CN116784324A - Foam disinfectant for invisible appliance, preparation method and application thereof - Google Patents

Foam disinfectant for invisible appliance, preparation method and application thereof Download PDF

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Publication number
CN116784324A
CN116784324A CN202310717924.2A CN202310717924A CN116784324A CN 116784324 A CN116784324 A CN 116784324A CN 202310717924 A CN202310717924 A CN 202310717924A CN 116784324 A CN116784324 A CN 116784324A
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China
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test
disinfectant
appliance
invisible appliance
foam
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黄香花
庄永辉
杨宇昊
黄婕妤
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Jiangsu Enwei Zhongxin Biopharmaceutical Co ltd
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Jiangsu Enwei Zhongxin Biopharmaceutical Co ltd
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Abstract

The invention discloses a foam disinfectant for an invisible appliance, which comprises the following raw materials in percentage by weight: 0.13-0.16% of benzalkonium chloride, 0.3-1.0% of sodium benzoate, 3-9% of glycerin, 9-15% of cocamidopropyl betaine, 0.2-1.0% of essence and the balance of purified water. The invention has simple and convenient process, easy method, obvious sterilization effect and capability of removing false tooth sediment; the invention has good effect of removing dirt and foreign odor on the false tooth, can effectively eliminate the harmful substances such as tooth face pigment deposition, dirt, bacteria and the like, has strong sterilization, is safe and nontoxic, has no corrosiveness on false tooth base materials, is convenient to use, and is an ideal sanitary article; the denture can be effectively kept bright and white from inside to outside after long-term use, has no damage to the denture, and is worthy of popularization and use; the surfactant can remove grease and protein substances adhered to the surface of the denture, and the bactericide can further strengthen the sterilization effect and has less damage to denture materials.

Description

Foam disinfectant for invisible appliance, preparation method and application thereof
Technical Field
The invention relates to the technical field of foam disinfectant, in particular to a foam disinfectant for an invisible appliance and a preparation method thereof.
Background
With the improvement of resident income, the oral consumption concept of residents in China is improved, the speed increase of the invisible orthodontic market is huge and is higher than the overall speed increase of the oral industry, the invisible orthodontic is that a dental socket made of transparent materials is worn in a patient's mouth, and the dental socket is used for exerting a constant force and controlling the moving direction on teeth, so that the aim of orthodontic teeth is achieved. The current amount of invisible orthodontic cases in China is about 10 tens of thousands of cases per year, and still has a high-speed increasing trend.
The invisible appliance is a thermoplastic removable transparent appliance which appears at the end of the 90 th century, and an arch wire and a bracket are not used in the process of correction, so that the invisible appliance can be removed without affecting the beauty. To achieve sustained tooth movement, each appliance needs to be worn in the mouth of the patient for 1-2 weeks, with a daily wear time of greater than 20 hours. It has been found that even if a patient strictly follows the order to maintain the hygiene of the oral cavity and the appliance during orthodontic treatment, the surface of the appliance adsorbs oral microorganisms, dental plaque biofilm is formed on the surface of the material, and a large amount of plaque accumulation increases the susceptibility to oral diseases. Thus having an important role in cleaning the worn invisible appliance.
The growth of plaque biofilm not only affects the aesthetics of the appliance, but is also a potential risk factor for the development of bacterial related diseases. After 6 months of orthodontic treatment, the total number of bacteria of streptococcus mutans, lactobacillus and candida albicans in the mouth can be greatly increased, and periodontal disease, halitosis and caries are extremely easy to cause. The cleaning of the appliance not only can reduce bacteria from entering the oral cavity, but also can keep the beauty, transparency and no peculiar smell of the appliance, and has a certain influence on the performance of the appliance, so that the final correction effect can be influenced to a certain extent.
Currently, the cleaning methods of the appliance mainly comprise a physical method and a chemical method. The physical cleaning mainly adopts toothbrush brushing, but the brushing can only remove partial dental plaque, the appliance is difficult to clean at the part close to the tooth tip and the concave part of the accessory, and the light transmittance and the elasticity of the appliance are greatly reduced due to the friction and abrasion of the toothbrush, so that the mechanical property of the appliance is reduced. Chemical cleaning mainly comprises various types of cleaning agents, such as hydrogen peroxide cleaning agents, mouthwash, chlorhexidine solution, biomembrane cleaning agents and the like, wherein the appliance is soaked or brushed, and then thoroughly washed by flowing water and worn. The chemical cleaning method can effectively reduce the accumulation of dental plaque, but has complicated operation and short effect, and the use of the strong oxidation bactericide easily causes the mechanical property attenuation of the appliance material to influence the correction accuracy; the surface roughness of the appliance is increased, bacterial plaques are more easily attached, the light transmittance is reduced, and the aesthetic effect is reduced.
