CN103446164A - Compound sulfamonomethoxine sodium injection and preparation method thereof - Google Patents
Compound sulfamonomethoxine sodium injection and preparation method thereof Download PDFInfo
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- CN103446164A CN103446164A CN2013104369059A CN201310436905A CN103446164A CN 103446164 A CN103446164 A CN 103446164A CN 2013104369059 A CN2013104369059 A CN 2013104369059A CN 201310436905 A CN201310436905 A CN 201310436905A CN 103446164 A CN103446164 A CN 103446164A
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Abstract
The invention discloses a compound sulfamonomethoxine sodium injection and a preparation method thereof. The compound sulfamonomethoxine sodium injection comprises, by weight, 5-30 parts of sulfamonomethoxine sodium, 1-4 parts of trimethoprim, 0.2-0.4 part of antioxidants, 25-45 parts of organic solvents, 1-2 parts of acid form modifiers, 1-5 parts of alkali form modifiers and 45-65 parts of water for injection. Through the technological improvement of the compound sulfamonomethoxine sodium injection, the using quantity of organic solvents is reduced, cost can be greatly lowered, and the risk for causing clinical irritation is lowered.
Description
Technical field
The invention belongs to the injection field, be specifically related to a kind of composite sulfamonomethoxine sodium injection and preparation method thereof.
Background technology
Sulfamonomethoxine sodium: its mechanism of action is the growth and breeding of anti-bacteria by suppressing folic acid in endobacillary metabolism, with PAB competition dihydrofolate synthetase.For the powerhouse of antibacterial activity in sulfonamides, most of gram positive bacterias and negative bacterium are had to stronger inhibitory action.It is slower that antibacterial produces drug resistance to it, is mainly used in responsive microbial various diseases, and Eperythrozoon, toxoplasma, fowl rabbit coccidiosis are all had to curative effect preferably.The acetyl rate is low, and crystalluria be difficult for to occur, and the effective blood drug concentration Babalus bubalis L. of holding time is 24 hours, and pig is 5.8 hours, goat 7 hours, and sheep is 2 hours.
Trimethoprim: antimicrobial spectrum is similar and active to sulfonamides stronger.Multiple gram positive bacteria and negative bacterium are had to antibacterial action.This product mechanism of action is to suppress dihydrofolate reductase, makes dihydrofoilic acid can not be reduced into tetrahydrofolic acid, thereby hinders sensitive organism folic acid metabolism and utilization, thereby hinders the synthetic of thalline nucleic acid.
Sulfonamides and trimethoprim share, can from two different links block folic acid metabolism simultaneously and double blocking, make antibacterial action strengthen decades of times to nearly a hundred times, or even bacteriostasis becomes bactericidal action, and can reduce the generation of Resistant strain.Clinical porcine respiratory, digestive tract, the urinary tract infection of being mainly used to.
The kind that the composite sulfamonomethoxine sodium injection is " veterinary drug national standard compilation " (first), traditional formulation method is regulated pH value after adopting the organic solvent heating for dissolving, the multiplex propylene glycol of organic solvent or PEG400 and ketopyrrolidine etc. are single or mix to use, but consumption is up to 40-80%.This kind of method not only expends a large amount of organic solvents, and a large amount of organic solvents also easily causes larger zest.
Summary of the invention
For the problems referred to above, the purpose of this invention is to provide a kind of composite sulfamonomethoxine sodium injection and preparation method thereof, solve the problem that existing method expends in a large number organic solvent and easily causes the stimulant of body.
Technical scheme of the present invention is:
The composite sulfamonomethoxine sodium injection, by weight, it is composed as follows:
5～30 parts of sulfamonomethoxine sodium;
1～4 part of trimethoprim;
0.2～0.4 part of antioxidant;
25～45 parts of organic solvents;
1～2 part of acid regulator;
1～5 part of alkali formula regulator;
45～65 parts of waters for injection.
Further, described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.
Further, described acid regulator is lactic acid.
Further, described alkali formula regulator is sodium hydroxide.
Further, described antioxidant is sodium thiosulfate.
Preferably, by weight, it is composed as follows: 20 parts of sulfamonomethoxine sodium; 3 parts of trimethoprims; 0.3 part, sodium thiosulfate; 35 parts of organic solvents; 1.5 parts of lactic acid; 3 parts of sodium hydroxide; 55 parts of waters for injection; Described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.
