CN104473868A - Cefquinome sulfate suspension injection and preparation method thereof - Google Patents
Cefquinome sulfate suspension injection and preparation method thereof Download PDFInfo
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- CN104473868A CN104473868A CN201410717313.9A CN201410717313A CN104473868A CN 104473868 A CN104473868 A CN 104473868A CN 201410717313 A CN201410717313 A CN 201410717313A CN 104473868 A CN104473868 A CN 104473868A
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Abstract
The invention relates to a cefquinome sulfate suspension injection. The cefquinome sulfate suspension injection is characterized by comprising the following components in mass-volume ratio: 2.5% of cefquinome sulfate, 1%-3% of a suspending agent, 0.1%-0.3% of an antioxidant, and balance of a solvent for injection, totaling 100%. The invention also provides a preparation method of the cefquinome sulfate suspension injection. Since a surfactant is used as the suspending agent, the stability of the suspension can be improved; the stability of the medicine is increased; the irritation of the medicine is reduced; and the cefquinome sulfate suspension injection is simple in preparation process, is prepared from cheap and easily available raw materials, and is suitable for industrial production, so that the cefquinome sulfate suspension injection has a wide application prospect.
Description
Technical field
The present invention relates to veterinary drug field, particularly cephalo-type veterinary drug, specifically relate to a kind of Cefquinome sulfate suspension injection and preparation method thereof.
Background technology
Cefquinome (Cefqu inome), have another name called Cefquinome, HOE 111., trade name gram hundred spies (Cobactan) are the forth generation animal specific cephalosporins that German Hirst company (H oechst AG) developed the eighties in 20th century.Because cefquinome is very low at gastral absorbance, be usually made into the form of sulfate clinically.Cefquinome has bactericidal action antibacterial and powerful widely, there is extremely strong killing action to staphylococcus aureus, streptococcus, pseudomonas aeruginosa, enterobacteria section (escherichia coli, Salmonella, klebsiella, citric acid fungus, serratia marcesens), also have good killing action to the staphylococcus of many methicillin-resistants and enterobacteria.Pig, the respiratory system infection of cattle and the clinical treatment of mammitis of cow are widely used in both at home and abroad.
Sulphuric acid cephalo quinoline (Cefquinome Sulfate, CS) be the 4th generation animal specific cephalosporins, because of its powerful antibacterial activity, the wide characteristic such as antimicrobial spectrum and low drug resistance and being widely used.But this medicine half-life is short, needs frequent drug administration, intramuscular injection is large to body zest, and its unstable chemcial property, the facile hydrolysis under acid or alkaline conditions of the beta-lactam nucleus in its structure, significantly limit its clinical practice.
Do not need frequent drug administration, zest little so a kind of and the Cefquinome sulfate medicament of its stable chemical nature, not facile hydrolysis extremely has practical value.
Summary of the invention
The object of the invention is to overcome above-mentioned shortcoming of the prior art, providing a kind of does not need frequent drug administration, zest little and sulphuric acid cephalo quinoline of its stable chemical nature, not facile hydrolysis and preparation method thereof.
To achieve these goals, one aspect of the present invention provides a kind of Cefquinome sulfate suspension injection, and its feature is, comprises the composition of following mass volume ratio:
Preferably, described suspending agent is at least one in glyceryl monostearate, sorbester p17, span 83, sorbester p37.
Preferably, described antioxidant is vitamin E.
Preferably, described solvent for injection is selected from least one in soybean oil, ethyl oleate, medium-chain fatty acid triglyceride, MCT.
The present invention provides a kind of preparation method of above-mentioned Cefquinome sulfate suspension injection on the other hand, and its feature is, comprises the following steps:
Step (1): by described mass volume ratio, gets Cefquinome sulfate and is placed in crusher for crushing to its 90% grain diameter≤20 μm, obtain aseptic Cefquinome sulfate after sterilizing;
Step (2): get solvent for injection heating, sterilizing after insulation, then be cooled to room temperature, obtain aseptic solvent for injection;
Step (3): by described mass percent, after getting antioxidant, suspending agent sterilizing, obtains aseptic antioxidant, aseptic suspending agent;
Step (4): described aseptic Cefquinome sulfate, described aseptic antioxidant and described aseptic suspending agent are added in described aseptic solvent for injection, is dispersed into suspension completely after stirring;
Step (5): by described suspension through ball mill super-refinement, obtains described Cefquinome sulfate suspension injection.
