CN1260174A - Liquid preparation containing norfloxacin and metronidazole - Google Patents
Liquid preparation containing norfloxacin and metronidazole Download PDFInfo
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- CN1260174A CN1260174A CN 99116310 CN99116310A CN1260174A CN 1260174 A CN1260174 A CN 1260174A CN 99116310 CN99116310 CN 99116310 CN 99116310 A CN99116310 A CN 99116310A CN 1260174 A CN1260174 A CN 1260174A
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Abstract
The liquid preparation for local application for curing aerobe or anaerobe or mixed infected aurinasal diseases and gynecological surgical pyogenic skin and mucocutaneous wound infections is mainly formed from norfloxacin and metronidazole. According to clinical requirements it can be made into ear drops, nose drops or other solution preparation for surgical and gynecological application.
Description
The present invention relates to a kind of liquid preparation that contains norfloxacin and metronidazole, be specifically related to the liquid preparation that use the part of a kind of ear for the treatment of aerobic, anaerobe or mixed infection, nose and outer, various suppurative skins of gynecological, mucosa traumatic infection.
At present, treatment suppurative otitis media, sinusitis and outside, employed chloramphenicol ear drop, compound neomycin nasal drop, furacilin solution, metronidazole solution etc. during gynecological various pyogenic infection, all can not act on aerobic, anaerobe simultaneously, and above-mentioned all kinds of infection great majority are aerobic, due to anaerobe or the two mixed infection, this is confirmed from the isolated bacterial strain of infected specimen institute of censorship.Therefore, use the Drug therapy of anti-aerobe or anaerobe resistant merely, often curative effect is relatively poor, and cure rate is low, and the course of treatment is long, causes suffering and financial burden to patient.
Purpose of the present invention promptly is that design, develop at the problems referred to above that occurred in suppurative otitis media clinically, sinusitis and outer, the gynecological infection a kind of can act on aerobic anaerobe simultaneously, wide spectrum, efficient, low toxicity, the inexpensive liquid preparation that contains norfloxacin and metronidazole.
Main composition of this liquid preparation and content are (percentage by weight):
Norfloxacin 0.3%-2.0% metronidazole 0.3%-1.0%
Above-mentioned basic composition can add different auxiliary material and impose different compound methods according to the clinical treatment needs makes down series preparation respectively:
One, the preparation of [(have another name called promise first [--down together)
The composition of promise first [and content are (percentage by weight)
Norfloxacin 0.3%-2.0% metronidazole 0.3%-1.0%
Glycerol 5.0%-10.0% distilled water is to full dose
1. the preparation of suspension type promise first [:
(1) get an amount of suspending agent and place and add an amount of dissolved in distilled water in the container, 40-50 ℃ of filtered while hot put cold back and become rubber cement standby.
(2) get formula ratio glycerol and place mortar, after the norfloxacin of crossing 100 mesh sieves was handled by crystallite, gradation joined to grind in the glycerol and disperses, and gradation adds the prepared rubber cement of step (1) then, progressively added distilled water again and ground and make suspension.
(3) get formula ratio metronidazole adding distil water dissolution filter, filtrate and step (2) gained suspension merges, and grinds, and last adding distil water grinds and stirs into milky white shape suspensoid to full dose.
Suspending agent can use conventional suspending agent well known in the art such as sodium carboxymethyl cellulose, carboxy-propyl cellulose sodium etc., and wherein preferred suspending agent is sodium carboxymethyl cellulose (CMC-Na), and consumption is generally 0.2-0.3%.
2. the preparation of solution-type promise first [:
(1) the formula ratio norfloxacin is joined dissolution filter in the solution of spirit of vinegar.
(2) get glycerol and put in the container, the norfloxacin liquid that adds step (1) gained stirs.
(3) get formula ratio metronidazole adding distil water heating for dissolving and filter, the filtrate gradation joins in the norfloxacin solution of step (2) gained, and the limit edged stirs, and adds NH
3H
2O transfers PH to 6.5-7.0, and last adding distil water is to full dose, and stirring promptly gets solution.
