CN105030894A - Iodophor disinfection paste and preparation method thereof - Google Patents
Iodophor disinfection paste and preparation method thereof Download PDFInfo
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Abstract
The invention aims to provide an iodophor disinfection paste being prepared from potassium iodate, citric acid, fatty alcohol, borneol, mint, ethanol, glycerol, polyethylene glycol, polyalkyloxygen (40) stearate, povidone iodine and purified water. The iodophor disinfection paste is suitable for disinfecting ruptured skin wounds such as burning, scale, bedsores and the like or polluted and infected wounds, and skin trauma and sport trauma and the like wounds. The iodophor disinfection paste can quickly kill purulent bacteria causing wound infection and bacteria and microorganism generated due to festers, thereby preventing and controlling infection. The disinfection paste has excellent formula so that the disinfection paste can improve discomfortableness on wound skin, has the effects of alleviating pain, preventing decay, regenerating tissue and moisturizing skin, and being free of scab. The iodophor disinfection paste can control infection, can promote growth of granulation tissues, can reduce healing time of the wound and can improve healing rate of the wound.
Description
Technical field
The invention belongs to pharmaceutical technology sectors, a kind of iodophor disinfection cream and preparation method thereof is provided especially.
Background technology
Preparation containing iodine is the skin and mucous membrane disinfection agent of the works very well that the current whole world is generally acknowledged, it has to bacterial propagule, bacterial spore, mycobacterium tuberculosis, fungus and virus etc. the effect killed fast, but the problems such as liquid povidone iodine exists when clinical treatment of wounds that zest is comparatively large, poorly water-soluble, easily distillation, painted, easily oxidized, the bactericidal action persistent period is short.
Summary of the invention
The object of the present invention is to provide a kind of Disinfection Effect good, iodophor disinfection cream of the good and good stability of safety and preparation method thereof.
Iodophor disinfection cream of the present invention, is characterized in that, medicine material weight proportion is:
Most preferably proportioning is:
Present invention also offers the preparation method of described iodophor disinfection cream, it is characterized in that, carry out according to the following steps:
1., get purified water in retort, be heated to 60 ~ 80 DEG C, under at the uniform velocity stirring, add potassium iodate, citric acid successively, be at the uniform velocity stirred to evenly;
2., polyoxyethylene stearate (40) ester, Polyethylene Glycol, fatty alcohol-polyoxyethylene ether is added again successively, keep temperature and continue at the uniform velocity to stir, be melted into after homogeneous ointment base until whole material and stop stirring, make ointment base, substrate temperature be kept to be not less than 60 DEG C;
3., by povidon iodine add in the retort under stirring, be homogeneous thick liquid after stirring, continue to be stirred to room temperature;
4., ripening is left standstill, curing time >=24 hours;
5., by glycerol, Borneolum Syntheticum, Herba Menthae respectively with stirring 30 minutes in the retort added to after dissolve with ethanol under stirring to fine and smooth, even, iodophor disinfection cream is given with gentle characteristic, obtained iodophor disinfection cream.
Step 1. in, after purified water being heated to 60 ~ 80 DEG C, getting 100ml purified water and add in measuring cup and dissolve potassium iodate; Get 200ml purified water again to add in measuring cup and dissolve citric acid, respectively above-mentioned two solution are added in retort.
Iodophor disinfection paste formulation side of the present invention separates:
1, povidon iodine: be the primary raw material of iodophor disinfection cream, iodine is provided.Be made up of iodine, PVP K30, potassium iodide.
1), iodine: iodine is atropurpureus crystal, iodine and PVP K30 complexation and obtain solubization, the indefinite form conjugate of formation, becomes the main body of iodophor disinfection cream of the present invention and plays bactericidal action.
2), PVP K30: PVP K30 also claims polyvinylpyrrolidone (being called for short PVP), white or off-white powder or granule, it is a kind of water-soluble high-molecular compound, record the pharmaceutic adjuvant in the Pharmacopoeia of the People's Republic of China two, there is film property, caking property, hygroscopicity, solubilising or cohesion, it is as the carrier of iodine, and the water solublity giving iodine eliminates the dyeability of iodine, and becomes the main component in iodophor disinfection cream of the present invention.