False stomatitis, i.e. chronic erythema type candidal stomatitis, is common in elderly people wearing complete dentures, but can also be seen in patients receiving orthodontic treatment, especially patients wearing removable appliances throughout the day, such as functional appliances, removable retainers. Incorrect treatment not only causes local discomfort such as burning sensation in the mouth, pain, but serious one may also cause systemic infection. The etiology study of denture has confirmed that denture stomatitis is associated with bacteria on the denture. The conventional denture cleanser is evaluated for detergency and sterilizing power, and the cleaning effect of the denture cleanser is not ideal, so that the product has low effectiveness or has no sterilizing capability under clinical conditions in terms of capability of removing deposits on the denture, and the hypochlorite and other components in the product have strong sterilizing function, but have corrosiveness on the base material of the denture and possibly burn the oral mucosa of a wearer under the condition of incomplete rinsing. It has been considered that plaque microorganisms attached to dentures or appliances are the causative agent of candidal stomatitis. The number of candida albicans in patients with denture stomatitis is about 150 times that in healthy people. In addition to daily oral hygiene measures, cleaning of the removable appliance with foam sanitizing is necessary. The false tooth is easier to attach bacteria, deposit dirt and pigment than the true tooth, form calculus, seriously affect the oral hygiene of a patient wearing the false tooth, and the false tooth needs to be disinfected and cleaned frequently and is not thoroughly cleaned and disinfected, so that peculiar smell can be generated, diet is affected, gastrointestinal functions are reduced, bacteria are bred, and ulcers or other oral and visceral diseases are caused.
Disclosure of Invention
Aiming at the defects and shortcomings of the prior art, the invention provides the invisible appliance foam disinfectant which is simple in process, feasible in method, capable of removing false tooth sediment and remarkable in sterilization effect, and the preparation method and the application thereof.
In order to achieve the above purpose, the invention adopts the following technical scheme:
the foam disinfectant for the invisible appliance is characterized by comprising the following raw materials in percentage by weight: 0.13-0.16% of benzalkonium chloride, 0.3-1.0% of sodium benzoate, 3-9% of glycerin, 9-15% of cocamidopropyl betaine, 0.2-1.0% of essence and the balance of purified water.
The preparation method of the foam disinfectant for the invisible appliance is characterized by comprising the following steps of:
s1, heating purified water to about 35 ℃, adding benzalkonium chloride, sodium benzoate and glycerin, and stirring for 20 minutes to obtain a solution I;
s2, uniformly stirring cocoamidopropyl betaine and essence to obtain a solution II;
and S3, adding the solution II into the solution I, and stirring for 10 minutes to form a uniform solution, thus obtaining the foam disinfectant.
The application of the foam disinfectant for the invisible appliance is characterized in that: and uniformly smearing foam generated by the foam disinfectant according to the pressure pump head on the invisible appliance, standing for 10 minutes, and then flushing with clear water.
The invention has the beneficial effects that:
the invention has simple and convenient process, easy method, obvious sterilization effect and capability of removing false tooth sediment; after a large number of toxicity, corrosion resistance, bacteriostasis and cleaning effect tests are passed, the invention has good effect of removing dirt and foreign odor on false teeth, can effectively eliminate harmful substances such as tooth face pigment deposition, dirt, bacteria and the like, has strong sterilization, is safe and nontoxic, has no corrosiveness on false tooth base materials, is convenient to use, and is an ideal cleaning and hygienic product. The denture can be used for a long time, can effectively keep the denture bright and white from inside to outside, has no damage to the denture, and is worthy of popularization and use. The surfactant can remove grease and protein substances adhered to the surface of the denture, and the bactericide can further strengthen the sterilization effect and has less damage to denture materials. The addition of the foaming agent is beneficial to further prolonging the service life, is used for multi-surface disinfection, and does not cause damage.
Detailed Description
The following examples are provided to further illustrate the invention.
The present invention will be described in further detail with reference to specific embodiments in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the detailed description is presented by way of example only and is not intended to limit the invention.
Example 1
The foam disinfectant for the invisible appliance consists of the following raw materials in percentage by weight: 0.13-0.16% of benzalkonium chloride, 0.3-1.0% of sodium benzoate, 3-9% of glycerin, 9-15% of cocamidopropyl betaine, 0.2-1.0% of essence and the balance of purified water.
In this embodiment:
1. benzalkonium chloride (main bactericide): sterilizing antiseptic and medicinal auxiliary material
1.1 as a cationic surfactant bactericide, can change the permeability of bacterial plasma membrane, enable bacterial cytoplasmic substances to extravasate, prevent metabolism and kill gram positive bacterial propagules, has stronger killing effect on the gram positive bacterial propagules and has no irritation to skin when the dosage is lower.
1.2, the disinfectant belongs to a dual-function disinfectant, and can kill bacteria and fungi and inactivate viruses; in addition, the disinfectant is low in toxicity, small in irritation, good in water solubility, convenient to use and store, and widely applied to skin and environment disinfection.
