CN101406447B - Technique for preparing compound ceftiofur oil suspension injection - Google Patents
Technique for preparing compound ceftiofur oil suspension injection Download PDFInfo
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- CN101406447B CN101406447B CN2007101897476A CN200710189747A CN101406447B CN 101406447 B CN101406447 B CN 101406447B CN 2007101897476 A CN2007101897476 A CN 2007101897476A CN 200710189747 A CN200710189747 A CN 200710189747A CN 101406447 B CN101406447 B CN 101406447B
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Abstract
The invention discloses a preparation process for compound recipe ceftiofur oil suspensoid injection. The preparation process comprises the following steps: (1) taking neutral soybean oil, filtrating, heating and sterilizing and cooling down the soybean oil, adding aluminum stearate into the soybean oil to prepare gel, diluting the gel into factice of 2+-0.2 percent through the filtrated and sterilized soybean oil, and filtrating the factice through a No.3 sintered glass funnel for standby; and (2) taking hydrochloric acid ceftiofur/sulbactam according to a recipe, mixing the hydrochloric acid ceftiofur/sulbactam with the factice, grinding the mixture, adding lecithin into the mixture till the mixture is ground evenly, and then obtaining the compound recipe ceftiofur oil suspensoid injection through shifting the ground hydrochloric acid ceftiofur/sulbactam into a graduated cylinder and so on. As the invention adopts the preparation method, compared with a single recipe ceftiofur preparation, the compound recipe ceftiofur oil suspensoid injection has the advantage that the compound recipe ceftiofur oil suspensoid injection has antibacterial activity against bacteria capable of resisting the single recipe ceftiofur, that is, the compound recipe ceftiofur oil suspensoid injection can effectively treat bacterial infection generating ESBLs.
Description
Technical field
The present invention relates to a kind of medicine, specifically relate to a kind of technique for preparing compound ceftiofur oil suspension injection.
Background technology
The ceftiofur ceftiofur has another name called Sai Defu (ceftiofur), is the cephalosporins of first animal specific of U.S. Pharmacia S.P.A. initiative.China has now copied successfully, is about to approval and produces.Its has a broad antifungal spectrum, antibacterial activity are strong, clinical and reference culture all there is strong antibacterial activity, since being used for the treatment of the respiratory system infection of cattle by FDA approval in 1988, because of its good antibacterial activity and body internal dynamics process, the application in the veterinary clinic treatment both at home and abroad is extensive day by day now.
Aspect preparation, state's external preparation has injection ceftiofur sodium and Ceftiofur Hydrochloride oil suspensoid injectio, domestic 07 year approved ceftiofur sodium raw materials and the production of Ceftiofur Hydrochloride oil suspensoid injectio, but do not see compound Ceftiofur Hydrochloride oil suspensoid injectio patent both at home and abroad, do not issue quality standard as yet.
Summary of the invention
Purpose of the present invention just is to provide a kind of technique for preparing compound ceftiofur oil suspension injection.
