CN108653200A - A kind of long-acting occrycetin injection and preparation method thereof - Google Patents
A kind of long-acting occrycetin injection and preparation method thereof Download PDFInfo
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- CN108653200A CN108653200A CN201710185914.3A CN201710185914A CN108653200A CN 108653200 A CN108653200 A CN 108653200A CN 201710185914 A CN201710185914 A CN 201710185914A CN 108653200 A CN108653200 A CN 108653200A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/65—Tetracyclines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Abstract
A kind of long-acting occrycetin injection of present invention offer and preparation method thereof, is related to a kind of preparation method technical field of Terramycin injection for veterinary use.The invention is prepared by the raw material comprising following weight parts：Contain 50 55kg of N methyl pyrrolidones per 150kg, 2 4kg of polyvinylpyrrolidone, 3 4kg of magnesium chloride, 0.4 0.5kg of sodium formaldehyde sulphoxylate, 0.1 0.2kg of disodium ethylene diamine tetraacetate, 7 8kg of occrycetin, 3 4kg of ethanol amine, remaining is water for injection.Property stabilization energy of the present invention is enough to be preserved for a long time, is not precipitated, is never degenerated, simple for process, is easy to produce in enormous quantities.
Description
Technical field
The present invention relates to a kind of Terramycin injection for veterinary use and preparation method thereof technical fields, more particularly to a kind of long-acting
The preparation method of occrycetin injection.
Background technology
Terramycin category tetracycline antibiotic, is broad-spectrum antibiotic, to most gram-positive bacterias, Gram-negative bacteria, is stood
Gram time body, Chlamydia, mycoplasma and certain protozoons have inhibiting effect.Currently, terramycin has become the use of the animals such as livestock and poultry
Extensive antibiotic is usually added in feed or is made injection.Terramycin, which is added in feed, can be used for animal
The prevention and treatment of various diseases, Ursocycline injection are then more used for the treatment of indication, but at present when terramycin is injected
Liquid for a long time shelve after just will produce deposited phenomenon, influence therapeutic effect, injection production and transport is required in this way it is excessively high,
It is unfavorable for transporting and uses.
Invention content
Shortcoming present in regarding to the issue above, a kind of long-acting occrycetin injection of present invention offer and its system
Preparation Method enables its injection to preserve for a long time, does not precipitate, never degenerates, simple for process, is easy to produce in enormous quantities.
To solve the above-mentioned problems, the present invention provides a kind of long-acting occrycetin injection, wherein by comprising following heavy
The raw material of amount part is prepared：Contain N-Methyl pyrrolidone 50-55kg, polyvinylpyrrolidone 2-4kg, chlorination per 150kg
Magnesium 3-4kg, sodium formaldehyde sulphoxylate 0.4-0.5kg, disodium ethylene diamine tetraacetate 0.1-0.2kg, occrycetin 7-8kg,
Ethanol amine 3-4kg, remaining is water for injection.
Preferably, it is prepared by the raw material comprising following weight parts：Contain N-Methyl pyrrolidone 50kg per 150kg,
Polyvinylpyrrolidone 2kg, magnesium chloride 3kg, sodium formaldehyde sulphoxylate 0.4kg, disodium ethylene diamine tetraacetate 0.1kg, hydrochloric acid
Terramycin 7kg, ethanol amine 3kg, remaining is water for injection.
Preferably, it is prepared by the raw material comprising following weight parts：Contain N-Methyl pyrrolidone 55kg per 150kg,
Polyvinylpyrrolidone 4kg, magnesium chloride 4kg, sodium formaldehyde sulphoxylate 0.5kg, disodium ethylene diamine tetraacetate 0.2kg, hydrochloric acid
Terramycin 8kg, ethanol amine 4kg, remaining is water for injection.
Preferably, it is prepared by the raw material comprising following weight parts：Contain N-Methyl pyrrolidone per 150kg
52.5kg, polyvinylpyrrolidone 3kg, magnesium chloride 3.5kg, sodium formaldehyde sulphoxylate 0.45kg, disodium ethylene diamine tetraacetate
0.15kg, occrycetin 7.5kg, ethanol amine 3.5kg, remaining is water for injection.
