮溶液を提供する方法であって、
(a)グルコースと、少なくとも1つの乾燥した酸と、少なくとも1つのマグネシウム塩と、任意にカリウム塩およびカルシウム塩とを含む透析前駆体組成物であって、前記グルコースおよび前記少なくとも1つのマグネシウム塩が前記透析酸前駆体組成物中に無水成分として存在する透析前駆体組成物を用意することと、
(b)前記透析前駆体組成物を、38℃/90%RHで水蒸気透過率が0.3g/m 2 /d未満である密封した耐湿性容器で提供することと、
(c)所定の体積の水を前記容器中の前記透析前駆体組成物に加えて混合し、それにより、溶液として前記透析酸濃縮物を得ることと
を含む方法。
[項9] 透析酸濃縮溶液を調製するための、項1〜7のいずれか一項に記載の透析酸前駆体組成物の使用。
[項10] 透析溶液、注入溶液、置換溶液、すすぎ溶液、またはプライミング溶液を調製するための、項1〜7のいずれか一項に記載の透析酸前駆体組成物の使用。
Claims (10)
- 透析酸濃縮溶液の調製中に使用し、水、ナトリウム含有濃縮物、および炭酸水素塩含有濃縮物と混合して即時使用可能な透析溶液にするための透析酸前駆体組成物であって、グルコースと、少なくとも1つの乾燥した酸と、少なくとも1つのマグネシウム塩と、任意にカリウム塩およびカルシウム塩とを含む粉末成分からなり、前記グルコースおよび前記少なくとも1つのマグネシウム塩は前記透析酸前駆体組成物中に無水成分として存在し、38℃/90%RHで水蒸気透過率が0.3g/m2/d未満である耐湿性容器中に密封されている透析酸前駆体組成物。
- 前記少なくとも1つの乾燥した酸が、乳酸、クエン酸、グルコン酸、グルコノ−δ−ラクトン、N−アセチルシステインおよびα−リポ酸を含む群から選択される、請求項1に記載の透析酸前駆体組成物。
- 前記透析酸前駆体組成物中の前記少なくとも1つのマグネシウム塩が、無水塩化マグネシウム、グルコン酸マグネシウム、クエン酸マグネシウム、乳酸マグネシウム、およびα−ケトグルタル酸マグネシウムを含む群から選択される、請求項1または請求項2に記載の透析酸前駆体組成物。
- 前記透析酸前駆体組成物中の前記カルシウム塩が、塩化カルシウム二水和物、塩化カルシウム一水和物、無水塩化カルシウム、グルコン酸カルシウム、クエン酸カルシウム、乳酸カルシウム、およびα−ケトグルタル酸カルシウムを含む群から選択される少なくとも1つである、請求項1〜3のいずれか一項に記載の透析酸前駆体組成物。
- 前記耐湿性容器の水蒸気透過率が、38℃/90%RHで0.2g/m2/d未満である、請求項1〜4のいずれか一項に記載の透析酸前駆体組成物。
- 前記耐湿性容器の水蒸気透過率が、38℃/90%RHで0.1g/m2/dを超える、請求項1〜5のいずれか一項に記載の透析酸前駆体組成物。
- 前記耐湿性容器内で所定の体積の水と混合して透析酸濃縮溶液を得るように構成される、請求項1〜6のいずれか一項に記載の透析酸前駆体組成物。
- 水、ナトリウム含有濃縮物、および炭酸水素塩含有濃縮物で希釈して即時使用可能な透析溶液を作製するための透析酸濃縮溶液を提供する方法であって、
(a)グルコースと、少なくとも1つの乾燥した酸と、少なくとも1つのマグネシウム塩と、任意にカリウム塩およびカルシウム塩とを含む透析酸前駆体組成物であって、前記グルコースおよび前記少なくとも1つのマグネシウム塩が前記透析酸前駆体組成物中に無水成分として存在する透析酸前駆体組成物を用意することと、
(b)前記透析酸前駆体組成物を、38℃/90%RHで水蒸気透過率が0.3g/m2/d未満である密封した耐湿性容器で提供することと、
(c)所定の体積の水を前記容器中の前記透析酸前駆体組成物に加えて混合し、それにより、溶液として透析酸濃縮物を得ることと
を含む方法。 - 透析酸濃縮溶液を調製するための、請求項1〜7のいずれか一項に記載の透析酸前駆体組成物の使用。
- 透析溶液、注入溶液、置換溶液、すすぎ溶液、またはプライミング溶液を調製するための、請求項1〜7のいずれか一項に記載の透析酸前駆体組成物の使用。
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PL2585039T3 (pl) | 2018-09-28 |
CA2803458A1 (en) | 2011-12-29 |
WO2011161056A2 (en) | 2011-12-29 |
TR201810427T4 (tr) | 2018-08-27 |
CN102985071A (zh) | 2013-03-20 |
AU2011269109B2 (en) | 2013-11-21 |
US20130189376A1 (en) | 2013-07-25 |
US11253543B2 (en) | 2022-02-22 |
JP2013530972A (ja) | 2013-08-01 |
EP2585039B1 (en) | 2018-04-25 |
EP2585039A2 (en) | 2013-05-01 |
KR101813740B1 (ko) | 2017-12-29 |
BR112012033044A2 (pt) | 2016-12-20 |
AU2011269109A1 (en) | 2013-02-07 |
CN102985071B (zh) | 2014-12-03 |
KR20130121815A (ko) | 2013-11-06 |
US20180050062A1 (en) | 2018-02-22 |
ES2677603T3 (es) | 2018-08-03 |
WO2011161056A3 (en) | 2012-03-01 |
TW201212909A (en) | 2012-04-01 |
TWI583378B (zh) | 2017-05-21 |
CA2803458C (en) | 2018-02-13 |
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