Purpose of the present invention can realize by following measure:
Technique for preparing compound ceftiofur oil suspension injection of the present invention is as follows:
(1), with neutral soybean oil 100 ± 2mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 115.5-126.5 ℃ then, after sterilizing 30 minutes-1 hour, taking-up 20-32mL is put and is chilled to 60～80 ℃, add stearic acid aluminum 2 ± 0.2 and restrain, be made into the gel of 6%-10%, and heat to 110-120 ℃ in wherein, kept 30 minutes-1 hour, be diluted to 2 ± 0.2% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 5 ± 0.5 gram and sulbactam 2.5 ± 0.25 grams by prescription,, and it is mixed with the 30-40mL factice, grinding, adding lecithin 0.05-0.07 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 30-40mL, when the factice temperature is not less than 70-80 ℃, benzyl alcohol 1 ± 0.1mL, Arlacel-80 0.15-0.2 gram, vitamin E 0.15-0.3 gram are added in the graduated cylinder, the limit edged stirs, and adds to 100 ± 2ml. with factice and will decide measured solution again stir the 30-45 branch in agitator, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
The prescription of preparation method of the present invention is as follows:
100mL suspension main component:
Soybean oil 100 ± 2mL
Ceftiofur Hydrochloride/sulbactam (5 ± 0.5 grams/2.5 ± 0.25 gram)
Phosphatidase 10 .05-0.07 gram
Aluminium stearate 2.0 ± 0.2g
Span-80?0.15-0.2g
Benzyl alcohol 1 ± 0.1mL
Vitamin E 0.15-0.3 gram
The preferred technique for preparing compound ceftiofur oil suspension injection of the present invention is as follows:
(1), with neutral soybean oil 100 ± 2mL, filter through No. 3 sintered glass filters or glass funnel, glass filter bulb or glass filter bulb rod, place pressure cooker or pressure sterilizing cabinet to be heated to 120-126.5 ℃ then, taking-up 25-32mL was put and is chilled to 60～80 ℃ after sterilization 30-45 divided, adding stearic acid aluminum 2 ± 0.2 restrains in wherein, be made into the gel of 6.25%-8%, and heat to 115-120 ℃, keep the 30-45 branch, be diluted to 2 ± 0.2% factice with the soybean oil that filters, sterilizes, No. 3 sintered glass funnels or glass filter bulbs or glass filter bulb rod filter, and be standby;
(2), get Ceftiofur Hydrochloride 5 ± 0.5 gram/sulbactams/2.5 ± 0.25 gram by prescription, the two weight ratio 2/1, and it is mixed with the 30-35mL factice, in mortar, grinding, adding lecithin 0.05-0.06 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 30-40mL, when the factice temperature is not less than 70-80 ℃, benzyl alcohol 1 ± 0.1mL, Arlacel-80 0.15-0.2 gram, vitamin E 0.15-0.3 gram are added in the graduated cylinder, the limit edged stirs, and adds to 100 ± 2ml. with factice and will decide measured solution again stir the 30-45 branch in agitator, with its abundant mixing; At last solution is sub-packed in while stirring in the ampoule of sterilizing-drying in sealing by fusing or the 100mL vial and seals, promptly.
The specific embodiment
The present invention does with detailed description below in conjunction with embodiment:
Embodiment 1
Technique for preparing compound ceftiofur oil suspension injection of the present invention is as follows:
(1), with neutral soybean oil 98mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 115.5 ℃ then, sterilize after 30 minutes, taking-up 20mL is put and is chilled to 60 ℃, add stearic acid aluminum 1.8 and restrain, be made into 6% gel, and heat to 110 ℃ in wherein, kept 30 fens, be diluted to 1.8% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 4.5 gram and sulbactam 2.25 grams by prescription,, and it is mixed with the 30mL factice, grinding, adding lecithin 0.05 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 30mL, when the factice temperature is not less than 70 ℃, benzyl alcohol 0.9mL, Arlacel-80 (span-80 other with) 0.15 gram, vitamin E 0.15 gram are added in the graduated cylinder, the limit edged stirs, and adds to 98ml. with factice and will decide measured solution again and stir in agitator 30 fens, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
Embodiment 2
Technique for preparing compound ceftiofur oil suspension injection is as follows:
