CN112625816A - Method for cleaning disinfectant containing guanidine compound on surface of medical equipment - Google Patents
Method for cleaning disinfectant containing guanidine compound on surface of medical equipment Download PDFInfo
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- CN112625816A CN112625816A CN202011599113.XA CN202011599113A CN112625816A CN 112625816 A CN112625816 A CN 112625816A CN 202011599113 A CN202011599113 A CN 202011599113A CN 112625816 A CN112625816 A CN 112625816A
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- medical equipment
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- guanidine
- disinfectant
- citrate
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- 238000004140 cleaning Methods 0.000 title claims abstract description 60
- 239000000645 desinfectant Substances 0.000 title claims abstract description 53
- 238000000034 method Methods 0.000 title claims abstract description 33
- ZRALSGWEFCBTJO-UHFFFAOYSA-N anhydrous guanidine Natural products NC(N)=N ZRALSGWEFCBTJO-UHFFFAOYSA-N 0.000 title claims abstract description 29
- CHJJGSNFBQVOTG-UHFFFAOYSA-N N-methyl-guanidine Natural products CNC(N)=N CHJJGSNFBQVOTG-UHFFFAOYSA-N 0.000 title claims abstract description 27
- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 title claims abstract description 27
- -1 guanidine compound Chemical class 0.000 title claims abstract description 25
- 150000002357 guanidines Chemical class 0.000 claims abstract description 35
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 30
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000012266 salt solution Substances 0.000 claims abstract description 19
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims abstract description 18
- 150000008043 acidic salts Chemical class 0.000 claims abstract description 16
- 239000011780 sodium chloride Substances 0.000 claims abstract description 15
- 235000019270 ammonium chloride Nutrition 0.000 claims abstract description 14
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229910052921 ammonium sulfate Inorganic materials 0.000 claims abstract description 9
- 235000011130 ammonium sulphate Nutrition 0.000 claims abstract description 9
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 8
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 8
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 8
- 239000001509 sodium citrate Substances 0.000 claims abstract description 8
- 239000003446 ligand Substances 0.000 claims abstract description 5
- 238000010828 elution Methods 0.000 claims description 18
- 210000004369 blood Anatomy 0.000 claims description 16
- 239000008280 blood Substances 0.000 claims description 16
- 238000005406 washing Methods 0.000 claims description 10
- 229920002413 Polyhexanide Polymers 0.000 claims description 9
- 230000008081 blood perfusion Effects 0.000 claims description 8
- 238000011010 flushing procedure Methods 0.000 claims description 6
- 230000001951 hemoperfusion Effects 0.000 claims description 6
- 238000001179 sorption measurement Methods 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 14
- 239000002253 acid Substances 0.000 abstract description 11
- 150000003863 ammonium salts Chemical class 0.000 abstract description 10
- 239000007864 aqueous solution Substances 0.000 abstract description 8
- 230000002378 acidificating effect Effects 0.000 abstract description 6
- 230000009286 beneficial effect Effects 0.000 abstract description 6
- 150000003839 salts Chemical class 0.000 abstract description 5
- 230000003472 neutralizing effect Effects 0.000 abstract description 4
- 239000000243 solution Substances 0.000 description 24
- 235000002639 sodium chloride Nutrition 0.000 description 16
- 230000010412 perfusion Effects 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 7
- 239000004480 active ingredient Substances 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 5
- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 description 4
- 239000003463 adsorbent Substances 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 239000013543 active substance Substances 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 239000007853 buffer solution Substances 0.000 description 2
- 150000001860 citric acid derivatives Chemical class 0.000 description 2
- 231100000135 cytotoxicity Toxicity 0.000 description 2
- 230000003013 cytotoxicity Effects 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 239000003480 eluent Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 2
- 229940033663 thimerosal Drugs 0.000 description 2
- 239000003899 bactericide agent Substances 0.000 description 1
- 125000002091 cationic group Chemical group 0.000 description 1
- 239000012459 cleaning agent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 150000007530 organic bases Chemical class 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000004753 textile Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
- C11D7/02—Inorganic compounds
- C11D7/04—Water-soluble compounds
- C11D7/10—Salts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B3/00—Cleaning by methods involving the use or presence of liquid or steam
- B08B3/04—Cleaning involving contact with liquid
- B08B3/08—Cleaning involving contact with liquid the liquid having chemical or dissolving effect
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
- C11D7/22—Organic compounds
- C11D7/26—Organic compounds containing oxygen
- C11D7/265—Carboxylic acids or salts thereof
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D2111/00—Cleaning compositions characterised by the objects to be cleaned; Cleaning compositions characterised by non-standard cleaning or washing processes
- C11D2111/10—Objects to be cleaned
- C11D2111/14—Hard surfaces
Landscapes
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
The invention provides a method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment. And cleaning guanidine compounds on the surface of the medical equipment by using an acidic salt solution with a pH value of 1.8-4.0, which is composed of 1-10 g/L citrate, 30-100 g/L sodium chloride, 3-12 g/L ammonium chloride and ammonium sulfate, wherein the medical equipment contains protein combined as a ligand. The method adopts strong acid weak base ammonium salt which is acidic in aqueous solution, and is beneficial to neutralizing and adsorbing guanidine compounds by adding a proper amount of ammonium salt. Sodium citrate is a weak acid strong base salt, and is alkaline in aqueous solution, so the content of citrate can be correspondingly reduced. The cleaning and removing effect of the guanidine compound is excellent, the residual trace amount of the guanidine compound on the surface of the medical equipment can be realized, and the negative influence on the function of the medical equipment containing protein can not be generated.
