CN1739505A - L-ornidazole injection prepn - Google Patents
L-ornidazole injection prepn Download PDFInfo
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- CN1739505A CN1739505A CN 200510094489 CN200510094489A CN1739505A CN 1739505 A CN1739505 A CN 1739505A CN 200510094489 CN200510094489 CN 200510094489 CN 200510094489 A CN200510094489 A CN 200510094489A CN 1739505 A CN1739505 A CN 1739505A
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- ornidazole
- laevo
- injection
- sodium
- acid
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Abstract
The present invention discloses L-ornidazole injection preparation as one kind of nitroimidazole antibiotics. The L-ornidazole injection preparation contains L-ornidazole or its salt or their hydrate. L-ornidazole is named chemically as S-(+)-1-(3-chloro-2-hydroxypropyl)-2-methyl-5- nitroimidazole. The L-ornidazole injection preparation is prepared with L-ornidazole, supplementary material and injection water, and may be prepared into injection for immediately injection, concentrated solution for injection after clinical re-compounding or powder for injection through further freeze drying. Compared with similar preparations, the L-ornidazole preparation has high pharmacodynamic activity, lower toxicity and stable quality.
Description
Technical field
The present invention relates to a kind of ejection preparation of nitro glyoxaline antibiotic laevo-ornidazole.
Background technology
Sale and clinical practice all is ornidazole racemies in the market, and ornidazole raceme activity is relatively poor, and toxicity is relatively large.
Summary of the invention
For improving the activity of medicine, reduce toxicity, the invention provides a kind of ejection preparation of single optical isomer laevo-ornidazole.
A kind of L-ornidazole injection preparation of the present invention, it comprises the laevo-ornidazole shown in the following structural formula or its salt or their hydrate; Chemical name is: S-(+)-1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitro imidazoles; With single dose laevo-ornidazole is added injection water and additives and can make, perhaps laevo-ornidazole is added injection water and additives and can make the sterilized powder that supplies to face with preceding wiring solution-forming through Freeze Drying Technique for injecting intravital sterile solution, laevo-ornidazole being added the injection water and additives can be made for the concentrated solution of facing with preceding wiring solution-forming.
Molecular formula is: C
7H
10ClN
3O
3
Molecular weight is: 219.6
The content of laevo-ornidazole is every dosage 25-500mg; Ejection preparation is that the used additives of sterile solution are the pH regulator agent and wait and open regulator; Ejection preparation is that the used additives of concentrated solution are noble gas and pH regulator agent; Ejection preparation is that the used additives of sterilized powder are pH regulator agent and filling bracket agent; Described additives also can comprise antioxidant or metal chelating agent; Antioxidant is pyrosulfurous acid potassium salt or sodium salt 0.01%-0.1%, sulphite 0.01%-0.5%, sodium sulfite 0.01%-0.5%, sodium thiosulfate 0.01%-0.5%, sodium formaldehyde sulphoxylate 0.1%-0.2%, thiourea 0.05%-0.1%, ascorbic acid 0.05%-0.2%, thioglycerol 0.1%-0.5%, glutathion 0.01%-0.2%, alanine 0.01%-0.5%, cysteine 0.01%-0.5%, gallic acid and propionic ester thereof or monooctyl ester .01%-0.1%, butylated hydroxyarisol 0.01%-0.1%, BHT 0.01%-0.5%, tocopherol α, β, δ 0.01%-0.1%, nordihydroguaiaretic acid 0.01%-0.5% or ascorbic acid palm fibre eleostearate 0.01%-0.5%; Metal chelating agent is disodiumedetate 0.01%-0.05% or dicarboxylic acid compound.The pH regulator agent is methanesulfonic acid, maleic acid, hydrochloric acid, sodium hydroxide, sodium bicarbonate, phosphate, acetic acid and salt thereof, the acid of Chinese holly rubber and salt thereof or aminoacid and salt thereof; Deng opening regulator is glucose 5%, sodium chloride 0.9%, glycerol 2.25% or sodium sulfate 1.6%; Filling bracket agent consumption accounts for the 70-95% of gross weight, and the filling bracket agent is 1: 1 mixture of cysteine, sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium chloride, lactose, glucose, sucrose, mannitol, gelatin hydrolysate, glycine, sorbitol, calcium lactobionate., bovine serum albumin, dextran, polyvinylpyrrolidone or lactose and mannitol or gelatin hydrolysate and mannitol mixture.
