JP7457364B2 - Cleaning agent for dialysis equipment and method for removing calcium scale in dialysis equipment using the same - Google Patents
Cleaning agent for dialysis equipment and method for removing calcium scale in dialysis equipment using the same Download PDFInfo
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- JP7457364B2 JP7457364B2 JP2020157819A JP2020157819A JP7457364B2 JP 7457364 B2 JP7457364 B2 JP 7457364B2 JP 2020157819 A JP2020157819 A JP 2020157819A JP 2020157819 A JP2020157819 A JP 2020157819A JP 7457364 B2 JP7457364 B2 JP 7457364B2
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- 238000000502 dialysis Methods 0.000 title claims description 174
- 239000012459 cleaning agent Substances 0.000 title claims description 163
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 title claims description 18
- 239000011575 calcium Substances 0.000 title claims description 18
- 229910052791 calcium Inorganic materials 0.000 title claims description 18
- 238000000034 method Methods 0.000 title claims description 12
- 239000003002 pH adjusting agent Substances 0.000 claims description 46
- 239000002738 chelating agent Substances 0.000 claims description 44
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 41
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 36
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 13
- 150000003839 salts Chemical class 0.000 claims description 12
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims description 10
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims description 10
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 8
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 8
- 150000001413 amino acids Chemical class 0.000 claims description 7
- 150000001875 compounds Chemical class 0.000 claims description 7
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 6
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 6
- 239000001630 malic acid Substances 0.000 claims description 6
- 235000011090 malic acid Nutrition 0.000 claims description 6
- QPCDCPDFJACHGM-UHFFFAOYSA-N N,N-bis{2-[bis(carboxymethyl)amino]ethyl}glycine Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(=O)O)CCN(CC(O)=O)CC(O)=O QPCDCPDFJACHGM-UHFFFAOYSA-N 0.000 claims description 5
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 claims description 5
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 5
- 229910021529 ammonia Inorganic materials 0.000 claims description 5
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims description 5
- 239000001530 fumaric acid Substances 0.000 claims description 5
- 229960003330 pentetic acid Drugs 0.000 claims description 5
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims description 5
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- 150000007522 mineralic acids Chemical class 0.000 claims description 4
- LNOPIUAQISRISI-UHFFFAOYSA-N n'-hydroxy-2-propan-2-ylsulfonylethanimidamide Chemical compound CC(C)S(=O)(=O)CC(N)=NO LNOPIUAQISRISI-UHFFFAOYSA-N 0.000 claims description 4
- 229910017604 nitric acid Inorganic materials 0.000 claims description 4
- MGFYIUFZLHCRTH-UHFFFAOYSA-N nitrilotriacetic acid Chemical compound OC(=O)CN(CC(O)=O)CC(O)=O MGFYIUFZLHCRTH-UHFFFAOYSA-N 0.000 claims description 4
- 150000007524 organic acids Chemical class 0.000 claims description 4
- 235000005985 organic acids Nutrition 0.000 claims description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims 1
- 239000003513 alkali Substances 0.000 claims 1
- 239000002994 raw material Substances 0.000 description 54
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 44
- 239000000203 mixture Substances 0.000 description 38
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 27
- 229910000019 calcium carbonate Inorganic materials 0.000 description 22
- 239000008213 purified water Substances 0.000 description 20
- 239000003599 detergent Substances 0.000 description 18
- 238000002360 preparation method Methods 0.000 description 18
- 239000007864 aqueous solution Substances 0.000 description 13
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 description 12
- 238000002560 therapeutic procedure Methods 0.000 description 12
- 238000004806 packaging method and process Methods 0.000 description 11
- 239000007788 liquid Substances 0.000 description 9
- 239000002351 wastewater Substances 0.000 description 9
- 238000010790 dilution Methods 0.000 description 8
- 239000012895 dilution Substances 0.000 description 8
- 238000004140 cleaning Methods 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 7
- 239000002699 waste material Substances 0.000 description 7
- 239000005708 Sodium hypochlorite Substances 0.000 description 6
- 239000013078 crystal Substances 0.000 description 6
- SUKJFIGYRHOWBL-UHFFFAOYSA-N sodium hypochlorite Chemical compound [Na+].Cl[O-] SUKJFIGYRHOWBL-UHFFFAOYSA-N 0.000 description 6
- 239000004115 Sodium Silicate Substances 0.000 description 5
- 239000002253 acid Substances 0.000 description 5
- 238000007865 diluting Methods 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 238000006386 neutralization reaction Methods 0.000 description 5
- 235000019645 odor Nutrition 0.000 description 5
- -1 alkanolamines (e.g. Chemical compound 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- 235000019353 potassium silicate Nutrition 0.000 description 4
- 235000019795 sodium metasilicate Nutrition 0.000 description 4
- DZCAZXAJPZCSCU-UHFFFAOYSA-K sodium nitrilotriacetate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CC([O-])=O DZCAZXAJPZCSCU-UHFFFAOYSA-K 0.000 description 4
- 229910052911 sodium silicate Inorganic materials 0.000 description 4
- POWFTOSLLWLEBN-UHFFFAOYSA-N tetrasodium;silicate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-][Si]([O-])([O-])[O-] POWFTOSLLWLEBN-UHFFFAOYSA-N 0.000 description 4
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 230000002378 acidificating effect Effects 0.000 description 3
- 150000007513 acids Chemical class 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 239000000385 dialysis solution Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 229920000137 polyphosphoric acid Polymers 0.000 description 3
- 150000004760 silicates Chemical class 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 description 2
- URDCARMUOSMFFI-UHFFFAOYSA-N 2-[2-[bis(carboxymethyl)amino]ethyl-(2-hydroxyethyl)amino]acetic acid Chemical compound OCCN(CC(O)=O)CCN(CC(O)=O)CC(O)=O URDCARMUOSMFFI-UHFFFAOYSA-N 0.000 description 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 2
- FSVCELGFZIQNCK-UHFFFAOYSA-N N,N-bis(2-hydroxyethyl)glycine Chemical compound OCCN(CCO)CC(O)=O FSVCELGFZIQNCK-UHFFFAOYSA-N 0.000 description 2
- JYXGIOKAKDAARW-UHFFFAOYSA-N N-(2-hydroxyethyl)iminodiacetic acid Chemical compound OCCN(CC(O)=O)CC(O)=O JYXGIOKAKDAARW-UHFFFAOYSA-N 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- YDONNITUKPKTIG-UHFFFAOYSA-N [Nitrilotris(methylene)]trisphosphonic acid Chemical compound OP(O)(=O)CN(CP(O)(O)=O)CP(O)(O)=O YDONNITUKPKTIG-UHFFFAOYSA-N 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- 230000000668 effect on calcium Effects 0.000 description 2
- DEFVIWRASFVYLL-UHFFFAOYSA-N ethylene glycol bis(2-aminoethyl)tetraacetic acid Chemical compound OC(=O)CN(CC(O)=O)CCOCCOCCN(CC(O)=O)CC(O)=O DEFVIWRASFVYLL-UHFFFAOYSA-N 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000012510 hollow fiber Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000003907 kidney function Effects 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000000123 paper Substances 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 2
- 238000005057 refrigeration Methods 0.000 description 2
- 159000000000 sodium salts Chemical class 0.000 description 2
- 229920003002 synthetic resin Polymers 0.000 description 2
- 239000000057 synthetic resin Substances 0.000 description 2
- 238000000108 ultra-filtration Methods 0.000 description 2
- ATRRKUHOCOJYRX-UHFFFAOYSA-N Ammonium bicarbonate Chemical compound [NH4+].OC([O-])=O ATRRKUHOCOJYRX-UHFFFAOYSA-N 0.000 description 1
- 229910000013 Ammonium bicarbonate Inorganic materials 0.000 description 1
- 239000004475 Arginine Substances 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- KXDHJXZQYSOELW-UHFFFAOYSA-N Carbamic acid Chemical class NC(O)=O KXDHJXZQYSOELW-UHFFFAOYSA-N 0.000 description 1
- DBVJJBKOTRCVKF-UHFFFAOYSA-N Etidronic acid Chemical compound OP(=O)(O)C(O)(C)P(O)(O)=O DBVJJBKOTRCVKF-UHFFFAOYSA-N 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- URWIWRCHIPAGBL-UHFFFAOYSA-N OCC1OP(=O)OP(=O)O1 Chemical compound OCC1OP(=O)OP(=O)O1 URWIWRCHIPAGBL-UHFFFAOYSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 1
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- 235000012538 ammonium bicarbonate Nutrition 0.000 description 1
- 239000001099 ammonium carbonate Substances 0.000 description 1
- 235000019270 ammonium chloride Nutrition 0.000 description 1
- 150000003863 ammonium salts Chemical class 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- GPRLSGONYQIRFK-UHFFFAOYSA-N hydron Chemical compound [H+] GPRLSGONYQIRFK-UHFFFAOYSA-N 0.000 description 1
- 238000005342 ion exchange Methods 0.000 description 1
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 238000005192 partition Methods 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 150000003009 phosphonic acids Chemical class 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000001902 propagating effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000001223 reverse osmosis Methods 0.000 description 1
- 239000010865 sewage Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- FDDDEECHVMSUSB-UHFFFAOYSA-N sulfanilamide Chemical compound NC1=CC=C(S(N)(=O)=O)C=C1 FDDDEECHVMSUSB-UHFFFAOYSA-N 0.000 description 1
- 229940124530 sulfonamide Drugs 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
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- Detergent Compositions (AREA)
Description
本発明は、透析機器用洗浄剤およびそれを用いた透析機器内のカルシウムスケールの除去方法に関し、より詳細には、透析機器内に沈着したカルシウムスケールを効率的に除去し得る透析機器用洗浄剤およびそれを用いた透析機器内のカルシウムスケールの除去方法に関する。 The present invention relates to a cleaning agent for dialysis equipment and a method for removing calcium scale in dialysis equipment using the same, and more specifically, a cleaning agent for dialysis equipment that can efficiently remove calcium scale deposited in dialysis equipment. and a method for removing calcium scale in dialysis equipment using the same.