Description
Technical Field
The invention relates to the technical field of medical equipment cleaning, in particular to a method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment.
Background
Most of the three types of medical devices come into contact with human blood, tissue or body fluids, especially medical devices used in extracorporeal blood circulation, such as dialyzers, filters, perfusors, etc. These medical devices are maintained strictly sterile when blood or body fluids from the body are re-delivered back into the body after contact with the medical devices. Generally, these medical devices are kept sterile by moist heat sterilization or radiation sterilization. In certain cases, however, some medical devices cannot be sterilized by existing sterilization methods because sterilization can compromise the functionality of such medical devices, such as protein-containing hemoperfusions.
To maintain the sterility of medical devices without affecting their function, researchers have used disinfectants, such as thimerosal or sodium azide, to store the medical devices. However, because of the low safety of thimerosal and sodium azide, researchers have used guanidine compounds as novel disinfectants for storing medical instruments.
The guanidine compound serving as a guanidine disinfectant has the advantages of strong bactericidal power, low toxicity, stable property and the like, is widely applied to the industries of medicine, textile, biotechnology and the like, and is also commonly used in hand sanitizer, wet tissues, cosmetics, contact lens care solution, wound dressing and the like. When the guanidine compound is used as a disinfectant of medical instruments, the concentration of the guanidine compound is generally 0.01-0.5 wt%. Although the solution containing the guanidine compound is very suitable for disinfection and storage of medical instruments in an extracorporeal blood circulation system, the guanidine compound is a polymer, has a large molecular weight (Mw 2900-15000), is a cationic bactericide, is very easy to combine with an adsorbent in medical equipment, is difficult to elute from the medical equipment, and affects the safety of the medical instruments. To ensure safety, the active ingredients of the disinfecting agent in the medical device need to be washed clean before use.
Medical devices used in extracorporeal blood circulation are generally flushed with saline prior to use. However, previous studies have shown that when medical devices containing guanidine compounds are washed with physiological saline, the medical devices still have high cytotoxicity (tertiary toxicity). Patent CN100548388 discloses a preservative for medical equipment, which is characterized in that neutral buffer solution, acidic eluent and neutral buffer solution are adopted to wash in sequence, and the composition of eluent, namely the washing step, is complex.
In view of the above, there is a need for an improved cleaning method of medical device disinfectant, which can make the medical device maintain its function and be safe and non-toxic to human body, so as to solve the above problems.
Disclosure of Invention
The invention aims to provide a method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment. The method does not damage the function of the medical apparatus, and can efficiently and quickly flush the disinfectant of the medical apparatus to make the disinfectant safe and harmless to the human body, in particular to the medical apparatus used for extracorporeal blood circulation.
In order to achieve the purpose, the invention provides a cleaning method of a disinfectant containing guanidine compounds on the surface of medical equipment, which comprises the steps of washing the medical equipment for a plurality of times by adopting an acid salt solution with the pH value of 1.8-4.0, wherein the acid salt solution contains 1-10 g/L of citrate, 30-100 g/L of sodium chloride, 3-12 g/L of ammonium chloride and 4-15 g/L of ammonium sulfate; the medical device has a protein that binds as a ligand.
As a further improvement of the invention, the guanidine compound in the disinfectant is polyhexamethylene biguanide hydrochloride.
As a further improvement of the invention, the mass content of the guanidine compound in the disinfectant is 0.01-0.6 wt%.
As a further improvement of the invention, the pH value of the acidic salt solution is 2.0-3.0.