Laevo-ornidazole is the nitro glyoxaline antibiotic---the single optical isomer of ornidazole, most anaerobe all there is stronger inhibition killing action, part aerobe such as moraxella Moraxella, bacillus Bacillus also there are certain inhibitory action, and have the activity of good trichomonacide, ameba worm, merchant infusorian.
After laevo-ornidazole enters the microbial cell of susceptible, under anaerobic or few oxygen environment and lower oxidation-reduction potential, its nitro easily is reduced into the amino of tool cytotoxicity by electron transfer protein, suppress the synthetic of cell DNA, and make synthetic dna degradation, destroy the double-spiral structure of DNA or block it and transcribe and duplicate, thereby make pathogen cells death, reach antibiotic anti-plasmic purpose.
Laevo-ornidazole mainly exists with former medicine with cytotoxicity and the intermediate supersession activated product with cytotoxicity in vivo mainly at liver metabolism.
Give rat laevo-ornidazole (400mg/kg/d), successive administration 2 years does not have influence to the life-span, does not cause the infringement of serious function and form.The long term toxicity test of Canis familiaris L. shows that laevo-ornidazole has good tolerability, and high dose (250mg/kg/d) gives laevo-ornidazole for a long time can cause the Canis familiaris L. neurotoxic symptom, but its neurotoxicity is a transient phenomenon, very fast disappearance after the drug withdrawal.
Specific toxicity studies show that various bacterial strain laevo-ornidazoles are had mutagenicity, but the experiment that the lymphocyte of personnel selection or Mus are done (micronucleus test, dominant lethal experiment) shows that it does not have mutagenicity to the not influence of mammiferous chromosome.In the animal teratology testing, laevo-ornidazole is negative, uses in the different periods in whole pregnancy period, does not all find untoward reaction.In all animal species that are studied (mice, rat, rabbit), the high dose administration, in the tire and term fetus fairly good to the toleration of laevo-ornidazole, do not find teratogenecity.Long poison to rat studies show that, the laevo-ornidazole non-carcinogenesis.Laevo-ornidazole has inhibitory action to the activity of male rat sperm, can reduce the rat reproductivity when high dose, shows contraceptive effect.It acts on and recovers naturally very soon after the drug withdrawal, and the prompting laevo-ornidazole may work by influencing epididymal function to the generation did not influence of sperm.
Laevo-ornidazole is as the new drug of anaerobe resistant, trichomonacide, ameba worm, merchant infusorian, and antimicrbial power is strong, long half time, and no specific toxicity, it is wide to be suitable for the crowd, and compliance is good, and toxic and side effects is low, has good application prospects.
Result of study shows, use single optical isomer can obtain than raceme better therapeutic and with lower toxic and side effects, the pharmacodynamics activity of L-ornidazole injection preparation of the present invention is better than the ornidazole raceme, pharmacology's toxicity is then low than ornidazole raceme, and steady quality, controlled, safe and effective.
The specific embodiment
Embodiment one,
Make laevo-ornidazole concentrated solution ejection preparation with following materials of weight proportions:
Laevo-ornidazole 51.0g (102% feeds intake)
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 200,5ml/ props up, and every ejection preparation contains laevo-ornidazole 250mg
Embodiment two,
Make laevo-ornidazole concentrated solution ejection preparation with following materials of weight proportions:
Laevo-ornidazole 51.0g (102% feeds intake)
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 100,10ml/ props up, and every ejection preparation contains laevo-ornidazole 500mg
Above embodiment one, two sample preparation processes are as follows:
1, dosing: get laevo-ornidazole, add injection water (about 60 ℃), stir and make dissolving, transfer about pH to 3.0 with 0.1mol/L hydrochloric acid to full dose.Add 0.05% active carbon, insulated and stirred 15 minutes.0.45 μ m microporous filter membrane is removed active carbon, coarse filtration liquid, measuring pH value of filtrate and content is the microporous filter membrane fine straining of 0.22 μ m with coarse filtration liquid via hole diameter after qualified.
2, embedding: the embedding of fine straining liquid to 5ml to 20ml ampoule, is charged into nitrogen simultaneously.
3, sterilization: the ampoule that embedding is good is put in the sterilization tank, 100 ℃ of flowing steams, and sterilization 30min, and leak with color water check and to seal ampoule.
4, lamp inspection, packing are examined entirely and are got product after qualified.
