CN109481671A - A kind of thimerosal and preparation method thereof - Google Patents

A kind of thimerosal and preparation method thereof Download PDF

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Publication number
CN109481671A
CN109481671A CN201811510815.9A CN201811510815A CN109481671A CN 109481671 A CN109481671 A CN 109481671A CN 201811510815 A CN201811510815 A CN 201811510815A CN 109481671 A CN109481671 A CN 109481671A
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thimerosal
ethyl alcohol
lysozyme
solution
disinfection
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尹东
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LINGFANG BIOLOGICAL TECHNOLOGY Co Ltd CHONGQING
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LINGFANG BIOLOGICAL TECHNOLOGY Co Ltd CHONGQING
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    • A01N37/44—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio analogue of a carboxylic group, e.g. amino-carboxylic acids
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    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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    • A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
    • A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
    • A01N47/42—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides containing —N=CX2 groups, e.g. isothiourea
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01017—Lysozyme (3.2.1.17)

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Abstract

A kind of thimerosal and preparation method thereof, it further includes the substance of following weight percent that thimerosal, which includes 80~120U/ml of lysozyme: polylysine salt 0.3~0.5%, chlorhexidine acetate 0.2~0.3%, 95% ethyl alcohol 0.2~0.3%, surplus is purified water；Preparation method dissolves to form solution A to lysozyme plus purified water；95% ethyl alcohol is added into chlorhexidine acetate to dissolve to form solution B；Solution A and solution B are mixed, polylysine salt is added, stirs 1-2h to being uniformly dissolved, visual inspection is without visible insoluble matter.The present invention has the advantage that: thimerosal safety, wide spectrum, efficiently, and it is environmentally friendly；Preparation method is simple, convenient for quantization production.

