CN1203864C - Spray formulation of providone iodine - Google Patents
Spray formulation of providone iodine Download PDFInfo
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- CN1203864C CN1203864C CN03131706.5A CN03131706A CN1203864C CN 1203864 C CN1203864 C CN 1203864C CN 03131706 A CN03131706 A CN 03131706A CN 1203864 C CN1203864 C CN 1203864C
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- povidone iodine
- spray
- rabbit
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- rufous liquid
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- 239000007921 spray Substances 0.000 title claims description 43
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 229940068944 providone-iodine Drugs 0.000 title 1
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 claims abstract description 49
- 229920000153 Povidone-iodine Polymers 0.000 claims abstract description 49
- 229960001621 povidone-iodine Drugs 0.000 claims abstract description 49
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 33
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 claims abstract description 30
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- JLKDVMWYMMLWTI-UHFFFAOYSA-M potassium iodate Chemical compound [K+].[O-]I(=O)=O JLKDVMWYMMLWTI-UHFFFAOYSA-M 0.000 claims abstract description 11
- 239000001230 potassium iodate Substances 0.000 claims abstract description 11
- 229940093930 potassium iodate Drugs 0.000 claims abstract description 11
- 235000006666 potassium iodate Nutrition 0.000 claims abstract description 11
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 27
- NOOLISFMXDJSKH-UHFFFAOYSA-N p-menthan-3-ol Chemical compound CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 10
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 9
- 229920000053 polysorbate 80 Polymers 0.000 claims description 9
- 235000019219 chocolate Nutrition 0.000 claims description 5
- 239000002689 soil Substances 0.000 claims 1
- 210000000214 mouth Anatomy 0.000 abstract description 10
- 238000005507 spraying Methods 0.000 abstract description 6
- 239000003795 chemical substances by application Substances 0.000 abstract description 5
- 210000004877 mucosa Anatomy 0.000 abstract description 4
- 239000000796 flavoring agent Substances 0.000 abstract description 2
- 241000894006 Bacteria Species 0.000 abstract 1
- 241000233866 Fungi Species 0.000 abstract 1
- 239000013543 active substance Substances 0.000 abstract 1
- 235000013355 food flavoring agent Nutrition 0.000 abstract 1
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical compound CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 abstract 1
- 235000019633 pungent taste Nutrition 0.000 abstract 1
- 230000009385 viral infection Effects 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 46
- 241000283973 Oryctolagus cuniculus Species 0.000 description 28
- 238000012360 testing method Methods 0.000 description 23
- 239000003814 drug Substances 0.000 description 14
- 239000000243 solution Substances 0.000 description 13
- 239000011630 iodine Substances 0.000 description 11
- 229910052740 iodine Inorganic materials 0.000 description 11
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical group [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 10
- 241000699670 Mus sp. Species 0.000 description 7
- 230000037396 body weight Effects 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- 238000006243 chemical reaction Methods 0.000 description 6
- 238000003756 stirring Methods 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- 238000002360 preparation method Methods 0.000 description 5
- 230000029058 respiratory gaseous exchange Effects 0.000 description 5
- 238000010998 test method Methods 0.000 description 4
- 231100000331 toxic Toxicity 0.000 description 4
- 238000010171 animal model Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 230000010247 heart contraction Effects 0.000 description 3
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000002547 new drug Substances 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 3
- 231100000027 toxicology Toxicity 0.000 description 3
- 206010020565 Hyperaemia Diseases 0.000 description 2
- 241000699666 Mus <mouse, genus> Species 0.000 description 2
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 2
- 238000011047 acute toxicity test Methods 0.000 description 2
- 210000003169 central nervous system Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 230000001186 cumulative effect Effects 0.000 description 2
- 239000002270 dispersing agent Substances 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 230000003118 histopathologic effect Effects 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 239000002085 irritant Substances 0.000 description 2
- 231100000021 irritant Toxicity 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 210000002200 mouth mucosa Anatomy 0.000 description 2