As a further improvement of the invention, the concentration of citrate in the acidic salt solution is 2-3 g/L, the concentration of sodium chloride is 50-60 g/L, and the concentration of ammonium chloride is 8-12 g/L.
As a further improvement of the present invention, the citrate is sodium citrate.
As a further improvement of the invention, the cleaning method is to wash the medical equipment from bottom to top for 5-12 times by using an acidic salt solution with the pH value of 1.8-4.0.
As a further improvement of the invention, when the number of times of washing is 5, the elution rate of the compounds containing guanidine on the surface of the medical equipment is more than 95 percent; when the washing times are 8 times, the elution rate of the guanidine compound on the surface of the medical equipment is more than 99 percent.
As a further improvement of the invention, the medical equipment is a hemoperfusion apparatus, and the elution volume of each flushing is the same as the volume of the adsorption column of the hemoperfusion apparatus.
As a further improvement of the invention, after the blood perfusion is carried out by adopting the medical equipment after the flushing, the content of the guanidine compounds in the perfused blood is less than 0.001 wt%.
The invention has the beneficial effects that:
1. the cleaning method of the disinfectant containing the guanidine compounds on the surface of the medical equipment, provided by the invention, is characterized in that an acid salt solution consisting of 1-10 g/L citrate, 30-100 g/L sodium chloride, 3-12 g/L ammonium chloride and 4-15 g/L ammonium sulfate is adopted to clean the guanidine compounds on the surface of the medical equipment, and a proper amount of ammonium salt is added, so that the cleaning effect is improved. And the elution rate can be optimized by strictly controlling the addition amounts of the four components of citrate, sodium chloride, ammonium chloride and ammonium sulfate.
2. The cleaning method of the disinfectant containing the guanidine compounds on the surface of the medical equipment adopts strong acid weak base ammonium salt which is acidic in an aqueous solution, and is beneficial to neutralizing and adsorbing the guanidine compounds by adding a proper amount of ammonium salt. Citrates such as sodium citrate are weak acid strong base salts, which are basic in aqueous solution, and therefore the citrate content can be reduced accordingly. Finally, the cleaning and removing effect on the guanidine compounds is better in the preferable content range of the invention, and the residual trace effect of the guanidine compounds on the surface of the medical equipment can be realized.
3. The method for cleaning the disinfectant containing the guanidine compound on the surface of the medical equipment has no negative influence on the function of the medical equipment, and the disinfectant can be simply, quickly and efficiently removed before the medical equipment is used.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in detail below with reference to specific embodiments.
It should be noted that, in order to avoid obscuring the present invention with unnecessary details, only the structures and/or processing steps closely related to the scheme of the present invention are shown in the specific embodiments, and other details not closely related to the present invention are omitted.
In addition, it is also to be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
The invention provides a method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment, which comprises the steps of washing the medical equipment for a plurality of times by adopting an acidic salt solution with the pH value of 1.8-4.0, wherein the acidic salt solution contains 1-10 g/L of citrate, 30-100 g/L of sodium chloride, 3-12 g/L of ammonium chloride and 4-15 g/L of ammonium sulfate; the medical device has a protein that binds as a ligand.
Wherein the guanidine compound in the disinfectant is polyhexamethylene biguanide hydrochloride. The mass content of the guanidine compound in the disinfectant is 0.01-0.6 wt%, and the molecular weight is 2900-15000. Polyhexamethylene biguanide hydrochloride is an organic base, and after the polyhexamethylene biguanide hydrochloride is used as a disinfectant of medical equipment, part of the polyhexamethylene biguanide hydrochloride remains on the surface of the medical equipment, so that the residual guanidine compound needs to be cleaned in order to ensure the reuse safety of the medical equipment. Especially, guanidine compounds are adsorbed and remained on the surface of the adsorbent as a disinfectant for hemoperfusion apparatus and the like.
Based on the above, the invention adopts the acidic saline solution with the above formula to wash the medical equipment for a plurality of times. Researches show that the addition of a proper amount of ammonium salt in an acidic salt solution is helpful for improving the cleaning effect. And the elution rate can be optimized by strictly controlling the addition amounts of the four components of citrate, sodium chloride, ammonium chloride and ammonium sulfate.
The pH value of the acidic salt solution is preferably 2.0-3.0.