透析療法は、腎機能の低下に伴って当該機能の一部を人工的に行う治療法である。透析療法では、患者の血管を血液回路に接続し、患者から採取した血液と透析液が透析機器接続の中空糸を介して限外濾過および拡散作用を行い、その後血液を患者の体内に戻すことによって行われる。 Dialysis therapy is a treatment method that artificially performs a portion of kidney function as the kidney function declines. In dialysis therapy, a patient's blood vessels are connected to a blood circuit, and the blood and dialysate collected from the patient undergo ultrafiltration and diffusion through hollow fibers connected to the dialysis machine, and then the blood is returned to the patient's body. carried out by.
この透析療法において、透析機器および透析液の送液チューブ等には、透析液中に含まれているカルシウム成分（例えば炭酸カルシウム）がスケールとなって沈着することがある。沈着したカルシウムスケールは、そのまま放置すると当該スケールを媒介して細菌が増殖する、透析機器自体が劣化して機器性能を低下させる等の問題を引き起こすことがある。このため、透析機器を使用する現場では、適宜カルシウムスケールを除去するための洗浄作業が行われている。 In this dialysis therapy, calcium components (for example, calcium carbonate) contained in the dialysate may deposit in the form of scale on the dialysis equipment, the dialysate delivery tube, and the like. If the deposited calcium scale is left as it is, it may cause problems such as bacteria propagating through the scale, deterioration of the dialysis equipment itself, and deterioration of equipment performance. For this reason, at sites where dialysis equipment is used, cleaning work is carried out to remove calcium scale as appropriate.
透析機器の洗浄には強酸、酢酸を含む酸性の洗浄剤や、次亜塩素酸ナトリウムを含む洗浄剤が使用されてきた。特に沈着したカルシウムスケールの除去には、従来、強酸や酢酸を含む透析機器用洗浄剤が使用されてきた。 Acidic cleaning agents containing strong acids, acetic acid, and cleaning agents containing sodium hypochlorite have been used to clean dialysis equipment. In particular, cleaning agents for dialysis equipment containing strong acids or acetic acid have been used to remove deposited calcium scale.
しかし、このような透析機器用洗浄剤は、洗浄後の排液の取扱いが煩雑である点が指摘されていた。当該このような排液は、強酸性または強アルカリ性のｐＨを有する。このため排液の処分には、所定の中和処理が必要である。特に透析療法を行う小規模施設では、当該処置および回収が作業的または経済的な負担を強いるものであった。一方、酢酸を含む透析機器用洗浄剤は、その強い刺激臭が作業者を不快にさせる点で敬遠される傾向にあった。 However, it has been pointed out that such cleaning agents for dialysis equipment require complicated handling of the waste fluid after cleaning. Such effluent has a strongly acidic or alkaline pH. Therefore, a predetermined neutralization process is required to dispose of the waste liquid. Particularly in small-scale facilities that perform dialysis therapy, the treatment and recovery impose an operational or economic burden. On the other hand, cleaning agents for dialysis equipment containing acetic acid have tended to be avoided because their strong irritating odor makes workers uncomfortable.
これに対し、酢酸を含む透析機器用洗浄剤に代えて、例えば、アルカリ剤とケイ酸塩とキレート剤とを含む水溶形態に調製された透析機器用洗浄剤（特許文献１）が知られている。特許文献１に記載の透析機器用洗浄剤は、酢酸のような不快な刺激臭が無いことに加え、次亜塩素酸ナトリウムを用いることもなく殺菌の効果も期待することができる。しかし、特許文献１に記載の洗浄剤は、ｐＨが１３付近と比較的高いアルカリ性を有し、依然として、透析療法を行う小規模施設には、排液の処理の点で過度な負担を強いるものであった。 In response to this, instead of dialysis equipment cleaning agents containing acetic acid, for example, a dialysis equipment cleaning agent prepared in a water-soluble form containing an alkaline agent, a silicate, and a chelating agent (Patent Document 1) is known. The dialysis equipment cleaning agent described in Patent Document 1 does not have an unpleasant irritating odor like acetic acid, and can be expected to have a sterilizing effect without using sodium hypochlorite. However, the cleaning agent described in Patent Document 1 has a relatively high alkalinity of about pH 13, and still places an excessive burden on small-scale facilities that perform dialysis therapy in terms of treating wastewater.
本発明は、上記問題の解決を課題とするものであり、その目的とするところは、酢酸のような不快な刺激臭が無く、かつ必ずしも排液の中和処理を必要としない透析機器用洗浄剤およびそれを用いた透析機器内のカルシウムスケールの除去方法を提供することにある。 The present invention aims to solve the above problems, and its purpose is to provide a cleaning method for dialysis equipment that does not have unpleasant irritating odors like acetic acid and does not necessarily require neutralization treatment of wastewater. An object of the present invention is to provide an agent and a method for removing calcium scale in dialysis equipment using the same.
本発明は、キレート剤、ｐＨ調整剤、および水を水溶液の形態で含有する、透析機器用洗浄剤であって、
該ｐＨ調整剤が、クエン酸、リンゴ酸、コハク酸、フマル酸、スルファミン酸、リン酸、塩酸、硫酸、硝酸、アンモニア、アルカノールアミン、無機アルカリ、および塩基性アミノ酸、ならびにそれらの塩からなる群から選択される少なくとも１種の化合物であり、そしてｐＨが４．８～９．２である、透析機器用洗浄剤である。
The present invention relates to a cleaning agent for dialysis equipment, comprising a chelating agent, a pH adjuster, and water in the form of an aqueous solution,
The dialysis equipment cleaner is one in which the pH adjuster is at least one compound selected from the group consisting of citric acid, malic acid, succinic acid, fumaric acid, sulfamic acid, phosphoric acid, hydrochloric acid, sulfuric acid, nitric acid, ammonia, alkanolamines, inorganic alkalis, and basic amino acids, and salts thereof, and has a pH of 4.8 to 9.2.
１つの実施形態では、上記キレート剤は、エチレンジアミン四酢酸およびニトリロ三酢酸、ならびにそれらの塩からなる群から選択される少なくとも１種の化合物である。 In one embodiment, the chelating agent is at least one compound selected from the group consisting of ethylenediaminetetraacetic acid and nitrilotriacetic acid, and salts thereof.
１つの実施形態では、本発明の透析機器用洗浄剤は酢酸を含有しない。 In one embodiment, the cleaning agent for dialysis equipment of the present invention does not contain acetic acid.
本発明はまた、上記透析機器用洗浄剤を調製するための洗浄剤原料組成物であって、
１質量部～４０質量部のキレート剤と、０．０１質量部～２０質量部のｐＨ調整剤とを含有し、そして
該ｐＨ調整剤が、クエン酸、リンゴ酸、コハク酸、フマル酸、スルファミン酸、リン酸、塩酸、硫酸、硝酸、アンモニア、アルカノールアミン、無機アルカリ、および塩基性アミノ酸、ならびにそれらの塩からなる群から選択される少なくとも１種の化合物である、洗浄剤原料組成物である。
The present invention also provides a cleaning agent raw material composition for preparing the cleaning agent for dialysis equipment, comprising:
Contains 1 part by mass to 40 parts by mass of a chelating agent and 0.01 part by mass to 20 parts by mass of a pH adjuster, and the pH adjuster is citric acid, malic acid, succinic acid, fumaric acid, sulfamine. A cleaning agent raw material composition which is at least one compound selected from the group consisting of acids, phosphoric acid, hydrochloric acid, sulfuric acid, nitric acid, ammonia, alkanolamines, inorganic alkalis, basic amino acids, and salts thereof. .
本発明はまた、上記透析機器用洗浄剤を調製するための洗浄剤原料キットであって、１質量部～４０質量部のキレート剤と、０．０１質量部～２０質量部のｐＨ調整剤とを別々に分離して含有し、そして該ｐＨ調整剤が、クエン酸、リンゴ酸、コハク酸、フマル酸、スルファミン酸、リン酸、塩酸、硫酸、硝酸、アンモニア、アルカノールアミン、無機アルカリ、および塩基性アミノ酸、ならびにそれらの塩からなる群から選択される少なくとも１種の化合物である、キットである。 The present invention also provides a cleaning agent raw material kit for preparing the cleaning agent for dialysis equipment, which comprises 1 part by mass to 40 parts by mass of a chelating agent, and 0.01 part by mass to 20 parts by mass of a pH adjusting agent. citric acid, malic acid, succinic acid, fumaric acid, sulfamic acid, phosphoric acid, hydrochloric acid, sulfuric acid, nitric acid, ammonia, alkanolamines, inorganic alkalis, and bases. The kit contains at least one compound selected from the group consisting of amino acids and salts thereof.