2. Sodium benzoate: preservative and pharmaceutical auxiliary materials.
2.1 preventing the growth and reproduction of microorganisms in the product;
2.2 has broad-spectrum antibacterial ability, no toxicity and skin irritation.
3. Glycerol: humectant, solvent and medicinal adjuvants.
3.1 maintaining moisture and reducing the freezing point of the product.
4. Cocamidopropyl betaine: solubilizers, emulsifiers, foaming agents, zwitterionic surfactants, derived from coconut oil.
4.1 and anionic, cationic, nonionic and other amphoteric surfactants have better compatibility. Avoiding the problem of poor compatibility of anions and cations and forming water-insoluble compound.
4.2 has good softness and abundant and stable foam. Has good decontamination, conditioning and antistatic effects. Stable in a wide pH range, and has small irritation to skin and eyes. The synergistic effect is generated by matching with other active substances, and the product is especially suitable for preparing mild infant products.
4.3 can be used in any pH value environment, has good compatibility with other surfactants, is hard water resistant, nontoxic, has small irritation, and can be foamed, decontaminated and antistatic.
4.4 the oil-soluble substances such as essence and the like are uniformly combined with other components to form a stable system through emulsification.
4.5 dissolving water-insoluble or slightly water-soluble substances such as greasy dirt and the like into water through the solubilization, so as to achieve the aim of washing, decontaminating, dispersing or suspending dirt and removing peculiar smell.
5. Essence: and the flavoring agent is used for covering bad smell of the raw materials.
6. The purified water adopts secondary purified water, and the ion quantity is low.
The invention mainly uses benzalkonium chloride quaternary ammonium salt to sterilize and disinfect, the surfactant dissolves the stain, water, preservative, humectant, etc., mainly used for cleaning and disinfecting the invisible appliance, for the invisible appliance, most of the like products on the market are soaked after the denture cleaning sheet is dissolved in water, the invention directly acts on the invisible appliance, and the operation is simple, convenient, efficient and time-saving.
1. The quaternary ammonium salt cationic surfactant with benzyl in the molecular structure has stronger bactericidal property; the cationic charges attach to the cell wall of the microorganism, destroy certain enzymes in the cell wall, affect the normal metabolic processes of the microorganism, and finally lead to the death of the microorganism.
2. The essence is solubilized by the surfactant, so that the essence is prevented from being separated out due to water insolubility.
3. The dirt is dispersed and suspended in water by utilizing the solubilization, emulsification and foaming actions of the surfactant, so as to achieve the purposes of decontamination and deodorizing.
Example 2
A preparation method of foam disinfectant for an invisible appliance comprises the following steps:
s1, heating purified water to about 35 ℃, adding benzalkonium chloride, sodium benzoate and glycerin, and stirring for 20 minutes to obtain a solution I;
s2, uniformly stirring cocoamidopropyl betaine and essence to obtain a solution II;
and S3, adding the solution II into the solution I, and stirring for 10 minutes to form a uniform solution, thus obtaining the foam disinfectant.
Example 3
The application of the foam disinfectant for the invisible appliance comprises uniformly smearing foam generated by a foam disinfectant pressing pump head on the invisible appliance, standing for 10min, and then flushing with clear water.
Example 4
The metal corrosiveness is detected, and the detection conditions are as follows:
1. equipment and method for manufacturing the same
1. Sample information: foam disinfectant for invisible appliance as test object
2 instrument equipment: electronic balance ME204 (WPE-RHO 131)
2. Method of
1. Inspection according to the disinfection technical Specification (2002 edition) 2.2.4
2. Detection environment: temperature: 25.2 ℃, humidity: 60% RH
3. Results
The test results of the corrosion rate and degree of the test object on the metal stainless steel, aluminum, carbon steel and copper are shown in the following table 1
TABLE 1 test results of metal corrosiveness detection
4. Conclusion(s)
The sample slightly corrodes metal stainless steel, and a small amount of rust is on the surface; slightly corroding aluminum, and slightly rust on the surface; the carbon steel is basically free from corrosion, and the surface is free from obvious change; copper is basically free from corrosion, the surface is free from obvious change, and the requirements of enterprise standard Q/320684EWZX033-2021 are met
Example 5
The disinfection simulation field test of the medical instrument is as follows:
1. equipment and method for manufacturing the same
1. Sample: the sample concentration of the invisible appliance foam disinfectant is stock solution.
2. 3% bovine serum albumin, standard hard water, tryptone soy agar medium (TSA); sand agar medium.
3. Dilution liquid: tryptone physiological saline solution (TPS).
4. Neutralizing agent: PBS solution of 2.0% tween 80+0.3% lecithin +0.3 sodium thiosulfate.
5. Aseptic graduated pipette, aseptic plate, test tube, constant temperature incubator, aseptic scissors, etc.
2. Method of
1. According to the disinfection technical Specification (2002 edition) 2.1.2.2
2. The neutralizer identification test adopts a suspension method identification test, and a pseudomonas aeruginosa (ATCC 15442) neutralizer selection test is carried out, wherein the sample concentration is stock solution, and the action time is 10min. The test temperature was 20.+ -. 1 ℃.
