CN115970018A - Irradiation sterilization treatment method for silicone rubber breathing tube - Google Patents
Irradiation sterilization treatment method for silicone rubber breathing tube Download PDFInfo
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- CN115970018A CN115970018A CN202211614425.2A CN202211614425A CN115970018A CN 115970018 A CN115970018 A CN 115970018A CN 202211614425 A CN202211614425 A CN 202211614425A CN 115970018 A CN115970018 A CN 115970018A
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Abstract
The invention provides an irradiation sterilization treatment method for a silicon rubber breathing tube, which comprises the following steps: s1: spraying the treating agent on the surface of a breathing tube, standing for 10-30min, drying the breathing tube, and packaging into a sterile packaging bag; s2: and (5) performing irradiation sterilization on the aseptically packaged respiratory tube obtained in the step (S1). The sterilization treatment method adopts the cobalt source irradiation method, has high sterilization efficiency, and can effectively kill bacteria and viruses. The material has a certain protection effect, can effectively avoid the problems of poor mechanical property, yellowing, material decomposition and the like caused by the change of material properties after the polymer material is subjected to radiation sterilization, and is suitable for medical instruments of polymer materials, particularly radiation sterilization treatment of silicone rubber breathing tubes.
Description
Technical Field
The invention relates to the technical field of irradiation sterilization of medical instruments, in particular to an irradiation sterilization treatment method for a silicone rubber breathing tube.
Background
The medical instruments need to be sterilized before use, and common sterilization techniques include dry heat sterilization, moist heat sterilization, ethylene oxide sterilization, radiation sterilization, plasma sterilization, filtration sterilization and the like.
Radiation sterilization is an effective method of killing microorganisms on most substances using ionizing radiation. Examples of electromagnetic waves used for sterilization include microwave, ultraviolet (UV), X-ray, and gamma-ray. They all control the growth of microorganisms or kill microorganisms in a specific manner. Compared with the traditional autoclave sterilization and ethylene oxide sterilization, the irradiation sterilization has the following advantages: (1) the physical penetration capacity is strong, and the sterilization is uniform and thorough; (2) no sterilizing agent pollution residue exists; (3) can be used for sterilizing heat-sensitive materials at room temperature; (4) the sterilization process does not contain water vapor, and can be used for sterilizing damp-proof medical instruments; (5) the sterilization efficiency is high, and the operation is simple; (6) stable process and low energy consumption. Radiation sterilization has become one of the common sterilization methods for sterile medical devices of the terminal sterilization type.
However, the polymer of medical devices containing high molecular materials is changed after being irradiated and sterilized by a cobalt source. Polymethyl methacrylate, ultra-high molecular weight polyethylene, polyvinyl chloride, silicone rubber, and the like are radiation sensitive polymers in which standard metered gamma radiation (25 kGy) sterilization causes irreversible structural changes. Such as gamma radiation, induces the dehydrogenation of alpha-methyl or methylene groups in the polymethylmethacrylate and the generation of free radicals in the ultra-high molecular weight polyethylene, resulting in irreversible structural changes in devices containing polymethylmethacrylate and ultra-high molecular weight polyethylene. Chinese patent CN109069697B discloses a method for sterilizing cornea by irradiation and a sterilized cornea, wherein the transparency, toughness and hydrophilicity of the cornea after gamma-ray irradiation sterilization are hardly changed, which is beneficial to prolonging the preservation time of the cornea. However, the method of radiation sterilization has narrow applicability and complicated treatment process.
Therefore, the development of an irradiation sterilization method which is suitable for medical devices containing high molecular materials, can effectively kill bacteria and viruses, has a simple treatment method and is efficient remains a problem to be solved.
Disclosure of Invention
Aiming at the problems, the invention provides an irradiation sterilization treatment method for a silicon rubber breathing tube, which adopts a cobalt source irradiation method, has high sterilization efficiency and can effectively kill bacteria and viruses.
The invention provides a radiation sterilization treatment method for a silicone rubber breathing tube, which specifically comprises the following steps:
s1: spraying the treating agent on the surface of a breathing tube, standing for 10-30min, drying the breathing tube, and packaging into a sterile packaging bag;
s2: and (5) performing irradiation sterilization on the aseptically packaged respiratory tube obtained in the step (S1).