本発明はまた、透析機器内に沈着したカルシウムスケールを除去するための方法であって、透析機器の送液チューブから、上記透析機器用洗浄剤を供給する工程を包含する、方法である。 The present invention also provides a method for removing calcium scale deposited in a dialysis machine, which includes the step of supplying the dialysis machine cleaning agent from a liquid feeding tube of the dialysis machine.
本発明によれば、酢酸のような不快な刺激臭を感じることなく、透析機器の洗浄を行うことができる。さらに、本発明によれば、排液の中和処理を必要とすることなく、そのまま下水道に流すことができる。これにより、本発明の透析機器用洗浄剤は、透析療法を行う施設の規模に関わらず広く使用することができる。こうした利点は、透析療法を行う小規模施設の設立を助け、過疎地、遠隔地などを含むより広範なエリアへの透析療法の普及にも貢献することができる。 According to the present invention, dialysis equipment can be cleaned without feeling unpleasant irritating odors such as acetic acid. Furthermore, according to the present invention, the wastewater can be directly discharged into the sewer system without requiring neutralization treatment. Thereby, the cleaning agent for dialysis equipment of the present invention can be widely used regardless of the scale of the facility where dialysis therapy is performed. These advantages can help establish small-scale facilities for dialysis therapy and contribute to the spread of dialysis therapy to wider areas, including depopulated and remote areas.
以下、本発明について詳述する。 The present invention will be explained in detail below.
（透析機器用洗浄剤）
本発明の透析機器用洗浄剤は、キレート剤、ｐＨ調整剤、および水を水溶液の形態で含有する。
(Cleaning agent for dialysis equipment)
The cleaning agent for dialysis equipment of the present invention contains a chelating agent, a pH adjusting agent, and water in the form of an aqueous solution.
本明細書中に用いられる「透析機器」は、透析療法に使用される人工透析装置およびその周辺機器（例えば透析液の送液チューブ）を包含する。このような透析機器は、例えば透析液を至適送液させ、患者から採取した血液と中空糸を介して接触させることにより用いられる。この時、送液される透析液中に含まれる金属イオン(例えば炭酸カルシウム）が、スケール（例えばカルシウムスケール）となって沈着することがある。本発明の透析機器用洗浄剤は、こうした透析装置内に沈着したスケールの除去を行うために使用される。 As used herein, the term "dialysis equipment" includes artificial dialysis devices used in dialysis therapy and their peripheral equipment (e.g., dialysis fluid delivery tubes). Such dialysis equipment is used, for example, by optimally delivering dialysis fluid and bringing it into contact with blood collected from a patient via hollow fibers. At this time, metal ions (e.g., calcium carbonate) contained in the delivered dialysis fluid may deposit as scale (e.g., calcium scale). The dialysis equipment cleaning agent of the present invention is used to remove such scale deposited in the dialysis equipment.
本発明の透析機器用洗浄剤を構成するキレート剤は、炭酸カルシウムなどのカルシウムスケールに対してキレート効果を発揮する好ましくは有機系の化合物である。有機系キレート剤の例としては、アミノカルボン酸塩が挙げられ、具体的な例としては、エチレンジアミン四酢酸（ＥＤＴＡ）、ニトリロ三酢酸（ＮＴＡ）、ジエチレントリアミン五酢酸（ＤＴＰＡ）、ヒドロキシエチルエチレンジアミン三酢酸（ＨＥＤＴＡ）、グリコールエーテルジアミン四酢酸（ＧＥＤＴＡ）、トリエチレンテトラミン六酢酸（ＴＴＨＡ）、ヒドロキシエチルイミノ二酢酸（ＨＩＤＡ）、ジヒドロキシエチルグリシン（ＤＨＥＧ）、ならびに、有機ホスホン酸、即ち、ヒドロキシエチリデンジホスホン酸（ＨＥＤＰ）、ニトリロトリス（メチレンホスホン酸）（ＮＴＭＰ）、およびそれらの中和塩（例えば、ナトリウム塩、カリウム塩）、ならびにそれらの組み合わせなどが挙げられる。カルシウムスケールに対するキレート効果に優れており、かつ入手が容易であるとの理由から、エチレンジアミン四酢酸（ＥＤＴＡ）、ニトリロ三酢酸（ＮＴＡ）、ジエチレントリアミン五酢酸（ＤＴＰＡ）、およびそれらの中和塩（例えば、ナトリウム塩、カリウム塩）、ならびにそれらの組み合わせが好ましい。カルシウムスケールに対するキレート効果が高く、かつ入手が容易であるとの理由から、エチレンジアミン四酢酸ナトリウムおよびニトリロ三酢酸ナトリウム、ならびにそれらの組み合わせがさらに好ましい。 The chelating agent constituting the cleaning agent for dialysis equipment of the present invention is preferably an organic compound that exhibits a chelating effect on calcium scale, such as calcium carbonate. Examples of organic chelating agents include aminocarboxylic acid salts, and specific examples include ethylenediaminetetraacetic acid (EDTA), nitrilotriacetic acid (NTA), diethylenetriaminepentaacetic acid (DTPA), and hydroxyethylethylenediaminetriacetic acid. (HEDTA), glycol ether diamine tetraacetic acid (GEDTA), triethylenetetraminehexaacetic acid (TTHA), hydroxyethyliminodiacetic acid (HIDA), dihydroxyethylglycine (DHEG), and organic phosphonic acids, i.e., hydroxyethylidene diphosphonate. (HEDP), nitrilotris(methylenephosphonic acid) (NTMP), and neutralized salts thereof (eg, sodium salt, potassium salt), and combinations thereof. Ethylenediaminetetraacetic acid (EDTA), nitrilotriacetic acid (NTA), diethylenetriaminepentaacetic acid (DTPA), and their neutralized salts (e.g. , sodium salt, potassium salt), as well as combinations thereof. More preferred are sodium ethylenediaminetetraacetate and sodium nitrilotriacetate, and combinations thereof, because they have a high chelating effect on calcium scale and are easily available.
キレート剤は、必ずしも限定されないが、使用直前の透析機器用洗浄剤の全体質量を基準として、好ましくは０．１質量％～４０質量％、より好ましくは０．５質量％～４０質量％の濃度で本発明の透析機器用洗浄剤内に含有されている。キレート剤の含有量が０．１質量％を下回ると、得られる洗浄剤中のキレート剤の絶対量が少なすぎるため、透析機器内のカルシウムスケールを効率よく除去することが困難となる場合がある。キレート剤の含有量が４０質量％を上回ると、多くのキレート剤を使用する点で生産コストを増大させる場合がある。 The chelating agent is not necessarily limited, but is preferably contained in the dialysis equipment cleaning agent of the present invention at a concentration of 0.1% to 40% by mass, more preferably 0.5% to 40% by mass, based on the total mass of the dialysis equipment cleaning agent immediately before use. If the chelating agent content is less than 0.1% by mass, the absolute amount of the chelating agent in the resulting cleaning agent is too small, making it difficult to efficiently remove calcium scale from within the dialysis equipment. If the chelating agent content is more than 40% by mass, production costs may increase due to the need to use a large amount of chelating agent.
ｐＨ調整剤は、透析機器用洗浄剤のｐＨを最終的に後述するような中性付近の領域に保持し、排液とする場合において下水道の排水基準（例えば、ｐＨ５～９）を満たす役割を果たす。 The pH adjuster plays the role of ultimately maintaining the pH of the dialysis equipment cleaning agent in a near-neutral region as described below, and meeting sewer drainage standards (for example, pH 5 to 9) when it is discharged. Fulfill.
本発明の透析機器用洗浄剤を構成するｐＨ調整剤の例としては、有機酸およびその塩、無機酸およびその塩、アルカリ、塩基性アミノ酸などが挙げられる。有機酸の例としては、クエン酸、リンゴ酸、スルファミン酸、コハク酸、およびフマル酸、ならびにそれらの組み合わせが挙げられる。無機酸の例としては、リン酸、塩酸、硫酸、および硝酸、ならびにそれらに組み合わせが挙げられる。アルカリの例としては、アンモニア、アルカノールアミン（例えば、モノエタノールアミン、ジエタノールアミン、トリエタノールアミン）、アンモニウム塩（例えば、塩化アンモニウム、重炭酸アンモニウム）、および無機アルカリ（例えば、水酸化ナトリウム、水酸化カリウム）、ならびにそれらの組み合わせが挙げられる。塩基性アミノ酸の例としては、アルギニン、リシン、トリプトファン、ならびにそれらの組み合わせが挙げられる。本発明において、ｐＨ調整剤は、上記キレート剤に対して酸性の調整が可能であるという理由から、有機酸および無機酸が好ましく、特に安価で入手が容易でありかつ安全性に優れているという理由から、クエン酸がより好ましい。 Examples of the pH adjusting agent constituting the cleaning agent for dialysis equipment of the present invention include organic acids and salts thereof, inorganic acids and salts thereof, alkalis, basic amino acids, and the like. Examples of organic acids include citric acid, malic acid, sulfamic acid, succinic acid, and fumaric acid, and combinations thereof. Examples of inorganic acids include phosphoric, hydrochloric, sulfuric, and nitric acids, and combinations thereof. Examples of alkalis include ammonia, alkanolamines (e.g., monoethanolamine, diethanolamine, triethanolamine), ammonium salts (e.g., ammonium chloride, ammonium bicarbonate), and inorganic alkalis (e.g., sodium hydroxide, potassium hydroxide). ), as well as combinations thereof. Examples of basic amino acids include arginine, lysine, tryptophan, and combinations thereof. In the present invention, the pH adjusting agent is preferably an organic acid or an inorganic acid because it is possible to adjust the acidity with respect to the above-mentioned chelating agent, and is particularly inexpensive, easy to obtain, and excellent in safety. Citric acid is more preferred for reasons.