Two, the preparation of nasal drop (have another name called promise first nasal drop--down together)
The composition of promise first nasal drop and content are (percentage by weight)
Norfloxacin 0.4%-1.5%, metronidazole 0.3%-1.0%, glycerol 5.0%-10.0%, distilled water are to full dose
(1) norfloxacin of getting formula ratio joins dissolution filter in the solution of spirit of vinegar, norfloxacin solution;
(2) get glycerol and put in the container, the norfloxacin liquid that adds step (1) gained stirs;
(3) get formula ratio metronidazole adding distil water heating for dissolving and filter, slowly join then in the prepared norfloxacin solution of step (2), the limit edged stirs, and uses NH
3H
2O transfers PH to 5.0-6.0, and last adding distil water stirs promptly to full dose.
Three, the preparation of the local solution that uses of surgery (have another name called promise first solution--down together)
Promise first solution is formed and content is (percentage by weight)
Norfloxacin 0.3%-2.0%, metronidazole 0.3%-1.0%, distilled water are to full dose
(1) norfloxacin of getting formula ratio joins dissolution filter in the solution of spirit of vinegar;
(2) get formula ratio metronidazole adding distil water heating for dissolving and filter, the filtrate gradation joins in the norfloxacin solution of step (1) gained, and the limit edged stirs, and adds NH
3H
2O transfers PH to 6.5-7.0, and last adding distil water is to full dose, and stirring promptly gets solution.
Four, the preparation (promise first solution) of the solution of gynecological part (vagina) use
Norfloxacin 0.3%-2.0%, metronidazole 0.3%-1.0%, cod-liver oil 10.0%, distilled water are to full dose.
(1) norfloxacin of getting formula ratio joins dissolution filter in the solution of spirit of vinegar, norfloxacin solution;
(2) get cod-liver oil and put in the container, the norfloxacin liquid that adds step (1) gained stirs;
(3) get formula ratio metronidazole adding distil water heating for dissolving and filter, slowly join then in the prepared norfloxacin solution of step (2), the limit edged stirs, and uses NH
3H
2O transfers PH to 5.5-6.5, and last adding distil water stirs promptly to full dose.
Quality control method of the present invention is to adopt ultraviolet spectrophotometry and high performance liquid chromatography to measure drug content respectively, and the accuracy height meets by " the quality standard that second one of Chinese pharmacopoeia nineteen ninety-five version and " Chinese Hospitals preparation standard " requirement are formulated.
Key component norfloxacin among the present invention has another name called norfloxacin, be third generation quinolione class antibacterials, gram positive bacteria and negative bacterium there is broad spectrum antibiotic activity, remarkable to the whole body actute infection effect that staphylococcus aureus, proteus mirabilis, bacillus pyocyaneus and escherichia coli cause, its antibacterial action is by suppressing DNA of bacteria gyrase activity, and the blocking-up DNA of bacteria is proteinic synthesizes and realize.
The choice drug that another key component metronidazole among the present invention is present anaerobe resistant is now reelected essential drugs into anaerobe resistant by The World Health Organization (WHO).Be widely used in various anaerobic infection diseases clinically.Because the metronidazole stable in properties, can with the most drug compatibility, be difficult for chemistry and physical change take place, do not influence the other drug curative effect, therefore norfloxacin and metronidazole just are based on their pharmacological properties separately as the principal agent compatibility of this preparation.
Show by extracorporeal bacteria inhibitor test, the big 2-4CM of antibacterial ring of the single norfloxacin of antibacterial chain rate of the promise first [that wide spectrum, norfloxacin efficient, low toxicity metronidazole compatibility remarkable with the anaerobe resistant effect, stable in properties are made, the obvious synergistic effect is arranged, and especially the anaerobe resistant effect strengthens.Table 1 is with norfloxacin and extracorporeal bacteria inhibitor test situation that the promise first [that norfloxacin and metronidazole compatibility are made is carried out respectively.
The external test of pesticide effectiveness table 1 of simple aloperidin solution and promise first [
Reagent | Staphylococcus aureus ATCC25923 | Aerugo Zymomonas mobilis ATCC27853 | Colon bacillus ATCC25922 |
Norfloxacin | ???? X21mm | ???? X9.5mm | ???? X21mm |
Promise first [ | ???? X23mm | ????X14mm | ???? X24mm |
In order to verify the therapeutic effect of the present invention to suppurative otitis media, the inventor is from year August in January, 1996 to 1998, use the present invention and treat example surplus the suppurative otitis media 1000, complete data person 203 examples, the oldest patient 64 years old, minimum patient 3 months, wherein chronic suppurative otitis media 192 examples, acute suppurative otitis media 8 examples, mastoid process postoperative infection 3 examples.