Preferably, the irradiation sterilization in step S2 adopts 60 And (5) performing Co-gamma ray irradiation sterilization.
Preferably, the temperature for radiation sterilization is 5-50 ℃.
Further preferably, the temperature for radiation sterilization is 20-30 ℃.
Preferably, the dose of the radiation sterilization is 15 to 40KGy.
Further preferably, the dose of the radiation sterilization is 20 to 30KGy.
Preferably, the humidity of the radiation sterilization is 10-100%.
Further preferably, the humidity of the radiation sterilization is 20-50%.
Preferably, the time for radiation sterilization is 15-45min.
Preferably, the treating agent is sprayed to a thickness of 1 to 100 μm.
Preferably, the treating agent comprises, by weight, 3-8 parts of a free radical scavenger, 1-4 parts of persulfate, 5-10 parts of chitosan, 1-8 parts of alcohol and 70-100 parts of water.
Preferably, the free radical scavenger is one or more of vitamin E, tea polyphenol, vitamin C, beta-carotene and selenium as trace element.
Further preferably, the free radical scavenger is vitamin C and tea polyphenol.
Further preferably, the mass ratio of the vitamin C to the tea polyphenol is 1.
When the gamma ray is used for carrying out irradiation sterilization treatment on the material, the gamma ray can oxidize other substances or generate free radicals to act on biomolecules, or directly act on the biomolecules to break hydrogen bonds, oxidize double bonds, destroy ring structures or polymerize certain molecules and the like, so that the structures of the biomacromolecules are destroyed and changed, and microorganisms are inhibited or killed. However, after medical devices made of high molecular materials are subjected to radiation sterilization, on one hand, the polymer structure of the medical devices may be changed; on the other hand, the material which is particularly suitable for silicon-containing rubber is strongly oxidized due to a large number of radicals generated by irradiation 60 The problems of reduced elasticity, poor mechanical property and the like occur after Co irradiation sterilization.
The inventor finds that when vitamin C and tea polyphenol are used as the free radical scavenger, especially when the mass ratio of the vitamin C to the tea polyphenol is 1-2.5, the scavenging effect of the free radicals is excellent, and the oxidation of the silicone rubber material can be effectively avoided. The inventors analyzed, probably because the simultaneous action of vitamin C and tea polyphenol helps to promote the reaction between it and free radicals. The tea polyphenol and the vitamin C reduce the potential difference between two substances through the coupling oxidation based on the redox potential difference, so that the reaction is easy to carry out, and on the other hand, the oil-water distribution coefficients of the two antioxidants are mutually complemented and reasonably distributed in a system, so that the effect of each antioxidant is fully exerted. And, the inventor analyzed that when vitamin C and tea polyphenol both constitute an antioxidant system, the antioxidant mainly comprising tocopherol can provide hydrogen atoms to become tocopherol radicals which lose the antioxidant property, but at the same time, vitamin C can provide hydrogen atoms to tocopherol to enable the tocopherol to regain the antioxidant property, thereby effectively maintaining and enhancing the radical scavenging effect. However, if the amount of the vitamin used is too large, the radical scavenging effect is rather lowered. It is possible that the excessive vitamins affect the balance of the antioxidant system formed and the antioxidant effect is reduced.
Further preferably, the radical scavenger further comprises a peroxidase.
More preferably, the peroxidase is 10-20% of the radical scavenger.
Further preferably, the peroxidase is one or more of superoxide dismutase, catalase and glutathione peroxidase.
Preferably, the peroxidase is superoxide dismutase.
Preferably, the persulfate is one or more of ammonium persulfate, potassium persulfate and sodium persulfate.
Further preferably, the persulfate is potassium persulfate.
In order to better reduce oxidation and molecular structure change of the silicone rubber material and avoid affecting the elasticity and other properties of the silicone rubber material, preferably, the chitosan is phenolic acid modified chitosan.
Further preferably, the mass ratio of the phenolic acid to the chitosan is 0.1-0.3.
Preferably, the phenolic acid is one or more of gentisic acid, protocatechuic acid, caffeic acid and gallic acid.