ｐＨ調整剤は、必ずしも限定されないが、使用直前の透析機器用洗浄剤の全体質量を基準として、好ましくは０．０１質量％～２０質量％、より好ましくは０．０３質量％～０．５質量％の濃度で本発明の透析機器用洗浄剤内に含有されている。ｐＨ調整剤の含有量が０．０１質量％を下回ると、得られる洗浄剤中のｐＨが強酸性または強アルカリ性となり、中性領域を保持することが困難となる場合がある。ｐＨ調整剤の含有量が２０質量％を上回ると、得られる洗浄剤のｐＨに大きな変動を与えることなく、むしろ多くのｐＨ調整剤を使用する点で生産コストを増大させる場合がある。 The pH adjuster is not necessarily limited, but is preferably 0.01% by mass to 20% by mass, more preferably 0.03% by mass to 0.5% by mass, based on the total mass of the cleaning agent for dialysis equipment immediately before use. % in the dialysis equipment cleaning agent of the present invention. When the content of the pH adjuster is less than 0.01% by mass, the pH of the resulting cleaning agent becomes strongly acidic or strongly alkaline, and it may be difficult to maintain the pH in the neutral range. When the content of the pH adjuster exceeds 20% by mass, the pH of the resulting cleaning agent does not change significantly, but the production cost may increase due to the use of a large amount of the pH adjuster.
なお、本発明の透析機器用洗浄剤は、使用中の作業者に対して不快な臭気を与えることを回避するために、酢酸を含有しないことが好ましい。 Note that it is preferable that the cleaning agent for dialysis equipment of the present invention does not contain acetic acid in order to avoid imparting an unpleasant odor to the operator during use.
本発明の透析機器用洗浄剤は、上記キレート剤およびｐＨ調整剤以外の他の成分を含有していてもよい。他の成分の例としては、セスキケイ酸ナトリウム、メタケイ酸ナトリウム、水ガラス、オルソケイ酸ナトリウムなどのケイ酸塩；およびポリリン酸；が挙げられる。本発明の透析機器用洗浄剤において、他の成分の含有量は特に限定されず、本発明の効果を損なわない程度の量が当業者によって適宜選択され得る。 The cleaning agent for dialysis equipment of the present invention may contain components other than the above-mentioned chelating agent and pH adjusting agent. Examples of other ingredients include silicates such as sodium sesquisilicate, sodium metasilicate, water glass, sodium orthosilicate; and polyphosphoric acid. In the dialysis equipment cleaning agent of the present invention, the content of other components is not particularly limited, and can be appropriately selected by those skilled in the art to an extent that does not impair the effects of the present invention.
本発明の透析機器用洗浄剤を構成する水は、常水をイオン交換、蒸留、逆浸透、限外濾過の単独またはそれらの組み合わせにより得られた精製水であることが好ましい。本発明の透析機器用洗浄剤は、上記キレート剤およびｐＨ調整剤が当該水に溶解され、水溶液の形態を有する。この水溶液のｐＨ（すなわち、本発明の透析機器用洗浄剤のｐＨ）は４．８～９．２、好ましくは５．０～９．０、より好ましくは６．１～８．８である。当該ｐＨがこのような範囲に調整されていることにより、本発明の透析機器用洗浄剤は、使用後（すなわち、透析機器内のカルシウムスケールの除去のために使用された後）のｐＨが高すぎたりまたは低すぎたりすることがなく、排液を別途処置や回収する作業を行うことなく、例えば下水道を通じてそのまま排水することが可能となる。 The water constituting the cleaning agent for dialysis equipment of the present invention is preferably purified water obtained by subjecting ordinary water to ion exchange, distillation, reverse osmosis, and ultrafiltration alone or in combination. The cleaning agent for dialysis equipment of the present invention has the form of an aqueous solution in which the chelating agent and pH adjusting agent are dissolved in the water. The pH of this aqueous solution (ie, the pH of the dialysis equipment cleaning agent of the present invention) is 4.8 to 9.2, preferably 5.0 to 9.0, more preferably 6.1 to 8.8. By adjusting the pH to such a range, the dialysis equipment cleaning agent of the present invention has a high pH after use (that is, after being used to remove calcium scale within the dialysis equipment). It is neither too high nor too low, and the waste liquid can be directly drained away, for example through a sewer system, without any separate treatment or collection work.
ここで、環境省による一律排水基準によれば、海域以外の公共用水域に排出されるものの水素イオン濃度（ｐＨ）で、５．８以上８．６以下が、そして海域に排出されるもののｐＨは５．０以上９．０以下が許容限度と定められている。本発明の透析機器用洗浄剤は、透析機器への洗浄を行うことにより、このような許容限度のｐＨを満足することになる。このため、使用後の排液について、中和や希釈の追加操作や専門業者による排液回収を必要とすることなく、そのまま下水道に流すことも可能である。この点において、当該追加操作や排液保管のための場所の確保が不要となり、施設の大小規模に関わらず、透析療法を積極的に採用することができる。 According to the uniform wastewater standards set by the Ministry of the Environment, the allowable limit for the hydrogen ion concentration (pH) of wastewater discharged into public waters other than the sea is 5.8 to 8.6, and for wastewater discharged into the sea is 5.0 to 9.0. The dialysis equipment cleaning agent of the present invention satisfies these allowable pH limits when used to clean dialysis equipment. Therefore, the wastewater after use can be directly discharged into the sewer without the need for additional neutralization or dilution operations or wastewater collection by a specialist company. In this respect, there is no need to secure a place for such additional operations or wastewater storage, and dialysis therapy can be actively adopted regardless of the size of the facility.
（透析機器用洗浄剤を調製するための洗浄剤原料組成物）
上記透析機器用洗浄剤は、例えば、当該透析機器用洗浄剤を調製するための洗浄剤原料組成物（以下、単に「洗浄剤原料組成物」ということがある）を用いて作製することができる。
(Cleaning agent raw material composition for preparing a cleaning agent for dialysis equipment)
The above-mentioned cleaning agent for dialysis equipment can be produced, for example, using a cleaning agent raw material composition (hereinafter sometimes simply referred to as “cleaning agent raw material composition”) for preparing the cleaning agent for dialysis equipment. .
本発明の洗浄剤原料組成物は、水（好ましくは精製水）による希釈を通じて、上記透析機器用洗浄剤を調製することができる固体または液体の組成物である。 The detergent raw material composition of the present invention is a solid or liquid composition that can be used to prepare the above-mentioned detergent for dialysis equipment through dilution with water (preferably purified water).
本発明の洗浄剤原料組成物は上記キレート剤およびｐＨ調整剤を含有する。 The cleaning agent raw material composition of the present invention contains the above-mentioned chelating agent and pH adjuster.
本発明の洗浄剤原料組成物において、キレート剤およびｐＨ調整剤の含有量の組み合わせは、必ずしも限定されないが、例えば１質量部～４０質量部、好ましくは２質量部～３０質量部のキレート剤に対し、例えば０．０１質量部～２０質量部、好ましくは０．０３質量部～５質量部のｐＨ調整剤が組み合わされる。キレート剤およびｐＨ調整剤がこのような含有量の範囲で組み合わせされていることにより、本発明の洗浄剤原料組成物は、所定量の水の添加のみによって、上記透析機器用洗浄剤を簡便に調製することができる。 In the cleaning agent raw material composition of the present invention, the combination of contents of the chelating agent and the pH adjusting agent is not necessarily limited, but for example, the content of the chelating agent is 1 part by mass to 40 parts by mass, preferably 2 parts by mass to 30 parts by mass. On the other hand, for example, 0.01 parts by mass to 20 parts by mass, preferably 0.03 parts by mass to 5 parts by mass of a pH adjuster is combined. By combining the chelating agent and the pH adjusting agent in such a content range, the cleaning agent raw material composition of the present invention can easily be used as the cleaning agent for dialysis equipment simply by adding a predetermined amount of water. It can be prepared.
本発明の洗浄剤原料組成物は、上記キレート剤およびｐＨ調整剤以外の他の成分を含有していてもよい。他の成分の例としては、セスキケイ酸ナトリウム、メタケイ酸ナトリウム、水ガラス、オルソケイ酸ナトリウムなどのケイ酸塩；およびポリリン酸；が挙げられる。本発明の洗浄剤原料組成物において、他の成分の含有量は特に限定されず、上記透析機器用洗浄剤の効果を損なわない程度の量が当業者によって適宜選択され得る。 The detergent raw material composition of the present invention may contain other components in addition to the above chelating agent and pH adjuster. Examples of other components include silicates such as sodium sesquisilicate, sodium metasilicate, water glass, and sodium orthosilicate; and polyphosphoric acid. In the detergent raw material composition of the present invention, the content of other components is not particularly limited, and a person skilled in the art can appropriately select an amount that does not impair the effect of the above dialysis equipment detergent.
本発明の洗浄剤原料組成物はまた、記透析機器用洗浄剤の調製の際に、キレート剤およびｐＨ調整剤、ならびに必要に応じて添加される他の成分が早期に均一に溶解した状態とするために、所定量の水（例えば、精製水）を含有し、これらの成分が予め均一に溶解した原液としての形態を有していてもよい。 The cleaning agent raw material composition of the present invention also allows the chelating agent, pH adjuster, and other components added as necessary to be uniformly dissolved at an early stage during the preparation of the cleaning agent for dialysis equipment. In order to do this, the solution may contain a predetermined amount of water (for example, purified water) and may be in the form of a stock solution in which these components are uniformly dissolved in advance.