3), potassium iodide: potassium iodide is colourless or white cubic crystal, and odorless has dense bitter saline taste.Proportion 3.13, fusing point 681 DEG C, boiling point 1330 DEG C is the Operand that the Pharmacopoeia of the People's Republic of China records, and as the cosolvent of iodine in iodophor disinfection cream of the present invention, participating in complex reaction, is also the stabilizing agent of mastic.
2, potassium iodate: be the stabilizing agent of iodophor disinfection cream.Povidone iodine constantly can dissociate available iodine in storage process, and available iodine decomposes generation iodide gradually, produces hydrion simultaneously.When there is appropriate iodate in solution, due to reaction IO-3+5I-+6H+=3H2O+3I2, available iodine being supplemented, maintains the concentration of available iodine, thus adding the stability of polyvidone.Potassium iodate is the medicine that enriches the iodine that the Pharmacopoeia of the People's Republic of China records, as synergist and stabilizing agent in iodophor disinfection cream, and strengthening sterilizing effect.
3, ethanol:
Ethanol is the solvent of Borneolum Syntheticum in iodophor disinfection cream the most, makes it easy to add in mastic.
4, Borneolum Syntheticum:
Borneolum Syntheticum is the crisp crystallization of lamellar of water white transparency or white translucent, gas delicate fragrance, acrid in the mouth, cool, is used as the sense of discomfort improving wound surface skin, and has certain pain relieving, anticorrosion, life effect in iodophor disinfection cream.
5, Polyethylene Glycol (6000)
The pharmaceutic adjuvant that Polyethylene Glycol (6000) records for the Pharmacopoeia of the People's Republic of China is white waxy solid, in the form of sheets, graininess or Powdered, adjusts pasty consistence, more can improve the stability of mastic as excipient in iodophor disinfection cream.
6, glycerol (glycerol)
Glycerol is the solvent lubricant that the Pharmacopoeia of the People's Republic of China records, and makes iodophor disinfection cream of the present invention have good moisture retention, is easier to coat on skin wound, and can keeps moisture state for a long time, improves sterilization effect.
7, citric acid: (citric acid)
Citric acid is a kind of important organic acid, clear crystal, and odorless, has very strong tart flavour, soluble in water, is also a kind of excellent intercalating agent and pH adjusting agent.In iodophor disinfection cream of the present invention, do pH value regulator, make mastic keep acid state, improve the stability of ointment.
8, fatty alcohol-polyoxyethylene ether
Fatty alcohol-polyoxyethylene ether structural formula is RO (CH
2cH
2o) nH, wherein n=9, it is the C class non-ionic surface active agent in polyethoxylated fatty alcohols series of products, this product itself is almost without sterilizing ability, increase with its fungicidal effectiveness after iodine complexation, be the surfactant that toxicity is minimum, it can give ointment good skin affinity, and strengthens disinfection effect.
9, polyoxyethylene stearate (40) ester
As a kind of water soluble excipient, it can make that ointment base is finer and smoother, pure white, emulsifying is evenly beneficial to coating, as ointment base and the emulsifying agent of iodophor disinfection cream, to increase the decomposition of medicine, improves bioavailability.
10, Herba Menthae
Can improve the sense of discomfort of wound surface skin in iodophor disinfection cream, and have certain analgesic effect, Main Function is the abnormal smells from the patient regulating iodophor disinfection cream.
Iodophor disinfection cream of the present invention is applicable to skin, mucosa sterilization; Can be used for ulceration skin wound, the wound such as burn, decubital ulcer chilblain or have the wound of pollution and infection and the sterilization of the wound such as skin injury, athletic injury.The present invention changes by fastidious formula combination the situation that the sterilization of domestic clinical practice iodine is single liquid on the basis of chelated iodine, fill up the blank of iodophor disinfection cream in domestic Operand sterile products, this mastic adds Chinese prescription and excellent Moisture factor, to improve the sense of discomfort of wound surface, wound healing is not formed a scab, and has the effect of pain relieving, anticorrosion, granulation promoting, moisturizing.This product is applied to wound surface, and mastic, wound surface and air insulated, externally stops antibacterial to invade, internally can continuous action wound, wound surface sterilizing.While infection control promote granulation tissue growth, shorten wound healing time, improve healing rate, can effectively prevention and corntrol wound surface infection generation and development.