1. case is selected
20 routine acute and chronic suppurative otitis medias adopt the randomized controlled test, behind the clinical definite, get in ear secretions and do aerobic, anaerobic culture simultaneously, positive rate of bacteria 100%, antibacterial culturing feminine gender or viewing duration whole body application antibiotic person is selected before the treatment.
2. medication and curative effect are judged:
After the patient cleans with 3% hydrogen peroxide, get and suffer from ear to upper, odd number group splashes into 4 of promise first [s, even number set splashes into 4 of chloramphenicol ear drops, and ear was bathed 10 minutes, every day 3 times, and after 4 days, remake antibacterial culturing, more the person did not continue for the 2nd course of treatment, remake antibacterial culturing in the 8th day, no longer continued after 8 days to observe.
Produce effects: inflammation disappears, dried ear.
Effectively: in ear secretions obviously reduces, and inflammation alleviates.
Invalid: the state of an illness is not seen and is alleviated or increase the weight of after 8 days.
3. result:
After the odd number group 100 routine promise first [treatments, produce effects 88 examples, (accounting for 88%), and effective 10 examples (accounting for 10%), total effective rate is 98%, (wherein the dried ear rate of 8 routine acute suppurative otitis medias is 100%).Even number set 100 examples produce effects 34 examples (accounting for 34%) after treating with chloramphenicol ear drop, effective 28 examples (accounting for 28%), total effective rate is 62%, learns X by statistics
2Check, there were significant differences for P<0.01, two a group curative effect.
Two groups of case antibacterial negative conversion rates are seen (table 2), learn by statistics and handle X
2Check, P<0.01, there were significant differences to prove two groups of case antibacterial negative conversion rates.
Table 2 promise first [and oxymycin [treatment antibacterial change the comparison of bright rate
The routine number of sick kind | Nuo Jia | Chloromycetin | ||||
Total routine number | Turn out cloudy for the first time | Turn out cloudy for the second time | Total routine number | Turn out cloudy for the first time | Turn out cloudy for the second time | |
Chronic otitis media 192 examples | ????96 | ????84 | ????11 | ????96 | ????31 | ????27 |
Acute otitis media 8 examples | ????4 | ????3 | ????1 | ????4 | ????3 | ????1 |
Add up to 200 examples | ????100 | ????87 | ????12 | ????100 | ????34 | ????28 |
Antibacterial negative conversion rate % | ????87 | ????12 | ????34 | ????28 | ||
Total negative conversion rate % | ????99 | ????62 |
Do not have burning sensation with no pain behind 103 examples (the containing mastoid process postoperative infection 3 examples) medicine of promise first [treatment, wherein pure tone tests before and after the 50 routine medications have 12 routine audition to improve all the other no significant changes of 10-15db, and all cases are not all found systemic adverse reactions.
In addition, the inventor is also from the otitis media infected specimen of 200 parts of censorships, isolate pathogenic bacterium 227 strains altogether, belong to 8 sections, 17 Pseudomonas, it is 17 examples that wherein plural bacterium infects, simple anaerobic infection is 25 examples, we adopt the Oxford agar diffusion method that the drug sensitive test of the present invention and chloramphenicol ear drop is carried out in isolated aerobe, and the result shows, the various antibacterials of the present invention to being got, total responsive rate is 95.6%, and chloromycetin is 43.17%.Tables of data understands that responsive rate of the present invention is apparently higher than chloramphenicol ear drop.Its result of the test sees Table 3.