本発明の洗浄剤原料組成物は、上記透析機器用洗浄剤の構成成分の１つである水を用いて所望のｐＨになるまで希釈され、透析機器用洗浄剤が作製される。この点で、当該洗浄剤原料組成物は、透析機器用洗浄剤と比較して比較的コンパクトな容量に抑えることができる。これにより、製造元または販売元から使用先（透析療法を行う施設）までの輸送効率を高めることができ、製造後および購入後の保管場所についても省スペースとすることができる。 The cleaning agent raw material composition of the present invention is diluted with water, which is one of the components of the cleaning agent for dialysis equipment, until it reaches a desired pH, thereby producing a cleaning agent for dialysis equipment. In this respect, the cleaning agent raw material composition can be kept in a relatively compact volume compared to a cleaning agent for dialysis equipment. As a result, it is possible to increase the efficiency of transportation from the manufacturer or seller to the place of use (facility where dialysis therapy is performed), and it is also possible to save space in storage locations after manufacture and purchase.
本発明の洗浄剤原料組成物は、必ずしも限定されないが、透明容器または必要に応じて遮光された容器中に収容され、例えば常温（１５℃～２５℃）にて保管される。 The cleaning agent raw material composition of the present invention is stored in, but not necessarily limited to, a transparent container or a light-shielded container if necessary, and stored, for example, at room temperature (15° C. to 25° C.).
その後、使用の際は、所定量の洗浄剤原料組成物が水（例えば、精製水）で希釈される。本発明の洗浄剤原料組成物から、上記透析機器用洗浄剤を得る際の水の希釈割合は、全体質量を基準として、好ましくは２５倍～２００倍、より好ましくは２５倍～１００倍である。希釈により得られた透析機器用洗浄剤は、後述のように透析機器内の洗浄のために直ちに使用されてもよく、あるいは使用まで、例えば暗所かつ冷蔵下にて保管されてもよい。 Thereafter, for use, a predetermined amount of the cleaning agent raw material composition is diluted with water (eg, purified water). The dilution ratio of water when obtaining the above cleaning agent for dialysis equipment from the cleaning agent raw material composition of the present invention is preferably 25 times to 200 times, more preferably 25 times to 100 times, based on the total mass. . The dialysis equipment cleaning agent obtained by dilution may be used immediately for cleaning inside the dialysis equipment as described below, or may be stored, for example, in the dark and under refrigeration, until use.
（透析機器用洗浄剤を調製するための洗浄剤原料キット）
あるいは、上記透析機器用洗浄剤は、例えば、当該透析機器用洗浄剤を調製するための洗浄剤原料キット（以下、単に「洗浄剤原料キット」ということがある）を用いて作製することができる。
(Cleaning agent raw material kit for preparing cleaning agent for dialysis equipment)
Alternatively, the dialysis equipment cleaner can be prepared, for example, by using a cleaner raw material kit for preparing the dialysis equipment cleaner (hereinafter, sometimes simply referred to as a "cleaner raw material kit").
本発明の洗浄剤原料キットは、当該キットの構成成分と、希釈のための水（好ましくは精製水）とを混合して、上記透析機器用洗浄剤を調製することができる。 In the cleaning agent raw material kit of the present invention, the cleaning agent for dialysis equipment can be prepared by mixing the constituent components of the kit with water for dilution (preferably purified water).
本発明の洗浄剤原料キットは上記キレート剤およびｐＨ調整剤を別々に分離して含有する。ここで、用語「別々に分離して含有する」とは、本発明の洗浄剤原料キットにおいてキレート剤とｐＨ調整剤とが予め分離された状態（すなわち、それらが混合されていない状態）で存在していることを示し、例えば、複数の包装容器（例えば、合成樹脂、紙、金属、またはガラス製の瓶、袋、箱、その他の成形体）内に各々が独立して収容されている状態、ならびに単一の包装容器（例えば、合成樹脂、紙、またはガラス製の瓶、袋、箱、その他の成形体）内で、例えば仕切り、隔壁等を介して完全に区分されて各々が独立して収容されている状態を包含する。 The detergent raw material kit of the present invention contains the chelating agent and pH adjuster separately. Here, the term "contained separately" means that the chelating agent and pH adjuster are present in a pre-separated state (i.e., not mixed) in the detergent raw material kit of the present invention, and includes, for example, a state in which each is contained independently in multiple packaging containers (e.g., bottles, bags, boxes, and other molded bodies made of synthetic resin, paper, metal, or glass), as well as a state in which each is contained independently in a single packaging container (e.g., bottles, bags, boxes, and other molded bodies made of synthetic resin, paper, or glass), completely separated, for example, by a partition, dividing wall, or the like.
本発明の洗浄剤原料キットにおいて、キレート剤およびｐＨ調整剤の含有量は、必ずしも限定されないが、例えば１質量部～４０質量部、好ましくは２質量部～３０質量部のキレート剤に対し、例えば０．０１質量部～２０質量部、好ましくは０．０３質量部～５質量部のｐＨ調整剤が組み合わされる。キレート剤およびｐＨ調整剤がこのような含有量の範囲で組み合わせされていることにより、本発明の洗浄剤原料キットは、当該構成成分（キレート剤およびｐＨ調整剤）と所定量の水との混合によって、上記透析機器用洗浄剤を簡便に調製することができる。 In the cleaning agent raw material kit of the present invention, the content of the chelating agent and the pH adjusting agent is not necessarily limited, but for example, the content of the chelating agent is 1 part by mass to 40 parts by mass, preferably 2 parts by mass to 30 parts by mass, for example. From 0.01 parts by weight to 20 parts by weight, preferably from 0.03 parts by weight to 5 parts by weight, of pH adjuster is combined. By combining the chelating agent and the pH adjusting agent in such a content range, the cleaning agent raw material kit of the present invention can be prepared by mixing the constituent components (the chelating agent and the pH adjusting agent) with a predetermined amount of water. Accordingly, the above-mentioned cleaning agent for dialysis equipment can be easily prepared.
本発明の洗浄剤原料キットは、上記キレート剤およびｐＨ調整剤以外の他の成分を含有していてもよい。他の成分の例としては、セスキケイ酸ナトリウム、メタケイ酸ナトリウム、水ガラス、オルソケイ酸ナトリウムなどのケイ酸塩；およびポリリン酸；が挙げられる。本発明の洗浄剤原料キットにおいて、他の成分の含有量は特に限定されず、上記透析機器用洗浄剤の効果を損なわない程度の量が当業者によって適宜選択され得る。 The cleaning agent raw material kit of the present invention may contain components other than the above-mentioned chelating agent and pH adjuster. Examples of other ingredients include silicates such as sodium sesquisilicate, sodium metasilicate, water glass, sodium orthosilicate; and polyphosphoric acid. In the cleaning agent raw material kit of the present invention, the contents of other components are not particularly limited, and can be appropriately selected by those skilled in the art to an extent that does not impair the effectiveness of the cleaning agent for dialysis equipment.
当該他の成分は、上記キレート剤またはｐＨ調整剤のいずれかを収容する包装容器に一緒に混合されていてもよく、上記キレート剤を収容する包装容器およびｐＨ調整剤を収容する包装容器のそれぞれに一緒に混合されていてもよく、上記キレート剤およびｐＨ調整剤を収容する各包装容器とは別の包装容器に収容されていてもよい。 The other components may be mixed together in a packaging container containing either the chelating agent or the pH adjusting agent, and each of the packaging containers containing the chelating agent and the pH adjusting agent. The chelating agent and the pH adjusting agent may be mixed together, or may be housed in a packaging container separate from the packaging containers containing the above-mentioned chelating agent and pH adjuster.
さらに、本発明の洗浄剤原料キットでは、透析機器用洗浄剤を調製するために必要とされる、希釈のための水（好ましくは精製水）もまた構成成分として含有していてもよい。 Furthermore, the cleaning agent raw material kit of the present invention may also contain water (preferably purified water) for dilution, which is required for preparing a cleaning agent for dialysis equipment, as a component.
当該水は、上記キレート剤またはｐＨ調整剤のいずれかを収容する包装容器に一緒に混合されていてもよく、上記キレート剤を収容する包装容器およびｐＨ調整剤を収容する包装容器のそれぞれに一緒に混合されていてもよく、上記キレート剤およびｐＨ調整剤を収容する各包装容器とは別の包装容器に収容されていてもよい。 The water may be mixed together in a packaging container that contains either the chelating agent or the pH adjuster, or may be mixed together in both the packaging container that contains the chelating agent and the packaging container that contains the pH adjuster, or may be contained in a packaging container separate from each of the packaging containers that contain the chelating agent and the pH adjuster.
本発明の洗浄剤原料キットは、上記透析機器用洗浄剤の構成成分の１つである水を用いて所望のｐＨになるまで希釈され、透析機器用洗浄剤が作製される。この点で、当該洗浄剤原料キットは、透析機器用洗浄剤と比較してコンパクトな容量に抑えることができる。これにより、製造元または販売元から使用先（透析療法を行う施設）までの輸送効率を高めることができ、製造後および購入後の保管場所についても省スペースとすることができる。 The cleaning agent raw material kit of the present invention is diluted with water, which is one of the components of the cleaning agent for dialysis equipment, until it reaches a desired pH, thereby producing a cleaning agent for dialysis equipment. In this respect, the cleaning agent raw material kit can be kept in a compact capacity compared to a cleaning agent for dialysis equipment. As a result, it is possible to increase the efficiency of transportation from the manufacturer or seller to the place of use (facility where dialysis therapy is performed), and it is also possible to save space in storage locations after manufacture and purchase.