The concentration of citrate in the acidic salt solution is preferably 2-3 g/L, the concentration of sodium chloride is preferably 50-60 g/L, and the concentration of ammonium chloride is preferably 8-12 g/L. The ammonium salt is strong acid weak base salt, is acidic in aqueous solution, and is beneficial to neutralizing and adsorbing guanidine compounds by adding a proper amount of ammonium salt. Citrates such as sodium citrate are weak acid strong base salts, which are basic in aqueous solution, and therefore the citrate content can be reduced accordingly. Finally, the cleaning and removing effect on the guanidine compounds is better in the preferable content range of the invention, and the residual trace effect of the guanidine compounds on the surface of the medical equipment can be realized.
The citrate is preferably sodium citrate.
The cleaning method preferably adopts an acidic salt solution with the pH value of 1.8-4.0 to wash the medical equipment for 5-12 times from bottom to top. When the number of times of washing is 5, the elution rate of the guanidine compound on the surface of the medical equipment is more than 95%, and when the number of times of washing is 8, the elution rate of the guanidine compound on the surface of the medical equipment is more than 99%.
The medical equipment is a blood perfusion device, and the elution volume of each flushing is the same as the volume of an adsorption column of the blood perfusion device.
After the flushed medical equipment is adopted for blood perfusion, the content of guanidine compounds in perfused blood is less than 0.001 wt%, so that the guanidine compounds on the surface of the medical equipment can be simply, quickly and efficiently eluted by repeatedly flushing the cleaning agent provided by the invention, and the use safety of the medical equipment is obviously improved.
Example 1
A solution having the following composition was prepared as a cleaning solution for a blood perfusion apparatus disinfectant:
2.58g sodium citrate, 58.44g sodium chloride, 10g ammonium chloride, 12g ammonium sulfate;
the solution pH was adjusted to 2.5 and made up to 1L.
Preparing solution with the concentration of 0.04 wt% of polyhexamethylene biguanide hydrochloride as a disinfectant and a preservative of the perfusion device. The cartridge was washed with 2.5L of the disinfectant, 250ml of a blood perfusion device containing protein as a ligand, then the perfusion device was filled with the solution, and the perfusion device was left at 4 ℃ for a while. Then, 2.5L of the cleaning solution prepared above is used for cleaning the blood perfusion device, and the flowing directions of the cleaning solution are from bottom to top. The results of one wash per 250ml wash volume as one elution volume were shown in table 1 for a total of 12 elution volumes.
4 identical perfusion vessels were prepared, washed as described above for 5, 8, 10 and 12 cleaning times, and blood was perfused through medical devices with different cleaning times, and then the content of guanidine compounds in the perfused blood was measured, and the results are shown in table 2.
TABLE 1 elution Effect of example 1 cleaning solution
Table 2 example 1 residual amount of guanidine compounds in blood after different number of washes
From previous experiments it was found that the concentration of polyhexamethylene biguanide hydrochloride as the liquid disinfectant active ingredient filled in the cartridge was below 400mg/L, indicating that reduced amounts of the active ingredient were adsorbed onto the adsorbent of the cartridge. As can be seen from the results of tables 1 and 2, the disinfectant was substantially washed clean after 5 washes, but a small amount of disinfectant residue was detected in the blood after perfusion using blood; after 8 times of cleaning, trace disinfectant residues can be detected in blood; the disinfectant is thoroughly cleaned after 10 times of cleaning, and the residual disinfectant in the blood is lower than the lower detection limit.
Examples 2 to 8 and comparative examples 1 to 3
Examples 2-8 and comparative examples 1-3 provide a method of cleaning a cartridge that is substantially the same as example 1, except that the cleaning solution formulation is shown in table 3. The table shows the mass of solute contained in 1L of cleaning solution, and the pH value of the cleaning solution is 2.5.
TABLE 3 cleaning solution compositions of examples 2-8 and comparative examples 1-3 and guanidine compound content in blood after 10 elution volumes
As can be seen from Table 3, the cleaning solutions of examples 2-8 all eluted most of the disinfectant active ingredients more effectively than the cleaning solutions of comparative examples 1-3. In examples 2-8, the residual disinfectant active ingredient content in the blood was less than 0.001 wt% after perfusion with blood. Experiments prove that 0.001 wt% of polyhexamethylene biguanide hydrochloride has 0-grade cytotoxicity and small harm to human bodies. However, in order to ensure the safety of the medical device to the maximum extent, the amount of the 3 components added in the cleaning solution is controlled so that the residual active components of the disinfectant in the blood after cleaning is less than 10mg/L, preferably less than 5mg/L, and even less than the lower limit of detection (the active components of the disinfectant are not detected basically, as in example 1, examples 5 and 6).
