CN104041511A - Solution for sterilizing and cleaning hemodialysis machine and preparation method of solution - Google Patents
Solution for sterilizing and cleaning hemodialysis machine and preparation method of solution Download PDFInfo
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- CN104041511A CN104041511A CN201410270259.8A CN201410270259A CN104041511A CN 104041511 A CN104041511 A CN 104041511A CN 201410270259 A CN201410270259 A CN 201410270259A CN 104041511 A CN104041511 A CN 104041511A
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- sodium pyrophosphate
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Abstract
The invention discloses a solution for sterilizing and cleaning a hemodialysis machine and a preparation method of the solution. The solution is prepared from peroxyacetic acid, hydrogen peroxide, water, glacial acetic acid and sodium pyrophosphate. The preparation method comprises the following steps: putting water, glacial acetic acid and sodium pyrophosphate into a solution preparing tank to prepare an inert solution; stirring for dissolving for 30 minutes; adding peroxyacetic acid and hydrogen peroxide in the solution preparing tank to obtain a mixed solution; and filtering the mixed solution through a three-section type membrane filter and performing filling to obtain the product. The product has stable performance and a validity period lasting for two years long, and is capable of effectively exterminating intestinal tract pathogenic bacteria, pyogenic cocci, pathogenic yeasts and bacterial spores.
Description
Technical field
The present invention relates to a kind of solution for sterilizing and cleaning, be specifically related to a kind of solution that can be used for haemodialysis control unit sterilization and clean and preparation method thereof.
Background technology
Haemodialysis control unit thimerosal is the important sterile products in haemodialysis control unit routine use and maintenance, effectively cleaning and sterilizing is carried out in the position such as counting pipeline, colorimetric pool of haemodialysis control unit and can make instrument stabilizer, extend the instrument life-span.
Treasure AK100 model haemodialysis control unit is applied very extensive at home, and cleaning fluid demand is large, but cleaning fluid used mostly is import CA CLEAN I, expensive, completely dependence on import.A kind of cleaning fluid is disclosed in US4745071, but this cleaning fluid composition complexity, cost is high.In like product, the concentration ratio of some product is higher in the market, when use, must manually dilute, and uses inconvenience also to increase work load, and product stability after dilution is bad; Some product is binary preparation, when use, prepares again, the same inconvenience that uses, and dialysis machine pipe-line system is disinfected and had great limitation; The product with same concentrations can't resolve again the stability problem of this series products, easily produces crystalline solid after opening, and impact is used, and therefore the use term of validity of product is not long; And although some external imported product has solved the stability problem of this series products, expensive.
Peracetic acid or hydrogen peroxide sterilization speed are fast, nontoxic, noresidue, are suitable for the sterilization of this class medicine equipment of haemodialysis control unit, but they use separately sterilization cleaning performance undesirable.Particularly Peracetic acid excitant is large, is corrosive; Stability of Hydrogen Peroxide is poor, is easily subject to metal ion catalysis decomposition and discharges oxygen, makes its oxidation disinfection Disability, brings much inconvenience to user.
Summary of the invention
The technical problem to be solved in the present invention is to overcome haemodialysis control unit sterilization and cleaning fluid poor stability in prior art, the problem that production cost is high, a kind of fill a prescription reasonable, stable performance, easy to use are provided, have and clean and sterilizing function, sterilization and the cleaning fluid of safe, nontoxic haemodialysis control unit.
The technical scheme that the present invention solves the problems of the technologies described above employing is:
For sterilization and the cleaning fluid of haemodialysis control unit, this product is containing Peracetic acid 1.6% ± 0.24 % by weight percentage; Hydrogen peroxide 6.0% ± 0.9%; Surplus is inert substance.
Described inert substance is made up of following material: water, glacial acetic acid and sodium pyrophosphate; The percetage by weight that each component accounts for described sterilization and cleaning fluid is water 68%-72%; Glacial acetic acid 19%-22%, sodium pyrophosphate 0.01%-0.03%.
Above-mentioned a kind of for the sterilization of haemodialysis control unit and the preparation method of cleaning fluid, comprise the following steps:
A) glacial acetic acid of above-mentioned weight proportion and sodium pyrophosphate are dropped in Agitation Tank, in preparing tank, add water, stirring and dissolving 30 minutes, makes inert substance solution;
B), to the Peracetic acid and the hydrogen peroxide that add above-mentioned weight proportion in above-mentioned inert substance solution, stir fully reaction;
C) by step B) in mixed solution through filtering filling product through three section type film filter.
The aperture of described three section type film filter filter membrane is for being respectively 1.2 μ m, 0.45 μ m, and 0.22 μ m, filtration order through 1.2 μ m filter membranes, then by 0.45 μ m filter membrane, is finally passed through 0.22 μ m filter membrane for first.
This sterilization and cleaning fluid can be killed pathogenic entero becteria, pyococcus, saccharomytes and bacterial spore.
The typical preparation method of Peracetic acid utilizes reacting of hydrogen peroxide and carboxylic acid and derivative thereof, concrete synthetic route has multiple, and Peracetic acid of the present invention adopts glacial acetic acid (mass concentration is 99.8%), and under the catalysis of phosphoric acid, original position is prepared Peracetic acid with hydrogen peroxide (mass concentration is 50%).