A kind of preparation method of long-acting occrycetin injection, wherein include the following steps：
S10, it takes 52.5kg organic solvents to be added in the retort of 200kg, 40kg injection waters is being added, and open stirring,
It is passed through nitrogen, the aqueous solution of polyvinylpyrrolidone is added after five minutes, and opens temperature lowering water；
S20, continue to stir above-mentioned solution magnesium chloride solution is added after ten minutes, then continuing stirring 15 minutes, temperature
When reaching 40 degree or so, speed of agitator is increased to 1100 revs/min, after being slowly added to ethanolamine solutions 3.5kg stirrings 30 minutes
Disodium ethylene diamine tetra-acetic acid solution is added；
S30, continue to stir above-mentioned solution sodium formaldehyde sulphoxylate solution is added after 15 minutes, continuing 15 points of stirring
Clock is slowly added to occrycetin 7.5kg, wait for adding completely start stirring 75 minutes, sampling survey ph, when control ph ranges exist
When between 8.7-8.9, injection water is added to 150kg；
S40, by above-mentioned solution with 0.22 micron polypropylene foldable filter element filter after, logical nitrogen gas tank is encapsulated in 100ml brown bottles,
It is preserved in cool dark place.
Preferably, in the S10, mixing speed is controlled to 600 revs/min.
Preferably, in the S10, polyvinylpyrrolidonesolution solution is added to 10kg by 3kg polyvinylpyrrolidones and injects
It in water, boils, until without white insoluble matter, solution can be used in yellow clear liquid.
Preferably, in the S20, magnesium chloride solution is added to by 3kg magnesium chlorides in 10kg injection waters, is boiled, in colourless
Clear liquid is for use；Disodium ethylene diamine tetra-acetic acid solution is added to by 150g disodium ethylene diamine tetraacetates in 11kg injection waters, is boiled
Boiling, it is for use in colourless clear liquid.
Preferably, in the S30, antioxidant solution is added to by 450g sodium formaldehyde sulfoxylates in 11kg injection waters,
Heating is burnt, temperature is less than 60 degree, and white liquid can use when bottom is without insoluble matter.
Compared with prior art, the present invention has the following advantages：
Product quality of the present invention is stable, production cost is low, easy to maintain, production Technology parameter is easily controlled, it is big to be suitable for
Batch production.
Specific implementation mode
In order to make the purpose , technical scheme and advantage of the present invention be clearer, the present invention is made with reference to example
It is further described, but example is not as a limitation of the invention.
The Ursocycline injection of the present invention, applicable object is various poultry and livestocks, and the approach of medication can be
It is subcutaneously injected or oral.
Embodiment 1：Contain N-Methyl pyrrolidone 50kg, polyvinylpyrrolidone 2kg, magnesium chloride 3kg, first per 150kg
Aldehyde closes sodium bisulphite 0.4kg, disodium ethylene diamine tetraacetate 0.1kg, occrycetin 7kg, ethanol amine 3kg, remaining is injection
Use water.
Embodiment 2：Contain N-Methyl pyrrolidone 55kg, polyvinylpyrrolidone 4kg, magnesium chloride 4kg, first per 150kg
Aldehyde closes sodium bisulphite 0.5kg, disodium ethylene diamine tetraacetate 0.2kg, occrycetin 8kg, ethanol amine 4kg, remaining is injection
Use water.
Embodiment 3：Contain N-Methyl pyrrolidone 52.5kg, polyvinylpyrrolidone 3kg, magnesium chloride per 150kg
3.5kg, sodium formaldehyde sulphoxylate 0.45kg, disodium ethylene diamine tetraacetate 0.15kg, occrycetin 7.5kg, ethanol amine
3.5kg, remaining is water for injection.
According to the following steps：
It takes 52.5kg organic solvents to be added in the retort of 200kg, 40kg injection waters is being added, and open stirring, is being passed through
Nitrogen, is added the aqueous solution of polyvinylpyrrolidone after five minutes, and opens temperature lowering water；
Continue to stir above-mentioned solution and magnesium chloride solution is added after ten minutes, is then continuing stirring 15 minutes, temperature reaches
At 40 degree or so, speed of agitator is increased to 1100 revs/min, is slowly added to be added after ethanolamine solutions 3.5kg is stirred 30 minutes
Disodium ethylene diamine tetra-acetic acid solution；
Continue to stir above-mentioned solution and sodium formaldehyde sulphoxylate solution is added after 15 minutes, is continuing stirring 15 minutes, delaying
It is slow that occrycetin 7.5kg is added, it waits for adding completely and starts stirring 75 minutes, ph is surveyed in sampling, when control ph ranges are in 8.7-8.9
Between when, injection water is added to 150kg；
After above-mentioned solution is filtered with 0.22 micron polypropylene foldable filter element, logical nitrogen gas tank is encapsulated in 100ml brown bottles, cool
Dark place preserves.
