CN105213304A - A kind of cefalexin suspension injection and preparation method thereof - Google Patents
A kind of cefalexin suspension injection and preparation method thereof Download PDFInfo
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- CN105213304A CN105213304A CN201510698164.0A CN201510698164A CN105213304A CN 105213304 A CN105213304 A CN 105213304A CN 201510698164 A CN201510698164 A CN 201510698164A CN 105213304 A CN105213304 A CN 105213304A
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- cefalexin
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Abstract
The invention provides a kind of cefalexin suspension injection, obtained by following method: cefalexin is crushed to grain diameter≤5 μm for subsequent use; By injection stage vegetable oil heat sterilization 30 minutes, be chilled to room temperature for subsequent use; Antibacterial after sterilizing is added in Polyethylene Glycol, and mixes with the injection stage vegetable oil after sterilizing and 4 solvents, after strong stirring mixing, add the cefalexin of pulverizing, homogeneous formation suspension injection.Cefalexin suspension injection of the present invention stable performance, quality meets Chinese veterinary pharmacopoeia relevant regulations; Cefalexin suspension injection cheaper starting materials is easy to get, and preparation technology is simple, and be applicable to industrialization large-scale production, therefore its application prospect is very wide.
Description
Technical field
The present invention relates to a kind of cephalosporins medicine injection and preparation method thereof, refer to a kind of cefalexin suspension injection and preparation method thereof especially, belong to field of animal.
Background technology
Cefalexin (Cephalexin) i.e. cephalexin, chemical name is: (6R, 7R)-3-methyl-7-[(R)-2-amino-2-phenylacetylamino]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid hydrate, one of important semi-synthetic antibiotics, belong to conventional 1st generation cephalosporin, because it absorbs fast, has a broad antifungal spectrum and toxicity is low and by wide clinical application.Except Enterococcus, methicillin-resistant Staphylococci, streptococcus pneumoniae, Hemolytic streptococcus, product or not produce the staphylococcic most of bacterial strain of penicillinase responsive to cefalexin.These product have better antibacterial action to neisseria, but the sensitivity of hemophilus influenza to these product is poor; These product have certain antibacterial action to part escherichia coli, proteus mirabilis, salmonella and shigella dysenteriae.All the other enterobacteriaceae lactobacteriaceaes, acinetobacter calcoaceticus, Pseudomonas aeruginosa, bacteroides fragilis all present drug resistance to these product.Fusobacterium and Wei Rong coccus are generally responsive to these product, and anaerobism gram positive coccus is to this product medium sensitivity.
, there is the problems such as duration of efficacy is short, bioavailable efficiency is lower in existing cefalexin preparation mainly oral administration.The preparation such as cefalexin and streptomycin sulfate combination is prepared into compound preparation by CN200810037594, does not meet present veterinary drug Registration regulations; CN201410657883 is by combinations such as cefalexin, PVC, ethyl celluloses, and be prepared into lyophilized powder, complex process, production cost is high.
Summary of the invention
Object of the present invention is exactly for the deficiencies in the prior art, provides a kind of preparation stable performance, duration of efficacy is long and bioavailability is high cefalexin suspension injection.
A kind of cefalexin suspension injection comprises following component:
Cefalexin content is 5 ~ 20% (W/V);
Antibacterial content is 1% (V/V);
All the other are Polyethylene Glycol and injection stage vegetable oil, and wherein, Polyethylene Glycol and injection stage vegetable oil ratio are 1:1 ~ 1:4.
Described antibacterial comprises benzyl alcohol, thimerosal and chlorobutanol, is preferably chlorobutanol.
Described Polyethylene Glycol comprises Liquid Macrogol and PEG400, is preferably PEG400.
Described injection stage vegetable oil comprises soybean oil, olive oil, is preferably soybean oil.
Present invention also offers a kind of preparation method of above-mentioned cefalexin injection, comprise the steps:
1) each component is taken by formula proportion;
2) cefalexin is crushed to grain diameter≤5 μm for subsequent use;
3) get injection stage vegetable oil heat sterilization 30 minutes, be chilled to room temperature for subsequent use;
4) antibacterial after sterilizing is added in Polyethylene Glycol;
5) by step 3) and 4) solvent mixing, after strong stirring mixing, add the cefalexin of pulverizing, homogeneous formation suspension injection.
Compared with prior art, the invention has the beneficial effects as follows:
1) cefalexin suspension injection of the present invention stable performance, quality meets Chinese veterinary pharmacopoeia relevant regulations;
2) cefalexin suspension injection cheaper starting materials of the present invention is easy to get;
3) cefalexin suspension injection preparation method of the present invention, preparation technology is simple, and be applicable to industrialization large-scale production, therefore its application prospect is very wide.
Detailed description of the invention
In the present embodiment adopt raw material to be sterile raw material, whole process is prepared in clean area.Cefalexin content used herein is 95%.
Embodiment 1
The spore ammonia benzyl suspension injection formula one of 5%:
Cefalexin, 5.26g;
Chlorobutanol, 1mL;
PEG400,20mL;
Soybean oil, 76.37mL.
The spore ammonia benzyl suspension injection preparation method of 5%:
1) each component is taken by above-mentioned formula proportion;
2) jet mill is adopted cefalexin to be crushed to grain diameter≤5 μm for subsequent use;
3) soybean oil is heated to 120 DEG C of sterilizings 30 minutes, is chilled to room temperature for subsequent use;
4) chlorobutanol after sterilizing is added in PEG400;
5) by step 3) and 4) solvent mixing, after strong stirring mixing, add the cefalexin of pulverizing, ultrasonic homogeneous formation suspension injection.