3. In-situ test of disinfection simulation of disinfectants on medical instruments, the test temperature is 20+/-1 ℃, and the relative humidity is as follows: 45%.
4. The disinfectant for the test is a stock solution of foam disinfectant for the invisible appliance, and the disinfection method comprises the following steps: soaking, and the action time is as follows: and 10min.
5. Sample for field test: hemostatic forceps.
1, a treatment method comprises the following steps: taking a sample stock solution, using sterile forceps to enable the tooth surface of the hemostatic forceps to face upwards, fixing the hemostatic forceps on a sterile support, using a sterile suction tube to drop and dye the 0.02m1 pseudomonas aeruginosa suspension on the tooth part, using a sterile L-shaped platinum wire to coat the suspension uniformly, and placing the suspension in a 37 ℃ incubator for drying for later use. Preparing disinfectant according to the dosage of 10m1 of each sample, and placing the disinfectant in a water bath at 20+/-2 ℃ for heat preservation for 5min. Immersing 30 bacteria-infected samples into a disinfectant for disinfection treatment for 10min, taking out the samples, and transferring the samples into a 10m1 neutralizer solution test tube to serve as test group samples.
2, replacing disinfectant with sterile distilled water, culturing and counting live bacteria in the same way on the same condition of three bacteria-infected samples, wherein the bacterial load of the bacteria-infected samples is 5×10 as the positive control group sample 5 cfu/sample-5×10 6 cfu/sample.
3 after the experiment is finished, the culture medium is inoculated with the unused neutralizer in the same batch, sampling liquid and diluent to be used as a negative control group sample. Detecting the number of samples: 30 samples.
3. Results
1. Pseudomonas aeruginosa neutralizer identification test
1.1 each experiment the first group grew aseptically and the second group grew aseptically. The second group has more growing bacteria than the first group, but has less growing bacteria than the first group, and the error rates among the 3 rd group, the 4 th group and the 5 th group are respectively 4.69%, 4.57% and 2.67%.
The serial numbers and the contents of each group in the table 1.2 are the same as those in the disinfection technical Specification (2002.1.1).
1.3 neutralization agent identification test results are shown in Table 1.
TABLE 1 results of Pseudomonas aeruginosa neutralizer identification test
4. Test results
The stock solution of the invisible appliance foam disinfectant for the inspection sample acts for 10min, and the average killing logarithmic value of the disinfection simulation field test of the medical instrument is more than 3.00. The results are shown in Table 2.
Table 2 results of simulated field test of foam disinfectant of invisible appliance on disinfection of medical instruments
Note that:
1. the number of positive control colonies was 5.6X10 5 ~6.7×10 5 cfu/sample, average 6.3X10 5 cfu/sample.
2. Negative control group: the same batch of neutralizer is aseptically grown, the same batch of diluent is aseptically grown, and the same batch of sampling liquid is aseptically grown.
5. Conclusion:
1. the neutralizing agent identification experiment shows that the PBS solution of 2.0 percent Tween 80 plus 0.3 percent lecithin plus 0.3 percent sodium thiosulfate can completely neutralize the stock solution of the invisible appliance foam disinfectant of the sample to be examined, and the neutralizing agent and the neutralizing product have no influence on the pseudomonas aeruginosa (ATCC 15442) and the culture medium of the test bacteria.
2. Under the condition that the test temperature is 20+/-1 ℃, the stock solution of the invisible appliance foam disinfectant is subjected to the action of a sample for 10 minutes, and the average killing logarithmic value of the disinfection simulation field test of the medical instrument is more than 3.00.
Example 6
PH value detection, the detection conditions are as follows:
1. equipment and method for manufacturing the same
1. Sample name of foam disinfectant for invisible appliance "
2. Sartorius pb-21 acidometer.
3. Small beakers, etc.
2. Method of
1. According to the "sterilizing technical Specification" 2002 edition 2.2.1.4.
3. Results
The results of the measurement are shown in Table 1
TABLE 1 determination of pH of foam disinfectant for invisible appliance
4. Conclusion(s)
The pH value of the examined sample 'invisible appliance foam disinfectant' is 7.05, which accords with the related requirements of Q/320684EWZX 033-2021.
