CN1593453A - Sterilizing and bacteria inhibiting pharmaceutical composition and its formulation and preparation process - Google Patents

Sterilizing and bacteria inhibiting pharmaceutical composition and its formulation and preparation process Download PDF

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CN1593453A
CN1593453A CN 03156592 CN03156592A CN1593453A CN 1593453 A CN1593453 A CN 1593453A CN 03156592 CN03156592 CN 03156592 CN 03156592 A CN03156592 A CN 03156592A CN 1593453 A CN1593453 A CN 1593453A
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iodine
sterilization
compositions
antibacterial medicines
diphenyl ether
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CN1259919C (en
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黄家章
黄萌
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YAKEXI PHARMACEUTICAL INST BEIJING
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YAKEXI PHARMACEUTICAL INST BEIJING
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Abstract

The invention discloses a skin and mucous membrane sterilization, compound iodine pharmaceutical composition and preparation process, wherein the composition comprises iodine, Triclosan and chlorhexidine acetate by the proportion of 0.01-2.0 : 0.005-1.0. The preparation can be made into various externally used form and disinfectant form through the conventional method.

Description

A kind of sterilization, antibacterial medicines compositions and preparation and preparation technology
Technical field
The present invention relates to a kind of sterilization, antibacterial medicines compositions, relate in particular to the sterilization of a kind of skin and mucosa, antibacterial compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen pharmaceutical composition and preparation and preparation technology.
Background technology
Povidone iodine (Iodophor) is iodine and surfactant, as the indefinite form conjugate of materials such as polyvinylpyrrolidone, polyoxyethylene ether, i.e. and polyvinylpyrrolidone-iodine (PVP-I), Nonyl pheno dodecane alcohol ether-iodine (NP 10-I), NPE-iodine (POP-I), PEG-I (PEG-I), alkylsulfonate-iodine (ASE-I), poly-third oxygen ether-iodine (PPE-I), alkane alkene imidazoles-iodine (PVI-I), polyvinyl alcohol-iodine (APA-I), ring glucoside-iodine povidone iodine such as (CD-I).In medical povidone iodine, (PVP-I) is the most frequently used for polyvinylpyrrolidone-iodine.Povidone iodine is to gram positive bacteria and negative bacterium sensitivity, and is effective to acid-fast bacilli, bacterial spore, fungus, lipophilic virus and hydrophilic viruses, but bactericidal action is slower, after 3 minutes, just can better bring into play bactericidal action, shorter at skin and mucosa reservation effective time, the low concentration bacteriostasis is also relatively poor.Trichloro hydroxyl diphenyl ether (DP300, triclosan) also is anti-bacterial drug, but it is undesirable to killing, prevent and treat the two mixed infection effect of skin, mucosa antibacterial or fungal infection or antibacterial and fungus, bacterial spore is not had killing action, and can not be used for the kill bacteria spore is the practical sterilization of purpose.Chlorhexidine acetate (Chlorhexidine, the former name chlorhexidine acetate, be called for short chlorhexidine or hibitane), be anti-bacterial drug, but it is undesirable to killing, prevent and treat the two mixed infection effect of skin, mucosa antibacterial or fungal infection or antibacterial and fungus, bacterial spore is not had killing action, and can not be used for the kill bacteria spore is the sterilization of purpose.
Summary of the invention
The purpose of this invention is to provide a kind of sterilization, antibacterial medicines compositions, the sterilization of a kind of skin and mucosa, antibacterial compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen pharmaceutical composition and preparation and preparation technology especially are provided.Overcome above-mentioned one-component can not more effectively kill and treat disease that skin bacterium or fungal infection or antibacterial and the two mixed infection of fungus cause and external can not be rapider and the long period continue the shortcoming of sterilizing.