Description

A kind of thimerosal and preparation method thereof
Technical field
The present invention relates to disinfection technology field, in particular to a kind of thimerosal and preparation method thereof.
Background technique
Prophylactic disinfection refers to do not find the infection sources in the case of, to may be by the article of pathogen contamination, place and human body Carry out disinfection measure.If public place sterilizes, means of transport is sterilized, and drinking-water and table-ware disinfection wash one's hands after an action of the bowels belong to it before meals.Doctor Operating room sterilizes in institute, the serious patient of immunocompromised host, if bone marrow transplant patient's prevention sexual isolation and disinfectant measure are also prevention Property disinfection.
Clinical various treatments, diagnosis process are both needed to skin degerming；Disinfection is the important link of control infection, the success of disinfection Whether directly affect therapeutic quality.Existing skin antiseptic is mostly chemical reagent, mainly has ethyl alcohol, iodine and contains iodine system Agent, chlorhexidine, quaternary ammonium compound, triclosan etc., wherein concentration is that the ethanol solution bactericidal effect of 60%-80% is best, But its persistence is poor, sterilization is general narrow, therefore ethanol solution, generally only as common sterilizing agent for external use, iodine is also to face with Iodic agent The widely used skin antiseptic of bed, but it is easy to colour on the skin with certain color, and cause elution is difficult to ask Topic, it is weaker to the effect of gram-negative bacteria and fungi for chlorhexidine, and it is narrow that quaternary ammonium compound equally exists fungicidal spectrum, blue to leather Negative bacterium effect is poor, and although triclosan is a kind of high-efficiency broad spectrum antibacterial agent, but its bactericidal effect relative to ethyl alcohol, iodine and contains Operand, chlorhexidine, quaternary ammonium compound are weaker.
For environment, the disinfectant used both at home and abroad is typically all chemosterilant, as Peracetic acid boils stifling air Sterilization, the spray disinfectants air method such as lactic acid, hydrogen peroxide, formaldehyde, but all there are certain defect, irritant smell, Corrosivity is strong, irritating to respiratory tract, and has damage to furniture, electric appliance, metal.
Therefore, it is badly in need of developing a kind of safety, wide spectrum, disinfection that is efficient, environmental-friendly, having user of service's skin protection Agent.
Summary of the invention
It is an object of the invention to provide a kind of thimerosal, safety, wide spectrum, efficiently, and it is environmentally friendly.
It is simple and easy it is a further object of the present invention to provide the preparation method of thimerosal, convenient for quantization production.
The object of the present invention is achieved like this, a kind of thimerosal, including 80~120U/ml of lysozyme, further includes following The substance of weight percent: polylysine salt 0.3~0.5%, chlorhexidine acetate 0.2~0.3%, 95% ethyl alcohol 0.2~ 0.3%, surplus is purified water.
In the present invention, lysozyme is commercially available lysozyme, will not because of organic solvent processing and inactivate, when being transferred to When in aqueous solution, the vigor of lysozyme can full recovery, and antimicrobial spectrum is wider, is not only limited to G- bacterium, also has to part G+ bacterium Inhibitory effect；There is antibacterial action to gram positive bacteria, aerobic sporeformer, hay bacillus, bacillus licheniformis etc., And will not have an adverse effect to the human body cell of not cell wall, therefore, it is suitable for the anti-corrosion of various food；In addition, the enzyme Enteron aisle corruption coccus can also be killed, enteron aisle resistance infection is increased, while baby intestinal bifidobacterium can also be promoted to be proliferated, is promoted It is conducive to digestion into milk casein curdled milk, so being the good additive of baby food, beverage again.Lysozyme to human body entirely without It is malicious, without side-effects, have effects that antibacterial, antiviral and antitumor, is a kind of safe natural antiseptic agent.Chlorhexidine acetate is Cationic surfactant, has a broad antifungal spectrum have killing effect to most Grain-positives and negative bacteria, also have to Pseudomonas aeruginosa Effect.For remote holder of performing the operation, skin, planing surface and sterilization of instruments, can produce after effect with ethyl alcohol, extend Disinfection Effect when It is long.Polylysine salt not only can inhibit the micrococcus luteus of the stronger G+ of heat resistance, but also to other natural antiseptic agents (such as Ni sin) It is not easy to inhibit the Escherichia coli of G-, salmonella fungistatic effect also very good, while may also suppress lactobacillus bulgaricus, thermophilic The growth of streptococcus, saccharomycete, and with lysozyme, the mutual chemiluminescence of chlorhexidine acetate, enhance disinfection.
What the another object in the present invention was realized in, a kind of preparation method of thimerosal, to lysozyme plus purified water Dissolution forms solution A；95% ethyl alcohol is added into chlorhexidine acetate to dissolve to form solution B；Solution A and solution B are mixed, are added Polylysine salt stirs 1-2h to being uniformly dissolved, and visual inspection is without visible insoluble matter.
By adopting the above-described technical solution, the present invention has the advantage that: thimerosal safety, wide spectrum, efficiently are and right It is environmental-friendly；Preparation method is simple, convenient for quantization production.
Specific embodiment
Below with reference to embodiment, the invention will be further described:
Embodiment 1
A kind of thimerosal, including 80~120U/ml of lysozyme further include the substance of following weight percent: polylysine Salt 0.3~0.5%, chlorhexidine acetate 0.2~0.3%, 95% ethyl alcohol 0.2~0.3%, surplus is purified water.
Embodiment 2
A kind of thimerosal, including lysozyme 100U/ml further include the substance of following weight percent: polylysine salt 0.4%, chlorhexidine acetate 0.25%, 95% ethyl alcohol 0.25%, surplus is purified water.
Embodiment 3
A kind of thimerosal, including lysozyme 80U/ml further include the substance of following weight percent: polylysine salt 0.3%, chlorhexidine acetate 0.2%, 95% ethyl alcohol 0.3%, surplus is purified water.
Embodiment 4
A kind of thimerosal, including lysozyme 120U/ml further include the substance of following weight percent: polylysine salt 0.5%, chlorhexidine acetate 0.3%, 95% ethyl alcohol 0.2%, surplus is purified water.
Embodiment 5
A kind of thimerosal dissolves to form solution A to lysozyme plus purified water；It is molten that 95% ethyl alcohol is added into chlorhexidine acetate Solution forms solution B；Solution A and solution B are mixed, are added polylysine salt, stirring 1-2h to being uniformly dissolved, visual inspection without it is visible not Molten substance.
Using the method in embodiment 5, operation is carried out to embodiment 1 to 4, thimerosal is made, and by Chongqing City's disease prevention Control centre examines, and examines project and result as follows:
One, examination by sensory organs
1, detect environmental condition: temperature is 17.5 DEG C, relative humidity 59%；
2, foundation: GB 27951-2011 5.1 is detected；
3, result: ocular estimate inspection under the conditions of natural light, the sample stoste are colourless transparent liquid, are not layered uniformly, nothing Precipitating and suspended matter, free from extraneous odour.
Two, lead, arsenic, mercury, chlorhexidine acetate
1, foundation: Ministry of Public Health's " cosmetics safety technical specification " (version in 2015) chapter 4 1.2,1.3,1.4 is detected；
2, embodiment 4 is inspected by random samples, testing result is as follows:
2, thimerosal lead content < 3.8mg/kg, arsenic content < 0.025mg/kg, mercury content < 0.003mg/kg, Meet the regulation of national standard (GB27951-2011).
Three, pH value measures