(1), with neutral soybean oil 99mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 118 ℃ then, sterilize after 35 minutes, taking-up 23mL is put and is chilled to 65 ℃, add stearic acid aluminum 1.9 and restrain, be made into 7% gel, and heat to 112 ℃ in wherein, kept 35 hours, be diluted to 1.9% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 4.8 gram and sulbactam 2.3 grams by prescription,, and it is mixed with the 35mL factice, grinding, adding lecithin 0.055 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 35mL, when the factice temperature is not less than 75 ℃, with benzyl alcohol 0.9mL, Arlacel-80: 0.16 gram, vitamin E 0.16 gram add in the graduated cylinder, the limit edged stirs, and adds to 99ml. with factice and will decide measured solution again and stir in agitator 35 fens, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
Embodiment 3,
Technique for preparing compound ceftiofur oil suspension injection is as follows:
(1), with neutral soybean oil 100mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 120 ℃ then, sterilize after 45 minutes, taking out 28 mL puts and is chilled to 70 ℃, add stearic acid aluminum 2 and restrain, be made into 8% gel, and heat to 118 ℃ in wherein, kept 45 fens, be diluted to 2% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 5 gram and sulbactam 2.5 grams by prescription,, and it is mixed with the 38mL factice, grinding, adding lecithin 0.06 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 37mL, when the factice temperature is not less than 78 ℃, with benzyl alcohol 1mL, Arlacel-80: 0.18 gram, vitamin E 0.18 gram add in the graduated cylinder, the limit edged stirs, and adds to 100ml. with factice and will decide measured solution again and stir in agitator 40 fens, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
Embodiment 4,
Technique for preparing compound ceftiofur oil suspension injection is as follows:
(1), with neutral soybean oil 101mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 124.5 ℃ then, sterilize after 50 minutes, taking-up 30mL is put and is chilled to 75 ℃, add stearic acid aluminum 2.1 and restrain, be made into 9% gel, and heat to 119 ℃ in wherein, kept 50 fens, be diluted to 2.1% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 5.3 gram and sulbactam 2.6 grams by prescription,, and it is mixed with the 38mL factice, grinding, adding lecithin 0.065 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 38mL, when the factice temperature is not less than 79 ℃, with benzyl alcohol 1.05mL, Arlacel-80: 0.19 gram, vitamin E 0.28 gram add in the graduated cylinder, the limit edged stirs, and adds to 101ml. with factice and will decide measured solution again and stir in agitator 43 fens, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
Embodiment 5,
Technique for preparing compound ceftiofur oil suspension injection is as follows:
(1), with neutral soybean oil 102mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 126.5 ℃ then, sterilize after 1 hour, taking-up 32mL is put and is chilled to 80 ℃, add stearic acid aluminum 2.2 and restrain, be made into 10% gel, and heat to 120 ℃ in wherein, kept 1 hour, be diluted to 2.2% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 5.5 gram and sulbactam 2.75 grams by prescription,, and it is mixed with the 40mL factice, grinding, adding lecithin 0.07 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 30-40mL, when the factice temperature is not less than 80 ℃, with benzyl alcohol 1.1mL, Arlacel-80: 0.2 gram, vitamin E 0.3 gram add in the graduated cylinder, the limit edged stirs, and adds to 102ml. with factice and will decide measured solution again and stir in agitator 45 fens, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
Embodiment 6
The prescription of technique for preparing compound ceftiofur oil suspension injection is as follows:
100mL suspension main component:
Soybean oil 100 ± 2mL
Ceftiofur Hydrochloride/sulbactam (5 ± 0.5 grams/2.5 ± 0.25 gram)
Phosphatidase 10 .05-0.07 gram
Aluminium stearate 2.0 ± 0.2g
Span-80?0.15-0.2g
Benzyl alcohol 1 ± 0.1mL
Vitamin E 0.1 5-0.3 gram
All the other compositions are existing conventional ingredient, and preparation method is with embodiment 1.