Embodiment three,
Make the laevo-ornidazole sterile solution with following materials of weight proportions:
Laevo-ornidazole 2.625g (105% feeds intake)
Sodium chloride 9g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 10 bottles, the 100ml/ bottle, every bottle of sterile solution contains laevo-ornidazole 250mg
Embodiment four,
Make the laevo-ornidazole sterile solution with following materials of weight proportions:
Laevo-ornidazole 2.625g (105% feeds intake)
Glucose 50g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 10 bottles, the 100ml/ bottle, every bottle of sterile solution contains laevo-ornidazole 250mg
Embodiment five,
Make the laevo-ornidazole sterile solution with following materials of weight proportions:
Laevo-ornidazole 2.625g (105% feeds intake)
Sodium chloride 9g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 5 bottles, the 200ml/ bottle, every bottle of sterile solution contains laevo-ornidazole 500mg
Embodiment six,
Make the laevo-ornidazole sterile solution with following materials of weight proportions:
Laevo-ornidazole 2.625g (105% feeds intake)
Glucose 50g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 5 bottles, the 200ml/ bottle, every bottle of sterile solution contains laevo-ornidazole 500mg
Embodiment seven,
Make the laevo-ornidazole sterile solution with following materials of weight proportions:
Laevo-ornidazole 5.25g (105% feeds intake)
Sodium chloride 9g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 10 bottles, the 100ml/ bottle, every bottle of sterile solution contains laevo-ornidazole 500mg
Embodiment eight,
Make the laevo-ornidazole sterile solution with following materials of weight proportions:
Laevo-ornidazole 5.25g (105% feeds intake)
Glucose 50g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 10 bottles, the 100ml/ bottle, every bottle of sterile solution contains laevo-ornidazole 500mg
The sample preparation process of above embodiment three to eight is as follows:
1, dosing: get sodium chloride and/or glucose and join dissolving (about 60 ℃) in the cylinder dense, add laevo-ornidazole, stir, medicine is all dissolved with the water for injection of total dosing amount 2/3.Transfer about pH to 4.0 with 0.1mol/L hydrochloric acid.Add 0.05% active carbon, insulated and stirred 15 minutes.0.45 μ m microporous filter membrane sucking filtration is removed active carbon, filtrate is advanced rare cylinder of joining, the dense cylinder of joining of reuse water for injection flushing, and through 0.45 μ m microporous filter membrane sucking filtration, filtrate enters rare cylinder of joining in the lump, and adds to the full amount of water for injection.Circulate in fine straining system (0.22 μ m microporous filter membrane) after stirring.
2, embedding: detect rare content of joining cylinder solution pH value, sodium chloride or glucose and laevo-ornidazole qualified after, with solution fill behind 0.22 μ m microporous filter membrane fine straining, every bottled 100ml-200ml adds butyl rubber plug, rolls lid.
3, sterilization: the infusion bottle that embedding is good is put in the sterilization tank, and 115 ℃, the 30min moist heat sterilization, and hunt leak with color water.
4, lamp inspection, packing get product after the full inspection.
Embodiment nine,
Make the ejection preparation of laevo-ornidazole sterilized powder with following materials of weight proportions
Laevo-ornidazole 26.25g (105% feeds intake)
Lactose 300g
0.1mol/L hydrochloric acid is an amount of
Add the injection water to 1000ml, be distributed into 100 bottles, every bottle of ejection preparation contains laevo-ornidazole 250mg
Above embodiment nine sample preparation processes are as follows:
1, dosing: get lactose and join dissolving (about 60 ℃) in the cylinder dense, add laevo-ornidazole, stir, medicine is all dissolved with the water for injection of total dosing amount 2/3.Transfer about pH to 3.0 with 0.1mol/L hydrochloric acid.Add 0.05% active carbon, insulated and stirred 15 minutes.0.45 μ m microporous filter membrane sucking filtration is removed active carbon, filtrate is advanced rare cylinder of joining, the dense cylinder of joining of reuse water for injection flushing, and through 0.45 μ m microporous filter membrane sucking filtration, filtrate enters rare cylinder of joining in the lump, and adds to the full amount of water for injection.Circulate in fine straining system (0.22 μ m microporous filter membrane) after stirring.
2, embedding: detect rare content of joining cylinder solution pH value and laevo-ornidazole qualified after, with solution cillin bottle fill behind 0.22 μ m microporous filter membrane fine straining, every bottled 10ml.
3, lyophilization: behind the false add plug, cillin bottle sent into carries out lyophilization in the freeze drying box, heat preservation and dryness after a period of time whole freeze-drying process promptly come to an end tamponade immediately, Zha Gai.
