CN104856961A - Preparation process of kanamycin sulfate for injection - Google Patents
Preparation process of kanamycin sulfate for injection Download PDFInfo
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- CN104856961A CN104856961A CN201510235039.6A CN201510235039A CN104856961A CN 104856961 A CN104856961 A CN 104856961A CN 201510235039 A CN201510235039 A CN 201510235039A CN 104856961 A CN104856961 A CN 104856961A
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- kanamycin sulfate
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Abstract
The invention relates to a preparation process of kanamycin sulfate for injection. The preparation process of kanamycin sulfate for injection comprises the following steps of extracting kanamycin sulfate, drying the kanamycin sulfate and preparing kanamycin sulfate powder, cleaning a reagent bottle, soaking the reagent bottle in a hydrochloric acid solution with the concentration of 0.01 mol/L-0.1mol/L, conducting spraying type flushing, drying and sterilization, quantitatively filling the kanamycin sulfate powder into the cleaned reagent bottle, filling nitrogen into the bottle, plugging a pretreated a rubber plug and using an aluminum cap to perform cover stabbing treatment. The problem that the production speed of kanamycin sulfate for injection is lower due to an existing kanamycin sulfate preparation process is solved.
Description
Technical field
The present invention relates to medical drugs preparation technology field, particularly, relate to a kind of preparation technology of kanamycin sulphate for injection.
Background technology
Kanamycin sulfate is colourless to micro-band yellow or yellowish green clear liquid.For aminoglycoside broad ectrum antibiotic, similar with neomycin to antimicrobial spectrum.The main severe infections caused as escherichia coli, Klebsiella, Proteus, pneumobacillus, clostridium perfringen and Shigella etc. gram negative bacteria, also has good antibacterial action to drug resistance gold staphylococcus.Be mainly used in the pulmonary infection caused by sensitive organism clinically.Urinary tract infection, biliary tract infection septicemia and abdominal cavity infection etc., both normal and other antibacterial use in conjunction rear.Also can be used for infecting the golden staphylococcus of this product sensitivity other antibiotics resistance.To treatment lungy, this product can be used as Second line Drug.This product is mainly combined with bacterial ribosome 30S subunit, anti-bacteria protein synthesis.
The effect and the safety that how to improve injecting drug use always are that pharmaceutical producing enterprise wishes the problem solved, the effect of injecting drug use solves from two aspects with safety is main, one is effect and the safety that Formulation guarantees medication, and two is effect and the safety that the process for producing of medicine guarantees medicine.Kanamycin sulphate for injection is a most existing injection agent, and its prescription is single, guarantees that the effect of its medicine and safe main path are exactly by controlling its preparation technology.
The preparation technology of existing kanamycin sulphate for injection causes kanamycin sulphate for injection speed of production slower.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation technology of kanamycin sulphate for injection, the problem causing kanamycin sulphate for injection speed of production slower with the preparation technology overcoming existing kanamycin sulphate for injection.
The present invention's adopted technical scheme that solves the problem is: kanamycin sulphate for injection
Preparation technology, comprise the following steps:
(1), the extraction of kanamycin sulfate: by mother solution and water by volume 1:8 ~ 1:10 dilute, add sodium bisulfate or the dibastic sodium phosphate solution of 1 ~ 3 normal concentration, until mother solution becomes clear, the hydrochloric acid or the sulphuric acid that add 2 normal concentrations again carry out acidification, regulate pH≤1, add alcoholic solution, stir while adding, separate out mother solution in solution, isolate upper strata milky white solution, the mother solution of precipitation can recycle; In isolated milky white solution, add the sodium hydroxide of 1 ~ 3 normal concentration, regulate pH to 8.0 ~ 9.0, standing, filtration obtains kanamycin sulfate wet product;
(2), the kanamycin sulfate of extraction dried and be prepared into Powdered;
(3), the preparation technology of kanamycin sulfate: first, cleaning is used for the reagent bottle of splendid attire kanamycin sulfate powder: being soaked in concentration by needing the reagent bottle of cleaning is in the hydrochloric acid solution of 0.01mol/L ~ 0.1 mol/L, reagent bottle after immersion is placed in ultrasonic device and carries out ultrasonic vibration washing, after ultrasonic, the water of reagent bottle inside and outside wall is drained, repeatedly fountain flushing is carried out with water after reagent bottle drains, dry with air again, air uses oven for drying after drying again, moist hear heat test is adopted to carry out sterilizing, secondly, kanamycin sulfate powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and is filled with nitrogen, then, cover pretreated plug, Zha Gai process is carried out again with aluminium lid, product is sealed.The cleaning of the reagent bottle of existing kanamycin sulphate for injection be all generally comprise ultrasonic, washing, dry, the steps such as sterilizing, the efficiency of washing is slower, the speed of cleaning reagent bottle is slower, the present invention by first cleaning with certain density hydrochloric acid solution before carrying out ultrasonic vibration to reagent bottle, hydrochloric acid solution can dirt fast on solubilising reagent bottle, the tough stains made comes off, carry out ultrasonic, now ultrasonicly just can fast dirt to be shaken off, improve dirt comes off in the speed of reagent bottle, so, the problem that the preparation technology that instant invention overcomes existing kanamycin sulphate for injection causes kanamycin sulphate for injection speed of production slower.