Embodiment 7
The technique for preparing compound ceftiofur oil suspension injection method is as follows
(1), with neutral soybean oil 100 ± 2mL, filter through No. 3 sintered glass filters or glass funnel, glass filter bulb or glass filter bulb rod, place pressure cooker or pressure sterilizing cabinet to be heated to 120-126.5 ℃ then, taking-up 25-32mL was put and is chilled to 60～80 ℃ after sterilization 30-45 divided, adding stearic acid aluminum 2 ± 0.2 restrains in wherein, be made into the gel of 6.25%-8%, and heat to 115-120 ℃, keep the 30-45 branch, be diluted to 2 ± 0.2% factice with the soybean oil that filters, sterilizes, No. 3 sintered glass funnels or glass filter bulbs or glass filter bulb rod filter, and be standby;
(2), get Ceftiofur Hydrochloride 5 ± 0.5 gram/sulbactams/2.5 ± 0.25 gram by prescription, the two weight ratio 2/1, and it is mixed with the 30-35mL factice, in mortar, grinding, adding lecithin 0.05-0.06 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride/sulbactam is transferred in the graduated cylinder, and add factice 30-40mL, when the factice temperature is not less than 70-80 ℃, benzyl alcohol 1 ± 0.1mL, Arlacel-80 0.15-0.2 gram, vitamin E 0.15-0.3 gram are added in the graduated cylinder, the limit edged stirs, and adds to 100 ± 2ml. with factice and will decide measured solution again stir the 30-45 branch in agitator, with its abundant mixing; At last solution is sub-packed in while stirring in the ampoule of sterilizing-drying in sealing by fusing or the 100mL vial and seals, promptly.
Wherein parameter generally should be got two end values and a plurality of intermediate value respectively, and should set according to actual needs and get final product.
Claims (2)
1. technique for preparing compound ceftiofur oil suspension injection, it is characterized in that: its preparation technology is as follows:
(1), with neutral soybean oil 100 ± 2mL, after filtration, place pressure cooker or pressure sterilizing cabinet to be heated to 115.5-126.5 ℃ then, after sterilizing 30 minutes-1 hour, taking-up 20-32mL is put and is chilled to 60～80 ℃, add stearic acid aluminum 2 ± 0.2 and restrain, be made into the gel of 6%-10%, and heat to 110-120 ℃ in wherein, kept 30 minutes-1 hour, be diluted to 2 ± 0.2% factice with the soybean oil that filters, sterilizes, refilter, standby;
(2), get Ceftiofur Hydrochloride 5 ± 0.5 gram and sulbactam 2.5 ± 0.25 grams, and it is mixed with the 30-40mL factice, grind, adding lecithin 0.05-0.07 restrains while grinding, until grinding well by prescription; Afterwards, ground Ceftiofur Hydrochloride and sulbactam are transferred in the graduated cylinder, and add factice 30-40mL, when the factice temperature is not less than 70-80 ℃, benzyl alcohol 1 ± 0.1mL, Arlacel-80 0.15-0.2 gram, vitamin E 0.15-0.3 gram are added in the graduated cylinder, and the limit edged stirs, and adds to 100 ± 2ml with factice, to decide measured solution again and in agitator, stir 30-45 minute, with its abundant mixing; At last solution is sealed in the sub-bottling while stirring, promptly.
2. technique for preparing compound ceftiofur oil suspension injection according to claim 1 is characterized in that: described preparation technology is as follows
(1), with neutral soybean oil 100 ± 2mL, filter through No. 3 sintered glass filters or glass funnel, glass filter bulb or glass filter bulb rod, place pressure cooker or pressure sterilizing cabinet to be heated to 120-126.5 ℃ then, sterilize after 30-45 minute and to take out 25-32mL and put and be chilled to 60～80 ℃, adding stearic acid aluminum 2 ± 0.2 restrains in wherein, be made into the gel of 6.25%-8%, and heat to 115-120 ℃, kept 30-45 minute, be diluted to 2 ± 0.2% factice with the soybean oil that filters, sterilizes, No. 3 sintered glass funnels or glass filter bulbs or glass filter bulb rod filter, and be standby;