本発明の洗浄剤原料キットは、必ずしも限定されないが、例えば常温（１５℃～２５℃）にて保管される。 The detergent raw material kit of the present invention is stored at room temperature (15° C. to 25° C.), for example, but not necessarily limited to.
使用の際は、本発明の洗浄剤原料キットの構成成分のうち、例えばキレート剤およびｐＨ調整剤、ならびに必要に応じて他の成分が予め混合され、その後所定量の水（例えば、精製水）で希釈される。あるいは、キレート剤、ｐＨ調整剤、および必要に応じて他の成分と所定量の水とが一緒に混合される。 When in use, the components of the cleaning agent raw material kit of the present invention, such as the chelating agent and pH adjuster, and other components as necessary, are premixed and then diluted with a predetermined amount of water (e.g., purified water). Alternatively, the chelating agent, pH adjuster, and other components as necessary are mixed together with a predetermined amount of water.
本発明の洗浄剤原料キットから、上記透析機器用洗浄剤を得る際の水の希釈割合は、全体質量を基準として、好ましくは２５倍～２００倍、より好ましくは２５倍～１００倍である。希釈により得られた透析機器用洗浄剤は、後述のように透析機器内の洗浄のために直ちに使用されてもよく、あるいは使用まで、例えば暗所かつ冷蔵下にて保管されてもよい。 The dilution ratio of water when obtaining the above-mentioned dialysis equipment cleaning agent from the cleaning agent raw material kit of the present invention is preferably 25 to 200 times, more preferably 25 to 100 times, based on the total mass. The dialysis equipment cleaning agent obtained by dilution may be used immediately to clean the inside of the dialysis equipment as described below, or may be stored, for example, in a dark place and under refrigeration until use.
（透析機器のカルシウムスケールの除去方法）
次に、透析機器内に沈着したカルシウムスケールの除去方法について説明する。
(Method for removing calcium scale from dialysis equipment)
Next, a method for removing calcium scale deposited within a dialysis machine will be described.
本発明では、透析機器の送液チューブから、上記透析機器用洗浄剤が供給される。供給のための送液条件（例えば、流速）は特に限定されず、使用する透析機器の種類、規模等に応じて当業者によって適宜選択され得る。 In the present invention, the dialysis equipment cleaning agent is supplied from the liquid feeding tube of the dialysis equipment. Liquid feeding conditions for supply (eg, flow rate) are not particularly limited and can be appropriately selected by those skilled in the art depending on the type, scale, etc. of the dialysis equipment to be used.
透析機器用洗浄剤を供給することができる透析機器内の構成部品の材料は、必ずしも限定されないが、例えば、テフロン（登録商標）、塩化ビニル、シリコーン、ステンレススチール、ポリエチレン、およびポリプロピレンが挙げられる。 Materials for components within the dialysis machine that can be supplied with dialysis machine cleaning agents include, but are not necessarily limited to, Teflon, vinyl chloride, silicone, stainless steel, polyethylene, and polypropylene.
なお、本発明においては、透析機器に上記透析機器用洗浄剤が供給された後、必要に応じて水（例えば、精製水）等が供給され、透析機器内に残存する洗浄剤が排出されてもよい。 In addition, in the present invention, after the dialysis equipment cleaning agent is supplied to the dialysis equipment, water (e.g., purified water) is supplied as needed, and the cleaning agent remaining in the dialysis equipment is discharged. Good too.
さらに、本発明においては、透析機器に上記透析機器用洗浄剤が供給された後、透析機器内には、次亜塩素酸ナトリウムまたはケイ酸塩（例えば、セスキケイ酸ナトリウム、メタケイ酸ナトリウム、水ガラス、およびオルソケイ酸ナトリウム）などの化合物を含有する水溶液が供給され、除菌洗浄が行われてもよい。このような除菌洗浄に使用される次亜塩素酸ナトリウムまたはケイ酸塩の水溶液の濃度は、特に限定されず、当業者にて適切な濃度が適宜選択され得る。 Further, in the present invention, after the dialysis equipment is supplied with the dialysis equipment cleaning agent, sodium hypochlorite or a silicate (e.g., sodium sesquisilicate, sodium metasilicate, water glass) is added to the dialysis equipment. , and sodium orthosilicate) may be supplied for disinfection cleaning. The concentration of the aqueous solution of sodium hypochlorite or silicate used in such sterilization cleaning is not particularly limited, and a suitable concentration can be appropriately selected by those skilled in the art.
ただし、次亜塩素酸ナトリウムの水溶液はアルカリ性であり強い酸化力を有するために金属に触れると錆を生じさせることがある。このため、次亜塩素酸ナトリウムの水溶液を用いて除菌洗浄を行う場合は、その排液は適切に中和処理されることが好ましい However, since the aqueous solution of sodium hypochlorite is alkaline and has strong oxidizing power, it may cause rust when it comes into contact with metal. For this reason, when performing sterilization cleaning using an aqueous solution of sodium hypochlorite, it is preferable that the waste liquid be appropriately neutralized.
このようにして、透析機器内の洗浄が行われ、透析機器内に沈着したカルシウムスケールが除去される。 In this way, the inside of the dialysis machine is cleaned, and calcium scale deposited inside the dialysis machine is removed.
以下、実施例を挙げて本発明を詳細に説明するが、本発明はこれらの実施例に限定されるものではない。 Hereinafter, the present invention will be explained in detail with reference to Examples, but the present invention is not limited to these Examples.
（実施例１：洗浄剤原料組成物の作製）
精製水７１．２質量部にエチレンジアミン四酢酸ナトリウム２５質量部を精製水に溶解することにより水溶液を調製した。次いで、この水溶液に、ｐＨ調整剤としてクエン酸３．８質量部を添加して溶解することによりｐＨを７．５に調整し、洗浄剤原料組成物（ＥＧ１）を得た。
(Example 1: Preparation of detergent raw material composition)
An aqueous solution was prepared by dissolving 25 parts by mass of sodium ethylenediaminetetraacetate in 71.2 parts by mass of purified water. Then, 3.8 parts by mass of citric acid was added and dissolved as a pH adjuster in this aqueous solution to adjust the pH to 7.5, thereby obtaining a cleaning agent raw material composition (EG1).
（実施例２：洗浄剤原料組成物の作製）
精製水６９．０質量部にニトリロ三酢酸ナトリウム２５質量部を溶解することにより水溶液を調製した。次いで、この水溶液に、ｐＨ調整剤としてクエン酸６．０質量部を添加して溶解することによりｐＨを７．５に調整し、洗浄剤原料組成物（ＥＧ２）を得た。
(Example 2: Preparation of cleaning agent raw material composition)
An aqueous solution was prepared by dissolving 25 parts by mass of sodium nitrilotriacetate in 69.0 parts by mass of purified water. Next, 6.0 parts by mass of citric acid was added as a pH adjuster to this aqueous solution and dissolved therein to adjust the pH to 7.5 to obtain a cleaning agent raw material composition (EG2).
（実施例３：洗浄剤原料組成物の作製）
精製水７０．２質量部に、エチレンジアミン四酢酸ナトリウム１２．５質量部およびニトリロ三酢酸ナトリウム１２．５質量部に溶解することにより、エチレンジアミン四酢酸ナトリウムおよびニトリロ三酢酸ナトリウムを合計して２５質量部の割合で含有する水溶液を調製した。次いで、この水溶液に、ｐＨ調整剤としてクエン酸４．８質量部を添加して溶解することによりｐＨを７．５に調整し洗浄剤原料組成物（ＥＧ３）を得た。
(Example 3: Preparation of cleaning agent raw material composition)
By dissolving 12.5 parts by mass of sodium ethylenediaminetetraacetate and 12.5 parts by mass of sodium nitrilotriacetate in 70.2 parts by mass of purified water, a total of 25 parts by mass of sodium ethylenediaminetetraacetate and sodium nitrilotriacetate is obtained. An aqueous solution containing the following ratio was prepared. Next, 4.8 parts by mass of citric acid as a pH adjuster was added and dissolved in this aqueous solution to adjust the pH to 7.5 to obtain a cleaning agent raw material composition (EG3).
（実施例４：透析機器用洗浄剤の調製）
実施例１で作製された洗浄剤原料組成物（ＥＧ１）を精製水で、全体質量を基準として２５倍に希釈することにより、透析機器用洗浄剤（ＥＴ１）を調製した。得られた透析機器用洗浄剤（ＥＴ１）のｐＨをｐＨメータ（株式会社堀場製作所製Ｆ－７２）で用いて測定した。得られた透析機器用洗浄剤（ＥＴ１）の特徴を表１に示す。
(Example 4: Preparation of cleaning agent for dialysis equipment)
A cleaning agent for dialysis equipment (ET1) was prepared by diluting the cleaning agent raw material composition (EG1) prepared in Example 1 with purified water 25 times based on the total mass. The pH of the obtained dialysis equipment cleaning agent (ET1) was measured using a pH meter (F-72 manufactured by Horiba, Ltd.). Table 1 shows the characteristics of the obtained dialysis equipment cleaning agent (ET1).