Example 7
And detecting the content and stability of the benzalkonium chloride saddle, wherein the detection conditions are as follows:
1. equipment and method for manufacturing the same
1. Sample name: "invisible appliance foam disinfectant".
2. 25mL piston buret
3. BSC-250 constant temperature and humidity tank.
2. Method of
The test basis is as follows: according to the disinfection Specification (-2002) 2.2.1.2.14
3. Results
TABLE 2 determination of "foam disinfectant for invisible appliance" benzalkonium chloride content and stability
Table 2 determination of the benzalkonium chloride content and stability of the foam disinfectant for the invisible appliance
4. Conclusion(s)
The content of the benzalkonium chloride of the examined sample (invisible appliance foam disinfectant) is 0153% (W/W) through measurement; after the sample is stored for 90 days under the condition of stability (the temperature is 37-40 ℃ and the relative humidity is more than or equal to 75 percent), the content of the benzalkonium chloride is 0.148 percent (W/W), the drop rate is 3.27 percent, the sample meets the relevant requirements of the 2002 edition of disinfection technical Specification, and the effective period of the sample storage can be defined as 2 years.
Example 8
Microbiological indicator detection, the detection conditions are as follows:
1. equipment and method for manufacturing the same
1. Sample name: foam disinfectant for invisible appliance "
Stx1202zh electronic balance.
3. Common nutrient agar medium, sa agar medium, SCDLP liquid medium, lactose bile salt fermentation medium, blood agar plate.
DH-600A electric heating constant temperature incubator.
5. Aseptic graduated pipettes, aseptic plates, aseptic test tubes, scissors, forceps, alcohol lamps, and the like.
2. Method of
The test basis is as follows: according to the result GB15979-2002 hygienic Standard for disposable hygienic products.
3. Results
Table 3 results of microorganism index determination of "foam disinfectant for invisible appliance
Table 3 results of the determination of microbial indicators of foam disinfectant for invisible appliance
4. Conclusion(s)
The microbiological index detection result of the invisible appliance foam disinfectant of the sample to be detected is determined to be in accordance with the specification of the result GB15979-2002 sanitary Standard of Disposable sanitary articles.
Example 9
The microbiocidal test was as follows:
1. equipment and method for manufacturing the same
1. Sample: the sample concentration of the invisible appliance foam disinfectant is stock solution.
2. Test strain: coli (8099), 6 generations of candida albicans (ATCC 10231), 6 generations of pseudomonas aeruginosa (ATCC 15442), staphylococcus aureus (ATCC 6538) and 6 generations.
3. 3% raw serum albumin, pancreatic protein Chen Shengli saline solution, standard hard water: common nutrient agar medium and sand agar medium.
4. 0.03mol/L Phosphate Buffer Solution (PBS).
5. Neutralizing agent: PBS with 2.0% Tween 80+0.3% lecithin+0.2% sodium thiosulfate
6. Aseptic graduated pipette, aseptic plate, aseptic test tube, constant temperature incubator, etc.
2. Method of
1. According to the 2002 edition of the disinfection technical Specification
2. The neutralizer identification test adopts a suspension method identification test, a staphylococcus aureus (ATCC 6538) neutralizer selection test, the sample concentration is stock solution, and the action time is 1min. Candida albicans (ATCC 10231) neutralizer selection test, the sample concentration is stock solution, and the action time is 1min. The test temperature was 20.+ -. 1 ℃.
3. The sterilization test is a suspension test. The test temperature was 20.+ -. 1 ℃ and the test was repeated three times.
3. Results
1. Staphylococcus aureus neutralizer identification assay
1.1
(1) The first group was grown aseptically and the second group was grown aseptically for each trial. The second group has more growing bacteria than the first group, but has less growing bacteria than the first group, and the error rates among the 3 rd group, the 4 th group and the 5 th group are 5.33%, 7.21% and 6.14% respectively.
(2) The serial numbers and the contents of each group in the table are the same as those in the disinfection technical Specification (2002.11).
1.2 neutralizer identification test results are shown in Table 4.
TABLE 4 identification test results of staphylococcus aureus neutralizer
2. Candida albicans neutralizer identification test
2.1
(1) The first group was grown aseptically and the second group was grown aseptically for each trial. The second group has more growing bacteria than the first group, but has less growing bacteria than the first group, and the error rates among the 3 rd group, the 4 th group and the 5 th group are respectively 4.69%, 7.31% and 5.33%.
(2) The serial numbers and the contents of each group in the table are the same as those in the disinfection technical Specification (2002.11).
2.2 neutralization agent identification test results are shown in Table 5.
TABLE 5 identification test results of Candida albicans neutralizer
3. Killing effect on test bacteria
The basic solution of the invisible appliance foam disinfectant acts as lmin, the killing logarithmic value of the basic solution can reach more than 5.00 for escherichia coli (8099), staphylococcus aureus (ATCC 6538) and pseudomonas aeruginosa (ATCC 15442), and the killing logarithmic value of the basic solution can reach more than 4.00 for candida albicans (ATCC 10231). The test was repeated three times. The results are shown in tables 6, 7, 8 and 9.
TABLE 6 killing effect of "foam disinfectant for invisible appliance" stock solution on Escherichia coli
Note that: the average growth colony number of the positive control group is 7.41 (7.38-7.46)
The negative control group was grown aseptically.