- 238000011587 new zealand white rabbit Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000007117 Oral Ulcer Diseases 0.000 description 1
- 208000025157 Oral disease Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 230000003444 anaesthetic effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000001741 anti-phlogistic effect Effects 0.000 description 1
- 208000002399 aphthous stomatitis Diseases 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 238000011888 autopsy Methods 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 239000000645 desinfectant Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- XMBWDFGMSWQBCA-UHFFFAOYSA-M iodide Chemical compound [I-] XMBWDFGMSWQBCA-UHFFFAOYSA-M 0.000 description 1
- 239000003589 local anesthetic agent Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 208000030194 mouth disease Diseases 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 239000007800 oxidant agent Substances 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
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- 238000001228 spectrum Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000007910 systemic administration Methods 0.000 description 1
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- 238000011282 treatment Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention discloses a povidone iodine spraying agent which is characterized in that the povidone iodine spraying agent contains povidone iodine as an active agent, potassium iodate, and/or potassium iodide, glycerol, and/or propanediol, a flavouring agent and water. The povidone iodine spraying agent not only has stable quality, but also has no pungency to a skin and a mucosa. The povidone iodine spraying agent is suitable for being used for an oral cavity, and is used for preventing and treating bacterium, fungus and virus infection.
Description
One, technical field
The present invention relates to field of pharmaceutical preparations, is a kind of spray that contains povidone iodine specifically.
Two, technical background
At present the medication situation of China's oral disease and pharyngolaryngitis is roughly: oral surgery (rectifying type etc. as exodontia, tooth) is generally all usually prevented traumatic infection with antibiosis, and is effective, but the genus systemic administration, is not rational use of drug.Oral medicine as inflammation treatments such as oral ulcer, with the anti-inflammatory type medicine, but lacks the ideal topical drug of curative effect based on the part.Also many for all kinds of infection of throat is main Therapeutic Method with oral antiphlogistic antibacterial class medicine.
Povidone iodine is a kind of soluble complex that iodine and polyvinylpyrrolidone (PVP) form.Compare with iodine and to have good water solubility, advantage such as volatility is little.Be a kind of wide spectrum, efficient, low toxicity, the disinfectant of safety." Chinese pharmacopoeia version in 2000 has been recorded dosage forms such as betagen solution, ointment, suppository, gel, makes povidone iodine be able to extensive use clinically.Be fit to the dosage form that use in the oral cavity but still lack at present.
Three, summary of the invention
The spray that the purpose of this invention is to provide a kind of povidone iodine, not only zest is little for it, safety is good, and be fit to skin, be particularly suitable for oral cavity and bottleneck throat use, and steady quality, can be as drug manufacture and use.
Below be detailed content of the present invention:
Povidone iodine spray of the present invention contains following components in weight percentage:
Povidone iodine 2-10%
Potassium iodate and/or potassium iodide 0.05-2.5%
Glycerol and/or propylene glycol 5-60%
Correctives 0.1-3%
Surplus is a water
The tween 80 that wherein also can further contain 0.1-2%.
Preferred Mentholum of correctives and/or chocolate essence.
Spray of the present invention, it is as follows preferably to fill a prescription:
Povidone iodine 50g
Potassium iodate 1g
Potassium iodide 1.5g
Glycerol 200ml
Propylene glycol 100ml
Tween 80 1g
Mentholum 2g
Water adds to 1000ml
Povidone iodine is a kind of soluble complex that iodine and polyvinylpyrrolidone form.Compare with iodine and to have good water solubility, advantage such as volatility is little.But povidone iodine available iodine in storage process can decompose gradually, in preparation, need to add certain stabilizing agent and just can make the quality of the pharmaceutical preparations stable, and prepared preparation must nonirritant or zest minimum.
Potassium iodate can be used as stability among the present invention, and it is a kind of strong oxidizer, makes the reduzate iodine anion of free-iodine be oxidized to iodine, and keeps disinfection vitality.