Two kinds of medicines of table 3 are to the drug sensitivity tests of various pathogenic bacterium
The bacterium name | Isolate | Promise first [ | Chloramphenicol ear drop | ||
Sensitive strain | Responsive rate % | Sensitive strain | Responsive rate % | ||
Staphylococcus aureus | ????66 | ????62 | ????93 | ????22 | ????34 |
Staphylococcus epidermidis | ????10 | ????9 | ????90 | ????4 | ????40 |
Micrococcus scarlatinae | ????4 | ????4 | ????100 | ????0 | ????0 |
The B group streptococcus | ????6 | ????6 | ????100 | ????2 | ????33.3 |
Corynebacterium | ????4 | ????4 | ????100 | ????2 | ????50 |
Bacillus subtilis | ????1 | ????1 | ????100 | ????1 | ????100 |
Colon bacillus | ????22 | ????21 | ????95 | ????14 | ????64 |
Bacillus proteus | ????17 | ????16 | ????94 | ????12 | ????70 |
Pneumonia Ke Gaobai Salmonella | ????6 | ????5 | ????83 | ????2 | ????333 |
Citrobacter | ????4 | ????4 | ????100 | ????3 | ????75 |
Other enterobacterias | ????8 | ????8 | ????100 | ????5 | ????62.5 |
Pseudomonas aeruginosa | ????17 | ????17 | ????100 | ????6 | ????35.3 |
Pseudomonas fluorescens | ????3 | ????3 | ????100 | ????1 | ????33.3 |
Pseudomonas cepacia | ????3 | ????3 | ????100 | ????2 | ????75 |
Acinetobacter calcoaceticus | ????8 | ????8 | ????100 | ????4 | ????50 |
Catarrhalis | ????4 | ????4 | ????100 | ????2 | ????50 |
Add up to | ????183 | ????175 | ????95.6 | ????79 | ????43.17 |
Simultaneously, with promise first nasal drop treatment sinusitis, selecting the age at random is case 50 examples in 10-60 year, and effective percentage is 97%, and curative effect is better than the compound neomycin nasal drop, and does not find in the therapeutic process that an example has untoward reaction to take place.With promise first solution treatment surgery pyogenic infection 36 examples, effective percentage is 100%, and curative effect obviously is better than furacilin solution, excellent trivial solution, ethacridine solution, 0.5% metronidazole solution, and short treating period.
With promise first solution treatment gynecological trichomonal vaginitis 25 examples, bacillary and other vaginitis 30 examples, total effective rate is 96% (being 100% to the trichomonal vaginitis effective percentage wherein), does not find obvious adverse reaction in the therapeutic process.
In sum, the present invention is to suppurative otitis media, sinusitis and outer, various suppurative skins of gynecological, mucosa traumatic infection curative effect height, has a broad antifungal spectrum, few side effects, and is simultaneously cheap, has obvious social and economic benefit.
Embodiments of the invention are described in detail in detail below.
Embodiment 1:
(1) get the 2g sodium carboxymethyl cellulose and place and add the 200ml dissolved in distilled water in the beaker, be heated to 40 ℃, filtered while hot is put cold back and is become rubber cement standby.
(2) get 50g glycerol and place in the mortar, after the norfloxacin 5g that crosses 100 mesh sieves was handled by crystallite, gradation joined to grind in the glycerol and disperses, and divides three times then and adds the prepared rubber cement of step (1), progressively added the 300ml distilled water again and ground and make suspension.
(3) get metronidazole 3g and place in the beaker, add distilled water 100ml, heating for dissolving is filtered filtrate and is merged with the obtained suspension of step (2), and grinding adds distilled water at last and stirs into milky white shape suspension to 1000ml, promptly.
Embodiment 2:
(1) get the 3g sodium carboxymethyl cellulose and place and add the 200ml dissolved in distilled water in the beaker, be heated to 40 ℃, filtered while hot is put cold back and is become rubber cement standby.
(2) getting 100g glycerol places in the mortar, after the norfloxacin 12g of 100 mesh sieves handles by crystallite excessively, gradation joins to grind in the glycerol and disperses, and divides three times then and adds the prepared rubber cement of step (1), progressively adds the grinding of 300ml distilled water again and makes suspension.
(3) get metronidazole 10g and place in the beaker, add distilled water 100ml, heating for dissolving is filtered filtrate and is merged with the obtained suspension of step (2), and grinding adds distilled water at last and stirs into milky white shape suspension to 1000ml, promptly.
Embodiment 3:
(1) get the 2.5g sodium carboxymethyl cellulose and place and add the 200ml dissolved in distilled water in the beaker, be heated to 40 ℃, filtered while hot is put cold back and is become rubber cement standby.