Preferably, the heating-up temperature in step (2) is 110 ~ 130 DEG C.
Preferably, in step (2), temperature retention time is 1 ~ 3 hour.
Adopt Cefquinome sulfate suspension injection of the present invention and preparation method thereof, because suspensoid generally has the characteristic of free settling, Cefquinome sulfate suspension injection prepared by the present invention adopts surfactant as suspending agent, it, for increasing the viscosity of disperse medium to reduce the sedimentation velocity of microgranule or to increase the hydrophilic additives of power, can improve the stability of suspension.Thus add the stability of medicine, reduce the stimulation of medicine, do not need frequent drug administration, preparation technology is simple, and cheaper starting materials is easy to get, and is applicable to industrialized great production, therefore has broad application prospects.
Detailed description of the invention
In order to more clearly understand technology contents of the present invention, below specific embodiment of the invention method is described further.
The experimental technique of unreceipted actual conditions in the following example, conventionally and condition, or selects according to catalogue.
The raw material sources used in following embodiment are:
Embodiment 1
Each raw material (with total amount for 100mL) is taken for following mass percent:
Get Ceftiofur Hydrochloride and put crusher for crushing to 90% grain diameter≤20 μm; Soybean oil is heated to 110 DEG C, is incubated sterilizing in 3 hours, then is cooled to room temperature; Add the sterilized sulphuric acid cefotaxime of recipe quantity, glyceryl monostearate and vitamin E, stir, make it be dispersed into suspension completely; By gained suspension through ball mill super-refinement, obtain described Cefquinome sulfate suspension injection.
Embodiment 2
Each raw material (with total amount for 100mL) is taken for following mass percent:
Get Ceftiofur Hydrochloride and put crusher for crushing to 90% grain diameter≤20 μm; Ethyl oleate is heated to 120 DEG C, is incubated sterilizing in 2 hours, then is cooled to room temperature; Add the sterilized sulphuric acid cefotaxime of recipe quantity, sorbester p17 and vitamin E, stir, make it be dispersed into suspension completely; By gained suspension through ball mill super-refinement, obtain described Cefquinome sulfate suspension injection.
Embodiment 3
Each raw material (with total amount for 100mL) is taken for following mass percent:
Get Ceftiofur Hydrochloride and put crusher for crushing to 90% grain diameter≤20 μm; MCT is heated to 130 DEG C, is incubated sterilizing in 1 hour, then is cooled to room temperature; Add the sterilized sulphuric acid cefotaxime of recipe quantity, span 83 and vitamin E, stir, make it be dispersed into suspension completely; By gained suspension through ball mill super-refinement, obtain described Cefquinome sulfate suspension injection.
Observe the outward appearance of above embodiment gained Cefquinome sulfate suspension injection, and carry out the mensuration of moisture and content, result is as shown in table 1.
Table 1
| Embodiment | Character | Moisture (%) | Content (%) |
| 1 | Light brown suspendible liquid | 0.13 | 100.3 |
| 2 | Light brown suspendible liquid | 0.11 | 99.7 |
| 3 | Light brown suspendible liquid | 0.10 | 100.5 |
As shown in Table 1, in Cefquinome sulfate suspension injection provided by the invention, medicaments uniformity is dispersed in disperse medium, is that one comparatively stablizes mixed suspension preparation.
Adopt Cefquinome sulfate suspension injection of the present invention and preparation method thereof, because suspensoid generally has the characteristic of free settling, Cefquinome sulfate suspension injection prepared by the present invention adopts surfactant as suspending agent, it, for increasing the viscosity of disperse medium to reduce the sedimentation velocity of microgranule or to increase the hydrophilic additives of power, can improve the stability of suspension.Thus add the stability of medicine, reduce the stimulation of medicine, do not need frequent drug administration, preparation technology is simple, and cheaper starting materials is easy to get, and is applicable to industrialized great production, therefore has broad application prospects.