Further, the concentration of alcoholic solution is 60% ~ 90%.
Further, the volume that alcoholic solution adds is the hydrochloric acid of acidify or 1 ~ 5 times of sulphuric acid volume.
Further, plug adopts rubber plug cleaning machine cleaning and sterilization treatment.Plug is avoided to have influence on the use of reagent bottle.
Further, aluminium lid need pass through and process, and pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
To sum up, the invention has the beneficial effects as follows:
1, the present invention by first cleaning with certain density hydrochloric acid solution before carrying out ultrasonic vibration to reagent bottle, hydrochloric acid solution can dirt fast on solubilising reagent bottle, the tough stains made comes off, carry out ultrasonic, now ultrasonicly just can fast dirt to be shaken off, improve dirt to come off in the speed of reagent bottle, and then improve kanamycin sulphate for injection speed of production.
2, the present invention is by all carrying out sterilization treatment to the plug of reagent bottle, Zha Gai and aluminium lid, avoids the problem of the performance impairment of the kanamycin sulfate caused because of reagent bottle.
Detailed description of the invention
Below in conjunction with embodiment, to the detailed description further of invention do, but embodiments of the present invention are not limited thereto.
Embodiment:
The preparation technology of kanamycin sulphate for injection, comprises the following steps:
(1), the extraction of kanamycin sulfate: by mother solution and water by volume 1:10 dilute, add sodium bisulfate or the dibastic sodium phosphate solution of 3 normal concentrations, until mother solution becomes clear, the hydrochloric acid or the sulphuric acid that add 2 normal concentrations again carry out acidification, regulate pH=1, add alcoholic solution, the concentration of alcoholic solution is 80%, the volume that alcoholic solution adds is the hydrochloric acid of acidify or 3 times of sulphuric acid volume, stir while adding, separate out mother solution in solution, isolate upper strata milky white solution, the mother solution of precipitation can recycle; In isolated milky white solution, add the sodium hydroxide of 2 normal concentrations, regulate pH to 8.5, standing, filtration obtains kanamycin sulfate wet product;
(2), the kanamycin sulfate of extraction dried and be prepared into Powdered;
(3), the preparation technology of kanamycin sulfate: first, cleaning is used for the reagent bottle of splendid attire kanamycin sulfate powder: being soaked in concentration by needing the reagent bottle of cleaning is in the hydrochloric acid solution of 0.05mol/L, reagent bottle after immersion is placed in ultrasonic device and carries out ultrasonic vibration washing, after ultrasonic, the water of reagent bottle inside and outside wall is drained, repeatedly fountain flushing is carried out with water after reagent bottle drains, dry with air again, air uses oven for drying after drying again, moist hear heat test is adopted to carry out sterilizing, secondly, kanamycin sulfate powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and is filled with nitrogen, then, cover pretreated plug, Zha Gai process is carried out again with aluminium lid, product is sealed, described plug adopts rubber plug cleaning machine cleaning and sterilization treatment, described aluminium lid need pass through and process, pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
As mentioned above, the present invention can be realized preferably.
