CN102475678A - 5% povidone iodine solution - Google Patents

5% povidone iodine solution Download PDF

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Publication number
CN102475678A
CN102475678A CN2010105562596A CN201010556259A CN102475678A CN 102475678 A CN102475678 A CN 102475678A CN 2010105562596 A CN2010105562596 A CN 2010105562596A CN 201010556259 A CN201010556259 A CN 201010556259A CN 102475678 A CN102475678 A CN 102475678A
Authority
CN
China
Prior art keywords
povidone iodine
solution
iodine
iodine solution
betagen solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2010105562596A
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Chinese (zh)
Inventor
顾小强
黄耀球
王胜伟
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
JIANGSU QINFEN PHARMACEUTICAL CO Ltd
Original Assignee
JIANGSU QINFEN PHARMACEUTICAL CO Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by JIANGSU QINFEN PHARMACEUTICAL CO Ltd filed Critical JIANGSU QINFEN PHARMACEUTICAL CO Ltd
Priority to CN2010105562596A priority Critical patent/CN102475678A/en
Publication of CN102475678A publication Critical patent/CN102475678A/en
Pending legal-status Critical Current

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Abstract

The invention relates to a povidone iodine solution and preparation method thereof, particularly to a 5% povidone iodine solution. The povidone iodine solution is characterized in that the preparation method comprises the following steps: (1) adding 5 weight parts of povidone iodine into 3 weight parts of ethanol, and stirring at room temperature; (2) adding 485 weight parts of water and 0.1 weight parts of sodium alkyl benzene sulfonate after povidone iodine is completely dissolved, and stirring; and (3) regulating pH to 3-6 with citric acid, mixing, and filtering to obtain the 5% povidone iodine solution.