Potassium iodide can form soluble complexes with iodine, and plays the hydrotropy effect, and makes iodine stable, not volatile.And complex reaction is reversible, so still can keep the sterilizing power of iodine.
Glycerol: as sweeting agent; Also can be used as the solvent of iodine, can relax the zest of iodine; And easily be attached on skin or the mucosa, make medicine be detained the affected part, and play the prolongation of effect effect.
Propylene glycol: be good dispersant, and have suitable viscosity.
Chocolate essence: the abnormal flavour that can cover iodine.
Mentholum: betagen solution is gone back bitter in the mouth except the foreign odor with iodine.The local anesthetic action of Mentholum is also effective to sheltering of bitterness, and therefore also available Mentholum carries out flavoring.
Tween 80: increase dispersion.
Make the active component povidone iodine stable by adding potassium iodate, potassium iodide in this prescription, add glycerol, propylene glycol, tween 80 as dispersant and cosolvent, can improve the infiltration rate and the absorbtivity of medicine-feeding part, but add the correctives covering smell, patient Geng Yi is accepted, increased the medication compliance.
Spray preparing process of the present invention is as follows:
Povidone iodine is stirred evenly, dissolves with 1/3 water yield, obtain solution I.Glycerol and/or propylene glycol and 1/3 water yield mixed stirring evenly, obtain solution II.With solution I and solution II merge stir solution III.In addition potassium iodide, potassium iodate are added with low amounts of water dissolving back respectively, be stirred to evenly, add tween 80, correctives, and add water to total amount, stir evenly.Pack in the container of being with nozzle.Need only a spray gently during use, medicinal liquid just is evenly distributed in skin or mucomembranous surface, and absorbs rapidly, reaches therapeutic effect.
Utilizing the spray stable storage of prescription of the present invention and preparation method preparation, below is the segmental stability result of the test:
(1), test basis: two ones of Chinese Pharmacopoeia versions in 2000
(2), sample and lot number: povidone iodine spray, content 10%, lot number: 000918,000920,000925.
(3), test item and detection method:
Character: visual examination.
PH value: press two appendix VIH of Chinese Pharmacopoeia version in 2000 pH algoscopy regulation and measure.
Content: press Chinese Pharmacopoeia version betagen solution in 2000 determination and measure.
(4), result of the test:
1, accelerated test the results are shown in Table 1.
2, long-term test results sees Table 2.
(5), conclusion: carry out stability test and assay according to Chinese Pharmacopoeia two ones of versions in 2000, quality is up to specification.
Table 1 povidone iodine spray stability accelerated test (30 ℃) result
| Lot number | Time (individual month) | Character | PH value | Content (labelled amount %) |
| 000918 | 0 | Rufous liquid | 5.33 | 11.09 |
| 1 | Rufous liquid | 5.38 | 10.90 | |
| 2 | Rufous liquid | 5.32 | 10.81 | |
| 3 | Rufous liquid | 5.27 | 10.63 | |
| 6 | Rufous liquid | 5.29 | 10.31 | |
| 000920 | 0 | Rufous liquid | 5.46 | 11.02 |
| 1 | Rufous liquid | 5.31 | 10.91 | |
| 2 | Rufous liquid | 5.33 | 10.88 | |
| 3 | Rufous liquid | 5.30 | 10.49 | |
| 6 | Rufous liquid | 5.22 | 10.17 | |
| 000925 | 0 | Rufous liquid | 5.35 | 11.50 |
| 1 | Rufous liquid | 5.34 | 11.43 | |
| 2 | Rufous liquid | 5.41 | 11.17 | |
| 3 | Rufous liquid | 5.22 | 10.88 | |
| 6 | Rufous liquid | 5.21 | 10.59 |