Its preparation process is:
The first step: get 15～25 parts of the bright waters for injection of making, add antioxidant to stir and make to dissolve fully;
Second step: add trimethoprim, drip the acid regulator, be heated to 60～80 ℃, stir and make it to dissolve fully;
The 3rd step: add organic solvent, be uniformly mixed, be cooled to 18～30 ℃;
The 4th step: drip alkali formula regulator, be adjusted to regulation pH scope 9.0～11.0;
The 5th step: add sulfamonomethoxine sodium, stir and make to dissolve fully, add remaining water for injection, be uniformly mixed;
The 6th step: use organic membrane filtration, the inflated with nitrogen embedding;
The 7th step: sterilizing, clarity detects, and obtains.
The present invention compared with prior art has following advantage:
The present invention, through process modification, reduces the use amount of organic solvent, but the decrease cost, and reduction causes clinical irritating risk.
The specific embodiment
Embodiment 1
The composite sulfamonomethoxine sodium injection, by weight, it is composed as follows:
5 parts of sulfamonomethoxine sodium; 4 parts of trimethoprims; 0.2 part of antioxidant; 25 parts of organic solvents; 2 parts of acid regulators; 5 parts of alkali formula regulators; 65 parts of waters for injection.Described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.Described acid regulator is lactic acid.Described alkali formula regulator is sodium hydroxide.Described antioxidant is sodium thiosulfate.
Its preparation process is:
The first step: get 25 parts of the bright waters for injection of making, add antioxidant to stir and make to dissolve fully;
Second step: add trimethoprim, drip the acid regulator, be heated to 60 ℃, stir and make it to dissolve fully;
The 3rd step: add organic solvent, be uniformly mixed, be cooled to 30 ℃;
The 4th step: drip alkali formula regulator, be adjusted to pH 11.0;
The 5th step: add sulfamonomethoxine sodium, stir and make to dissolve fully, add 40 parts of waters for injection, be uniformly mixed;
The 6th step: with 0.22 micron organic membrane filtration, inflated with nitrogen embedding 5ml, 10ml, 50ml, 100ml;
The 7th step: 115 ℃ of 0.2MPa sterilizings 15 minutes, clarity detects, and obtains.
Embodiment 2
The composite sulfamonomethoxine sodium injection, by weight, it is composed as follows:
30 parts of sulfamonomethoxine sodium; 1 part of trimethoprim; 0.4 part of antioxidant; 45 parts of organic solvents; 1 part of acid regulator; 1 part of alkali formula regulator; 45 parts of waters for injection.Described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.Described acid regulator is lactic acid.Described alkali formula regulator is sodium hydroxide.Described antioxidant is sodium thiosulfate.
Its preparation process is:
The first step: get 15 parts of the bright waters for injection of making, add antioxidant to stir and make to dissolve fully;
Second step: add trimethoprim, drip the acid regulator, be heated to 80 ℃, stir and make it to dissolve fully;
The 3rd step: add organic solvent, be uniformly mixed, be cooled to 18 ℃;
The 4th step: drip alkali formula regulator, be adjusted to pH 9.0;
The 5th step: add sulfamonomethoxine sodium, stir and make to dissolve fully, add 30 parts of waters for injection, be uniformly mixed;
The 6th step: with 0.22 micron organic membrane filtration, inflated with nitrogen embedding 5ml, 10ml, 50ml, 100ml;
The 7th step: 115 ℃ of 0.2MPa sterilizings 15 minutes, clarity detects, and obtains.
Embodiment 3
The composite sulfamonomethoxine sodium injection, by weight, it is composed as follows:
20 parts of sulfamonomethoxine sodium; 3 parts of trimethoprims; 0.3 part of antioxidant; 35 parts of organic solvents; 1.5 parts of acid regulators; 3 parts of alkali formula regulators; 55 parts of waters for injection.Described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.Described acid regulator is lactic acid.Described alkali formula regulator is sodium hydroxide.Described antioxidant is sodium thiosulfate.