Peracetic acid and hydrogen peroxide are peroxide (O-O), and they can manufacture oxygen (elementary oxygen) after contacting with organic matter, and elementary oxygen can be oxidized kill microorganisms and decompose the metabolite of microorganism, and remaining elementary oxygen becomes stable oxygen.It is very fast that decomposition of peracetic acid produces the speed of elementary oxygen, can bring into play at short notice Disinfection Effect, and hydrogen peroxide can maintain the Disinfection Effect of long period and remove organic matter.
CH
3COOOH→CH
3COOH+1/2O
2
H
2O
2→H
2O+1/2O
2
The acetic acid that decomposition of peracetic acid produces can dissolve and remove calcium carbonate, and last acetic acid is oxidized to carbonic acid gas and water by elementary oxygen.
CH
3COOH+1/2O
2→CO
2+H
2O
In inert substance solution of the present invention, sodium pyrophosphate has outside the function of demineralized water, the insoluble salt of dissolving calcium, magnesium again, but sodium pyrophosphate has certain alkalescence, can make peroxide breakdown (Peracetic acid and hydrogen peroxide).For head it off, acetic acid is first added in the present invention's employing makes sodium pyrophosphate solution sex change prepare inertia solution, thereby has controlled the alkalescence of sodium pyrophosphate; Stir to prepare this sterilization and wash solution with Peracetic acid and hydrogen peroxide again, prepare product and not only there is good clean result, and stability of solution is fine.
This product must be to go out permeable treatment system from reverse osmosis using in dilution water in thinned water used and preparation process, meets the requirement of U.S. AAMI and ASAIO haemodialysis water water standard (2001) water quality.For the haemodialysis control unit of different model, concrete cleaning and sterilization method please refer to the instruction in equipment operating specification.The dilution ratio of machine is set, makes Peracetic acid concentration be not less than 0.662g/L, be not less than 20 minutes minimum time of contact.
Through evidence, the haemodialysis cleaning of the present invention's development and thimerosal appearance colorless is transparent, physical and chemical index stable performance, has no crystallization, muddiness, precipitation during use, and every physical and chemical index performance is stable.
Compared with prior art the present invention has the following advantages:
1, Disinfection Effect performance is high and also can sterilize fast and effectively under low temperature environment, and bactericidal range is wide, is a kind of wide spectrum, efficient, quick-acting chemosterilant;
2, product stability is good, is at present domesticly uniquely can accomplish that the term of validity reaches the product of 2 years;
3, can effectively remove the organic substance that is attached to haemodialysis control unit internal duct, for example biomembrane (biofilm); Also there is excellent effect for the biomembranous generation of prevention.Can very effectively remove the precipitation of calcium carbonate that accumulates in haemodialysis control unit internal duct, and effectively pre-sludge proof occurs, thereby reach the effect of cleaning.
Embodiment
Embodiment 1
First get 0.01kg sodium pyrophosphate, 19.0kg glacial acetic acid, 61.2kg reverse osmosis water in Agitation Tank, open stirring stirring at room temperature and after 30 minutes, obtain inert substance solution.
Stir after 2 hours to obtain thimerosal mother liquor to drop into 3.5kg percetage by weight in above-mentioned inert substance Agitation Tank be 40% Peracetic acid, the 17.3kg percetage by weight hydrogen peroxide that is 30% in 25 DEG C-35 DEG C, mother liquor is through the then filling final products that obtain of three section type filtering with microporous membrane (filter filter membrane aperture and be respectively 1.2 μ m-0.45 μ m-0.22 μ m, flow through filter membrane aperture precedence from big to small).
Embodiment 2
Get 0.02kg sodium pyrophosphate, 20.0kg glacial acetic acid, 56.0kg reverse osmosis water in Agitation Tank, open stirring stirring at room temperature and after 30 minutes, obtain inert substance solution.
Stir after 2.5 hours to obtain thimerosal mother liquor to drop into 4.0kg percetage by weight in above-mentioned Agitation Tank be 40% Peracetic acid, the 20.0kg percetage by weight hydrogen peroxide that is 30% in 25 DEG C-35 DEG C, mother liquor is through the then filling final products that obtain of three section type filtering with microporous membrane (filter filter membrane aperture and be respectively 1.2 μ m-0.45 μ m-0.22 μ m, flow through filter membrane aperture precedence from big to small).
Embodiment 3
Get 0.03kg sodium pyrophosphate, 22.0kg glacial acetic acid, 56.0kg reverse osmosis water in Agitation Tank, open stirring stirring at room temperature and after 30 minutes, obtain inert substance solution.
Stir after 2 hours to obtain thimerosal mother liquor to drop into 4.6kg percetage by weight in above-mentioned Agitation Tank be 40% Peracetic acid, the 20.0kg percetage by weight hydrogen peroxide that is 30% in 25 DEG C-35 DEG C, mother liquor is through the then filling final products that obtain of three section type filtering with microporous membrane (filter filter membrane aperture and be respectively 1.2 μ m-0.45 μ m-0.22 μ m, flow through filter membrane aperture precedence from big to small).