Description

5% betagen solution
Technical field
The present invention relates to a kind of betagen solution and preparation method thereof, especially 5% betagen solution.
Background technology
Povidone iodine (PVP-I) is yellowish-brown to rufous amorphous powder; Soluble in water or pure, be insoluble to EC.Its formation be a kind of be carrier with surfactant polyvinylpyrrolidone (PVP), water solublity and stability is good indefinite form chelated iodine all.Major part exists with associating iodine form, and having only few part is free-iodine, in solvent, releases gradually iodine, plays a kind of sustained release utility, to keep more permanent sterilizing power.PVP is a kind of hydrophilic polymer, no antibiotic effectiveness own.PVP forms small bag chamber carrier in process of production, and the iodide ion complexation in the body cavity of microcapsule, is formed PVP-I.Under aqueous solution state; Because it is for the affine effectiveness of cell membrane; Can iodine directly be guided to antibacterial thing cellular surface, this can directly guide to iodine the cell surface of antibacterial for improving iodine, and this is meaningful for carrying periodic antibacterial activity; The attack target of iodine is bacterial cell membrane and cytoplasma membrane, in seconds killing bacteria immediately just.Work as sulfhydryl compound; The necessary molecules of biological existence such as peptide class, aminoacid, enzyme, lipid and nucleic acid are with after PVP-I contacts; Immediately by iodine oxidation or iodate; Make it loss of activity, cause various antibacterials, pathogenic bacteria, fungus, infusorian can not survive, breed and death, reach the bactericidal action of long period and can not make it to form the antibiotic property of medicine.
Betagen solution; It is a kind of broad-spectrum disinfectant washing liquid; Can thoroughly kill pathogen such as the surperficial various bacteria of skin mucosa, fungus, virus rapidly, be used to treat cervicitis, cervical erosion, vaginitis, gynecological's mixed infection and not clear cause of disease gynecological infection are had special efficacy.
Be usually used in: the 1. skin degerming of operative site; 2. treatment is scalded; 3. treat trichomonal vaginitis; 4. treat suppurative scytitis and cutaneous fungal infection; 5. the sterilization of tableware and tableware.
Summary of the invention
The invention provides a kind of betagen solution and preparation method thereof with broad-spectrum disinfectant effect.
The present invention can realize in the following manner: the solution of povidone iodine is following raw materials by weight percent preparation: povidone iodine 5%, and ethanol 3%, sodium alkyl benzene sulfonate 0.1%, citric acid is an amount of, and all the other are water.Its preparation method may further comprise the steps: get in the ethanol that 5 parts povidone iodine joins 3 parts by weight (1), stirs under the room temperature; (2) povidone iodine dissolves the water of 485 parts of back addings and 0.1 part sodium alkyl benzene sulfonate fully, stirs; (3) with the citric acid adjust pH to 3-6, the mixing after-filtration promptly gets 5% betagen solution.
Povidone iodine (PVP-I) is yellowish-brown to rufous amorphous powder; Soluble in water or pure, be insoluble to EC.Povidone iodine can be killed multiple Gram-positive and negative bacteria, spore, fungus, colon bacillus, dysentery bacterium, tetracoccus, bacillus subtilis, Bacillus proteus, bacillus pyocyaneus, gonococcus, have a liking for the false single-skin drum bacterium of wheat tooth, citrobacter, diphtheroid, foreskin bacillus, Bacillus anthracoides, Candida albicans, Gypsum Fibrosum appearance trichophyton, flagellate, chlamydia.Its stable performance, fungicidal effectiveness is strong, has no stimulation, and is a kind of iodine medical bactericide and health and epidemic prevention disinfectant of well containing.Dodecyl sodium sulfate is a kind of anion surfactant, has the high-effective cleansing effect.Citric acid is a kind of acidity regulator.
Betagen solution provided by the invention be disinfection preservative, various bacteria, brood cell, virus, fungus etc. are had killing action.After its mechanism of action is these article contact wound surface or affected part, can depolymerization discharge contained iodine performance bactericidal action.Characteristics are little to tissue irritation, are applicable to skin, mucosa infection.
Betagen solution provided by the invention is applicable to suppurative dermatitis, cutaneous fungal infection, the slight burn and scald of small size, also is used for the sterilization of small size skin, mucosa wound.
Betagen solution provided by the invention is a rufous liquid.
The specific embodiment
Following embodiment only is used to illustrate the present invention, is not to be to limit the invention.
Embodiment 1
5% Preparation of Povidone Iodine Solution:
1, dissolving: ethanol 15L is joined in the dissolving pan of 500L, slowly add povidone iodine 25kg under stirring, room temperature continues down to stir after 30 minutes to make it to dissolve fully.With purified water 485L, join in the dissolving pan, add sodium alkyl benzene sulfonate 0.5kg again, continue stirring and stop after 30 minutes stirring, with Fructus Citri Limoniae acid for adjusting pH value to 3~6, stop to stir after-filtration.
2, filter: will dissolve good feed liquid through 5 μ m filter sticks, sucking filtration is to head tank.The qualified back fill of half-finished detection.
3, fill: with installing the 500ml piston pump on the filling machine.By the fill of every bottle of 500mL loading amount, spiral cover.
4, packing: stick the label of betagen solution, dress capsule and description are with the specification vanning of 500mL * 30 bottle.Put into the quality certification, packing, warehouse-in is up to the standards.
Embodiment 2
The method for preparing of medicinal sodium chloride provided by the invention, its quality control standard is according to " Chinese Pharmacopoeia version (two ones) in 2010 " and company standard.Standard is following:
1. character: these article are rufous liquid.
2. differentiate: (1) these article 1-5 of getting drips, and adds 1 of water 10mL and starch indicator solution, promptly shows bluish violet.(2) get these article 10mL, put in the 50mL conical flask, bottleneck covers one and placed for 60 seconds with the moistening filter paper of starch indicator solution, does not show blue.
3.pH value: should be 3.0-6.5.
4. assay: it is an amount of that precision takes by weighing these article, puts in the beaker, adds water to 125mL, according to " Chinese Pharmacopoeia version (an one) in 2010 " potentiometric titration, with the titration of sodium thiosulfate volumetric solution.Every 1mL sodium thiosulfate volumetric solution is equivalent to the iodine of 12.68mg.
Embodiment 3
According to production technology provided by the invention, production lot is 2100 bottles 5% betagen solution, and according to " Chinese Pharmacopoeia version (two ones) in 2010 " and company standard check, its assay is following:
Inspection item Standard code Assay
Character Be rufous liquid Up to specification
Differentiate Should be positive reaction Be positive reaction
PH value Should be 3.0~6.5 4.2
Loading amount Should be up to specification Up to specification
Bacterial population Should cross 100/mL Do not detect
Mycete and yeast Should cross 100/mL Do not detect
Staphylococcus aureus Should detect Do not detect
Pseudomonas aeruginosa Should detect Do not detect
Assay Should be 8.6~11.9% of labelled amount 10.0%
Embodiment 4
According to production technology provided by the invention, production lot is 1260 bottles 5% betagen solution, and according to " Chinese Pharmacopoeia version (two ones) in 2005 " and company standard check, its assay is following:
Inspection item Standard code Assay
Character Be rufous liquid Up to specification
Differentiate Should be positive reaction Be positive reaction
PH value Should be 3.0~6.5 3.4
Loading amount Should be up to specification Up to specification
Assay Should be 8.6~11.9% of labelled amount 10.1%
Embodiment 4
According to production technology provided by the invention, production lot is 900 bottles 5% betagen solution, and according to " Chinese Pharmacopoeia version (two ones) in 2005 " and company standard check, its assay is following:
Inspection item Standard code Assay
[0033]
Character Be rufous liquid Up to specification
Differentiate Should be positive reaction Be positive reaction
PH value Should be 3.0~6.5 4.5
Loading amount Should be up to specification Up to specification
Assay Should be 8.6~11.9% of labelled amount 10.0%