（実施例５：透析機器用洗浄剤の調製）
実施例１で作製された洗浄剤原料組成物（ＥＧ１）を精製水で、全体質量を基準として５０倍に希釈することにより、透析機器用洗浄剤（ＥＴ２）を調製した。得られた透析機器用洗浄剤（ＥＴ２）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ２）の特徴を表１に示す。
(Example 5: Preparation of cleaning agent for dialysis equipment)
The detergent raw material composition (EG1) prepared in Example 1 was diluted with purified water 50 times based on the total mass to prepare a detergent for dialysis equipment (ET2). The pH of the resulting detergent for dialysis equipment (ET2) was measured in the same manner as in Example 4. The characteristics of the resulting detergent for dialysis equipment (ET2) are shown in Table 1.
（実施例６：透析機器用洗浄剤の調製）
実施例２で作製された洗浄剤原料組成物（ＥＧ２）を精製水で、全体質量を基準として２５倍に希釈することにより、透析機器用洗浄剤（ＥＴ３）を調製した。得られた透析機器用洗浄剤（ＥＴ３）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ３）の特徴を表１に示す。
(Example 6: Preparation of cleaning agent for dialysis equipment)
A cleaning agent for dialysis equipment (ET3) was prepared by diluting the cleaning agent raw material composition (EG2) produced in Example 2 with purified water 25 times based on the total mass. The pH of the obtained dialysis equipment cleaning agent (ET3) was measured in the same manner as in Example 4. Table 1 shows the characteristics of the obtained dialysis equipment cleaning agent (ET3).
（実施例７：透析機器用洗浄剤の調製）
実施例２で作製された洗浄剤原料組成物（ＥＧ２）を精製水で、全体質量を基準として５０倍に希釈することにより、透析機器用洗浄剤（ＥＴ４）を調製した。得られた透析機器用洗浄剤（ＥＴ４）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ４）の特徴を表１に示す。
(Example 7: Preparation of cleaning agent for dialysis equipment)
A cleaning agent for dialysis equipment (ET4) was prepared by diluting the cleaning agent raw material composition (EG2) prepared in Example 2 with purified water 50 times based on the total mass. The pH of the obtained dialysis equipment cleaning agent (ET4) was measured in the same manner as in Example 4. Table 1 shows the characteristics of the obtained dialysis equipment cleaning agent (ET4).
（実施例８：透析機器用洗浄剤の調製）
実施例３で作製された洗浄剤原料組成物（ＥＧ３）を精製水で、全体質量を基準として２５倍に希釈することにより、透析機器用洗浄剤（ＥＴ５）を調製した。得られた透析機器用洗浄剤（ＥＴ５）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ５）の特徴を表１に示す。
(Example 8: Preparation of cleaning agent for dialysis equipment)
The detergent raw material composition (EG3) prepared in Example 3 was diluted with purified water 25 times based on the total mass to prepare a detergent for dialysis equipment (ET5). The pH of the resulting detergent for dialysis equipment (ET5) was measured in the same manner as in Example 4. The characteristics of the resulting detergent for dialysis equipment (ET5) are shown in Table 1.
（実施例９：透析機器用洗浄剤の調製）
実施例３で作製された洗浄剤原料組成物（ＥＧ３）を精製水で、全体質量を基準として５０倍に希釈することにより、透析機器用洗浄剤（ＥＴ６）を調製した。得られた透析機器用洗浄剤（ＥＴ６）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ６）の特徴を表１に示す。
(Example 9: Preparation of cleaning agent for dialysis equipment)
A cleaning agent for dialysis equipment (ET6) was prepared by diluting the cleaning agent raw material composition (EG3) prepared in Example 3 with purified water 50 times based on the total mass. The pH of the obtained dialysis equipment cleaning agent (ET6) was measured in the same manner as in Example 4. Table 1 shows the characteristics of the obtained dialysis equipment cleaning agent (ET6).
（比較例１：透析機器用洗浄剤の調製）
酸洗浄剤として、クエン酸およびリンゴ酸を主成分として含有する市販の透析機器用洗浄剤（アムテック株式会社製サンフリーＳＮ）を精製水で、全体質量を基準として２００倍に希釈することにより、透析機器用洗浄剤（ＣＴ１）を調製した。得られた透析機器用洗浄剤（ＣＴ１）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＣＴ１）の特徴を表１に示す。
(Comparative Example 1: Preparation of cleaning agent for dialysis equipment)
As an acid cleaner, a commercially available dialysis equipment cleaner (Sunfree SN manufactured by Amtech Co., Ltd.) containing citric acid and malic acid as main components was diluted with purified water 200 times based on the total mass. A cleaning agent for dialysis equipment (CT1) was prepared. The pH of the obtained dialysis equipment cleaning agent (CT1) was measured in the same manner as in Example 4. Table 1 shows the characteristics of the obtained dialysis equipment cleaning agent (CT1).
（炭酸カルシウムの溶解量の評価）
実施例４～９および比較例１で調製した透析機器用洗浄剤（ＥＴ１）～（ＥＴ６）および（ＣＴ１）を５０ｍＬずつビーカーに小分けし、それぞれに約０．１ｇの炭酸カルシウムを添加して、撹拌した後２５℃でそのまま３０分間放置した。
(Evaluation of dissolved amount of calcium carbonate)
The dialysis equipment cleaning agents (ET1) to (ET6) and (CT1) prepared in Examples 4 to 9 and Comparative Example 1 were divided into 50 mL portions into beakers, and about 0.1 g of calcium carbonate was added to each. After stirring, the mixture was left to stand at 25°C for 30 minutes.
次いで、各ビーカー中の洗浄剤を濾過し、得られた残渣を２５℃で十分に乾燥させた後、その質量を測定することにより、炭酸カルシウムの添加量から残渣の質量を引いて、各洗浄剤による炭酸カルシウムの溶解量を算出した。また、この濾過にあたり、排液となる濾液を回収し、ｐＨをｐＨメータ（株式会社堀場製作所製Ｆ－７２）で用いて測定した。得られた結果を表１に示す。 Next, the cleaning agent in each beaker is filtered, the resulting residue is sufficiently dried at 25°C, and the mass is measured, and the mass of the residue is subtracted from the amount of calcium carbonate added. The amount of calcium carbonate dissolved by the agent was calculated. In addition, during this filtration, the filtrate as waste liquid was collected and its pH was measured using a pH meter (F-72 manufactured by Horiba, Ltd.). The results obtained are shown in Table 1.
表１に示すように、実施例４～９で調製した透析機器用洗浄剤（ＥＴ１）～（ＥＴ６）のいずれも、比較例１で調製した透析機器用洗浄剤（ＣＴ１）と比較して、略同等またはそれ以上の炭酸カルシウムを溶解していた。 As shown in Table 1, all of the dialysis equipment cleaners (ET1) to (ET6) prepared in Examples 4 to 9 had a lower Approximately the same amount or more of calcium carbonate was dissolved.
一方、比較例１で調製した透析機器用洗浄剤（ＣＴ１）のｐＨは調製時および排液段階のいずれを参照しても低い値となっており、下水道排水基準ｐＨ５．０～９．０の許容限度を下回るものであった。これに対し、実施例４～９で調製した透析機器用洗浄剤（ＥＴ１）～（ＥＴ６）のｐＨ調製時および排液段階のいずれについても、当該許容限度の範囲内にあるものであった。 On the other hand, the pH of the dialysis equipment cleaning agent (CT1) prepared in Comparative Example 1 was a low value, both at the time of preparation and at the drainage stage, which exceeded the sewage drainage standard pH of 5.0 to 9.0. It was below the permissible limit. On the other hand, the pH of the dialysis equipment cleaners (ET1) to (ET6) prepared in Examples 4 to 9 was within the permissible limits both during pH adjustment and during the draining stage.
このことから、実施例４～９で調製した透析機器用洗浄剤（ＥＴ１）～（ＥＴ６）はいずれも、炭酸カルシウムに対して優れた溶解性能を有するとともに、排液の処分にあたり、ｐＨが上記許容限度の範囲内にあり、特に中和処理や専門業者による排液回収を特に必要としないものであることがわかる。 From this, all of the dialysis equipment cleaning agents (ET1) to (ET6) prepared in Examples 4 to 9 have excellent dissolution performance for calcium carbonate, and when disposing of the waste fluid, the pH is above the above level. It can be seen that it is within the permissible limit and does not particularly require neutralization treatment or collection of waste liquid by a specialized company.
（実施例１０：洗浄剤原料組成物の作製および透析機器用洗浄剤の調製）
実施例１で得られた洗浄剤原料組成物（ＥＧ１）を精製水で、容量を基準として２５倍に希釈することにより、透析機器用洗浄剤（ＥＴ７）を調製した。得られた透析機器用洗浄剤（ＥＴ７）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ７）の特徴を表２に示す。
(Example 10: Preparation of cleaning agent raw material composition and preparation of cleaning agent for dialysis equipment)
A cleaning agent for dialysis equipment (ET7) was prepared by diluting the cleaning agent raw material composition (EG1) obtained in Example 1 with purified water 25 times based on the volume. The pH of the obtained dialysis equipment cleaning agent (ET7) was measured in the same manner as in Example 4. Table 2 shows the characteristics of the obtained dialysis equipment cleaning agent (ET7).