The objective of the invention is to be achieved through the following technical solutions:
A kind of sterilization, antibacterial medicines compositions comprise the medicament that following component is made: povidone iodine, trichloro hydroxyl diphenyl ether or chlorhexidine acetate;
Described povidone iodine is the indefinite form conjugate of known iodine and surfactant, and described surfactant is optional from polyvinylpyrrolidone, polyoxyethylene ether etc.; Described povidone iodine can be selected from one of following indefinite form conjugate: vinylpyrrolidone-iodine (PVP-I), Nonyl pheno dodecane alcohol ether-iodine (NP 10-I), NPE-iodine (POP-I), PEG-I (PEG-I), alkylsulfonate-iodine (ASE-I), poly-third oxygen ether-iodine (PPE-I), alkane alkene imidazoles-iodine (PVI-I), polyvinyl alcohol-iodine (APA-I), ring glucoside-iodine (CD-I) etc., especially be polyvinylpyrrolidone-iodine (PVP-I);
Described component can be the component of following weight portion proportioning ratio:
Povidone iodine: trichloro hydroxyl diphenyl ether or chlorhexidine acetate are (0.02~2.0): (0.005~1.0) is preferably (0.2~1.0): (0.05~0.6) is preferably 0.5: 0.3;
Described povidone iodine weight portion is with effective iodometer;
Described sterilization, antibacterial medicines compositions also can comprise available adjuvant on the materia medica;
Described medicament can be said skin and mucosa delivery dosage form on the pharmaceutics; Especially can be solution, tincture, lotion, spray, liniment, ointment, ointment, membrane, varnish, suppository, gel;
Described medicament also can be said disinfectant on the pharmaceutics; Especially can be liquid disinfectant, sterilized cotton ball (cotton swab), granule, ointment, gel, disinfectant tablet, membrane, effervescent and disinfectant powder.
The present invention also provides described sterilization, antibacterial medicines preparation of compositions method, may further comprise the steps:
Take by weighing povidone iodine, trichloro hydroxyl diphenyl ether or chlorhexidine acetate according to the above ratio, the preparation method of complying with conventional dermatologic or disinfectant is prepared from skin and mucosa delivery dosage form or disinfectant;
Described preparation method also comprises the pharmaceutically available adjuvant of adding.
The present invention has following effect and advantage:
1) medicine of the present invention has collaborative and potentiation to microorganisms such as antibacterium, funguses.Utilize two kinds of drug component effects separately, make up the back and find aspect killing microorganisms, to have more by composition medicine snap action and long period continue antibacterial, bactericidal action, and kept that two kinds of medicines property of medicine in the compound medicines preparation is stable, the characteristics of effect stability than one pack system.
2) can be used as compound external-use local application and disinfectant, as compositions ointment, solution and disinfectant etc., the patient who clinically dermatophytes is merged bacterial infection, unique curative effect and disinfective action are arranged, also do not influence simple fungus or bacterial infection treating for skin disease effect and remove pathogen.Clinical principium test above-mentioned composition ointment and solution are treated dermatophytes or antibacterial, or the patient of fungus and bacteria mixed infection, and are used for sterilizations such as surgical patient, surgical operation, gynecological, the department of stomatology as disinfectant, all obtain significant curative effect.
Above-mentioned advantage of the present invention and effect can illustrate by following experiment.
One, to the bacteriostasis of several frequently seen malignant bacteria and fungus
1, materials and methods
Fungus is drawn from the air force general hospital department of dermatologry, and antibacterial is drawn from preventive medicine academy of science institute of Antibiotics and air force general hospital clinical laboratory.Used strain is escherichia coli, staphylococcus aureus, bacillus subtilis black variety gemma brood body and Candida albicans.
Fungi culture medium is the Sha Shi broth bouillon, and by mainly being made up of 1% peptone and 2% glucose, PH is 6-6.5; Bacteria culture media is an ordinary broth, and PH is 7.
The preparation of medicinal liquid culture medium is in povidone iodine (PVP-I) the ratio preparation different with trichloro hydroxyl diphenyl ether or chlorhexidine acetate.Each composite formula 5mg with 1ml 95% dissolve with ethanol, adds sterile distilled water to 5ml earlier again; Respectively draw above-mentioned dosing 0.2ml then, be added to respectively in the culture medium of 1.8ml, shake up the medicinal liquid culture medium that the back two-fold dilution goes out variable concentrations.During experiment, add bacterium liquid 0.02ml among every pipe medicinal liquid culture medium 1ml; 1ml contains antibacterial or spore brood body 10 5-10 6Individual or yeast-like fungi 10 3-10 4Individual.Be put in after shaking up in the 35-37 ℃ of incubator and cultivated 24 hours, wherein yeast-like fungi is 48 hours, observed result.