Claims (2)

1. a betagen solution is characterized in that, contains the component of following weight portion:
Povidone iodine 5%
Ethanol 3%
Sodium alkyl benzene sulfonate 0.1%
Citric acid is an amount of
Surplus is a water.
2. 5% betagen solution as claimed in claim 1 is characterized in that its preparation method comprises: get in the ethanol that 5 parts povidone iodine joins 3 parts by weight (1), stirs under the room temperature; (2) povidone iodine dissolves the water of 485 parts of back addings and 0.1 part sodium alkyl benzene sulfonate fully, stirs; (3) with the citric acid adjust pH to 3-6, the mixing after-filtration promptly gets 5% betagen solution.
CN2010105562596A 2010-11-24 2010-11-24 5% povidone iodine solution Pending CN102475678A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN2010105562596A CN102475678A (en) 2010-11-24 2010-11-24 5% povidone iodine solution

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN2010105562596A CN102475678A (en) 2010-11-24 2010-11-24 5% povidone iodine solution

Publications (1)

Publication Number Publication Date
CN102475678A true CN102475678A (en) 2012-05-30

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CN2010105562596A Pending CN102475678A (en) 2010-11-24 2010-11-24 5% povidone iodine solution

Country Status (1)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104147043A (en) * 2014-08-13 2014-11-19 武汉新大地环保材料有限公司 Povidone iodine and preparation method and application thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1689410A (en) * 2004-04-26 2005-11-02 中国科学院生物物理研究所 Highly efficient compound iodine disinfectant with strong permeability and its preparation method
CN101176700A (en) * 2007-10-29 2008-05-14 广东庆发药业有限公司 Antimicrobial disinfection hand cleanser and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1689410A (en) * 2004-04-26 2005-11-02 中国科学院生物物理研究所 Highly efficient compound iodine disinfectant with strong permeability and its preparation method
CN101176700A (en) * 2007-10-29 2008-05-14 广东庆发药业有限公司 Antimicrobial disinfection hand cleanser and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
国家药典委员会: "《中国华人民共和国药典 2010版 二部》", 31 January 2010, 中国医药科技出版社 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104147043A (en) * 2014-08-13 2014-11-19 武汉新大地环保材料有限公司 Povidone iodine and preparation method and application thereof

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Application publication date: 20120530