Embodiment 2
The spore ammonia benzyl suspension injection formula two of 5%:
Cefalexin, 5.26g;
Benzyl alcohol, 1mL;
PEG400,48.19mL;
Olive oil, 48.19mL.
The spore ammonia benzyl suspension injection preparation method of 5%:
1) each component is taken by above-mentioned formula proportion;
2) jet mill is adopted cefalexin to be crushed to grain diameter≤5 μm for subsequent use;
3) olive oil is heated to 130 DEG C of sterilizings 30 minutes, is chilled to room temperature for subsequent use;
4) benzyl alcohol after sterilizing is added in PEG400;
5) by step 3) and 4) solvent mixing, after strong stirring mixing, add the cefalexin of pulverizing, ultrasonic homogeneous formation suspension injection.
Embodiment 3
10% spore ammonia benzyl suspension injection formula:
Cefalexin, 10.52g;
Thimerosal, 1mL;
Liquid Macrogol, 30mL;
Soybean oil, 63.74mL.
The spore ammonia benzyl suspension injection preparation method of 10%:
1) each component is taken by above-mentioned formula proportion;
2) jet mill is adopted cefalexin to be crushed to grain diameter≤5 μm for subsequent use;
3) soybean oil is heated to 130 DEG C of sterilizings 30 minutes, is chilled to room temperature for subsequent use;
4) thimerosal after sterilizing is added in Liquid Macrogol;
5) by step 3) and 4) solvent mixing, after strong stirring mixing, add the cefalexin of pulverizing, ultrasonic homogeneous formation suspension injection.
Embodiment 4
20% spore ammonia benzyl suspension injection formula:
Cefalexin, 21.04g;
Chlorobutanol, 1mL;
PEG400,25mL;
Soybean oil, 63.48mL.
The spore ammonia benzyl suspension injection preparation method of 20%:
1) each component is taken by above-mentioned formula proportion;
2) jet mill is adopted cefalexin to be crushed to grain diameter≤5 μm for subsequent use;
3) soybean oil is heated to 120 DEG C of sterilizings 30 minutes, is chilled to room temperature for subsequent use;
4) chlorobutanol after sterilizing is added in PEG400;
5) by step 3) and 4) solvent mixing, after strong stirring mixing, add the cefalexin of pulverizing, ultrasonic homogeneous formation suspension injection.
Embodiment 5
Prepared sample is checked according to " veterinary drug national standard compilation---veterinary drug provincial standard rising national standard the 3rd " and " Chinese veterinary pharmacopoeia 2010 editions " annex standard, main project comprises cefalexin content (labelled amount percentage ratio), particle diameter and sedimentation volume ratio, and concrete outcome is as follows:
Claims (5)
1. a cefalexin suspension injection, is characterized in that, comprises following component:
Cefalexin content is 5 ~ 20%(W/V);
Antibacterial content is 1%(V/V);
All the other are Polyethylene Glycol and injection stage vegetable oil, and wherein, Polyethylene Glycol and injection stage vegetable oil ratio are 1:1 ~ 1:4.
2. cefalexin suspension injection as claimed in claim 1, it is characterized in that, described antibacterial is chlorobutanol.
3. cefalexin suspension injection as claimed in claim 1, it is characterized in that, described Polyethylene Glycol is PEG400.
4. cefalexin suspension injection as claimed in claim 1, it is characterized in that, described injection stage vegetable oil is soybean oil.
5. the preparation method of the cefalexin suspension injection as described in claim 1-5, is characterized in that, comprise the following steps:
1) each component is taken by formula proportion;
2) cefalexin is crushed to grain diameter≤5 μm for subsequent use;
3) injection stage vegetable oil heat sterilization, is chilled to room temperature for subsequent use;
4) antibacterial after sterilizing is added in Polyethylene Glycol;
5) by step 3) and 4) solvent mixing, after strong stirring mixing, add the cefalexin of pulverizing, homogeneous formation suspension injection.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510698164.0A CN105213304A (en) | 2015-10-22 | 2015-10-22 | A kind of cefalexin suspension injection and preparation method thereof |
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| CN201510698164.0A CN105213304A (en) | 2015-10-22 | 2015-10-22 | A kind of cefalexin suspension injection and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309365A (en) * | 2016-10-14 | 2017-01-11 | 成都乾坤动物药业股份有限公司 | Cefalexin oil suspension and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008030469A2 (en) * | 2006-09-07 | 2008-03-13 | Merial Limited | Soft chewable, tablet, and long-acting injectable veterinary antibiotic formulations |
| CN101822637A (en) * | 2009-12-31 | 2010-09-08 | 天津瑞普生物技术股份有限公司 | Beta-lactam antibiotics-containing suspension injection |
| CN102018669A (en) * | 2010-11-19 | 2011-04-20 | 武汉回盛生物科技有限公司 | Long-acting ceftiofur hydrochloride injection and preparation method thereof |
-
2015
- 2015-10-22 CN CN201510698164.0A patent/CN105213304A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008030469A2 (en) * | 2006-09-07 | 2008-03-13 | Merial Limited | Soft chewable, tablet, and long-acting injectable veterinary antibiotic formulations |
| CN101822637A (en) * | 2009-12-31 | 2010-09-08 | 天津瑞普生物技术股份有限公司 | Beta-lactam antibiotics-containing suspension injection |
| CN102018669A (en) * | 2010-11-19 | 2011-04-20 | 武汉回盛生物科技有限公司 | Long-acting ceftiofur hydrochloride injection and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 农业部: "中华人民共和国农业部公告 第839号", 《中华人民共和国农业部公告 第839号》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309365A (en) * | 2016-10-14 | 2017-01-11 | 成都乾坤动物药业股份有限公司 | Cefalexin oil suspension and preparation method thereof |
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Application publication date: 20160106 |