A large number of experiments show that, 3 data of embodiment are maximally efficient to data, and test result is as follows in the present invention：
The stability test of product：This product is stored in 40 DEG C ± 2 DEG C of temperature, 65 ± 5 degree of humidity by observations in 6 months and
Detection, as a result product colour variation is little, and within the limits prescribed, content is stablized relatively, and end in the 6th month is dropped at present
2.2%, the results showed that, the shelf-life of this product should be not less than defined 2 years terms of validity.
In Vitro Bacteriostasis contrast test：It takes and sells product (the Ursocycline injection lot number of Pfizer production in the market：
30453022A) using Escherichia coli as test organisms, two kinds of drugs are diluted with doubling dilution, as a result the minimum of this product
Mlc is consistent with import Ursocycline injection, no marked difference.
Drug metabolism is tested：Health experiment rabbit 10 is taken, is precisely weighed, 2.2 kilograms of average weight, presses per kilogram body
Weight 0.2ml intramuscular injection this product adopts experiment rabbit painstaking effort respectively at 0.5h, 2h, 4h, 8h, 16h, 32h, 48h, 60h, 72h, 84h,
Terramycin content in experiment rabbit blood is measured respectively, as a result remains to detect the terramycin containing 1ug in every ml blood in 72h,
It remains to identify terramycin in 84h blood.The result shows that the drug effect of this product is 72h or more.
The clinical test of pesticide effectiveness：SPF dysentery characterized by white mucous stool piglet 60 is taken, is randomly divided into two groups by weight size, every group 30, averagely body
6.2 kilograms are weighed, presses per kilogram of body weight 0.2ml intramuscular injection this product and import Ursocycline injection, as a result two groups of healing respectively
Rate is 96% and 94% respectively.The result shows that this product is slightly better than import Ursocycline injection in clinical drug effect.
The foregoing description of the disclosed embodiments enables those skilled in the art to implement or use the present invention.
Various modifications to these embodiments will be apparent to those skilled in the art, as defined herein
General Principle can be realized in other embodiments without departing from the spirit or scope of the present invention.Therefore, of the invention
It is not intended to be limited to the embodiments shown herein, and is to fit to and the principles and novel features disclosed herein phase one
The widest range caused.
Claims (9)
1. a kind of long-acting occrycetin injection, which is characterized in that be prepared by the raw material comprising following weight parts：Often
150kg contains N-Methyl pyrrolidone 50-55kg, polyvinylpyrrolidone 2-4kg, magnesium chloride 3-4kg, and formaldehyde closes bisulphite
Sodium 0.4-0.5kg, disodium ethylene diamine tetraacetate 0.1-0.2kg, occrycetin 7-8kg, ethanol amine 3-4kg, remaining is injection
Use water.
2. a kind of long-acting occrycetin injection as described in claim 1, which is characterized in that by including following weight parts
Raw material is prepared：Contain N-Methyl pyrrolidone 50kg, polyvinylpyrrolidone 2kg, magnesium chloride 3kg per 150kg, formaldehyde closes
Sodium bisulphite 0.4kg, disodium ethylene diamine tetraacetate 0.1kg, occrycetin 7kg, ethanol amine 3kg, remaining is water for injection.
3. a kind of long-acting occrycetin injection as described in claim 1, which is characterized in that by including following weight parts
Raw material is prepared：Contain N-Methyl pyrrolidone 55kg, polyvinylpyrrolidone 4kg, magnesium chloride 4kg per 150kg, formaldehyde closes
Sodium bisulphite 0.5kg, disodium ethylene diamine tetraacetate 0.2kg, occrycetin 8kg, ethanol amine 4kg, remaining is water for injection.
4. a kind of long-acting occrycetin injection as described in claim 1, which is characterized in that by the original comprising following weight parts
Material is prepared：Contain N-Methyl pyrrolidone 52.5kg, polyvinylpyrrolidone 3kg, magnesium chloride 3.5kg, formaldehyde per 150kg
Sodium bisulphite 0.45kg is closed, disodium ethylene diamine tetraacetate 0.15kg, occrycetin 7.5kg, ethanol amine 3.75kg, remaining is
Water for injection.