1, instrument and equipment: PB-21 type pH meter (24792173)
2, correction buffer: complete buffer pH4.7.9 (production of Shanghai City Ai Jian chemical reagent work)；
3, test basis: " disinfection technology standard " (version in 2002) 2.2.1.4；
4, test atmosphere: 25.0 DEG C of temperature, relative humidity 51%；
5, thimerosal made of embodiment 2 is sample 1-1, and thimerosal made of embodiment 3 is sample 1-2；
6, result is as follows:
7, the pH value of thimerosal is 4.92.
Four, sterility test
1, thimerosal made of embodiment 4 is sample；
2, instrument and equipment: LRH-150 biochemical cultivation case；
3, foundation: GB 27951-2011 appendix A .3.4 is detected；
4, testing conditions: 21.5 DEG C of environment temperature, relative humidity 51%；
5, result such as following table meets the regulation of national standard (GB27951-2011).
Note: sterility test positive control has bacterium growth, Negative control Sterile growth.
Five, to surface disinfection effect field test
1, experimental bacteria: Candida albicans ATCC 10231 (the 5th generation) is provided by China General Microbiological bacterium collection；
2, use thimerosal made of embodiment 4 for sample；
3, neutralizer: contain 1% lecithin, 5% Tween 80,0.5% sodium thiosulfate, 0.5% glycine, 0.5% group of ammonia The nutrient broth of acid；
4, culture medium: sabouraud's agar；
5, instrument: LHR-150 biochemical cultivation case, KMF-115 constant temperature and humidity incubator；
6, test basis: " disinfection technology standard " (version in 2002) 2.2.3.3；
7, preservation condition: 37 DEG C~40 DEG C insulating boxs are placed 3 months；
8, laboratory sample concentration: saving front and back is the sample stoste, and 20.2 DEG C of test temperature；
9, result such as following table, the sample are placed 3 months through 37 DEG C~40 DEG C insulating boxs, and thimerosal stoste is to white after storage Candida albicans acts on 1.0min and kills logarithm >=4.00；
Note: negative control group asepsis growth.
10, the sample acts on killing logarithm >=4.00 of 1.0min, sample through 37 DEG C of accelerated tests, thimerosal stoste Bactericidal effect at room temperature at least keep 2 years.
Six, to surface disinfection effect field test
1, use thimerosal made of embodiment 4 for sample；
2, sample solution: contain 1% lecithin, 5% Tween 80,0.5% sodium thiosulfate, 0.5% glycine, 0.5% group of ammonia The nutrient broth of acid；
3, test basis: " disinfection technology standard " (version in 2002) 2.1.2.10；
4, disinfection time 5min；
5, study subject is wooden desktop, uses 25cm2Dimension board demarcate area, sterilize 30 parts of forward and backward collecting sample；
6, it is smeared using cotton swab, sampling is used as positive control before sterilizing, and negative control is with batch non-inoculation medium；
7, at 20 DEG C ± 1 DEG C, the sterilized stock solution, disinfection 5min, to the average killing logarithm of body surface natural bacteria Value is 2.01 (1.14~3.51), the result is as follows:
Note: negative control group asepsis growth.
8, under test conditions, the disinfectant stock solution, disinfection 5min, the average killing pair to body surface natural bacteria Number >=1.0, up to disinfection Eligibility requirements.
Seven, skin degerming is tested
1, thimerosal made of embodiment 4 is sample；
2, neutralizer: contain 1% lecithin, 5% Tween 80,0.5% sodium thiosulfate, 0.5% glycine, 0.5% group of ammonia The nutrient broth of acid；
3, test basis: " disinfection technology standard " (version in 2002) 2.1.2.8；
4, thimerosal stoste is sprayed directly on on the inside of subject's right forearm, disinfection time 3min；
5,30 people of Gong subject, with cotton examination swabing sampling within the scope of the dimension board of 3.0cm*10.0cm, left forearm inside As positive controls, negative control is with the non-inoculation medium of batch；
6,20 DEG C ± 1 DEG C of experimental temperature；
Note: negative control group asepsis growth.
As a result table as above, thimerosal disinfection 3min, to the average killing logarithm of 30 person-times of skin surface natural bacterias Value is 1.77 (1.07~2.63)；
7, under test conditions, the disinfectant stock solution, disinfection 3min are averaged to 30 person-times of skin surface natural bacterias Logarithm >=1.0 are killed, up to disinfection Eligibility requirements.
Eight, opponent's sterilizing test
1, thimerosal made of embodiment 4 is sample；
2, neutralizer: contain 1% lecithin, 5% Tween 80,0.5% sodium thiosulfate, 0.5% glycine, 0.5% group of ammonia The nutrient broth of acid；
3, test basis: " disinfection technology standard " (version in 2002) 2.1.2.6；
4, the five fingers that thimerosal stoste is sprayed directly on to subject's right hand are bent into face finger tip at finger root, disinfection time 1min；
5,30 people of Gong subject, left hand try swabing sampling as positive controls, with cotton, and negative control is not connect with batch Kind culture medium；
6, under experimental conditions, the sterilized stock solution, disinfection 1min, the average killing pair to 30 person-times of natural bacterias on hand Numerical value is 1.73 (1.08~2.84), and concrete outcome is as follows:
Note: negative control group asepsis growth.
7, under test conditions, the disinfectant stock solution, disinfection 1min put down 30 subject's watch face natural bacterias Logarithm >=1.0 are killed, up to disinfection Eligibility requirements.
Nine, toxicology test
1, test basis
In Ministry of Public Health's " disinfection technology standard " version in 2002 " 2.3.1 acute oral toxicity test "；
In Ministry of Public Health's " disinfection technology standard " version in 2002 " 2.3.3 Skin Irritation Test "；
In Ministry of Public Health's " disinfection technology standard " version in 2002 " 2.3.4 acute eye irritation test "；
In Ministry of Public Health's " disinfection technology standard " version in 2002 " 2.3.6 Skin allergy test "；
In Ministry of Public Health's " disinfection technology standard " version in 2002 " 2.3.8.4 mice bone marrow micronucleus "；
2, toxicity conclusion
Acute oral toxicity test: acute oral LD of the submitted sample to male and female Kunming mouse50It is all larger than 5000mg/ Kg.bw is nontoxic according to the Ministry of Public Health " disinfection technology standard " (2002) true border of acute toxicity evaluation criterion；
Multiple intact skin irritant test: submitted sample skin wound repair integral mean value is 0 point, is belonged to nonirritant；
Single-use skin irritant test: damaged skin irritant test reaction integral of submitted sample is 0 point, is belonged to stingless Swash property；
Acute eye irritation test: it rinses within 30 seconds after submitted sample stoste eye drip, by " eye in " disinfection technology standard " 2002 editions Irritative response grade scale " belongs to nonirritant；
Allergy test: submitted sample allergy skin sensitization rate is 0%, and sensitization intensity is extremely slight；
Micronucleus test: submitted sample is to Kunming mouse Polychromatic erythrocyte without cause micronucleus effect.
Use scope:
1, it is suitable for skin, hand, general surface disinfection (such as furniture, toy, desktop, bathtub, door handle, children's joy The surface sterilization of happy facility and other items, environment)；
2, it is suitable for hospital surgery operation room medical staff's hand and forearm sterilizes；
3, it is suitable for damaged skin to sterilize；Dressing change in surgical department, treatment of wounds and burn surface skin degerming；
4, it is suitable for children, pregnant woman.
Application method:
It is carried out disinfection using this product stoste, is used after can not diluting.
1, skin degerming: this product is sprayed on skin, is acted on 3 minutes；
2, hand-wrist bones: being sprayed on hand for this product, rubs repeatedly 1 minute；
3, hospital surgery operation room medical staff hand-wrist bones: after surgical hand, this product is taken to be sprayed under both hands, forearm and upper arm 1/3 skin acts on 3 minutes；
4, surface disinfection: sprinkling this product on a surface of an, acts on 5 minutes；
5, wound and surface of a wound disinfection: directly sprinkling this product acts on 3 minutes in wound.
It saves: being protected from light, it is closed, it is stored at room temperature.