Iodophor disinfection cream of the present invention is to staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa sterilize experiment situation:
1, staphylococcus aureus
1) staphylococcus aureus nertralizer qualification test
Test temperature 20 DEG C ± 1 DEG C, test repetition 3 times.When iodophor disinfection cream concentration is prototype, be mixture in the 0.03mol/LPBS of 10.0% Tween 80 containing 3.0g/L sodium thiosulfate, 3.0g/L lecithin, volume fraction, can effectively in neutralization solution and the agent of phage surface residual disinfectancy to the effect of test organisms, and nertralizer and neutralized reaction product have no adverse effects to test organisms and culture medium.
2) the quantitative sterilize experiment of staphylococcus aureus
Test temperature 20 DEG C ± 1 DEG C, test repetition 3 times.When iodophor disinfection cream concentration is prototype, action time 5min, to the equal > 3.00 of kill oncomelania of each time of staphylococcus aureus.
2, Candida albicans
1) mixture qualification test in Candida albicans
Test temperature 20 DEG C ± 1 DEG C, test repetition 3 times.When iodophor disinfection cream concentration is prototype, be mixture in the 0.03mol/LPBS of 10.0% Tween 80 containing 3.0g/L sodium thiosulfate, 3.0g/L lecithin, volume fraction, can effectively in neutralization solution and the agent of phage surface residual disinfectancy to the effect of test organisms, and nertralizer and neutralized reaction product have no adverse effects to test organisms and culture medium.
2) the quantitative sterilize experiment of Candida albicans
Test temperature 20 DEG C ± 1 DEG C, test repetition 3 times.When iodophor disinfection cream concentration is prototype, action time 5min, to the equal > 3.00 of kill oncomelania of each time of Candida albicans.
3, the quantitative sterilize experiment of Pseudomonas aeruginosa
Test temperature 20 DEG C ± 1 DEG C, test repetition 3 times.When iodophor disinfection cream concentration is prototype, action time 5min, to the equal > 3.00 of kill oncomelania of each time of Pseudomonas aeruginosa.
4, field trial
Test ambient temperature is 20 DEG C ± 2 DEG C, and experimental enviroment relative humidity is 50% ± 5%.Iodophor disinfection cream concentration is prototype, and sterilization dose is 2.5g/ people, action time 5min, to the equal > 1.00 of the average kill oncomelania of skin surface natural bacteria.
The toxicological security situation of each component in iodophor disinfection paste formulation of the present invention:
1, povidon iodine: be made up of iodine, PVP K30, potassium iodide.
1), iodine:
Being major antibacterial effective ingredient in iodophor disinfection cream of the present invention, is the basic Cidex-7 of country that the Pharmacopoeia of the People's Republic of China records.Toxic and corrosivity, tool special odor, toxicity belongs to moderate class, and the diluent of iodine is 0.5% at effective content, is low concentration, without cumulative toxicity, non-corrosiveness.People's per os LDLo:28mg/kg.Rat oral LD50:14g/kg; Its mouse oral LD50:22g/kg.To mucosa without obvious stimulation effect, to eye and skin non-stimulated.And iodine is and PVP K30 complexation and obtain solubization in the present invention, forms indefinite form conjugate, belong to low toxicity, nonirritant disinfectant.
2), PVP K30:
PVP K30 has excellent physiological inertia, does not participate in human metabolism, has again excellent biocompatibility, and not forming any stimulation to skin, mucosa, eye etc., is the excellent pharmaceutic adjuvant had no side effect.PVP K30 and copolymer have good dispersion and film property, make it in this iodophor disinfection cream, become the carrier of iodine, make mastic have film property, stability and affinity, strengthen the moistening of mastic and lubricant effect simultaneously.
3) potassium iodide
Potassium iodide is the raw material preparing iodide, and purposes is photosensitive emulsifying agent or food additive.Expectorant, diuretic, goiter preventing agent and hyperthyroidism Preoperative medication is done at pharmaceutically potassium iodide.Acute oral toxicity: LD50:2779mg/kg; Eye irritation is tested: microstimulation; Subacute and chronic poison: non-carcinogenesis data so far.Without carcinogenic display; Bacterial mutagenesis: Salmonella: negative; Dust Xi Shi escherichia coli: negative.Up to the present breeding function is not had to damage data.