(2), get Ceftiofur Hydrochloride 5 ± 0.5 gram and sulbactam 2.5 ± 0.25 grams by prescription, the two weight ratio 2/1, and it is mixed with the 30-35mL factice, in mortar, grinding, adding lecithin 0.05-0.06 restrains while grinding, until grinding well; Afterwards, ground Ceftiofur Hydrochloride and sulbactam are transferred in the graduated cylinder, and add factice 30-40mL, when the factice temperature is not less than 70-80 ℃, benzyl alcohol 1 ± 0.1mL, Arlacel-80: 0.15-0.2 gram, vitamin E 0.15-0.3 gram are added in the graduated cylinder, the limit edged stirs, and adds to 100 ± 2ml. with factice and will decide measured solution again stir the 30-45 branch in agitator, with its abundant mixing; At last solution is sub-packed in while stirring sealing by fusing in the ampoule of sterilizing-drying, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2007101897476A CN101406447B (en) | 2007-10-12 | 2007-10-12 | Technique for preparing compound ceftiofur oil suspension injection |
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| CN2007101897476A CN101406447B (en) | 2007-10-12 | 2007-10-12 | Technique for preparing compound ceftiofur oil suspension injection |
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| CN101406447B true CN101406447B (en) | 2010-08-25 |
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Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101721366B (en) * | 2010-01-13 | 2011-09-21 | 洛阳惠中兽药有限公司 | Components and preparation method of beta-lactam injection |
| CN101780088A (en) * | 2010-02-26 | 2010-07-21 | 商丘爱己爱牧动物药业有限公司 | Compound Ceftiofur Hydrochloride injecta |
| CN101953889B (en) * | 2010-09-07 | 2013-04-10 | 西北农林科技大学 | Compound ceftiofur suspension emulsion injection and preparation method thereof |
| CN102813623B (en) * | 2012-09-19 | 2014-07-02 | 上海同仁药业有限公司 | Method for preparing ceftiofur hydrochloride suspension injection |
| CN103316349B (en) * | 2013-06-21 | 2015-08-12 | 成都乾坤动物药业有限公司 | A kind of oil suspension stabilizing agent, oil suspension for animals and preparation method thereof |
| CN105640880A (en) * | 2014-11-11 | 2016-06-08 | 天津瑞贝特科技发展有限公司 | Ceftiofur sodium suspension and preparation method thereof |
| CN106309360B (en) * | 2016-09-13 | 2018-08-10 | 上海公谊药业有限公司 | A kind of preparation method of long-acting ceftiofur hydrochloride injection |
| CN107595852A (en) * | 2017-09-13 | 2018-01-19 | 南通荣成医药化工有限公司 | A kind of new compound preparation of ceftiofur sodium |
| CN109568255A (en) * | 2018-12-19 | 2019-04-05 | 南京农业大学 | Compound long-acting injection and preparation method thereof containing Ceftiofur and Meloxicam |
| CN111228211A (en) * | 2020-01-14 | 2020-06-05 | 开封嘉骏生物科技有限公司 | Production formula and production process of ceftiofur hydrochloride injection |
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| CN1238690A (en) * | 1996-12-09 | 1999-12-15 | 法玛西雅厄普约翰美国公司 | Improved pharmaceutical compositions |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1238690A (en) * | 1996-12-09 | 1999-12-15 | 法玛西雅厄普约翰美国公司 | Improved pharmaceutical compositions |
| CN1536987A (en) * | 2001-02-19 | 2004-10-13 | 株式会社Lg生命科学 | Sustained-release suspension of ceftiofur hydrochloride |
Non-Patent Citations (4)
| Title |
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| John R. Chenault et al.Efficacy of ceftiofur hydrochloride sterile suspensionadministered parenterally for the treatment of acutepostpartum metritis in dairy cows.Journal of the American Veterinary Medical Association224 10.2004,224(10),Abstract. |
| John R. Chenault et al.Efficacy of ceftiofur hydrochloride sterile suspensionadministered parenterally for the treatment of acutepostpartum metritis in dairy cows.Journal of the American Veterinary Medical Association224 10.2004,224(10),Abstract. * |
| 赵清泉等.头孢噻呋混悬液和头孢噻呋钠冻干粉对人工诱发猪大肠杆菌病的疗效.中国畜牧兽医31 12.2041,31(12),40-41. |
| 赵清泉等.头孢噻呋混悬液和头孢噻呋钠冻干粉对人工诱发猪大肠杆菌病的疗效.中国畜牧兽医31 12.2041,31(12),40-41. * |
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