Preferably, the phenolic acid is gallic acid.
Further preferably, the chitosan has an average molecular weight of 2000-3000Da.
Chitosan is a natural aminopolysaccharide which has certain antioxidant activity and bacteriostatic activity, but the antioxidant activity is low. However, the inventors have found that when chitosan is used, the change in the properties of the material after sterilization treatment is low, the elasticity thereof can be effectively maintained, and excellent properties such as aging resistance are provided. The inventor analyzes that probably because the chitosan material can form a layer of protective film on the surface of the material, the chitosan material can effectively prevent the water transfer between the material and the environment, avoid the influence of water molecules on the surface of the material on the performance of the material under the irradiation condition, reduce the contact reaction between free radicals and high molecular polymers, and avoid the problems of oxidation, poor elasticity and the like of the silicon rubber material.
In particular, when the phenolic acid-modified chitosan is used, the effect thereof can be further enhanced. The inventor analyzes that the functional groups (-OH/-NH) of the modified chitosan material are probably caused 2 ) The hydrogen bonding between the silicon rubber material and water molecules is destroyed by phenolic acid, so that the water molecule content on the surface of the silicon rubber material is further reduced, and the content of surface free radicals is reduced. Meanwhile, the inventor unexpectedly discovers that the long-acting oxidation resistance of the modified chitosan can be further enhanced, and the modified chitosan has a long-lasting free radical scavenging effect. Probably because the treating agent system simultaneously contains vitamin C, the used phenolic acid ester and active oxygen molecules are subjected to redox reaction to generate phenoxy free radicals, and the vitamin C can reduce the phenoxy free radicals to promote the phenolic acid ester to be regenerated and is acted with other components in the system together to achieve reaction balance, so that the long-time free radical scavenging effect can be kept, and the problems of oxidative yellowing of the silicon rubber material, poor elasticity, poor aging resistance and the like are avoided. However, if the radical scavenging action of the treatment agent is too strong, the sterilization effect by irradiation may be adversely affected.
Further preferably, the preparation method of the phenolic acid modified chitosan comprises the following steps:
step 1: adding dried chitosan into an acetic acid solution, and uniformly stirring to obtain a mixed solution A;
step 2: dissolving phenolic acid and 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide hydrochloride in ethanol, adding N-hydroxysuccinimide, and stirring for 1h in ice bath to obtain a mixed solution B;
and step 3: dropwise adding the mixed solution B into the mixed solution A, and stirring in an ice bath for 40min;
and 4, step 4: and standing the mixture for 24h, centrifuging, taking supernatant, dialyzing, and drying to obtain the phenolic acid modified chitosan.
Preferably, the alcohol is one or more of isopropanol, ethanol, n-butanol, n-octanol, n-pentanol and polyethylene glycol.
Preferably, the alcohol is polyethylene glycol.
Further preferably, the polyethylene glycol has an average molecular weight of 2500-5000Da.
Compared with the prior art, the invention has the following beneficial effects:
the sterilization treatment method adopts the cobalt source irradiation method, has high sterilization efficiency, and can effectively kill bacteria and viruses. The material has a certain protection effect, can effectively avoid the problems of poor mechanical property, yellowing, material decomposition and the like caused by the change of material properties after the high polymer material is subjected to irradiation sterilization, and is particularly suitable for the irradiation sterilization treatment of the silicone rubber breathing tube.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be noted that the following examples are intended to further illustrate the present invention, but are not intended to limit the present invention.
Examples
Example 1
The embodiment provides an irradiation sterilization treatment method for a silicone rubber breathing tube, which specifically comprises the following steps:
s1: spraying the treating agent on the surface of a breathing tube, standing for 15min, drying the breathing tube, and then filling into a sterile packaging bag;
s2: and (5) performing irradiation sterilization on the aseptically packaged respiratory tube obtained in the step (S1).
And the irradiation sterilization in the step S2 adopts 60 Co-gamma ray irradiation sterilization.
The temperature of irradiation sterilization is 25 ℃; the dose of radiation sterilization is 25KGy; the humidity of irradiation sterilization is 30%; the irradiation sterilization time is 30min; the sprayed thickness of the treating agent was about 30 μm.