Comparing the effect of the cleaning solutions of comparative examples 1 to 3 on the cleaning of the cartridge, the concentration of the active ingredient of the disinfectant in 10 elution volumes was measured and the results are shown in table 4.
TABLE 4 cleaning elution Effect of comparative examples 1 to 3
As can be seen from table 4, the cleaning solution of example 1 not only cleaned the disinfectant active substances adsorbed on the adsorbent, but also required the least amount of cleaning solution, as compared with the cleaning solutions of comparative examples 1 to 3. It can be seen that the cleaning effect is significantly reduced when no sodium chloride or ammonium chloride is added to the cleaning solution. And when the content of sodium chloride is too low, the cleaning effect is also obviously reduced. The invention is proved that the proper amount of ammonium chloride is added into the acidic salt solution, which is beneficial to improving the cleaning effect. And the elution rate can be optimized by strictly controlling the addition amounts of the four components of citrate, sodium chloride, ammonium chloride and ammonium sulfate.
In summary, the cleaning method of the disinfectant containing the guanidine compounds on the surface of the medical equipment provided by the invention adopts strong acid and weak base ammonium salt, is acidic in an aqueous solution, and is beneficial to neutralizing and adsorbing the guanidine compounds by adding a proper amount of ammonium salt. Sodium citrate is a weak acid strong base salt, and is alkaline in aqueous solution, so the content of citrate can be correspondingly reduced. The cleaning solution can efficiently and quickly remove active substances of the disinfectant in the perfusion apparatus by using a small volume, can realize the effect of trace residual guanidine compounds on the surface of medical equipment, does not generate negative influence on the function of the medical equipment containing protein, and ensures the safety of the perfusion apparatus in use.
Although the present invention has been described in detail with reference to the preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the spirit and scope of the present invention.
Claims (10)
1. A cleaning method of a disinfectant containing guanidine compounds on the surface of medical equipment is characterized in that acidic salt solution with the pH value of 1.8-4.0 is adopted to wash the medical equipment for a plurality of times, wherein the acidic salt solution contains 1-10 g/L of citrate, 30-100 g/L of sodium chloride, 3-12 g/L of ammonium chloride and 4-15 g/L of ammonium sulfate; the medical device has a protein that binds as a ligand.
2. The method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment according to claim 1, wherein the guanidine compounds in the disinfectant are polyhexamethylene biguanide hydrochloride.
3. The method for cleaning the disinfectant containing the guanidine compound on the surface of the medical equipment as claimed in claim 2, wherein the mass content of the guanidine compound in the disinfectant is 0.01-0.6 wt%.
4. The method for cleaning the disinfectant containing the guanidine compound on the surface of the medical equipment as claimed in claim 1, wherein the pH value of the acidic salt solution is 2.0-3.0.
5. The method for cleaning the disinfectant containing the guanidine compounds on the surface of the medical equipment as claimed in claim 1, wherein the concentration of citrate in the acidic salt solution is 2-3 g/L, the concentration of sodium chloride is 50-60 g/L, and the concentration of ammonium chloride is 8-12 g/L.
6. The method of claim 5, wherein the citrate is sodium citrate.
7. The method for cleaning the disinfectant containing the guanidine compounds on the surface of the medical equipment as claimed in claim 1, wherein the cleaning method comprises the step of washing the medical equipment 5-12 times from bottom to top by using an acidic salt solution with a pH value of 1.8-4.0.
8. The method for cleaning the disinfectant containing the guanidine compound on the surface of the medical equipment as claimed in claim 1 or 7, wherein when the number of times of washing is 5, the elution rate of the guanidine compound on the surface of the medical equipment is more than 95%; when the washing times are 8 times, the elution rate of the guanidine compound on the surface of the medical equipment is more than 99 percent.
9. The method for cleaning the disinfectant containing guanidine compounds on the surface of medical equipment according to any one of claims 1 to 8, wherein the medical equipment is a hemoperfusion apparatus, and the elution volume of each flushing is the same as the volume of an adsorption column of the hemoperfusion apparatus.
10. The method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment according to claim 9, wherein the content of guanidine compounds in the perfused blood is less than 0.001 wt% after the blood perfusion is performed by using the medical equipment after the flushing.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3417360A1 (en) * | 1983-05-11 | 1985-01-10 | Kikkoman Corp., Noda | Method for the determination of guanidino compounds and reagent for carrying out the method |
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| WO2001035743A1 (en) * | 1999-11-16 | 2001-05-25 | S. C. Johnson Commercial Markets, Inc. | Fast acting disinfectant and cleaner |
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