Table 7 "foam disinfectant for invisible appliance" stock solution has killing effect on staphylococcus aureus.
Note that: the average growth colony number of the positive control group is 7.38 (7.32-7.43)
The negative control group was grown aseptically.
Table 8 Effect of the stock solution of "foam disinfectant for invisible appliance" on killing Candida albicans
Note that: the average growth colony number of the positive control group is 7.34 (7.28-7.40)
The negative control group was grown aseptically.
Table 9 effect of foam disinfectant stock solution of invisible Jiaozi device on killing Pseudomonas aeruginosa
Note that: the average growth colony number of the positive control group is 7.36 (7.30-7.43)
The negative control group was grown aseptically.
4. Conclusion(s)
1. The neutralizer identification experiment shows that PBS with 2.0 percent of Tween 80, 0.3 percent of lecithin and 0.2 percent of sodium thiosulfate can completely neutralize the invisible appliance foam disinfectant of the sample to be inspected. The neutralizer and the neutralization product have no influence on test bacteria such as escherichia coli (8099), staphylococcus aureus (ATCC 6538), pseudomonas aeruginosa (ATCC 15442), candida albicans (ATCC 10231) and culture medium.
2. Under the condition that the test temperature is 20+/-1 ℃, the stock solution of the invisible appliance foam disinfectant is subjected to the action for 1min, the average killing pair number of the stock solution on escherichia coli (8099) and pseudomonas aeruginosa (ATCC 15442) staphylococcus aureus (ATCC 6538) can reach more than 5.00, and the average killing pair number of the stock solution on candida albicans (ATCC 10231) can reach more than 4.00.
Example 10
The disinfectant was tested for disinfection on other surfaces (wooden desktops) in the field as follows:
1. equipment and method for manufacturing the same
1. Sample: the sample concentration of the invisible appliance foam disinfectant is stock solution.
2. 3% bovine serum albumin, standard hard water, pancreatic protein Chen Dadou agar medium (TSA): common nutrient agar medium.
3. Dilution liquid: 0.03mo1/L phosphate buffer pH7.2 with 0.1% Tween 80.
4. Neutralizing agent: PBS with 2.0% tween 80+0.3% lecithin +0.2% sodium thiosulfate.
5. Aseptic graduated pipette, aseptic plate, test tube, specification plate, constant temperature incubator, aseptic gauze, aseptic cotton swab, scissors, etc.
2. Method of
1. According to the disinfection technical Specification (2002 edition) 2.1.2.10
2. The neutralizer identification test uses a suspension method identification test, and the concentration of a sample of the neutralizer selection test for staphylococcus aureus (ATCC 6538) is stock solution, and the action time is 3min. The test temperature is 20+/-1 DEG C
3. The disinfectant is used for on-site identification test of other surfaces (wooden table tops), the test temperature is 20+/-1 ℃, and the relative humidity is as follows: 45%.
4. The disinfectant for the test is foam disinfectant stock solution of the invisible appliance, and the disinfection method comprises the following steps: spraying for 3min
5. Test object: a wooden tabletop.
1, a treatment method comprises the following steps: before disinfection, the sterile cotton swab is wetted in a test tube containing 5mL of diluent, and a wooden table top is 25cm 2 One block is smeared and sampled, and the block is transversely and vertically reciprocated 8 times respectively. After sampling, the sampling end of the cotton swab is cut into an original 5mL diluent test tube in a sterile operation mode, and the sample is oscillated for 20s or beaten for 80 times to be properly diluted and then used as a positive control group sample.
2 sterilizing the wooden table top by using foam disinfectant stock solution of the invisible appliance for sample inspection, wetting the sterilized cotton swab in a neutralizing agent test tube containing 5m1, smearing and sampling a sterilizing area block, and transversely and vertically reciprocating for 8 times. After sampling, the swab sampling end is sheared into the original 5m sampling liquid test tube in a sterile operation mode, and the electric mixer is oscillated for 20s or is vibrated for 80 times to be used as a sample of a disinfection group.
3 the same batch of unused neutralizer, 1.0mL of each diluent and 1 to 2 parts of cotton swab are used as negative control group samples. The number of samples tested was 30 and the test was repeated three times.
3. Results
1. Staphylococcus aureus neutralizer identification assay
1.1 each experiment the first group grew aseptically and the second group grew aseptically. The second group has more growing bacteria than the first group, but has less growing bacteria than the first group, and the error rates among the 3 rd group, the 4 th group and the 5 th group are 5.33%, 7.21% and 6.14% respectively.
The serial numbers and the contents of each group in the table 1.2 are the same as those in the disinfection technical Specification (2002.1.1).
1.3 neutralizer identification test results are shown in Table 10.