Its preparation process is:
The first step: get 20 parts of the bright waters for injection of making, add antioxidant to stir and make to dissolve fully;
Second step: add trimethoprim, drip the acid regulator, be heated to 70 ℃, stir and make it to dissolve fully;
The 3rd step: add organic solvent, be uniformly mixed, be cooled to 25 ℃;
The 4th step: drip alkali formula regulator, be adjusted to pH 10.0;
The 5th step: add sulfamonomethoxine sodium, stir and make to dissolve fully, add 35 parts of waters for injection, be uniformly mixed;
The 6th step: with 0.22 micron organic membrane filtration, inflated with nitrogen embedding 5ml, 10ml, 50ml, 100ml;
The 7th step: 115 ℃ of 0.2MPa sterilizings 15 minutes, clarity detects, and obtains.
quality testing:
This product detects according to " veterinary drug national standard compilation " (first) composite sulfamonomethoxine sodium injection, all the regulation of compound standard.
study on the stability:
This product, by accelerated test, natural reserved, detects according to quality standard, all compound regulation.
Claims (7)
1. the composite sulfamonomethoxine sodium injection, is characterized in that, by weight, it is composed as follows:
5～30 parts of sulfamonomethoxine sodium;
1～4 part of trimethoprim;
0.2～0.4 part of antioxidant;
25～45 parts of organic solvents;
1～2 part of acid regulator;
1～5 part of alkali formula regulator;
45～65 parts of waters for injection.
2. composite sulfamonomethoxine sodium injection according to claim 1, is characterized in that, described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.
3. composite sulfamonomethoxine sodium injection according to claim 1, is characterized in that, described acid regulator is lactic acid.
4. composite sulfamonomethoxine sodium injection according to claim 1, is characterized in that, described alkali formula regulator is sodium hydroxide solution.
5. composite sulfamonomethoxine sodium injection according to claim 1, is characterized in that, described antioxidant is sodium thiosulfate.
6. composite sulfamonomethoxine sodium injection according to claim 1, is characterized in that, by weight, it is composed as follows:
20 parts of sulfamonomethoxine sodium;
3 parts of trimethoprims;
0.3 part, sodium thiosulfate;
35 parts of organic solvents;
1.5 parts of lactic acid;
3 parts of sodium hydroxide;
55 parts of waters for injection;
Described organic solvent is propylene glycol and the PEG400 mixture according to volume ratio 1:1.
7. the preparation method according to the described composite sulfamonomethoxine sodium injection of claim 1～6 any one, is characterized in that, its preparation process is:
The first step: get 15～25 parts of the bright waters for injection of making, add antioxidant to stir and make to dissolve fully;
Second step: add trimethoprim, drip the acid regulator, be heated to 60～80 ℃, stir and make it to dissolve fully;
The 3rd step: add organic solvent, be uniformly mixed, be cooled to 18～30 ℃;
The 4th step: drip alkali formula regulator, be adjusted to regulation pH scope 9.0～11.0;
The 5th step: add sulfamonomethoxine sodium, stir and make to dissolve fully, add remaining water for injection, be uniformly mixed;
The 6th step: use organic membrane filtration, the inflated with nitrogen embedding;
The 7th step: sterilizing, clarity detects, and obtains.
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| CN201310436905.9A CN103446164B (en) | 2013-09-24 | 2013-09-24 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
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| CN201310436905.9A CN103446164B (en) | 2013-09-24 | 2013-09-24 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
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| CN103446164A true CN103446164A (en) | 2013-12-18 |
| CN103446164B CN103446164B (en) | 2015-10-28 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224806A (en) * | 2014-09-11 | 2014-12-24 | 河南迪冉生物科技有限公司 | Preparation method of sulfamonomethoxine sodium injection |
| CN104274472A (en) * | 2014-09-12 | 2015-01-14 | 安徽天安动物药业有限公司 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
| CN114129510A (en) * | 2021-12-03 | 2022-03-04 | 聊城大学 | Compound sulfanilamide injection and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102188436A (en) * | 2011-03-28 | 2011-09-21 | 郑州百瑞动物药业有限公司 | Injection for treating porcine mixed infection |
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2013
- 2013-09-24 CN CN201310436905.9A patent/CN103446164B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102188436A (en) * | 2011-03-28 | 2011-09-21 | 郑州百瑞动物药业有限公司 | Injection for treating porcine mixed infection |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224806A (en) * | 2014-09-11 | 2014-12-24 | 河南迪冉生物科技有限公司 | Preparation method of sulfamonomethoxine sodium injection |
| CN104274472A (en) * | 2014-09-12 | 2015-01-14 | 安徽天安动物药业有限公司 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
| CN114129510A (en) * | 2021-12-03 | 2022-03-04 | 聊城大学 | Compound sulfanilamide injection and preparation method thereof |
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| CN103446164B (en) | 2015-10-28 |
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