In this description, the present invention is described with reference to its specific embodiment.But, still can make various amendment and conversion obviously and not deviate from the spirit and scope of the present invention.Therefore, description is regarded in an illustrative, rather than a restrictive.
Claims (7)
1. a Cefquinome sulfate suspension injection, is characterized in that, comprises the composition of following mass volume ratio:
2. Cefquinome sulfate suspension injection according to claim 1, is characterized in that, described suspending agent is at least one in glyceryl monostearate, sorbester p17, span 83, sorbester p37.
3. Cefquinome sulfate suspension injection according to claim 1, is characterized in that, described antioxidant is vitamin E.
4. Cefquinome sulfate suspension injection according to claim 1, is characterized in that, described solvent for injection is selected from least one in soybean oil, ethyl oleate, medium-chain fatty acid triglyceride, MCT.
5. a preparation method for Cefquinome sulfate suspension injection according to claim 1, is characterized in that, comprises the following steps:
Step (1): by described mass volume ratio, gets Cefquinome sulfate and is placed in crusher for crushing to its grain diameter≤20 μm of 90%, obtain aseptic Cefquinome sulfate after sterilizing;
Step (2): get solvent for injection heating, sterilizing after insulation, then be cooled to room temperature, obtain aseptic solvent for injection;
Step (3): by described mass percent, after getting antioxidant, suspending agent sterilizing, obtains aseptic antioxidant, aseptic suspending agent;
Step (4): described aseptic Cefquinome sulfate, described aseptic antioxidant and described aseptic suspending agent are added in described aseptic solvent for injection, is dispersed into suspension completely after stirring;
Step (5): by described suspension through ball mill super-refinement, obtains described Cefquinome sulfate suspension injection.
6. the preparation method of Cefquinome sulfate suspension injection according to claim 1, is characterized in that, the heating-up temperature in step (2) is 110 ~ 130 DEG C.
7. the preparation method of Cefquinome sulfate suspension injection according to claim 1, is characterized in that, in step (2), temperature retention time is 1 ~ 3 hour.
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| CN201410717313.9A CN104473868A (en) | 2014-12-01 | 2014-12-01 | Cefquinome sulfate suspension injection and preparation method thereof |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105640881A (en) * | 2015-12-30 | 2016-06-08 | 中国药科大学 | Cefquinome sulfate muscle injection and preparation method thereof |
| CN106491532A (en) * | 2016-11-01 | 2017-03-15 | 四川美嘉龙生物科技有限公司 | A kind of cefquinome sulfate injection and preparation technology |
| CN107789357A (en) * | 2016-08-31 | 2018-03-13 | 瑞普（天津）生物药业有限公司 | A kind of animal compound Cefquinome sulfate breast injection and preparation method thereof |
| CN108578362A (en) * | 2018-05-30 | 2018-09-28 | 河北维尔利动物药业集团有限公司 | A kind of cephalo dimension star suspension injection and preparation method thereof |
| CN112156011A (en) * | 2020-08-19 | 2021-01-01 | 四川爱邦伟业生物工程有限责任公司 | Preparation method for producing cefquinome sulfate injection by using emulsification stirring tank and colloid mill in combined manner |
| CN112569186A (en) * | 2020-12-19 | 2021-03-30 | 杭州爱力迈动物药业有限公司 | Preparation method and application of cefquinome sulfate sustained-release suspension injection |
| CN113209015A (en) * | 2020-01-21 | 2021-08-06 | 江西邦诚动物药业有限公司 | Long-acting ceftiofur hydrochloride suspension injection and preparation process thereof |