According to " disinfection technology standard " (version in 2002) 2.2 sterile products physics and chemistry technical specifications, the product in embodiment 1-3 is carried out to physics and chemistry detection, test result is as follows:
1. in haemodialysis control unit thimerosal, the average content of Peracetic acid is 16.7g/L;
2. in haemodialysis control unit thimerosal, the average content of hydrogen peroxide is 59.4g/L;
3. place after 3 months at 37 DEG C of constant temperature, in this effect product sterilization liquid, the content of Peracetic acid is 16.7g/L, with identical before placement, show that this product has good stability, be valid up to 2 years (placing 2 years according to being just equal to normal temperature in " disinfection technology standard ").
To the bactericidal effect of embodiment 1-3 product, test according to " disinfection technology standard " (version in 2002) 2.1.2.2 item:
Show through 5 repeated tests, haemodialysis control unit is through work one-period: (Peracetic acid content is 5776mg/L after machine operation 3min, to suck about 100mL thimerosal, content of hydrogen peroxide is 2048mg/L), soaking disinfection 20min(is disinfective action 15min during comprising 70 DEG C), rinse 2 times and emptying waste liquid finally by reverse osmosis water.Complete period amounts to about 45min.Kill logarithm value >6.26 to what dye bacillus subtilis black variety gemma on polyfluortetraethylene pipe, show that this product has good bactericidal effect.
With reference to embodiments of the invention, the present invention is given to explanation above.But these embodiment are only for illustrative purposes, and are not intended to limit the scope of the invention.Scope of the present invention is limited by claims and equivalent thereof.Do not depart from the scope of the present invention, those skilled in the art can make a variety of substitutions and modifications, and these substitutions and modifications all should fall within the scope of the present invention.
Claims (4)
1. for a solution for sterilization and the cleaning of haemodialysis control unit, it is characterized in that this product is containing Peracetic acid 1.6% ± 0.24 % by weight percentage; Hydrogen peroxide 6.0% ± 0.9%; Surplus is inert substance.
2. the solution of a kind of sterilization and cleaning for haemodialysis control unit according to claim 1, is characterized in that described inert substance is made up of following material: water, glacial acetic acid and sodium pyrophosphate; The percetage by weight that each component accounts for described cleaning and antiseptic solution is respectively water 68%-72%; Glacial acetic acid 19%-22%, sodium pyrophosphate 0.01%-0.03%.
3. according to a kind of preparation method for the sterilization of haemodialysis control unit and the solution of cleaning described in claim 1 or 2, it is characterized in that comprising the following steps:
A) glacial acetic acid of weight proportion described in the claims 2 and sodium pyrophosphate are dropped in Agitation Tank, to the water that adds described weight proportion in Agitation Tank, stirring and dissolving 30 minutes, makes inert substance solution;
B) to the Peracetic acid and the hydrogen peroxide that add weight proportion described in claim 1 or 2 in above-mentioned inert substance solution, fully stirring reaction;
C) by step B) the filling product that obtains of middle mixed solution process three section type film filter filtration.
4. preparation method according to claim 3, is characterized in that the aperture of described three section type film filter filter membrane is for being respectively 1.2 μ m, 0.45 μ m, 0.22 μ m.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107593763A (en) * | 2017-10-13 | 2018-01-19 | 吉林省富生医疗器械有限公司 | A kind of thimerosal of haemodialysis control unit and preparation method thereof |
CN109258641A (en) * | 2018-10-23 | 2019-01-25 | 广西润帮和医疗科技有限公司 | A kind of multifunctional disinfectant and preparation method thereof for haemodialysis control unit cleaning and sterilizing |
CN113331187A (en) * | 2021-06-29 | 2021-09-03 | 西安好快客商贸有限公司 | Special disinfectant for medical instruments and preparation method thereof |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1694949A (en) * | 2002-08-28 | 2005-11-09 | 李镇植 | A composition for disinfecting or washing medical instruments and a process for the preparation thereof |
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2014
- 2014-06-18 CN CN201410270259.8A patent/CN104041511B/en active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1694949A (en) * | 2002-08-28 | 2005-11-09 | 李镇植 | A composition for disinfecting or washing medical instruments and a process for the preparation thereof |
Non-Patent Citations (2)
Title |
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吴雨龙: "《精细化工概论》", 31 August 2009, 科学出版社 * |
韩长日,宋小平: "《药物制造技术》", 31 March 2000, 科学技术文献出版社 * |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107593763A (en) * | 2017-10-13 | 2018-01-19 | 吉林省富生医疗器械有限公司 | A kind of thimerosal of haemodialysis control unit and preparation method thereof |
CN109258641A (en) * | 2018-10-23 | 2019-01-25 | 广西润帮和医疗科技有限公司 | A kind of multifunctional disinfectant and preparation method thereof for haemodialysis control unit cleaning and sterilizing |
CN113331187A (en) * | 2021-06-29 | 2021-09-03 | 西安好快客商贸有限公司 | Special disinfectant for medical instruments and preparation method thereof |
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