Table 2 povidone iodine spray room temperature reserved sample observing result of the test
| Lot number | Time (individual month) | Character | PH value | Content (labelled amount %) |
| 000918 | 0 | Rufous liquid | 5.23 | 11.27 |
| 1 | Rufous liquid | 5.25 | 11.25 | |
| 2 | Rufous liquid | 5.04 | 11.10 | |
| 3 | Rufous liquid | 5.08 | 11.19 | |
| 6 | Rufous liquid | 5.28 | 11.01 | |
| 9 | Rufous liquid | 5.24 | 10.90 | |
| 12 | Rufous liquid | 5.33 | 11.09 | |
| 18 | Rufous liquid | 5.58 | 11.38 | |
| 24 | Rufous liquid | 5.02 | 11.31 | |
| 31 | Rufous liquid | 5.04 | 10.54 | |
| 000920 | 0 | Rufous liquid | 5.46 | 11.01 |
| 1 | Rufous liquid | 5.52 | 10.90 | |
| 2 | Rufous liquid | 5.45 | 10.98 | |
| 3 | Rufous liquid | 5.50 | 10.83 | |
| 6 | Rufous liquid | 5.45 | 10.92 | |
| 9 | Rufous liquid | 5.44 | 10.90 | |
| 12 | Rufous liquid | 5.48 | 11.02 | |
| 18 | Rufous liquid | 5.53 | 11.35 | |
| 24 | Rufous liquid | 4.87 | 10.68 | |
| 31 | Rufous liquid | 4.89 | 9.79 | |
| 000925 | 0 | Rufous liquid | 5.35 | 11.77 |
| 1 | Rufous liquid | 5.49 | 11.61 | |
| 2 | Rufous liquid | 5.36 | 11.65 | |
| 3 | Rufous liquid | 5.38 | 11.65 | |
| 6 | Rufous liquid | 5.36 | 11.56 | |
| 9 | Rufous liquid | 5.35 | 11.53 | |
| 12 | Rufous liquid | 5.39 | 11.50 | |
| 18 | Rufous liquid | 5.53 | 11.78 | |
| 24 | Rufous liquid | 4.97 | 11.31 | |
| 31 | Rufous liquid | 4.98 | 10.46 |
Another advantage of the present invention is that prepared spray safety, zest is little, is suitable for skin, is particularly suitable for mucosa and bottleneck throat and uses, and has no side effect.
Below be the part pharmaceutical research data of spray of the present invention:
One, povidone iodine spray oral administration acute toxicity test
Summary
Povidone iodine spray rabbit oral administration 4 hours, dosage are pressed body surface area and are calculated, and clinical 51.1 times of using dosage of behaving approximately produce overt toxicity effect, none death of rabbit after 7 days to rabbit.LD50 is greater than 3.8ml/kg.
(1). test objective:
Observation is tried thing and is given the toxic reaction and the death condition that are produced behind the rabbit.
(2). test material:
1. tried thing:
Povidone iodine spray of the present invention;
Povidone iodine spray excipient.
3. experimental animal:
New zealand white rabbit, about body weight 2.5kg, male and female half and half.
(3). test method:
1. the selection of dosage: select greater than clinical 50 times dosage, 3.8ml/kg.
2. test method: get 12 of above-mentioned rabbit, be divided into 3 groups at random, every group of 4 rabbit, male and female half and half, divide 3 groups to be respectively povidone iodine spray dosage group, vehicle group and blank group.When povidone iodine spray dosage group and vehicle group administration, the rabbit mouth is strutted, nozzle is aimed at the rabbit oral cavity, be sprayed into medicine respectively, spray 3 times at every turn, once every spraying in 10 minutes, sprayed altogether in 4 hours 24 times, promptly the administration cumulative volume is about about 3.80ml/kg.At once observe after the administration, observed continuously 7 days, record rabbit overall health of patients, variations such as body weight, breathing, circulation, central nervous system, extremity activity then should be done histopathologic examination if death occurs.
(4). result of the test:
Rabbit weight increase after the administration, no significant changes such as breathing, circulation, central nervous system, extremity activity, povidone iodine spray dosage group after seven days, all none death of vehicle group and blank group rabbit.