その後、得られた透析機器用洗浄剤（ＥＴ７）について、上記と同様にして炭酸カルシウムの溶解量の評価を行った。得られた結果を表２に示す。 Thereafter, the amount of calcium carbonate dissolved in the obtained dialysis equipment cleaning agent (ET7) was evaluated in the same manner as above. The results obtained are shown in Table 2.
（比較例２：洗浄剤原料組成物の作製および透析機器用洗浄剤の調製）
キレート剤（エチレンジアミン四酢酸ナトリウム）を含有させず、かつクエン酸の変わりにモノエタノールアミン３．４質量部を添加したこと以外は実施例１と同様にして洗浄剤原料組成物（ＣＧ１）を作製した。また、この洗浄剤原料組成物（ＣＧ１）を用いたこと以外は実施例１０と同様にして透析機器用洗浄剤（ＣＴ２）を調製し、上記と同様にして炭酸カルシウムの溶解量の評価を行った。得られた結果を表２に示す。
(Comparative Example 2: Preparation of cleaning agent raw material composition and preparation of cleaning agent for dialysis equipment)
A cleaning agent raw material composition (CG1) was prepared in the same manner as in Example 1, except that the chelating agent (sodium ethylenediaminetetraacetate) was not contained and 3.4 parts by mass of monoethanolamine was added instead of citric acid. did. In addition, a cleaning agent for dialysis equipment (CT2) was prepared in the same manner as in Example 10 except that this cleaning agent raw material composition (CG1) was used, and the amount of dissolved calcium carbonate was evaluated in the same manner as above. Ta. The results obtained are shown in Table 2.
表２に示すように、実施例１０で調製した透析機器用洗浄剤（ＥＴ７）は、比較例２で調製した透析機器用洗浄剤（ＣＴ２）と比較して、炭酸カルシウムを著しく溶解していた。このことから、炭酸カルシウムの溶解には、キレート剤であるエチレンジアミン四酢酸ナトリウムが大きく影響を及ぼしていることがわかる。 As shown in Table 2, the dialysis equipment cleaning agent (ET7) prepared in Example 10 dissolved calcium carbonate significantly more than the dialysis equipment cleaning agent (CT2) prepared in Comparative Example 2. This shows that the chelating agent sodium ethylenediaminetetraacetate has a significant effect on the dissolution of calcium carbonate.
（実施例１１：洗浄剤原料キットの作製および透析機器用洗浄剤の調製）
エチレンジアミン四酢酸ナトリウム２５質量部と、ｐＨ調整剤としてクエン酸３．８質量部とをそれぞれポリエチレン製の袋に別々に添加して梱包することにより、洗浄剤原料キット（ＥＫ１）を作製した。
(Example 11: Production of cleaning agent raw material kit and preparation of cleaning agent for dialysis equipment)
A detergent raw material kit (EK1) was prepared by separately adding 25 parts by mass of sodium ethylenediaminetetraacetate and 3.8 parts by mass of citric acid as a pH adjuster into polyethylene bags and packing them.
上記洗浄剤原料キット（ＥＫ１）の各袋を開封し、これら内容物（キレート剤およびｐＨ調整剤）を１００質量部の精製水に溶解（容量を基準として５０倍に希釈）することにより、透析機器用洗浄剤（ＥＴ８）を調製した。得られた透析機器用洗浄剤（ＥＴ８）のｐＨを実施例４と同様にして測定した。得られた透析機器用洗浄剤（ＥＴ８）の特徴を表３に示す。 By opening each bag of the cleaning agent raw material kit (EK1) and dissolving the contents (chelating agent and pH adjuster) in 100 parts by mass of purified water (diluted 50 times based on volume), dialysis was performed. An equipment cleaner (ET8) was prepared. The pH of the obtained dialysis equipment cleaning agent (ET8) was measured in the same manner as in Example 4. Table 3 shows the characteristics of the obtained dialysis equipment cleaning agent (ET8).
その後、得られた透析機器用洗浄剤（ＥＴ８）について、上記と同様にして炭酸カルシウムを溶解し、これを濾過して得られた濾液（排液）を回収し、ｐＨをｐＨメータ（株式会社堀場製作所製Ｆ－７２）で用いて測定した。得られた結果を表３に示す。 Thereafter, calcium carbonate was dissolved in the obtained dialysis equipment cleaning agent (ET8) in the same manner as above, and the resulting filtrate (effluent) was collected by filtration, and the pH was measured using a pH meter (Co., Ltd. Measurements were made using Horiba's F-72). The results obtained are shown in Table 3.
表３に示すように、実施例１１で調製した透析機器用洗浄剤（ＥＴ８）の排液段階のｐＨは、洗浄剤調製時のｐＨと比較して、所定量の炭酸カルシウムを溶解により幾分上昇したものの、下水道排水基準ｐＨ５．０～９．０の許容限度を下回るものであったことがわかる。 As shown in Table 3, the pH at the drainage stage of the dialysis equipment cleaning agent (ET8) prepared in Example 11 was slightly lower than the pH at the time of cleaning agent preparation due to the dissolution of a predetermined amount of calcium carbonate. It can be seen that although the pH value increased, it was below the permissible limit of the sewerage drainage standard pH 5.0 to 9.0.
（実施例１２：シリコーンチューブに沈着した炭酸カルシウムの除去）
透析機器に使用されるシリコーンチューブ（内径８ｍｍ、肉厚３ｍｍ）を長さ方向に約２ｃｍの長さで切断してサンプルを作製し、これを、２種類の市販の透析液の混合液（Ａ液９０ｍＬとＢ液９１０ｍＬとの混合液）に室温で１日間浸漬し、サンプルのチューブ内に炭酸カルシウムの結晶を析出させた。
(Example 12: Removal of calcium carbonate deposited on silicone tube)
A silicone tube (inner diameter 8 mm, wall thickness 3 mm) used in dialysis equipment was cut into a length of approximately 2 cm to prepare a sample. This sample was immersed in a mixture of two types of commercially available dialysis fluids (a mixture of 90 mL of solution A and 910 mL of solution B) at room temperature for one day to cause calcium carbonate crystals to precipitate in the sample tube.
次いで、このサンプルを、実施例５で調製した透析機器用洗浄剤（ＥＴ１）２００ｍＬ中に室温にて１２時間で浸漬した。その後サンプルを取り出し、チューブ内面が露出するように軸方向に沿ってサンプルを分割して、チューブ内表面の状態を当該透析機器用洗浄剤（ＥＴ１）に浸漬する前のサンプルと比較して目視で観察した。 Next, this sample was immersed in 200 mL of the dialysis equipment cleaning agent (ET1) prepared in Example 5 at room temperature for 12 hours. The sample was then removed and divided along the axial direction so that the inner surface of the tube was exposed, and the condition of the inner surface of the tube was visually observed in comparison with the sample before it was immersed in the dialysis equipment cleaning agent (ET1).
透析機器用洗浄剤（ＥＴ１）に浸漬していないサンプルでは、チューブ内面に炭酸カルシウムの結晶が多く観察できたが、透析機器用洗浄剤（ＥＴ１）に浸漬したサンプルでは、チューブ内面に炭酸カルシウムの結晶がほとんど観察されなかった。 Many calcium carbonate crystals were observed on the inner surface of the tube in the sample that was not soaked in the dialysis equipment cleaner (ET1), but calcium carbonate crystals were observed on the inner surface of the tube in the sample that was soaked in the dialysis equipment cleaner (ET1). Almost no crystals were observed.
（比較例３：シリコーンチューブに沈着した炭酸カルシウムの除去）
実施例１１と同様にして、サンプルのチューブ内に炭酸カルシウムの結晶を析出させた。
(Comparative Example 3: Removal of calcium carbonate deposited on silicone tube)
In the same manner as in Example 11, calcium carbonate crystals were precipitated in the sample tube.
次いで、このサンプルを、比較例２で調製した透析機器用洗浄剤（ＣＴ２）２００ｍＬ中に室温にて１２時間で浸漬した。その後サンプルを取り出し、チューブ内面が露出するように軸方向に沿ってサンプルを分割して、チューブ内表面の状態を当該透析機器用洗浄剤（ＣＴ２）に浸漬する前のサンプルと比較して目視で観察した。 Next, this sample was immersed in 200 mL of the dialysis equipment cleaning agent (CT2) prepared in Comparative Example 2 at room temperature for 12 hours. After that, take out the sample, divide the sample along the axial direction so that the inner surface of the tube is exposed, and visually compare the condition of the inner surface of the tube with the sample before immersing it in the dialysis equipment cleaning agent (CT2). Observed.
透析機器用洗浄剤（ＣＴ２）に浸漬したサンプル、および浸漬していないサンプルのいずれにも、チューブ内面に炭酸カルシウムの結晶が多く観察できた。 Many calcium carbonate crystals were observed on the inner surface of the tube in both the sample immersed in the dialysis equipment cleaning agent (CT2) and the sample not immersed.
Claims (5)
透析機器の送液チューブから、請求項１から４のいずれかに記載の透析機器用洗浄剤を供給する工程を包含する、方法。 1. A method for removing calcium scale deposited in a dialysis machine, comprising:
A method comprising the step of supplying the dialysis equipment cleaning agent according to any one of claims 1 to 4 from a supply tube of the dialysis equipment.
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| JP2001161811A (en) | 1999-12-13 | 2001-06-19 | Aisei:Kk | Detergent for artificial dialyzing apparatus |
| JP2002301149A (en) | 2001-04-04 | 2002-10-15 | Arukusu:Kk | Disinfectant/detergent composition for artificial dialyzer and method for disinfecting and washing artificial dialyzer |
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