TABLE 10 identification test results of staphylococcus aureus neutralizer
4. Test results
The stock solution of the invisible appliance foam disinfectant for the inspection sample acts for 3min, and the average killing logarithmic value of the stock solution on natural bacteria on a wooden tabletop is more than 1.00. The results are shown in Table 11, table 12 and Table 13.
Table 11 foam disinfectant for invisible appliance on-site identification test results of other surface disinfection
Negative control group: the same batch of neutralizer is aseptically grown, the same batch of diluent is aseptically grown, and the same batch of cotton is aseptically grown.
Table 12 foam disinfectant for invisible appliance on-site identification test results of other surface disinfection
Negative control group: the same batch of neutralizer is aseptically grown, the same batch of diluent is aseptically grown, and the same batch of cotton is aseptically grown.
Table 13 foam disinfectant for invisible appliance on-site identification test results of other surface disinfection
Negative control group: the same batch of neutralizer is aseptically grown, the same batch of diluent is aseptically grown, and the same batch of cotton is aseptically grown.
5. Conclusion:
1. the neutralizing agent identification experiment shows that PBS (phosphate buffer solution) with 2.0 percent of Tween 80 plus 0.3 percent of lecithin plus 0.2 percent of sodium thiosulfate can completely neutralize stock solution of a sample to be examined, and the neutralizing agent and a neutralizing product have no influence on staphylococcus aureus (ATCC 6538) and a culture medium of test bacteria.
2. Under the condition that the test temperature is 20+/-1 ℃, the stock solution of the invisible appliance foam disinfectant is subjected to the action of a sample for 3min, and the average killing logarithmic value of natural bacteria on a wooden tabletop is more than 1.00.
Example 11
Acute oral toxicity test, multiple skin irritation test, mice marrow multipotent erythrocyte micronucleus test, the conditions are as follows:
1. test materials
1. The test object is a foam disinfectant for invisible appliance "
2. Experimental animals: 70 Kunming mice, each half of male and female, weighing 18-22 g, primary animals (license number: SYXK (Shaanxi) 2018-007); the weight of the Japanese big ear white rabbits is 2.0-2.5 kg, and the first-class animals (license number: SYXK (Shan) 2018-007) are respectively female and male.
3. Animal room environment: temperature is 22-25 ℃, relative humidity: 45 to 55 percent
2. Acute oral toxicity test method
1. Test article: foam disinfectant for invisible appliance "
2. The test method comprises the following steps: mice fasted for 16 hours prior to the test, without limitation to drinking water. The test is weighed and the test subjects are gastrically administered to the mice at a dose of 5000mg/kg. The dose was 0.1m1/10g.bw, and the animal reaction was closely observed for 14 consecutive days.
3. Test results: no abnormal poisoning of the systems of the mice was observed during the observation period, nor was there any death (the results are shown in Table 14)
Table 14 test results of acute oral toxicity of foam disinfectant for invisible appliance to mice
3. One-time complete skin irritation test
1. The test basis is as follows: experimental results were carried out by the method of 2002 edition of "Disinfection technical Specification" 2.3.3.3.1
2. Dose of test substance: 0.5 mL/min.
3. The test method comprises the following steps: skin was prepared by shearing on both sides of the spine of each rabbit 24 hours prior to the test, without damaging the skin. The dehairing range was about 3cm by 3cm on the left and right. The next day 0.5mL of the test article was directly dropped onto the whole dehaired skin on one side with an area of 2.5cm by 2.5cm, then covered with a layer of non-irritating plastic film and then fixed with non-irritating adhesive tape. The other side was peeled off the skin as a blank (or solvent control). The application time is 4 hours. After the test is completed, the residual test substance is removed with warm water or a non-irritating solvent. Skin local reactions were observed 1h, 24h and 48h after removal of the test subjects, respectively, and a stimulus response score was performed.
4. Test results: the skin of the rabbit of the tested object group is observed to have no red spot edema (the result is shown in Table 15)
Table 15 "flower is remarkableFoam disinfectant for invisible appliance for rabbit with one-time complete skin irritation test result>
5. Conclusion: the average score of the response of the invisible appliance foam disinfectant to the primary complete skin stimulus of the rabbits is 0. According to the skin irritation reaction grading standard in 2002 edition of disinfection technical Specification, the once complete skin irritation reaction of the invisible appliance foam disinfectant belongs to nonirritating.