4, lamp inspection, packing are examined entirely and are got product after qualified.
In the present invention, if production equipment and raw materials quality are poor slightly, then need to add antioxidant or metal chelating agent in the L-ornidazole injection preparation, described antioxidant is pyrosulfurous acid potassium salt or sodium salt 0.01%-0.1%, sulphite 0.01%-0.5%, sodium sulfite 0.01%-0.5%, sodium thiosulfate 0.01%-0.5%, sodium formaldehyde sulphoxylate 0.1%-0.2%, thiourea 0.05%-0.1%, ascorbic acid 0.05%-0.2%, thioglycerol 0.1%-0.5%, glutathion 0.01%-0.2%, alanine 0.01%-0.5%, cysteine 0.01%-0.5%, gallic acid and propionic ester thereof or monooctyl ester .01%-0.1%, butylated hydroxyarisol 0.01%-0.1%, BHT 0.01%-0.5%, tocopherol α, β, δ 0.01%-0.1%, nordihydroguaiaretic acid 0.01%-0.5% or ascorbic acid palm fibre eleostearate 0.01%-0.5%; Metal chelating agent is disodiumedetate 0.01%-0.05% or dicarboxylic acid compound.
Outside the pH regulator agent demineralizing acid, can also be methanesulfonic acid, maleic acid, sodium hydroxide, sodium bicarbonate, phosphate, acetic acid and salt thereof, citric acid and salt thereof or aminoacid and salt thereof.
Deng opening regulator except that glucose, sodium chloride, can also be glycerol 2.25% or sodium sulfate 1.6%.
Filling bracket agent consumption accounts for the 70-95% of L-ornidazole injection preparation gross weight, the filling bracket agent can also be 1: 1 mixture of cysteine, sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium chloride, glucose, sucrose, mannitol, gelatin hydrolysate, glycine, sorbitol, calcium lactobionate., bovine serum albumin, dextran, polyvinylpyrrolidone or lactose and mannitol or gelatin hydrolysate and mannitol mixture except that lactose.
Claims (10)
1, a kind of L-ornidazole injection preparation, it comprises the laevo-ornidazole shown in the following structural formula or its salt or their hydrate; Chemical name is: S-(+)-1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitro imidazoles; Can make for injecting intravital sterile solution, laevo-ornidazole being added the injection water and additives can be made for the concentrated solution of facing with preceding wiring solution-forming laevo-ornidazole is added injection water and additives, perhaps laevo-ornidazole be added injection water and additives and can make the sterilized powder that supplies to face with preceding wiring solution-forming through Freeze Drying Technique.
2, L-ornidazole injection preparation according to claim 1, the content that it is characterized in that laevo-ornidazole are every dosage 25-500mg.
3, L-ornidazole injection preparation according to claim 1 is characterized in that ejection preparation is that the used additives of sterile solution are the pH regulator agent and wait and open regulator.
4, L-ornidazole injection preparation according to claim 1 is characterized in that ejection preparation is that the used additives of concentrated solution are noble gas and pH regulator agent.
5, L-ornidazole injection preparation according to claim 1 is characterized in that ejection preparation is that the used additives of sterilized powder are pH regulator agent and filling bracket agent.
6,, it is characterized in that described additives also can comprise antioxidant or metal chelating agent according to claim 3,4 or 5 described L-ornidazole injection preparations.
7, L-ornidazole injection preparation according to claim 6 is characterized in that antioxidant is pyrosulfurous acid potassium salt or sodium salt 0.01%-0.1%, sulphite 0.01%-0.5%, sodium sulfite 0.01%-0.5%, sodium thiosulfate 0.01%-0.5%, sodium formaldehyde sulphoxylate 0.1%-0.2%, thiourea 0.05%-0.1%, ascorbic acid 0.05%-0.2%, thioglycerol 0.1%-0.5%, glutathion 0.01%-0.2%, alanine 0.01%-0.5%, cysteine 0.01%-0.5%, gallic acid and propionic ester thereof or monooctyl ester .01%-0.1%, butylated hydroxyarisol 0.01%-0.1%, BHT 0.01%-0.5%, tocopherol α, β, δ 0.01%-0.1%, nordihydroguaiaretic acid 0.01%-0.5% or ascorbic acid palm fibre eleostearate 0.01%-0.5%; Metal chelating agent is disodiumedetate 0.01%-0.05% or dicarboxylic acid compound.