2, polyoxyethylene stearate (40) ester:
Polyoxyethylene stearate (40) ester is used as substrate and the emulsifying agent of ointment, and nontoxic, difficult combustion, increases decomposition and the bioavailability of medicine.American Pharmacopeia XV version is as the aqueous ointment base such as legal.The dispersion disintegrate of medicine in its dispersion and in stripping to the equal comparative superiority of medicament solubilization effect.
3, glycerol
Glycerol has been acknowledged as the material of nontoxic safety, natural or the full one-tenth glycerol of human or animal's n of high dose oral is without adverse effect, human vein is injected 5% glycerin solution and intoxicating phenomenon is not occurred, and National occupational safety and health science meeting (NIOSH) specify that in water, glycerol content is harmless at more than 1000mg/L.
4, potassium iodate:
Potassium iodate has higher stability.Human body can tolerate quite a large amount of potassium iodate, therefore under the dosage generally enriched the iodine, potassium iodate is foolproof, has no adverse reaction more.Every day, oral 50mg potassium iodate had no any toxic reaction, and oral more than 1000 times of being greater than physiological need amount just toxic reaction can occur usually.
5, Polyethylene Glycol
Polyethylene Glycol is neutral, nontoxic and has the high molecular polymer of unique physicochemical property and good biocompatibility, is also can as one of synthetic polymer of injection drug in body through the only a few of FDA approval.Along with the difference of mean molecule quantity, character also produces difference thereupon, from colourless, odorless, thick liquid to waxy solid; Toxicity reduces with the increase of molecular weight, and the PVOH of molecular weight 4000-8000 is safe to human body.
6, fatty alcohol-polyoxyethylene ether
Fatty alcohol-polyoxyethylene ether is at room temperature white mastic, nontoxic, non-stimulated, by a large amount of and be widely used in civilian and industrial all kinds of detergents and in personal care product.
7, citric acid: (citric acid)
Citric acid is very wide in occurring in nature distribution, can homergy in reinforcement, and suitable dosage is harmless.
8, ethanol:
Be organic solvent good in formula, and there is stronger osmosis, little to human body zest, nontoxic, harmless to article.
9, Borneolum Syntheticum:
Borneolum Syntheticum has many medical values, " Newly Revised Canon of Materia Medica ": " main trusted subordinate's pathogen, rheumatism is gathered, and deaf, improving eyesight, goes conjunctival congestion skin nebula ".Compendium of Material Medica: " treat sore throat, headache, nose is flat, toothache, typhoid fever protrusion of the tongue, children's's pox sunken "." medical center bun want ": " Borneolum Syntheticum master falls apart stagnated fire, can deep heat, controls infantile convulsion, expectorant fan, sore throat, and swelling of the tongue, toothache, deafness, breath, conjunctival congestion cataract, pox poison cave in, parasite killing, hemorrhoid, expedite the emergence of, and property is walked and do not keep, also can granulation promoting pain relieving.So loose and easily exhaust, be that YIN-cold is also after all ".To the test of Borneolum Syntheticum toxicity and safety, the LD of gavage mice
50for 1059mg/kg.Real genus is nontoxic.
10, Herba Menthae:
Herba Menthae acrid in the mouth, cool in nature." detailed outline " is recorded: " Herba Menthae, pungently can disperse, cool can be sharp clearly, specially dispel the heat in pathogenic wind expelling.Therefore headache, wind syndrome of head, eyes, throat, all diseases of ability to speak, children's's fever (of children) accompanied by fear and scrofula, skin ulcer scabies are key medicine.To the test of Herba Menthae toxicity and safety, the LD of gavage mice
50for 1059mg/kg.Real genus is nontoxic.
The toxicological security test of iodophor disinfection cream of the present invention
1, test method is according to Ministry of Public Health " disinfection technology standard " version in 2002.
2, experimental result:
(1) chmice acute mouth toxicity test (LD
50): tested material iodophor disinfection cream is to the acute oral toxicity maximum tolerated dose of female male mice (or LD
50) > 5000mg/kgBW, true border non-poisonous material.
(2) repeatedly intact skin irritant test: tested material iodophor disinfection cream of the present invention to White Rabbit repeatedly the scoring of intact skin results of stimulation be nonirritant by skin irritation strength grading standard determination.