The drug effect criterion, the limpid medicine blank pipe that is same as of meat soup is for there being bacteriostasis; Meat soup is obviously muddy, or the Mycoderma growth is arranged, and then is no bacteriostasis.
3, result
Bacteriostatic test shows, povidone iodine and trichloro hydroxyl diphenyl ether, povidone iodine and povidone iodine chlorhexidine acetate medicinal liquid are different to the minimal inhibitory concentration (MIC) of common malignant bacteria of 4 strains and fungus (representing bacterium), povidone iodine and trichloro hydroxyl diphenyl ether, povidone iodine and chlorhexidine acetate are in (0.02~2.0): lower to the minimal inhibitory concentration of several frequently seen pathomycete during the preparation of (0.005~1.0) weight portion proportioning ratio, effect (sees Table 1-2 by force,), behind proof povidone iodine and trichloro hydroxyl diphenyl ether or the chlorhexidine acetate compatibility, the effect of antibacterium and fungus is unaffected, compositions is better than its component drug, and two medicine compatibilities have synergism and potentiation are arranged.
Two, to the killing action of several frequently seen malignant bacteria, spore and fungus
1, materials and methods
The bactericidal assay method is the carrier quantitation method.Used strain is escherichia coli, staphylococcus aureus, bacillus subtilis black variety gemma and Candida albicans.Bacteria suspension is with containing 2% peptone water solution dilution.Used nertralizer is the buffer (PH7.4) that contains materials such as 0.1mol sodium thiosulfate, 5% Tween 80,0.3%P lecithin, 1% histidine and 20% calf serum, can remove the drug residue effect in compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution and its component medicine.
Test is defat calico sheet (1.0 * 1.0cm with carrier 2).The microbiological contamination method is for dripping the method for dying.During test, the microbiological contamination print is put into the medicinal liquid that splendid attire is good in advance (each print consumption 5ml), act on to official hour, aseptic method is taken out the test print, move on to contain 5ml nertralizer solution in vitro, in and 5-10 minute, sampling 0.5ml inoculation plate, 2 plates of each sample inoculation then with agar tilt-pour process counting survival clump count, and calculate bactericidal effect.
2, result
Through evidence, povidone iodine (PVP-I) demonstrates killing effect preferably with the compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen medicinal liquid (2) of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen medicinal liquid (1), povidone iodine and the povidone iodine chlorhexidine acetate of trichloro hydroxyl diphenyl ether to escherichia coli, staphylococcus aureus and white beads, and 1 minute killing rate of (20-25 ℃) effect can reach 99.99% at normal temperatures; Act on 5 minutes, can reach 100% (seeing Table 3-4).Compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (1) and (2) act on 1 minute to the bacillus subtilis black variety gemma killing effect, and its killing rate can reach 96.08%-97.88%.But its one pack system medicine povidone iodine, trichloro hydroxyl diphenyl ether, chlorhexidine acetate solution, relatively poor to spores of bacillus subtilin and 1 minute effect of Candida albicans effect respectively, iodophor solution is 68.56%-78.68%, and trichloro hydroxyl diphenyl ether and chlorhexidine acetate solution are respectively 0%-88.60% and 0%-96.56%.To spores of bacillus subtilin and 1 minute effect of Candida albicans effect, compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (1) or (2) with carry out statistics relatively with its component medicine trichloro hydroxyl diphenyl ether solution or chlorhexidine acetate solution, there were significant differences (p<0.01).