| CN113209014A (en) * | 2020-01-21 | 2021-08-06 | 江西邦诚动物药业有限公司 | Long-acting cefquinome sulfate suspension injection and preparation process thereof |
| CN113952298A (en) * | 2021-12-08 | 2022-01-21 | 江苏农牧科技职业学院 | Cefquinome sulfate nano suspension and preparation method thereof |
| CN117982413A (en) * | 2024-04-03 | 2024-05-07 | 山东恒邦中科生物工程有限公司 | Preparation method of cefquinome sulfate injection |
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| CN101347407A (en) * | 2008-09-17 | 2009-01-21 | 河北远征药业有限公司 | Cefquinome sulfate injection and process for producing the same |
| CN101987100A (en) * | 2010-11-10 | 2011-03-23 | 洛阳惠中兽药有限公司 | Method for preparing Cefquinome sulfate suspension injection |
| CN102319210A (en) * | 2011-09-29 | 2012-01-18 | 武汉回盛生物科技有限公司 | A kind of long-acting veterinary cefquinome sulfate injection and preparation method thereof |
| CN102813623A (en) * | 2012-09-19 | 2012-12-12 | 上海同仁药业有限公司 | Method for preparing ceftiofur hydrochloride suspension injection |
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| CN101347407A (en) * | 2008-09-17 | 2009-01-21 | 河北远征药业有限公司 | Cefquinome sulfate injection and process for producing the same |
| CN101987100A (en) * | 2010-11-10 | 2011-03-23 | 洛阳惠中兽药有限公司 | Method for preparing Cefquinome sulfate suspension injection |
| CN102319210A (en) * | 2011-09-29 | 2012-01-18 | 武汉回盛生物科技有限公司 | A kind of long-acting veterinary cefquinome sulfate injection and preparation method thereof |
| CN102813623A (en) * | 2012-09-19 | 2012-12-12 | 上海同仁药业有限公司 | Method for preparing ceftiofur hydrochloride suspension injection |
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105640881A (en) * | 2015-12-30 | 2016-06-08 | 中国药科大学 | Cefquinome sulfate muscle injection and preparation method thereof |
| CN107789357A (en) * | 2016-08-31 | 2018-03-13 | 瑞普（天津）生物药业有限公司 | A kind of animal compound Cefquinome sulfate breast injection and preparation method thereof |
| CN106491532A (en) * | 2016-11-01 | 2017-03-15 | 四川美嘉龙生物科技有限公司 | A kind of cefquinome sulfate injection and preparation technology |
| CN108578362A (en) * | 2018-05-30 | 2018-09-28 | 河北维尔利动物药业集团有限公司 | A kind of cephalo dimension star suspension injection and preparation method thereof |
| CN113209015A (en) * | 2020-01-21 | 2021-08-06 | 江西邦诚动物药业有限公司 | Long-acting ceftiofur hydrochloride suspension injection and preparation process thereof |
| CN113209014A (en) * | 2020-01-21 | 2021-08-06 | 江西邦诚动物药业有限公司 | Long-acting cefquinome sulfate suspension injection and preparation process thereof |
| CN112156011A (en) * | 2020-08-19 | 2021-01-01 | 四川爱邦伟业生物工程有限责任公司 | Preparation method for producing cefquinome sulfate injection by using emulsification stirring tank and colloid mill in combined manner |
| CN112569186A (en) * | 2020-12-19 | 2021-03-30 | 杭州爱力迈动物药业有限公司 | Preparation method and application of cefquinome sulfate sustained-release suspension injection |
| CN113952298A (en) * | 2021-12-08 | 2022-01-21 | 江苏农牧科技职业学院 | Cefquinome sulfate nano suspension and preparation method thereof |
| CN113952298B (en) * | 2021-12-08 | 2023-02-17 | 江苏农牧科技职业学院 | Cefquinome sulfate nano suspension and preparation method thereof |
| CN117982413A (en) * | 2024-04-03 | 2024-05-07 | 山东恒邦中科生物工程有限公司 | Preparation method of cefquinome sulfate injection |
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Address after: 201199 No. 500 Xin Xin Road, Shanghai, Minhang District Applicant after: Shanghai Tongren pharmaceutical Limited by Share Ltd Address before: 201199 No. 500 Xin Xin Road, Shanghai, Minhang District Applicant before: Shanghai Tongren Pharmaceutical Co., Ltd. |
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