(3) acute eye irritation test: tested material iodophor disinfection cream of the present invention is judged to be nonirritant to the scoring of White Rabbit acute eye irritation test result by eye irritation reaction grade scale.
(4) repeatedly vaginal mucomembranous irritant test: tested material iodophor disinfection cream of the present invention to White Rabbit repeatedly the scoring of vaginal mucosa irritation result be pole subexcite by vaginal mucosa irritation strength grading standard determination.
(5) mice bone marrow micronucleus: each dosage group of tested material iodophor disinfection of the present invention cream is compared with solvent control group, and micronucleus cell rate there was no significant difference, result of the test is negative.Have no and cause the effect of PCEMNR micronucleus.
The advantage of iodophor disinfection cream of the present invention is that its main ingredient used is the complexation carrier of iodine, and complexation is complete, good stability; Mastic is easy to smear, and can clean, not painted, convenient nursing and operation; Owing to adding excellent moisturizing ingredient in mastic, keep moistening after mastic can be made to be applied in skin wound and do not form a scab, easily accepted by doctors and patients.
Detailed description of the invention
The preparation method of the embodiment of the present invention is:
1., get purified water in agitator tank, be heated to 60 DEG C, under at the uniform velocity stirring, add potassium iodate, citric acid successively, be at the uniform velocity stirred to evenly.
2., polyoxyethylene stearate (40) ester, Polyethylene Glycol, fatty alcohol-polyoxyethylene ether is added again successively, keep temperature and continue at the uniform velocity to stir, be melted into after homogeneous ointment base until whole material and stop stirring, make ointment base, keep substrate temperature to be not less than 60 DEG C.
3., by povidon iodine adding in the tank under stirring, is homogeneous thick liquid after stirring, and continues to be stirred to room temperature and places ripening.
4., stir or under Temperature fall to 35 DEG C or room temperature, stop ripening.
5., by glycerol, Borneolum Syntheticum, Herba Menthae respectively with stirring 30 minutes in the tank added to after dissolve with ethanol under stirring to fine and smooth, even, iodophor disinfection cream is obtained.
6., assay.
Embodiment 1
The weight proportion of the medicine material of iodophor disinfection cream is:
Embodiment 2
The weight proportion of the medicine material of iodophor disinfection cream is:
Embodiment 3
The weight proportion of the medicine material of iodophor disinfection cream is:
1, stability experiment:
Get 3 batches, iodophor disinfection cream sample at random, often criticize 3 pipes, to put in 37 DEG C of (relative humidity > 75%) calorstats 3 months, after testing, deposit front iodophor disinfection cream available iodine content average out to 0.537%, 37 DEG C (relative humidity > 75%) constant temperature is after 3 months, and available iodine content drops to 0.519%, and rate of descent is 3.4%.Meet the requirement that storage life that " disinfection technology standard " version in 2002 specifies is 2 years, stable performance.
2, open wound wound healing situation: iodophor disinfection cream sample is applied to wound surface, pain relief in five days, the fresh granulation tissue growth of wound surface pinkiness visible particulate, wound surface skin has new life.Reach wound healing in 15 days, pain relief wound surface occurs that fresh granules shape granulation tissue grows, and wound scope obviously reduces.For the position of infecting and fester, first can dilute mastic with sterile distilled water by 10: 1, clean is carried out to wound, then by mastic uniform application in wound surface.
Burn clinical care is totally 32 examples, and wherein I, II degree burn 27 example, treats wound healing after 3 ~ 35 days; Degree of depth II degree burn 5 example, treats wound healing after 40 ~ 80 days.
Open wound Clinic Case is in table 1:
3, killing bacteria situation: the killing rate of iodophor disinfection cream described in the embodiment of the present invention to staphylococcus aureus, Candida albicans and Pseudomonas aeruginosa is all more than or equal to 99.999%.