8,, it is characterized in that the pH regulator agent is methanesulfonic acid, maleic acid, hydrochloric acid, sodium hydroxide, sodium bicarbonate, phosphate, acetic acid and salt thereof, citric acid and salt thereof or aminoacid and salt thereof according to claim 3,4 or 5 described L-ornidazole injection preparations.
9, L-ornidazole injection preparation according to claim 3 is characterized in that waiting a regulator is glucose 5%, sodium chloride 0.9%, glycerol 2.25% or sodium sulfate 1.6%.
10, L-ornidazole injection preparation according to claim 5, it is characterized in that filling bracket agent consumption accounts for the 70-95% of gross weight, the filling bracket agent is 1: 1 mixture of cysteine, sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium chloride, lactose, glucose, sucrose, mannitol, gelatin hydrolysate, glycine, sorbitol, calcium lactobionate., bovine serum albumin, dextran, polyvinylpyrrolidone or lactose and mannitol or gelatin hydrolysate and mannitol mixture.
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|---|---|---|---|
| CN 200510094489 CN1739505A (en) | 2005-09-19 | 2005-09-19 | L-ornidazole injection prepn |
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| CN 200510094489 CN1739505A (en) | 2005-09-19 | 2005-09-19 | L-ornidazole injection prepn |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006114042A1 (en) * | 2005-04-28 | 2006-11-02 | Nanjing Sanhome Pharmaceutical Co., Ltd. | Application of levo-ornidazole in preparation of anti-anaerobic bacteria infection medicine |
| CN104510702A (en) * | 2013-10-05 | 2015-04-15 | 长春海悦药业有限公司 | Ornidazole-containing pharmaceutical composition and preparation thereof |
| CN104983678A (en) * | 2015-08-04 | 2015-10-21 | 山东齐都药业有限公司 | Ornidazole infusion preparation and preparation technology thereof |
| CN107184548A (en) * | 2017-06-21 | 2017-09-22 | 大连中信药业股份有限公司 | A kind of safe L-ornidazole injection liquid and preparation method thereof |
| CN107224429A (en) * | 2017-06-21 | 2017-10-03 | 大连中信药业股份有限公司 | A kind of safe L-ornidazole injection liquid and preparation method thereof |
| CN107640335A (en) * | 2017-07-31 | 2018-01-30 | 芜湖杨燕制药有限公司 | A kind of traditional Chinese medicine embedding aftertreatment technology |
| CN107651251A (en) * | 2017-08-31 | 2018-02-02 | 芜湖杨燕制药有限公司 | A kind of insect-expelling saligna injection liquid filling sterilizing technique |
-
2005
- 2005-09-19 CN CN 200510094489 patent/CN1739505A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006114042A1 (en) * | 2005-04-28 | 2006-11-02 | Nanjing Sanhome Pharmaceutical Co., Ltd. | Application of levo-ornidazole in preparation of anti-anaerobic bacteria infection medicine |
| CN104510702A (en) * | 2013-10-05 | 2015-04-15 | 长春海悦药业有限公司 | Ornidazole-containing pharmaceutical composition and preparation thereof |
| CN104510702B (en) * | 2013-10-05 | 2017-09-12 | 长春海悦药业股份有限公司 | A kind of pharmaceutical composition containing Ornidazole and its preparation |
| CN104983678A (en) * | 2015-08-04 | 2015-10-21 | 山东齐都药业有限公司 | Ornidazole infusion preparation and preparation technology thereof |
| CN107184548A (en) * | 2017-06-21 | 2017-09-22 | 大连中信药业股份有限公司 | A kind of safe L-ornidazole injection liquid and preparation method thereof |
| CN107224429A (en) * | 2017-06-21 | 2017-10-03 | 大连中信药业股份有限公司 | A kind of safe L-ornidazole injection liquid and preparation method thereof |
| CN107224429B (en) * | 2017-06-21 | 2019-04-05 | 大连中信药业股份有限公司 | A kind of highly-safe L-ornidazole injection liquid and preparation method thereof |
| CN107184548B (en) * | 2017-06-21 | 2019-04-05 | 大连中信药业股份有限公司 | A kind of highly-safe L-ornidazole injection liquid and preparation method thereof |
| CN107640335A (en) * | 2017-07-31 | 2018-01-30 | 芜湖杨燕制药有限公司 | A kind of traditional Chinese medicine embedding aftertreatment technology |
| CN107651251A (en) * | 2017-08-31 | 2018-02-02 | 芜湖杨燕制药有限公司 | A kind of insect-expelling saligna injection liquid filling sterilizing technique |
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