The treating agent comprises, by weight, 3 parts of a free radical scavenger, 1 part of persulfate, 5 parts of chitosan, 1 part of alcohol and 70 parts of water.
The free radical scavenger is vitamin C and tea polyphenol (the total mass of the vitamin C and the tea polyphenol is 3 parts) with the mass ratio of 1; the persulfate is potassium persulfate; the chitosan is gallic acid modified chitosan; the alcohol is polyethylene glycol.
The preparation method of the gallic acid modified chitosan comprises the following steps:
step 1: adding dried 2g of chitosan into 100ml of acetic acid solution, and uniformly stirring to obtain a mixed solution A;
and 2, step: dissolving 0.4g of gallic acid and 0.3g of 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide hydrochloride in 10ml of ethanol, adding 0.25g of N-hydroxysuccinimide, and stirring for 1h in ice bath to obtain a mixed solution B;
and 3, step 3: dropwise adding the mixed solution B into the mixed solution A, and stirring in an ice bath for 40min;
and 4, step 4: and standing the mixture for 24h, centrifuging for 30min at the speed of 1000r/min, taking supernatant, dialyzing for 3d with deionized water, and freeze-drying a sample to obtain the phenolic acid modified chitosan.
Vitamin C was purchased from Shanghai Michelin Biotechnology, inc.; tea polyphenols are purchased from Shanghai Maxin Biotechnology, inc.; superoxide dismutase was purchased from Shanghai Maxin Biotechnology, inc.; chitosan was purchased from Shanghai Maxin Biotechnology, inc.; gallic acid was purchased from Shanghai Merlin Biotechnology, inc.; polyethylene glycol was purchased from Shandong Kunbo Biotech, inc.
1-ethyl-3- (3-dimethylaminopropyl) carbodiimide hydrochloride has a CAS number of 25952-53-8; the CAS number for N-hydroxysuccinimide is 6066-82-6.
Example 2
The embodiment provides an irradiation sterilization treatment method for a silicone rubber breathing tube, which specifically comprises the following steps:
s1: spraying the treating agent on the surface of the breathing tube, standing for 15min, drying the breathing tube, and packaging into sterile packaging bags;
s2: and (5) performing irradiation sterilization on the aseptically packaged respiratory tube obtained in the step (S1).
And the irradiation sterilization in the step S2 adopts 60 Co-gamma ray irradiation sterilization.
The temperature of irradiation sterilization is 25 ℃; the dose of radiation sterilization is 25KGy; the humidity of irradiation sterilization is 30 percent; the irradiation sterilization time is 30min; the sprayed thickness of the treating agent was about 30 μm.
The treating agent comprises, by weight, 8 parts of a free radical scavenger, 4 parts of persulfate, 10 parts of chitosan, 8 parts of alcohol and 100 parts of water.
The free radical scavenger is vitamin C and tea polyphenol (the total mass of the vitamin C and the tea polyphenol is 8 parts) with the mass ratio of 1; the persulfate is potassium persulfate; the chitosan is gallic acid modified chitosan; the alcohol is polyethylene glycol.
The preparation method of gallic acid modified chitosan is the same as example 1.
The specific raw material sources of this example are the same as those of example 1.
Example 3
The embodiment provides an irradiation sterilization treatment method for a silicone rubber breathing tube, which specifically comprises the following steps:
s1: spraying the treating agent on the surface of the breathing tube, standing for 15min, drying the breathing tube, and packaging into sterile packaging bags;
s2: and (5) performing irradiation sterilization on the aseptically packaged respiratory tube obtained in the step (S1).
And the irradiation sterilization in the step S2 adopts 60 Co-gamma ray irradiation sterilization.
The temperature of irradiation sterilization is 25 ℃; the dose of radiation sterilization is 25KGy; the humidity of irradiation sterilization is 30 percent; the irradiation sterilization time is 30min; the sprayed thickness of the treating agent was about 30 μm.
The treating agent comprises, by weight, 5 parts of a free radical scavenger, 2.5 parts of persulfate, 8 parts of chitosan, 4 parts of alcohol and 85 parts of water.