4, toxicity and irritant test the results are shown in Table 2:
| Content of the test | Test condition | Test index | Conclusion |
| Damaged skin stimulation index | Continuous 48h | 0 | Non-stimulated |
| Eye irritant test | —— | 0 | Non-stimulated |
| Repeatedly Skin Irritation Test | Continuous 14 days | 0 | Non-stimulated |
| Acute oral toxicity test | —— | —— | Actual nontoxic level |
| Polychromatic erythrocytes micronucleus test | —— | —— | Negative |
Above-described embodiment, only for technical conceive of the present invention and feature are described, its object is to person skilled in the art can be understood content of the present invention and implement according to this, can not limit the scope of the invention with this.All equivalences done according to spirit of the present invention change or modify, and all should be encompassed within protection scope of the present invention.
Claims (4)
1. an iodophor disinfection cream, is characterized in that, the medicine material weight proportion of this iodophor disinfection cream is:
2. according to iodophor disinfection cream described in claim 1, it is characterized in that, the medicine material weight proportion of this iodophor disinfection cream is:
3. a preparation method for iodophor disinfection cream described in claim 1, is characterized in that, carries out according to the following steps:
1., get purified water in retort, be heated to 60 ~ 80 DEG C, under at the uniform velocity stirring, add potassium iodate, citric acid successively, be at the uniform velocity stirred to evenly;
2., add polyoxyethylene stearate (40) ester, Polyethylene Glycol more successively, fatty alcohol-polyoxyethylene ether keeps temperature and continuation is at the uniform velocity stirred, be melted into after homogeneous ointment base until whole material and stop stirring, make ointment base, substrate temperature be kept to be not less than 60 DEG C;
3., by povidon iodine add in the retort under stirring, be homogeneous thick liquid after stirring, continue to be stirred to room temperature.
4., ripening is left standstill, curing time >=24 hours.
5., by glycerol, Borneolum Syntheticum, Herba Menthae respectively with stirring 30 minutes in the retort added to after dissolve with ethanol under stirring to fine and smooth, even, iodophor disinfection cream is obtained.
4., according to the preparation method of iodophor disinfection cream described in claim 3, it is characterized in that:
Step 1. in, after purified water being heated to 60 ~ 80 DEG C, getting 100ml purified water and add in measuring cup and dissolve potassium iodate; Get 200ml purified water again to add in measuring cup and dissolve citric acid, respectively above-mentioned two solution are added in retort;
Step 2. in, make whole material be melted into homogeneous ointment base in being added that retort is inherent at the uniform velocity stirred by polyoxyethylene stearate (40) ester, Polyethylene Glycol, fatty alcohol-polyoxyethylene ether;
Step 3. in, povidon iodine is added in the retort under stirring, stir after be homogeneous thick liquid, continuation stirring make mastic temperature be down to room temperature;
Step 4. in, leave standstill ripening and curing time >=24 hours;
Step 5. in, stir >=30 minutes in the retort that glycerol, Borneolum Syntheticum, Herba Menthae add under stirring, to mastic evenly, only fine and smooth.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109303065A (en) * | 2018-09-17 | 2019-02-05 | 深圳市疾病预防控制中心（深圳市卫生检验中心、深圳市预防医学研究所） | A kind of liquid and application method removing microbial contamination |
| CN111228299A (en) * | 2020-03-23 | 2020-06-05 | 上海宇昂水性新材料科技股份有限公司 | Water-soluble nano povidone iodine ointment and preparation method thereof |
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| CN1192905A (en) * | 1998-03-25 | 1998-09-16 | 康承银 | Compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen |
| CN101642467A (en) * | 2008-08-06 | 2010-02-10 | 吴天祥 | Long-acting disinfection paste |
| CN102885852A (en) * | 2012-10-23 | 2013-01-23 | 武汉迪奥药业有限公司 | Povidone iodine ointment and preparation method thereof |
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| CN1192905A (en) * | 1998-03-25 | 1998-09-16 | 康承银 | Compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen |
| CN101642467A (en) * | 2008-08-06 | 2010-02-10 | 吴天祥 | Long-acting disinfection paste |
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| CN109303065A (en) * | 2018-09-17 | 2019-02-05 | 深圳市疾病预防控制中心（深圳市卫生检验中心、深圳市预防医学研究所） | A kind of liquid and application method removing microbial contamination |
| CN111228299A (en) * | 2020-03-23 | 2020-06-05 | 上海宇昂水性新材料科技股份有限公司 | Water-soluble nano povidone iodine ointment and preparation method thereof |
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Application publication date: 20151111 |