(2) get 80g glycerol and place in the mortar, after the norfloxacin 10g that crosses 100 mesh sieves was handled by crystallite, gradation joined to grind in the glycerol and disperses, and divides three times then and adds the prepared rubber cement of step (1), progressively added the 300ml distilled water again and ground and make suspension.
(3) get metronidazole 5g and place in the beaker, add distilled water 100ml, heating for dissolving is filtered filtrate and is merged with the obtained suspension of step (2), and grinding adds distilled water at last and stirs into milky white shape suspension to 1000ml, promptly.
Embodiment 4:
(1) gets dissolution filter in the solution that norfloxacin 10g joins the 50ml spirit of vinegar;
(2) get glycerol 80g and place in the beaker, the norfloxacin solution stirring that adds step (1) gained is even;
(3) get metronidazole 5g adding distil water 200ml heating for dissolving and filter, the filtrate gradation joins in the norfloxacin solution of step (2) gained, and the limit edged stirs, and adds NH
3H
2O transfers PH to 6.5-7.0, and last adding distil water stirs promptly to 1000ml.
Embodiment 5:
(1) get dissolution filter in the solution that norfloxacin 3g joins the 50ml spirit of vinegar, norfloxacin solution;
(2) get metronidazole 3g adding distil water 200ML heating for dissolving and filter, its filtrate is slowly joined in the prepared norfloxacin solution of step (1), the limit edged stirs, and adds NH
3H
2O transfers PH to 6.5-7.0, and last adding distil water stirs and promptly gets promise first solution to 1000ml.
Embodiment 6:
(1) get dissolution filter in the solution that norfloxacin 20g joins the 50ml spirit of vinegar, norfloxacin solution;
(2) get metronidazole 10g adding distil water 200ml heating for dissolving and filter, its filtrate is slowly joined in the prepared norfloxacin solution of step (1), the limit edged stirs, and adds NH
3H
2O transfers PH to 6.5-7.0, and last adding distil water stirs and promptly gets promise first solution to 1000ml.
Embodiment 7:
(1) norfloxacin 4g is joined dissolution filter in the solution of 80ml spirit of vinegar;
(2) get glycerol 50g and place in the beaker, the norfloxacin solution stirring that adds poly-(1) gained of step is even;
(3) get metronidazole 3g adding distil water 300ml heating for dissolving and filter, filtrate joins in the norfloxacin solution of step (2) gained at twice, and the limit edged stirs, and adds NH
3H
2O transfers PH to 5.0-6.0, and last adding distil water promptly gets promise first nasal drop to 1000ml.
Embodiment 8:
(1) norfloxacin 15g is joined dissolution filter in the solution of 80ml spirit of vinegar;
(2) get glycerol 100g and place in the beaker, the norfloxacin solution stirring that adds step (1) gained is even;
(3) get metronidazole 10g adding distil water 300ml heating for dissolving and filter, filtrate joins in the norfloxacin solution of step (2) gained at twice, and the limit edged stirs, and adds NH
3H
2O transfers PH to 5.0-6.0, and last adding distil water promptly gets promise first nasal drop to 1000ml.
Embodiment 9:
(1) norfloxacin 15g is joined dissolution filter in the solution of 80ml spirit of vinegar;
(2) get cod-liver oil 100g and place in the beaker, the norfloxacin solution stirring that adds step (1) gained is even;
(3) get metronidazole 5g adding distil water 200ml heating for dissolving and filter, filtrate joins in the norfloxacin solution of step (2) gained at twice, and the limit edged stirs, and adds NH
3H
2O transfers PH to 5.5-6.5, and last adding distil water stirs and promptly gets gynecological's solution to 1000ml.