The external bacteriostasis of table 1 povidone iodine and trichloro hydroxyl diphenyl ether variable concentrations compatibility to several frequently seen pathogenic microorganism
Minimal inhibitory concentration (MIC, μ g/ml)
Povidone iodine: trichloro hydroxyl diphenyl ether
Staphylococcus aureus e coli bacillus subtilis brood body Candida albicans
0.02∶0.1 2.500 1.250 2.500 5.000
0.1∶0.2 2.500 1.250 0.625 5.000
0.3∶0.5 0.625 0.625 0.625 1.250
0.3∶1.0 0.625 0.32125 0.625 0.625
0.3∶2.0 --- --- --- ---
0.3∶0.1 1.250 1.259 1.250 2.500
0.5∶0.3 0.625 0.625 0.625 2.50
0.5∶0.5 0.3125 0.3125 0.625 1.25
0.5∶0.8 0.3125 0.3125 0.3125 1.25
0.5∶1.0 0.1562 0.1562 0.3125 0.625
0.5∶2.0 --- --- --- ---
1.0∶0.2 0.625 0.625 0.625 1.25
1.0∶0.3 0.625 0.625 0.625 1.25
1.0∶0.5 0.1562 0.3125 0.625 0.626
1.0∶0.8 0.1562 0.1562 0.1562 0.62
2.0∶1.0 0.1562 0.1562 0.1562 0.3215
2.5∶0.5 --- --- --- ---
1.0: 0.0 (single medicine contrast) 5.000 5.000 10.000 10.000
0.0: 1.0 (single medicine contrasts) 0.0250 0.625 0.625 2.500
Annotate: 1. antibacterial and brood body bacterium were cultivated 24 hours, and Candida albicans is cultivated 48 hours observed results.
2. the high dissolving of "---" drug level is bad, can't observed result.
The external bacteriostasis of table 2 povidone iodine and chlorhexidine acetate variable concentrations compatibility to several frequently seen pathogenic microorganism
Minimal inhibitory concentration (MIC, μ g/ml)
Povidone iodine: chlorhexidine acetate
Staphylococcus aureus e coli bacillus subtilis brood body Candida albicans
0.02∶0.1 2.500 2.500 2.500 5.000
0.1∶0.2 1.250 1.250 1.250 2.500
0.3∶0.5 0.625 0.625 0.625 1.250
0.3∶1.0 0.3125 0.32125 0.625 0.625
0.3∶2.0 --- --- --- ---
0.3∶0.1 1.250 1.259 1.250 2.500
0.5∶0.3 0.625 0.625 0.625 2.50
0.5∶0.5 0.3125 0.625 0.625 1.25
0.5∶0.8 0.3125 0.3125 0.625 1.25
0.5∶1.0 0.1562 0.1562 0.3125 0.625
0.5∶2.0 --- --- --- ---
1.0∶0.2 0.625 0.625 0.625 1.25
1.0∶0.3 0.625 0.625 0.625 1.25
1.0∶0.5 0.1562 0.3125 0.625 0.626
1.0∶0.8 0.1562 0.1562 0.1562 0.62
2.0∶1.0 --- --- --- ---
2.5∶0.5 --- --- --- ---
1.0: 0.0 (single medicine contrast) 5.000 5.000 10.000 10.000
0.0: 1.0 (single medicine contrasts) 1.250 0.625 0.625 2.500
Annotate: 1. antibacterial and brood body bacterium were cultivated 24 hours, and Candida albicans is cultivated 48 hours observed results.
2. the high dissolving of "---" drug level is bad, can't observed result.
Table 3 compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (1) and component medicine thereof are to the killing effect of several microorganisms
The strain classification contrasts different (Min) killing rates action time (%) of average bacterium number
(cfu/ sheet) 135 10
Compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (1):
Staphylococcus aureus 1,150,000 99.99 99.99 100.00 100.00
Escherichia coli 1,080,000 99.99 99.99 100.00 100.00
Spores of bacillus subtilin 1,166,000 96.08 99.99 99.99 100.00
Candida albicans 125,600 99.99 99.99 100.00 100.00
Iodophor solution:
Staphylococcus aureus 1,150,000 99.90 99.65 99.96 100.00
Escherichia coli 1,080,000 90.92 99.98 99.99 100.00
Spores of bacillus subtilin 1,166,000 68.56 92.78 99.52 100.00
Candida albicans 125,600 78.68 99.80 99.96 100.00
Trichloro hydroxyl diphenyl ether solution:
Staphylococcus aureus 1,150,000 99.88 98.96 99.98 100.00
Escherichia coli 1,080,000 97.96 98.88 99.99 100.00
Spores of bacillus subtilin 1,166,000 0.00 16.86 28.66 40.80
Candida albicans 125,600 88.60 98.95 99.92 100.00
Annotate: compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (1) contains 0.5% (referring to available iodine content, down together) povidone iodine and 0.3% trichloro hydroxyl diphenyl ether, and iodophor solution contains 0.5% povidone iodine, and trichloro hydroxyl diphenyl ether solution contains 0.3% trichloro hydroxyl diphenyl ether.
