CN104224806A - Preparation method of sulfamonomethoxine sodium injection - Google Patents
Preparation method of sulfamonomethoxine sodium injection Download PDFInfo
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- CN104224806A CN104224806A CN201410459240.8A CN201410459240A CN104224806A CN 104224806 A CN104224806 A CN 104224806A CN 201410459240 A CN201410459240 A CN 201410459240A CN 104224806 A CN104224806 A CN 104224806A
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- sulfamonomethoxine sodium
- sulfamonomethoxine
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Abstract
The invention belongs to the technical field of a veterinary drug, and in particular relates to a preparation method of a sulfamonomethoxine sodium injection. The method adopts the following raw materials: 0.8-1.2 parts of sulfamonomethoxine sodium, 0.2-0.4 part of trimethoprim, 2-4 parts of an organic solvent, 6-8 parts of injection water and 0.01-0.03 part of a pH regulator. The sulfamonomethoxine sodium injection prepared by the method disclosed by the invention, by adopting a solvent which is formed by mixing the organic solvent and the injection water, solves a problem that the sulfamonomethoxine sodium is quite instable due to a property of dissolving in water; and therefore, the prepared injection is stable in performance, high in product yield, effective and safe, and applicable to industrial mass production.
Description
technical field
The invention belongs to veterinary drug technical field, be specifically related to a kind of preparation method of sulfamonomethoxine sodium injection.
background technology
Sulfamonomethoxine sodium is the sulphonamides that in sulfonamides for animals, antibacterial action is the strongest, especially has stronger inhibitory action to most of gram positive bacteria and negative bacterium, and it is slower that antibacterial produces drug resistance to this medicine.Be mainly used in the various diseases (as hyperpyrexia disease, streptococcicosis, Haemophilus parasuis, toxoplasmosis, bowel oedema disease, eperythrozoonosis, contagious pleuropneumonia, pasteurellosis bacillus pneumonia etc.) caused by sensitive organism, toxoplasma, Eperythrozoon and mixed infection thereof.
At present, also there are some defects when making injection in sulfamonomethoxine sodium, and the solubization matter of such as sulfamonomethoxine sodium is very unstable, and the drug effect affecting injection plays.
summary of the invention
The object of the present invention is to provide a kind of preparation method of the sulfamonomethoxine sodium injection had good stability.
The present invention is by the following technical solutions:
The preparation method of sulfamonomethoxine sodium injection, comprises the following steps:
A. the raw material of following weight portion is got in proportion: sulfamonomethoxine sodium 0.8-1.2 part, trimethoprim (TMP) 0.2-0.4 part, organic solvent 2-4 part, water for injection 6-8 part, pH adjusting agent 0.01-0.03 part;
B. sodium hydroxide partial syringe water is mixed with 20% sodium hydroxide solution for subsequent use;
C. in organic solvent, add remaining water for injection stir, add sulfamonomethoxine sodium, trimethoprim (TMP) stirs, the sodium hydroxide solution adjust ph with 20% is to 9-11, and survey content, embedding, sterilizing, obtains sulfamonomethoxine sodium injection.
Trimethoprim (TMP) is trimethoprim.
Organic solvent is ethanol (95V%) or propylene glycol.
PH adjusting agent is sodium hydroxide.
The mode that the sulfamonomethoxine sodium injection that the inventive method obtains adopts organic solvent to match with water for injection is as solvent, solve the problem that the solubization matter of sulfamonomethoxine sodium is very unstable, make the injection stable in properties obtained, product yield is high, effective and safe, is applicable to industrialization large-scale production.
detailed description of the invention
Embodiment 1:
The preparation method of sulfamonomethoxine sodium injection, comprises the following steps:
A. sulfamonomethoxine sodium 0.8 part, trimethoprim 0.2 part, 95V% ethanol 2 parts, water for injection 6 parts, sodium hydroxide 0.01 part is got;
B. sodium hydroxide partial syringe water is mixed with the solution for standby of 20%;
C. in ethanol, add remaining water for injection stir, add sulfamonomethoxine sodium, trimethoprim stirs, by the sodium hydroxide solution adjust ph to 9 of 20%, survey content, embedding, sterilizing, obtains sulfamonomethoxine sodium injection.
Embodiment 2:
The preparation method of sulfamonomethoxine sodium injection, comprises the following steps:
A. sulfamonomethoxine sodium 1.0 parts, trimethoprim 0.3 part, 95V% ethanol 3 parts, water for injection 7 parts, sodium hydroxide 0.02 part is got;
B. sodium hydroxide partial syringe water is mixed with the solution for standby of 20%;
C. in ethanol, add remaining water for injection stir, add sulfamonomethoxine sodium, trimethoprim stirs, and by the sodium hydroxide solution adjust ph to 11 of 20%, survey content, embedding, sterilizing, obtains sulfamonomethoxine sodium injection.