5. a kind of preparation method of long-acting occrycetin injection as described in claim 1, which is characterized in that including following
Step：
S10, it takes 52.5kg organic solvents to be added in the retort of 200kg, 40kg injection waters is being added, and open stirring, is being passed through
Nitrogen, is added the aqueous solution of polyvinylpyrrolidone after five minutes, and opens temperature lowering water；
S20, continue to stir above-mentioned solution magnesium chloride solution is added after ten minutes, then continuing stirring 15 minutes, temperature reaches
At 40 degree or so, speed of agitator is increased to 1100 revs/min, is slowly added to be added after ethanolamine solutions 3.5kg is stirred 30 minutes
Disodium ethylene diamine tetra-acetic acid solution；
S30, continue to stir above-mentioned solution sodium formaldehyde sulphoxylate solution is added after 15 minutes, continuing stirring 15 minutes, delaying
It is slow that occrycetin 7.5kg is added, it waits for adding completely and starts stirring 75 minutes, ph is surveyed in sampling, when control ph ranges are in 8.7-8.9
Between when, injection water is added to 150kg；
S40, by above-mentioned solution with 0.22 micron polypropylene foldable filter element filter after, logical nitrogen gas tank is encapsulated in 100ml brown bottles, cool
Dark place preserves.
6. the preparation method of long-acting occrycetin injection as claimed in claim 5, which is characterized in that in the S10, stir
Speed control is mixed to 600 revs/min.
7. the preparation method of long-acting occrycetin injection as claimed in claim 5, which is characterized in that in the S10, gather
Vinylpyrrolidone solution is added to by 3kg polyvinylpyrrolidones in 10kg injection waters, is boiled, until without white insoluble matter,
Solution can be used in yellow clear liquid.
8. the preparation method of long-acting occrycetin injection as claimed in claim 5, which is characterized in that in the S20, chlorine
Change magnesium solution to be added in 10kg injection waters by 3.5kg magnesium chlorides, boil, it is for use in colourless clear liquid；Ethylenediamine tetra-acetic acid
Two sodium solutions are added to by 150g disodium ethylene diamine tetraacetates in 11kg injection waters, are boiled, for use in colourless clear liquid.
9. the preparation method of long-acting occrycetin injection as claimed in claim 5, which is characterized in that in the S30, resist
Oxidizing agent solution is added to by 450g sodium formaldehyde sulfoxylates in 11kg injection waters, burns heating, and temperature is less than 60 degree, white liquid
Body can use when bottom is without insoluble matter.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710185914.3A CN108653200A (en) | 2017-03-27 | 2017-03-27 | A kind of long-acting occrycetin injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201710185914.3A CN108653200A (en) | 2017-03-27 | 2017-03-27 | A kind of long-acting occrycetin injection and preparation method thereof |
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| CN108653200A true CN108653200A (en) | 2018-10-16 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693826A (en) * | 2019-11-18 | 2020-01-17 | 成都新亨药业有限公司 | Long-acting oxytetracycline injection for livestock and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0096942A2 (en) * | 1982-06-15 | 1983-12-28 | Aesculaap B.V. | Oxytetracycline composition and process for preparing an oxytetracycline composition |
| CN104352506A (en) * | 2014-10-13 | 2015-02-18 | 四川维尔康动物药业有限公司 | Long-acting oxytetracycline injection for veterinary use and preparation technology thereof |
| CN104382933A (en) * | 2014-12-08 | 2015-03-04 | 重庆综艺制药有限公司 | Long-acting compound terramycin injection for animals |
| CN104398528A (en) * | 2014-12-08 | 2015-03-11 | 重庆综艺制药有限公司 | Preparation method of long-acting veterinary compound oxytetracycline injection |
| CN104721133A (en) * | 2015-04-14 | 2015-06-24 | 四川美嘉龙生物科技有限公司 | Oxytetracycline preparation and preparation method |
-
2017
- 2017-03-27 CN CN201710185914.3A patent/CN108653200A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0096942A2 (en) * | 1982-06-15 | 1983-12-28 | Aesculaap B.V. | Oxytetracycline composition and process for preparing an oxytetracycline composition |
| CN104352506A (en) * | 2014-10-13 | 2015-02-18 | 四川维尔康动物药业有限公司 | Long-acting oxytetracycline injection for veterinary use and preparation technology thereof |
| CN104382933A (en) * | 2014-12-08 | 2015-03-04 | 重庆综艺制药有限公司 | Long-acting compound terramycin injection for animals |
| CN104398528A (en) * | 2014-12-08 | 2015-03-11 | 重庆综艺制药有限公司 | Preparation method of long-acting veterinary compound oxytetracycline injection |
| CN104721133A (en) * | 2015-04-14 | 2015-06-24 | 四川美嘉龙生物科技有限公司 | Oxytetracycline preparation and preparation method |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693826A (en) * | 2019-11-18 | 2020-01-17 | 成都新亨药业有限公司 | Long-acting oxytetracycline injection for livestock and preparation method thereof |
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