Table 4 compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (2) and component medicine thereof are to the killing effect of several microorganisms
The strain classification contrasts different (Min) killing rates action time (%) of average bacterium number
(cfu/ sheet) 135 10
Compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (2):
Staphylococcus aureus 1,150,000 99.99 99.99 100.00 100.00
Escherichia coli 1,080,000 99.99 99.99 100.00 100.00
Spores of bacillus subtilin 1,166,000 97.88 99.99 99.99 100.00
Candida albicans 125,600 99.99 99.99 100.00 100.00
Iodophor solution:
Staphylococcus aureus 1,150,000 89.90 99.65 99.96 100.00
Escherichia coli 1,080,000 90.92 99.98 99.99 100.00
Spores of bacillus subtilin 1,166,000 68.56 92.78 99.52 100.00
Candida albicans 125,600 78.68 99.80 99.96 100.00
Chlorhexidine acetate solution:
Staphylococcus aureus 1,150,000 99.90 99.99 100.00 100.00
Escherichia coli 1,080,000 99.96 99.99 100.00 100.00
Spores of bacillus subtilin 1,166,000 0.00 18.86 32.70 46.55
Candida albicans 125,600 96.56 99.99 100.00 100.00
Annotate: compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution (2) contains 0.5% povidone iodine and 0.3% chlorhexidine acetate, and iodophor solution contains 0.5% povidone iodine, and chlorhexidine acetate solution contains 0.3% chlorhexidine acetate.
Three, the clinical case report for example
The present composition, be povidone iodine: when trichloro hydroxyl diphenyl ether or chlorhexidine acetate formulation weight part proportioning ratio are 0.02~2.0: 0.005~1.0 formulated topical agent and disinfectant, the disease of treatment trauma infection contamination, pre-bacteriological protection, fungal infection and fungus, bacteria mixed infection is had better therapeutic effect and disinfective action.
Example 1. passes * *, the man, 32 years old, because of hand skin skin injury, begin not draw attention, back bacterial infection, the red and swollen suppuration is diagnosed as the wound bacterial infection, and antibacterial culturing is an infection of staphylococcus aureus.Then give the external of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen spray, 1 week of logotype, recovery from illness.
Example 2. ten thousand * *, the male, 20 years old, because of itching, bifilar inboard skin lesion companion go to a doctor April, be diagnosed as tinea cruris.Sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give 1 week of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen solution logotype, the 2nd all sings and symptomses disappear, and fungus microscope examination and cultivation all show negative, clinical recovery.
Example 3. once * *, the male, 32 years old, went to a doctor in 1 week because of the inboard skin lesion companion of left side foot 3-5 toe itches, be diagnosed as tinea pedis.Sings and symptoms is obvious before the treatment, and fungal culture is a Candida albicans.Then give 1 week of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen ointment logotype, the 2nd all sings and symptomses disappear, and fungus microscope examination and cultivation all show negative, clinical recovery.
Example 4. finishes * *, the male, 25 years old, because of skin lesion companion between the biped toe itches half a year, to itch recently and scratch, the state of an illness increases the weight of, and mixes red and swollen the prescription on individual diagnosis, is diagnosed as between toe the type tinea pedis and mixes bacterial infection.Sings and symptoms is all heavier before the treatment, and microscopy is cultivated and is alpha fungus, and antibacterial culturing is golden yellow staphylococcus.Then give 1 week of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen emulsifiable paste logotype, sings and symptoms disappears substantially during drug withdrawal, and fungus microscope examination and antibacterial culturing are all negative; The 2nd week, clinical and fungus, bacteriology checking were all fully recovered.