Claims (5)

1. a kind of thimerosal, which is characterized in that further include the substance of following weight percent including 80~120U/ml of lysozyme: Polylysine salt 0.3~0.5%, chlorhexidine acetate 0.2~0.3%, 95% ethyl alcohol 0.2~0.3%, surplus is purified water.
2. thimerosal according to claim 1, which is characterized in that further include following weight hundred including lysozyme 100U/ml The substance of score: polylysine salt 0.4%, chlorhexidine acetate 0.25%, 95% ethyl alcohol 0.25%, surplus is purified water.
3. thimerosal according to claim 1, which is characterized in that further include following weight hundred including lysozyme 80U/ml The substance of score: polylysine salt 0.3%, chlorhexidine acetate 0.2%, 95% ethyl alcohol 0.3%, surplus is purified water.
4. thimerosal according to claim 1, which is characterized in that further include following weight hundred including lysozyme 120U/ml The substance of score: polylysine salt 0.5%, chlorhexidine acetate 0.3%, 95% ethyl alcohol 0.2%, surplus is purified water.
5. according to claim 1 to a kind of preparation method of thimerosal described in any claim in 4, which is characterized in that Lysozyme adds purified water to dissolve to form solution A；95% ethyl alcohol is added into chlorhexidine acetate to dissolve to form solution B；By solution A and Solution B mixing, is added polylysine salt, stirs 1-2h to being uniformly dissolved, visual inspection is without visible insoluble matter.
CN201811510815.9A 2018-12-11 2018-12-11 A kind of thimerosal and preparation method thereof Pending CN109481671A (en)

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Application publication date: 20190319