4. Mouse bone marrow multipotent erythrocyte micronucleus test
1. The test object is a foam disinfectant for invisible appliance "
2. The test method comprises the steps of adopting 50 Kunming mice, weighing 25-30 g, dividing the mice into 5 groups randomly, and dividing the mice into 10 animals each. The test was performed in three dosage groups of 5.00g/kg.bw, 2.50g/kg.bw, 1.25g/kg.bw, and in addition in a solvent (distilled water) control group and a cyclophosphamide positive control group (CP, 40 mg/kg.bw). Weighing 10.0g, 5.0g and 25g of samples, adding distilled water to 20mL, and uniformly suspending to prepare suspension with the concentration of 50.0%, 25.0% and 12.5% respectively for later use. Distilled water was used as a solvent control. Weighing 0.04-gCP, adding 10mL of distilled water, and dissolving uniformly to prepare 0.4% solution for later use. The gastric lavage volume is 10mL/kg.bw, the test adopts a 30h gastric lavage method, the interval is 24h, the animal is killed after the cervical vertebra is removed for 6h after the sample is given for the second time, femur marrow is taken to be tabletted according to the stipulated method in the disinfection technical Specification, the femur marrow is fixed, after Giemsa staining, the number of micronucleus-containing cells in 1000 polynuclear erythrocytes (PCE) is counted per mouse under an oil microscope, and the thousandth rate of micronuclei is calculated. The ratio of the multipotent erythrocytes to the mature erythrocytes (PCE/NCE) was observed in 200 erythrocytes.
3. Test results the results are shown in Table 16
Table 16 foam disinfectant for invisible appliance and test result of micronucleus of mice marrow multi-staining erythrocyte
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Note that: * Represents P < 0.01.
5. Conclusion:
according to the acute oral toxicity grading standard in the 'disinfection technical Specification' 2002, the acute oral toxicity of the original liquid mouse of the 'invisible appliance foam disinfectant' is of a practically nontoxic grade; the average score of the stock solution of the invisible appliance foam disinfectant for the multiple skin irritation reaction of the rabbits is 0. According to the skin irritation reaction grading standard in 2002 edition of disinfection technical Specification, the stock solution of the invisible appliance foam disinfectant is non-irritating to household skin irritation reaction; the stock solution of the invisible appliance foam disinfectant has no irritation to the reaction of a complete skin irritation test of rabbits; the test result of the bone marrow multi-staining erythrocyte micronucleus of the mice in each dose group of the stock solution of the invisible appliance foam disinfectant is negative, and meets the relevant requirements of the 2002 edition of disinfection technical Specification.
In conclusion, the invention does not contain alcohol, abrasive and bleaching agent; the quick-acting sterilization rate of the medical grade sterilization component is up to 99%; rapidly foaming, and removing peculiar smell; can deeply wrap and clean, penetrate into the tooth socket, clean and have no mark; neutral pH value, mild and no irritation, no damage to denture, dental socket, orthosis, etc.; the carrying is convenient, and the cleaning time is short; can kill suppurative coccus, enteropathogenic bacteria, pathogenic fungi and common infectious bacteria in hospitals; can be used for low-level disinfection of the surface of the invisible appliance.
The invention uses benzalkonium chloride as a main sterilization component and plays a synergistic effect with other functional auxiliary agents, thereby playing a good cleaning effect. After the worn invisible appliance is processed, the sterilizing rate of common bacteria in the appliance is high, so that the dysbacteriosis of the flora in the appliance and the damage to a human body caused by the dysbacteriosis are avoided. Meanwhile, the components of the foam disinfectant and the appliance cannot react chemically, and the performance and the use effect of the appliance are not affected. The cleaned appliance has low bacterial residue and no peculiar smell; the auxiliary agents used in the foam disinfectant are all green raw materials which are nontoxic, harmless, free of stimulation and rapid in biodegradation, and have no harm to human bodies and the environment. The raw material composition and the foam state of the cleaning agent reduce the damage effect on the appliance, and the light transmittance and the mechanical property of the appliance are not affected after the cleaning agent is used for many times, so the cleaning agent has good application value and wide market prospect and is suitable for general popularization and application.
The foregoing is merely illustrative of the present invention and not restrictive, and other modifications and equivalents thereof may occur to those skilled in the art without departing from the spirit and scope of the present invention.

Claims (3)

1. The foam disinfectant for the invisible appliance is characterized by comprising the following raw materials in percentage by weight: 0.13-0.16% of benzalkonium chloride, 0.3-1.0% of sodium benzoate, 3-9% of glycerin, 9-15% of cocamidopropyl betaine, 0.2-1.0% of essence and the balance of purified water.
2. A method for preparing the foam disinfectant for the invisible appliance according to claim 1, comprising the following steps:
s1, heating purified water to about 35 ℃, adding benzalkonium chloride, sodium benzoate and glycerin, and stirring for 20 minutes to obtain a solution I;
s2, uniformly stirring cocoamidopropyl betaine and essence to obtain a solution II;
and S3, adding the solution II into the solution I, and stirring for 10 minutes to form a uniform solution, thus obtaining the foam disinfectant.
3. Use of the foam disinfectant for invisible appliances according to claim 1 or 2, characterized in that: and uniformly smearing foam generated by the foam disinfectant according to the pressure pump head on the invisible appliance, standing for 10 minutes, and then flushing with clear water.
CN202310717924.2A 2023-06-16 2023-06-16 Foam disinfectant for invisible appliance, preparation method and application thereof Pending CN116784324A (en)

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