The free radical scavenger is vitamin C and tea polyphenol (the total mass of the vitamin C and the tea polyphenol is 5 parts) with the mass ratio of 1; the persulfate is potassium persulfate; the chitosan is gallic acid modified chitosan; the alcohol is polyethylene glycol.
The preparation method of gallic acid modified chitosan is the same as example 1.
The specific raw material sources of this example are the same as those of example 1.
Example 4
The embodiment provides a radiation sterilization treatment method for a silicone rubber breathing tube, which is implemented by the same steps as embodiment 3, and is different from embodiment 3 in that the mass ratio of vitamin C to tea polyphenol is 1.
Example 5
The embodiment provides a radiation sterilization treatment method for a silicone rubber breathing tube, which has the same specific implementation steps as embodiment 3, and is different from embodiment 3 in that the mass ratio of gallic acid to chitosan in modified chitosan is 0.1.
Comparative example 1
The embodiment provides a radiation sterilization treatment method for a silicone rubber breathing tube, which is implemented by the same steps as embodiment 3, and is different from embodiment 3 in that the free radical scavenger is tea polyphenol and superoxide dismutase.
Comparative example 2
The embodiment provides a radiation sterilization treatment method for a silicone rubber breathing tube, which is implemented by the same steps as embodiment 3, and is different from embodiment 3 in that chitosan is unmodified chitosan.
Comparative example 3
The embodiment provides a radiation sterilization treatment method for a silicone rubber breathing tube, which is implemented by the same steps as embodiment 3, and is different from embodiment 3 in that the mass ratio of vitamin C to tea polyphenol is 1.
Performance test
1. Colony number detection
The initial contamination detection was performed according to the detection method in GB16383 2014 quality control for radiation sterilization and disinfection of medical and health products, and the sterility of the sterilized material was checked according to the sterility test method in the pharmacopoeia of the people's republic of china (second part) (2020 edition).
2. Yellowing resistance test
And (3) carrying out a yellowing resistance grade test by using a lamp tube type yellowing resistance tester, installing an ultraviolet lamp tube in a test box working chamber, controlling the temperature in the test box to be 50 ℃, selecting the ultraviolet lamp tube with the specification of 15W and the wavelength of 280-400 mm to irradiate the sample for 12 hours, and comparing the irradiated sample with a colorimetric card for standard judgment.
The silicone rubber breathing tubes of examples 1-5 and comparative examples 1-3 were tested for sterilization effect and the results are shown in table 1 below.
Claims (10)
1. An irradiation sterilization treatment method for a silicone rubber breathing tube is characterized by comprising the following steps:
s1: spraying the treating agent on the surface of the breathing tube, standing for 10-30min, drying the breathing tube, and packaging into sterile packaging bags;
s2: and (5) performing irradiation sterilization on the aseptically packaged respiratory tube obtained in the step (S1).
2. The method for radiation sterilization treatment of silicone rubber breathing tube according to claim 1, wherein the radiation sterilization in step S2 is performed by 60 And (5) performing Co-gamma ray irradiation sterilization.
3. The radiation sterilization treatment method for the silicone rubber breathing tube according to claim 1, wherein the temperature of the radiation sterilization is 5-50 ℃.
4. The method according to claim 1, wherein the radiation sterilization dose is 15-40KGy.
5. The radiation sterilization treatment method for the silicone rubber breathing tube according to claim 1, wherein the radiation sterilization time is 15-45min.
6. The radiation sterilization treatment method for the silicone rubber breathing tube according to claim 1, wherein the treatment agent in step S1 comprises 1-8 parts by weight of a radical scavenger, 1-4 parts by weight of persulfate, 5-10 parts by weight of chitosan, 1-10 parts by weight of alcohol, and 80-100 parts by weight of water.
7. The method of claim 6, wherein the free radical scavenger is one or more of vitamin E, tea polyphenols, vitamin C, beta-carotene, and selenium.
8. The method of claim 7, wherein the free radical scavenger is ascorbic acid and tea polyphenols.
9. The radiation sterilization treatment method for the silicone rubber breathing tube according to claim 8, wherein the mass ratio of the vitamin C to the tea polyphenol is 1.
10. The method of claim 6, wherein the chitosan is phenolic acid modified chitosan.
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