Example 5. parties * *, the male, 20 years old, excuse portion suffered from furuncle and phyma and mixes prescription on individual diagnosis in red and swollen 5 days, and antibacterial culturing is golden yellow staphylococcus, is diagnosed as suppurative folliculitis.Sings and symptoms is obvious before the treatment, gives compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen antiseptic solution sterilizing then, and logotype is used 5 times, and sings and symptoms disappeared in the 5th day, antibacterial culturing feminine gender, clinical recovery.
Example 6. Liu * *, the male, 22 years old, because of being caused the breakage of left lower limb lower limb by bicycle wound because of carelessness, bled in many places, disinfect with the compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen disinfectant lotion, every day secondary, for three days on end, wound is not seen infection, wound healing after 4 days.
Case 7. Huangs * *, the women, 25 years old, because of itching, right cervical region skin lesion companion went to a doctor in 2 weeks, and the fungus microscope examination positive is diagnosed as tinea corporis, and sings and symptoms is obvious before the treatment, and fungal culture is a trichophyton.Then give the external of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen varnish, 1 week of logotype, the clinical and mycology recovery from illness of the 2nd week.
Case 8. merchants * *, the male, 28 years old, because of itching, preceding chest and back skin lesion companion went to a doctor in 1 year, be diagnosed as tinea versicolor.Sings and symptoms is obviously long-pending before the treatment, the fungus microscope examination positive.Then give the compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen lotion for treatment, in 1 week of logotype, sings and symptoms disappears during the 2nd all drug withdrawal, negative fungal examination, clinical recovery.
Case 9. Shen * *, the male, 25 years old, the companion itched 2 years because of the both legs skin lesion, itched recently and scratched, and the state of an illness increases the weight of, and mixes red and swollen the prescription on individual diagnosis, is diagnosed as antibacterial and fungal infection.Sings and symptoms is all heavier before the treatment, and microscopy is cultivated and is alpha fungus, and antibacterial culturing is positive, gives the treatment of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen gel then, and in 2 weeks of logotype, sings and symptoms disappears substantially during drug withdrawal, and fungus microscope examination and antibacterial culturing are negative; The 3rd all clinical recoveries.
Case 10. kings * *, the women, 26 years old, because of itching, external genital portion skin lesion companion went to a doctor in 1 year, be diagnosed as condyloma acuminatum, give the treatment of compounded Dianfu-medicine prepared from iodine and hoevillite containing interhalogen liniment then, in 10 weeks of logotype, sings and symptoms disappears during drug withdrawal, clinically is judged to healing.
The specific embodiment
Embodiment 1
Ointment
Take by weighing raw material povidone iodine (PVP-I) 0.5 gram by 0.5: 0.3 formula proportion and (refer to available iodine content, trichloro hydroxyl diphenyl ether 0.3 gram down together),, earlier with a small amount of 95% dissolve with ethanol, use the 0/W dosage form, excipient is octadecanol 4 grams, stearic acid 4 grams, glyceryl monostearate 3.5 grams, vaseline 10 grams, glycerol 10 grams, soil temperature-80 2 gram and surplus distilled water mix homogeneously, the ultraviolet sterilization is mixed with ointment 100 grams.
Embodiment 2
Ointment
Take by weighing raw material povidone iodine (PVP-I) 0.2 gram, chlorhexidine acetate 0.6 gram by 0.2: 0.6 formula proportion, earlier with a small amount of 95% dissolve with ethanol, use the 0/W dosage form, excipient is octadecanol 4 grams, stearic acid 10 grams, glyceryl monostearate 5 grams, vaseline 6 grams, glycerol 10 grams, triethanolamine 0.8 gram and surplus distilled water mix homogeneously, ointment 100 grams are made in sterilization.
Embodiment 3
Solution or lotion
Take by weighing raw material povidone iodine (PVP-I) 0.02 gram, trichloro hydroxyl diphenyl ether 1.0 grams by 0.02: 1.0 formula proportion, add 20ml95% ethanol, the 20ml propylene glycol, surplus distilled water mix homogeneously, solution or lotion 100ml are made in sterilization.