Claims (7)
1. one kind is applicable to the local liquid preparation that uses, and it is characterized in that described liquid preparation mainly contains 0.3%-2.0% norfloxacin (percentage by weight), 0.3%-1.0% (percentage by weight) metronidazole;
2. liquid preparation according to claim 1 is characterized in that the suspendible [that said preparation is made up of the glycerol of 0.3%-2.0% (percentage by weight) norfloxacin, 0.3%-1.0% (percentage by weight) metronidazole, 5.0%-10.0% (percentage by weight) and an amount of suspending agent and surplus distilled water;
3. liquid preparation according to claim 1 and 2 is characterized in that said suspending agent is sodium carboxymethyl cellulose, carboxy-propyl cellulose sodium;
4. liquid preparation according to claim 1 is characterized in that said preparation is by after norfloxacin that is dissolved in 0.3%-2.0% in the spirit of vinegar (percentage by weight) and 0.3-1.0% (percentage by weight) the metronidazole aqueous solution, with NH
3H
2O transfers PH to 6.5-7.0, adds the prepared [of surplus distilled water again;
5. liquid preparation according to claim 1 is characterized in that said preparation is by after norfloxacin that is dissolved in 0.3%-2.0% in the spirit of vinegar (percentage by weight) and 0.3-1.0% (percentage by weight) the metronidazole aqueous solution, with NH
3H
2O transfers PH to 6.5-7.0, adds the prepared solution that is applicable to the surgery pyogenic infection of surplus distilled water again;
6. liquid preparation according to claim 1, it is characterized in that said preparation is behind the glycerol and 0.3%-1.0% (percentage by weight) metronidazole aqueous solution by norfloxacin that is dissolved in 0.4-1.5% in the spirit of vinegar (percentage by weight) and 5.0-10.0% (percentage by weight), with NH
3H
2O transfers PH to 5.0-6.0, and adding distil water is to the prepared nasal drop of full dose
7. liquid preparation according to claim 1, it is characterized in that said preparation be by after the cod-liver oil of the norfloxacin and 10.0% (percentage by weight) that is dissolved in 0.3%-2.0% in the spirit of vinegar (percentage by weight) and 0.3-1.0% (percentage by weight) the metronidazole aqueous solution with NH
3H
2O transfers PH to 5.5-6.5, and adding distil water is to the prepared solution that is applicable to that gynecological uses of full dose;
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN 99116310 CN1206990C (en) | 1999-01-13 | 1999-01-13 | Liquid preparation containing norfloxacin and metronidazole |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 99116310 CN1206990C (en) | 1999-01-13 | 1999-01-13 | Liquid preparation containing norfloxacin and metronidazole |
Publications (2)
Publication Number | Publication Date |
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CN1260174A true CN1260174A (en) | 2000-07-19 |
CN1206990C CN1206990C (en) | 2005-06-22 |
Family
ID=5279138
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CN 99116310 Expired - Fee Related CN1206990C (en) | 1999-01-13 | 1999-01-13 | Liquid preparation containing norfloxacin and metronidazole |
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CN (1) | CN1206990C (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102247387A (en) * | 2011-03-21 | 2011-11-23 | 陕西宏府怡悦制药有限公司 | Norfloxacin phenazopyridine tablets and preparation process method and use thereof |
CN102406922A (en) * | 2011-12-05 | 2012-04-11 | 江西信尔诚动物药业有限公司 | Compound long-acting norfloxacin nicotinate suspension for livestock and preparation method thereof |
CN102845452A (en) * | 2012-08-13 | 2013-01-02 | 青阳县天元精细化工有限公司 | Underwear disinfecting agent |
CN107823133A (en) * | 2017-11-23 | 2018-03-23 | 铜陵市东方矿冶机械有限责任公司 | Chloromycetin in glycerin auristilla and preparation method thereof |
-
1999
- 1999-01-13 CN CN 99116310 patent/CN1206990C/en not_active Expired - Fee Related
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102247387A (en) * | 2011-03-21 | 2011-11-23 | 陕西宏府怡悦制药有限公司 | Norfloxacin phenazopyridine tablets and preparation process method and use thereof |
CN102406922A (en) * | 2011-12-05 | 2012-04-11 | 江西信尔诚动物药业有限公司 | Compound long-acting norfloxacin nicotinate suspension for livestock and preparation method thereof |
CN102845452A (en) * | 2012-08-13 | 2013-01-02 | 青阳县天元精细化工有限公司 | Underwear disinfecting agent |
CN107823133A (en) * | 2017-11-23 | 2018-03-23 | 铜陵市东方矿冶机械有限责任公司 | Chloromycetin in glycerin auristilla and preparation method thereof |
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Publication number | Publication date |
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CN1206990C (en) | 2005-06-22 |
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