Embodiment 3:
The preparation method of sulfamonomethoxine sodium injection, comprises the following steps:
A. sulfamonomethoxine sodium 1.2 parts, trimethoprim 0.4 part, propylene glycol 4 parts, water for injection 8 parts, sodium hydroxide 0.03 part is got;
B. sodium hydroxide partial syringe water is mixed with the solution for standby of 20%;
C. in propylene glycol, add remaining water for injection stir, add sulfamonomethoxine sodium, trimethoprim stirs, and by the sodium hydroxide solution adjust ph to 10 of 20%, survey content, embedding, sterilizing, obtains sulfamonomethoxine sodium injection.
Number in embodiment 1-3 is parts by weight.
Titrimetry examination content and product yield examination are carried out to the product of example 1-3.
Titrimetry is examined or check: often prop up the content of medicine and the ratio of labelled amount; Product yield: the ratio of paid number and receivable number.Result is as follows:
Embodiment 1 product: gained sulfamonomethoxine sodium injection content is 98.6%, yield 96.1%.
Embodiment 2 product: gained sulfamonomethoxine sodium injection content is 100.9%, yield 96.8%.
Embodiment 3 product: gained sulfamonomethoxine sodium injection content is 102.2%, yield 96.7%.
Stability data
(1) accelerated test
Embodiment 1
Packaging: low borosilicate glass ampoule bottle
Investigation condition: temperature 40 ± 2 DEG C, relative humidity 75 ± 5%; Result is as following table:
(2) experiment for long-term stability
Embodiment 2
Packaging: low borosilicate glass ampoule bottle
Investigation condition: temperature 25 ± 2 DEG C, relative humidity 60 ± 5%, the results are shown in following table:
Found out by data in table, in accelerated test and long term test, in injection, the content of the effective ingredient sulfamonomethoxine sodium of side is basicly stable, does not significantly reduce, the short-term of the florfenicol injection that the present invention obtains and long-time stability good.
Claims (4)
1. the preparation method of sulfamonomethoxine sodium injection, is characterized in that, comprises the following steps:
A. the raw material of following weight portion is got in proportion: sulfamonomethoxine sodium 0.8-1.2 part, trimethoprim (TMP) 0.2-0.4 part, organic solvent 2-4 part, water for injection 6-8 part, pH adjusting agent 0.01-0.03 part;
B. sodium hydroxide partial syringe water is mixed with 20% sodium hydroxide solution for subsequent use;
C. in organic solvent, add remaining water for injection stir, add sulfamonomethoxine sodium, trimethoprim (TMP) stirs, the sodium hydroxide solution adjust ph with 20% is to 9-11, and survey content, embedding, sterilizing, obtains sulfamonomethoxine sodium injection.
2. the preparation method of sulfamonomethoxine sodium injection as claimed in claim 1, is characterized in that: trimethoprim (TMP) is trimethoprim.
3. the preparation method of sulfamonomethoxine sodium injection as claimed in claim 1 or 2, is characterized in that: organic solvent is ethanol or propylene glycol.
4. the preparation method of sulfamonomethoxine sodium injection as claimed in claim 1 or 2, is characterized in that: pH adjusting agent is sodium hydroxide.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410459240.8A CN104224806A (en) | 2014-09-11 | 2014-09-11 | Preparation method of sulfamonomethoxine sodium injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410459240.8A CN104224806A (en) | 2014-09-11 | 2014-09-11 | Preparation method of sulfamonomethoxine sodium injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104224806A true CN104224806A (en) | 2014-12-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410459240.8A Pending CN104224806A (en) | 2014-09-11 | 2014-09-11 | Preparation method of sulfamonomethoxine sodium injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114452251A (en) * | 2021-12-17 | 2022-05-10 | 四川志邦生物科技有限公司 | Sulfamonomethoxine sodium injection and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810627A (en) * | 2009-12-17 | 2010-08-25 | 河南省康星药业有限公司 | Compound sulfamonomethoxine/compound sulfamonomethoxine sodium injection and preparation method |
| 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 |
| CN103006674A (en) * | 2012-12-14 | 2013-04-03 | 江苏恒丰强生物技术有限公司 | Compound sulfamonomethoxine sodium solution and preparation method thereof |
| CN103446164A (en) * | 2013-09-24 | 2013-12-18 | 四川康而好动物药业有限公司 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
-
2014
- 2014-09-11 CN CN201410459240.8A patent/CN104224806A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810627A (en) * | 2009-12-17 | 2010-08-25 | 河南省康星药业有限公司 | Compound sulfamonomethoxine/compound sulfamonomethoxine sodium injection and preparation method |
| 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 |
| CN103006674A (en) * | 2012-12-14 | 2013-04-03 | 江苏恒丰强生物技术有限公司 | Compound sulfamonomethoxine sodium solution and preparation method thereof |
| CN103446164A (en) * | 2013-09-24 | 2013-12-18 | 四川康而好动物药业有限公司 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114452251A (en) * | 2021-12-17 | 2022-05-10 | 四川志邦生物科技有限公司 | Sulfamonomethoxine sodium injection and preparation method thereof |
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Application publication date: 20141224 |
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