Claims (5)
1. the preparation technology of kanamycin sulphate for injection, is characterized in that, comprises the following steps:
(1), the extraction of kanamycin sulfate: by mother solution and water by volume 1:8 ~ 1:10 dilute, add sodium bisulfate or the dibastic sodium phosphate solution of 1 ~ 3 normal concentration, until mother solution becomes clear, the hydrochloric acid or the sulphuric acid that add 2 normal concentrations again carry out acidification, regulate pH≤1, add alcoholic solution, stir while adding, separate out mother solution in solution, isolate upper strata milky white solution, the mother solution of precipitation can recycle; In isolated milky white solution, add the sodium hydroxide of 1 ~ 3 normal concentration, regulate pH to 8.0 ~ 9.0, standing, filtration obtains kanamycin sulfate wet product;
(2), the kanamycin sulfate of extraction dried and be prepared into Powdered;
(3), the preparation technology of kanamycin sulfate: first, cleaning is used for the reagent bottle of splendid attire kanamycin sulfate powder: being soaked in concentration by needing the reagent bottle of cleaning is in the hydrochloric acid solution of 0.01mol/L ~ 0.1 mol/L, reagent bottle after immersion is placed in ultrasonic device and carries out ultrasonic vibration washing, after ultrasonic, the water of reagent bottle inside and outside wall is drained, repeatedly fountain flushing is carried out with water after reagent bottle drains, dry with air again, air uses oven for drying after drying again, moist hear heat test is adopted to carry out sterilizing, secondly, kanamycin sulfate powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and is filled with nitrogen, then, cover pretreated plug, Zha Gai process is carried out again with aluminium lid, product is sealed.
2. the preparation technology of kanamycin sulphate for injection according to claim 1, is characterized in that, the concentration of described alcoholic solution is 60% ~ 90%.
3. the preparation technology of kanamycin sulphate for injection according to claim 1 and 2, is characterized in that, the volume that described alcoholic solution adds is the hydrochloric acid of acidify or 1 ~ 5 times of sulphuric acid volume.
4. the preparation technology of kanamycin sulphate for injection according to claim 1, is characterized in that, described plug adopts rubber plug cleaning machine cleaning and sterilization treatment.
5. the preparation technology of the kanamycin sulphate for injection according to claim 1 or 4, it is characterized in that, described aluminium lid need pass through and process, and pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510235039.6A CN104856961A (en) | 2015-05-11 | 2015-05-11 | Preparation process of kanamycin sulfate for injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510235039.6A CN104856961A (en) | 2015-05-11 | 2015-05-11 | Preparation process of kanamycin sulfate for injection |
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| CN104856961A true CN104856961A (en) | 2015-08-26 |
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| CN201510235039.6A Pending CN104856961A (en) | 2015-05-11 | 2015-05-11 | Preparation process of kanamycin sulfate for injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107814009A (en) * | 2017-09-29 | 2018-03-20 | 芜湖杨燕制药有限公司 | A kind of transfusion bottle during sterilization method in traditional Chinese medicine production |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1110687A (en) * | 1995-02-09 | 1995-10-25 | 郑伟萍 | Method of extracting kanamycin from kanamycin mother liquid |
| CN102127127A (en) * | 2011-01-14 | 2011-07-20 | 山东齐发药业有限公司 | Kanamycin extracting process |
| CN103301131A (en) * | 2013-06-17 | 2013-09-18 | 四川制药制剂有限公司 | Preparation method of piperacillin sodium sulbactam sodium for injection |
-
2015
- 2015-05-11 CN CN201510235039.6A patent/CN104856961A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1110687A (en) * | 1995-02-09 | 1995-10-25 | 郑伟萍 | Method of extracting kanamycin from kanamycin mother liquid |
| CN102127127A (en) * | 2011-01-14 | 2011-07-20 | 山东齐发药业有限公司 | Kanamycin extracting process |
| CN103301131A (en) * | 2013-06-17 | 2013-09-18 | 四川制药制剂有限公司 | Preparation method of piperacillin sodium sulbactam sodium for injection |
Non-Patent Citations (3)
| Title |
|---|
| 唐燕辉等: "《药物制剂工程与技术》", 31 August 2009 * |
| 张佐等: "《实用药剂学》", 30 November 1983 * |
| 李忠琴等: ""从结晶母液中提取分离卡那霉素A、B的工艺优化研究"", 《中国抗生素杂志》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107814009A (en) * | 2017-09-29 | 2018-03-20 | 芜湖杨燕制药有限公司 | A kind of transfusion bottle during sterilization method in traditional Chinese medicine production |
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Application publication date: 20150826 |