Embodiment 4
Tincture
Take by weighing raw material povidone iodine (PEG-I) 2.0 grams, chlorhexidine acetate 0.005 gram by 2.0: 0.005 formula proportion, add 50ml95% ethanol, the 20ml propylene glycol, 10ml glycerol and surplus distilled water mix homogeneously, tincture 100ml is made in sterilization.
Embodiment 5
Suppository
Take by weighing raw material povidone iodine (PEG-I) 0.5 gram, chlorhexidine acetate 0.5 gram, Polyethylene Glycol-1,000 73.5 grams, Polyethylene Glycol-4,000 25 grams by 0.5: 0.5 formula proportion.-4000 fusings of Polyethylene Glycol during preparation-1000 and Polyethylene Glycol are treated to add when temperature is reduced to 50 ℃ the above-mentioned raw materials medicine and are stirred evenly, and make suppository 100ml, irritate mould then, promptly.
Embodiment 6
Spray
Take by weighing raw material povidone iodine (PVP-I) 0.25 gram, trichloro hydroxyl diphenyl ether 0.3 gram by 0.25: 0.3 formula proportion, add 20ml95% ethanol, 20ml glycerol and surplus distilled water, mix homogeneously, spray 100ml is made in sterilization.
Embodiment 7
Ointment
Take by weighing raw material povidone iodine (PEG-I) 0.3 gram, chlorhexidine acetate 0.5 gram by 0.3: 0.5 formula proportion, earlier with a small amount of 95% dissolve with ethanol, use the 0/W dosage form, excipient is octadecanol 4 grams, stearic acid 4 grams, glyceryl monostearate 3.5 grams, vaseline 10 grams, glycerol 10 grams, soil temperature-80 2 gram and surplus distilled water, mix homogeneously, ointment 100 grams are made in sterilization.
Embodiment 8
Membrane
Take by weighing raw material povidone iodine (PVP-I) 0.5 gram, trichloro hydroxyl diphenyl ether 0.5 gram by 0.5: 0.5 formula proportion,, add among the 15 gram polyvinyl alcohol 17-88 of elder generation with dissolved in distilled water earlier with a small amount of 95% dissolve with ethanol, with adding with stirring, add 30 gram glycerol, adding distil water is to 100g, stirs evenly to get final product.
Embodiment 9
Ointment
Take by weighing povidone iodine (PVP-I) 1.0 grams, trichloro hydroxyl diphenyl ether 0.5 gram raw material by 1.0: 0.5 formula proportion, earlier with a small amount of 95% dissolve with ethanol, use the 0/W dosage form, excipient is octadecanol 4 grams, stearic acid 10 grams, glyceryl monostearate 5 grams, vaseline 6 grams, glycerol 10 grams, triethanolamine 0.8 gram and surplus distilled water, mix homogeneously, sterilization is mixed with ointment 100 grams.
Embodiment 10
Liquid disinfectant
Take by weighing raw material povidone iodine (PEG-I) 0.5 gram, trichloro hydroxyl diphenyl ether 0.3 gram by 0.5: 0.3 formula proportion, add 25ml 95% ethanol, 10ml glycerol and surplus distilled water, mix homogeneously, disinfectant 100ml is made in sterilization.
Embodiment 11
Disinfectant powder
Take by weighing raw material povidone iodine (PEG-I) 0.2 gram, chlorhexidine acetate 0.1 gram by 0.2: 0.1 formula proportion,, add starch 20g, Pulvis Talci surplus earlier with a small amount of 95% dissolve with ethanol, mix homogeneously, powder 100g is made in sterilization.
Embodiment 12
Sterilization granule or effervescent tablet
Take by weighing raw material povidone iodine (PVP-I) 0.5 gram, trichloro hydroxyl diphenyl ether 0.6 gram by 0.5: 0.6 formula proportion, adding citric acid 0.5 gram, sodium bicarbonate 0.5 gram, surplus add to starch 100.0 grams, mixing, granulate, make granule according to a conventional method, pack promptly, or tabletting, effervescent tablet made.

Claims (9)

1, a kind of sterilization, antibacterial medicines compositions comprise following component: povidone iodine, trichloro hydroxyl diphenyl ether or chlorhexidine acetate.