(5). conclusion (of pressure testing)
Povidone iodine spray rabbit oral administration does not produce the overt toxicity effect to rabbit, and LD50 is greater than 3.80ml/kg.
Subordinate list: rabbit body weight, breathing, heart beating situation of change after the heavy dose of administration in povidone iodine spray oral cavity:
| Group | Test period | Body weight (kg) (X ± SD) | Breathing (inferior) (X ± SD) | Heart beating (inferior) (X ± SD) |
| The blank group | Before the administration | 2.43±0.13 | 179±20 | 60.5±10.2 |
| After the administration the 3rd day | 2.53±0.13 | 181±12 | 57.5±10.5 | |
| After the administration the 7th day | 2.70±0.09 | 174±14 | 56.5±7.5 | |
| Vehicle group | Before the administration | 2.50±0.16 | 189±27 | 62.0±13.0 |
| After the administration the 3rd day | 2.60±0.16 | 188±16 | 64.0±7.0 | |
| After the administration the 7th day | 2.74±0.22 | 177±16 | 60.0±9.1 | |
| Povidone iodine spray group | Before the administration | 2.58±0.19 | 176±30 | 58.5±9.4 |
| After the administration the 3rd day | 2.69±0.21 | 170±9 | 58.5±6.8 | |
| After the administration the 7th day | 2.80±0.20 | 181±8 | 61.5±9.7 |
Annotate: after the administration of this table rabbit the 3rd day, the 7th day body weight, breathing, heart beating situation of change through with administration before comparison, do not see notable difference.
List of references: new drug (Western medicine) preclinical study guideline compilation (pharmacy pharmacology's toxicology) P219-220 page or leaf
Two, povidone iodine spray oral administration irritant test
Summary
Povidone iodine spray rabbit oral administration 4 hours, dosage are pressed body surface area and are calculated, and clinical 24.77 times of using dosage of behaving approximately produce the obvious stimulation effect to rabbit.
(1). test objective:
Observation is tried thing and is given the irritant reaction situation that produced behind the rabbit.
(2). test material:
1, tried thing: povidone iodine spray of the present invention, lot number: 000925.
2. reference substance: povidone iodine spray excipient.
3. experimental animal: new zealand white rabbit, about body weight 2.5kg, the male and female dual-purpose.
(3) test method:
Get 9 of above-mentioned rabbit, be divided into 3 groups at random, every group of 3 rabbit, the male and female dual-purpose, divide 3 groups to be respectively povidone iodine spray dosage group, vehicle group and blank group.
When povidone iodine spray dosage group and vehicle group administration, the rabbit mouth is strutted, nozzle is aimed at the rabbit oral cavity, be sprayed into medicine respectively, spray 3 times at every turn, every spraying in 20 minutes 1 time, sprayed altogether in 4 hours 12 times, promptly the administration cumulative volume is about about 1.9ml/kg.Put to death rabbit in 24 hours after the administration, cut the rabbit mouth, the observation panel transmucosal has or not phenomenons such as hyperemia, redness, and the mucosa of getting in the buccal position is done the tissue slice inspection.
(4). result of the test:
Dissected rabbit in 24 hours after the administration, povidone iodine spray dosage group, vehicle group and blank group rabbit oral mucosa there is no phenomenons such as hyperemia, redness.
(5). conclusion (of pressure testing)
Povidone iodine spray rabbit oral administration does not produce stimulation to the rabbit oral mucosa.The body surface area conversion is pressed in metering, clinical 24.77 times of using dosage of behaving approximately.
List of references: new drug (Western medicine) preclinical study guideline compilation (pharmacy pharmacology's toxicology) P220 page or leaf
Three, povidone iodine spray mice oral administration acute toxicity test
Summary
The maximal dose of povidone iodine spray mouse stomach single administration is 40ml/kg.
(1). test objective:
Observation is tried thing and is once given the toxic reaction and the death condition that are produced behind the mice.