2, sterilization according to claim 1, antibacterial medicines compositions, described compositions can be the medicament that following weight portion proportioning ratio component is made:
Povidone iodine: trichloro hydroxyl diphenyl ether or chlorhexidine acetate are 0.02~2.0: 0.005~1.0.
3, sterilization according to claim 1, antibacterial medicines compositions, described compositions can be the medicament that the component of following weight portion proportioning ratio is made:
Povidone iodine: trichloro hydroxyl diphenyl ether or chlorhexidine acetate are 0.2~1.0: 0.05~0.6.
4, sterilization according to claim 1, antibacterial medicines compositions, described compositions can be the medicament that the component of following weight portion proportioning ratio is made:
Povidone iodine: trichloro hydroxyl diphenyl ether or chlorhexidine acetate are 0.5: 0.3.
5, sterilization according to claim 1, antibacterial medicines compositions, described povidone iodine can be selected from one of indefinite form conjugate of following iodine and surfactant: polyvinylpyrrolidone-iodine, Nonyl pheno dodecane alcohol ether-iodine, NPE-iodine, PEG-I, alkylsulfonate-iodine, poly-third oxygen ether-iodine, alkane alkene imidazoles-iodine, polyvinyl alcohol-iodine, ring glucoside-iodine.
6, sterilization according to claim 1, antibacterial medicines compositions, described povidone iodine are polyvinylpyrrolidone-iodine.
7, sterilization according to claim 1, antibacterial medicines compositions also comprise available adjuvant on the pharmaceutics.
8, sterilization according to claim 1, antibacterial medicines compositions, described medicament can be solution, lotion, tincture, spray, liniment, ointment, emulsifiable paste, membrane, varnish, suppository, gel skin and mucosa exterior-applied formulation; Or solution, sterilized cotton ball, disinfecting cotton swab, granule, disinfectant tablet, ointment, gel, membrane, effervescent and disinfectant powder sterilization dosage form.
9, a kind of sterilization, antibacterial medicines preparation of compositions method, may further comprise the steps: the ratio in one of claim 1-4 takes by weighing raw material povidone iodine, trichloro hydroxyl diphenyl ether or chlorhexidine acetate, and the preparation method preparation according to conventional external preparation for skin medicine or disinfectant promptly gets described sterilization, antibacterial medicines compositions again.
CN 03156592 2003-09-10 2003-09-10 Sterilizing and bacteria inhibiting pharmaceutical composition and its formulation and preparation process Expired - Fee Related CN1259919C (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102698358A (en) * 2012-06-14 2012-10-03 杭州普瑞美克生物科技有限公司 Preparation method for disposable compound iodine medical disinfecting large cotton bar
CN103988849A (en) * 2014-05-21 2014-08-20 德州安捷高科消毒制品有限公司 Process for preparing compound iodine disinfectant
CN107027806A (en) * 2017-06-08 2017-08-11 太仓优活生物技术有限公司 A kind of sterilized articles therefrom good with Disinfection Effect
CN107496448A (en) * 2017-09-30 2017-12-22 蚌埠科卫消毒药剂有限公司 A kind of Povidone Iodine Disinfection Solution and preparation method thereof
CN108992462A (en) * 2018-09-21 2018-12-14 四川悦康源通药业有限公司 A kind of compound povidone iodine composition and preparation method thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102698358A (en) * 2012-06-14 2012-10-03 杭州普瑞美克生物科技有限公司 Preparation method for disposable compound iodine medical disinfecting large cotton bar
CN103988849A (en) * 2014-05-21 2014-08-20 德州安捷高科消毒制品有限公司 Process for preparing compound iodine disinfectant
CN107027806A (en) * 2017-06-08 2017-08-11 太仓优活生物技术有限公司 A kind of sterilized articles therefrom good with Disinfection Effect
CN107496448A (en) * 2017-09-30 2017-12-22 蚌埠科卫消毒药剂有限公司 A kind of Povidone Iodine Disinfection Solution and preparation method thereof
CN108992462A (en) * 2018-09-21 2018-12-14 四川悦康源通药业有限公司 A kind of compound povidone iodine composition and preparation method thereof

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