(2). test material:
1. tried thing: povidone iodine spray of the present invention, lot number: 000925.
2. experimental animal: Kunming kind white mice, about body weight 19g-21g, male and female half and half.
(3). test method:
Get this product, after trial test, get 20 of above-mentioned mices, male and female half and half are pressed gastric infusion of povidone iodine spray stock solution, 0.8ml/20g, and promptly dosage is 40ml/kg.At once observe after the administration, observed continuously 7 days, reaction of record mouse toxicity and death condition if any death, should in time perform an autopsy on sb, and if any the visible pathological changes of naked eyes, then should do histopathologic examination.
(4). result of the test:
Mice Non Apparent Abnormality reaction after the administration, none death of mice after seven days.
(5). conclusion (of pressure testing)
The maximal dose of a gastric infusion of povidone iodine spray mice is 40ml/kg.Press the body surface area conversion, clinical 195.5 times of using dosage of behaving approximately.
List of references: new drug (Western medicine) preclinical study guideline compilation (pharmacy pharmacology's toxicology) P.198-199
Four, the specific embodiment:
Embodiment 1
Povidone iodine 50g
Potassium iodate 1g
Potassium iodide 1.5g
Glycerol 200ml
Propylene glycol 100ml
Tween 80 1g
Mentholum 2g
Water adds to 1000ml
Povidone iodine is stirred evenly, dissolves with 1/3 water yield, obtain solution I.Glycerol and/or propylene glycol and 1/3 water yield mixed stirring evenly, obtain solution II.With solution I and solution II merge stir solution III.In addition potassium iodide, potassium iodate are added with low amounts of water dissolving back respectively, be stirred to evenly, add tween 80, Mentholum, chocolate essence, and add water to total amount, stir evenly.Pack in the container of being with nozzle.
Embodiment 2
Povidone iodine 50g
Potassium iodate 1g
Glycerol 300ml
Tween 80 1g
Mentholum 2g
Chocolate essence 10g
Water adds to 1000ml
Preparation method is with embodiment 1.
Claims (4)
1, a kind of spray of povidone iodine is characterized in that containing following components in weight percentage:
Povidone iodine 2-10%
Potassium iodate and potassium iodide 0.05-2.5%
Glycerol and/or propylene glycol 5-60%
Correctives 0.1-3%
Surplus is a water.
2, the described spray of claim 1 wherein also contains the tween 80 that weight ratio is 0.1-2%.
3, the described spray of claim 1, wherein correctives is Mentholum and/or chocolate essence.
4, the spray of claim 1, form by following component and weight:
Povidone iodine 50g
Potassium iodate 1g
Potassium iodide 1.5g
Glycerol 200ml
Propylene glycol 100ml
Soil temperature-80 1g
Mentholum 2g
Water adds to 1000ml.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN03131706.5A CN1203864C (en) | 2003-07-23 | 2003-07-23 | Spray formulation of providone iodine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN03131706.5A CN1203864C (en) | 2003-07-23 | 2003-07-23 | Spray formulation of providone iodine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1481812A CN1481812A (en) | 2004-03-17 |
| CN1203864C true CN1203864C (en) | 2005-06-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN03131706.5A Expired - Fee Related CN1203864C (en) | 2003-07-23 | 2003-07-23 | Spray formulation of providone iodine |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1203864C (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021248196A1 (en) * | 2020-06-10 | 2021-12-16 | Firebrick Pharma Limited | Improved virucidal formulations |
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- 2003-07-23 CN CN03131706.5A patent/CN1203864C/en not_active Expired - Fee Related
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| AU2021203846B2 (en) * | 2021-06-10 | 2022-11-24 | Firebrick Pharma Limited | Virucidal formulations containing povidone-iodine |
| WO2023053137A1 (en) * | 2021-09-28 | 2023-04-06 | Kejriwal Anil | Molecular iodine, alcohol, and propanediol based formulation and its application for relieving body odor |
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