CN103181890A - Amikacin sulphate injection and preparation method for same - Google Patents
Amikacin sulphate injection and preparation method for same Download PDFInfo
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- CN103181890A CN103181890A CN201110443918XA CN201110443918A CN103181890A CN 103181890 A CN103181890 A CN 103181890A CN 201110443918X A CN201110443918X A CN 201110443918XA CN 201110443918 A CN201110443918 A CN 201110443918A CN 103181890 A CN103181890 A CN 103181890A
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Abstract
The invention discloses an amikacin sulphate injection and a preparation method for the same. According to the preparation method disclosed by the invention, an antioxidant, a complexant and injection water are added in amikacin sulphate. The amikacin sulphate injection and the preparation method for the same disclosed by the invention are simple in production process and low in cost, solve the problem that the amikacin sulphate injection cannot meet the requirement of terminal sterilisation and make up the shortages of the prior art, and are suitable for modern production.
Description
Technical field
The present invention relates to a kind of amikacin sulfate injection and preparation method thereof.
Background technology
Amikacin sulfate injection belongs to semi-synthetic aminoglycoside antibiotics, stable to most aminoglycoside inactive enzymes, so be particularly useful for treating gram negative bacilli to the severe infections due to kanamycin, gentamycin or the tobramycin Resistant strain, be used widely clinically.
In existing patent and document, the amikacin sulfate injection that CN101584658A reports is veterinary drug, only adds disodium edetate in its prescription, and sterilising conditions is indeterminate.We adopt 115 ℃ according to its formulation and technology that provides, sterilization in 30 minutes, and the obvious flavescence of results sample color has not met standard code.For making amikacin sulfate injection can satisfy terminal sterilization, must improve its formulation and technology.
Summary of the invention
The objective of the invention is to disclose a kind of amikacin sulfate injection; Another purpose of the present invention is to disclose the preparation method of this amikacin sulfate injection.
Amikacin sulfate injection supplementary material of the present invention consists of:
Amikacin sulfate 50～400 weight portions
Antioxidant 0.5～10.0 weight portion
Chelating agent 0.05～1.0 weight portion
Water for injection adds to 1000 parts by volume
Amikacin sulfate injection supplementary material composition of the present invention is preferably:
Amikacin sulfate 100～200 weight portions
Antioxidant 1.0～4.0 weight portions
Chelating agent 0.1～0.4 weight portion
Water for injection adds to 1000 parts by volume
Amikacin sulfate injection supplementary material composition of the present invention is preferably:
Amikacin sulfate 100 weight portions
Antioxidant 1.5 weight portions
Chelating agent 0.1 weight portion
Water for injection adds to 1000 parts by volume
Amikacin sulfate injection supplementary material composition of the present invention is preferably:
Amikacin sulfate 200 weight portions
Antioxidant 3 weight portions
Chelating agent 0.2 weight portion
Water for injection adds to 1000 parts by volume
Amikacin sulfate injection supplementary material composition of the present invention is preferably:
Amikacin sulfate 400 weight portions
Antioxidant 6 weight portions
Chelating agent 0.4 weight portion
Water for injection adds to 1000 parts by volume
Amikacin sulfate injection preparation method of the present invention comprises the steps:
1, in dilute preparing tank, measure 70～80% water for injection by prescription, be chilled to 20 ℃～30 ℃, feed nitrogen and make it saturated;
2, adding formula ratio chelating agent, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio antioxidant, adds the 1000 parts by volume saturated water for injection of nitrogen at last;
3, the medicinal charcoal that adds amount of preparation 0.1% (W/V) stirred 20～40 minutes, regulated pH to 5.2～6.4 with 0.1mol/L sodium hydroxide or 0.1mol/L hydrochloric acid; Amikacin content should be 95%～105% of labelled amount;
4, medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
5, fill under nitrogen current is sealed;
6,115 ℃～121 ℃, sterilization in 20～40 minutes, namely.
Amikacin sulfate injection preparation method of the present invention is preferably as follows step:
1, in dilute preparing tank, measure 75% water for injection by prescription, be chilled to 25 ℃, feed nitrogen and make it saturated;
2, adding formula ratio chelating agent, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio antioxidant, adds the 1000 parts by volume saturated water for injection of nitrogen at last;
3, the medicinal charcoal that adds amount of preparation 0.1% (W/V) stirred 30 minutes, regulated pH to 5.8 with the 0.1mol/L sodium hydroxide; Amikacin content should be 95%～105% of labelled amount;
4, medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
5, fill under nitrogen current is sealed;
6,115 ℃, sterilization in 30 minutes, namely.
Antioxidant of the present invention be in sodium sulfite or the sodium pyrosulfite any; Chelating agent be in calcium disodium edetate or the disodium edetate any.
The relation of above-mentioned weight portion and parts by volume is the relation of g/ml.
Production technology of the present invention is simple, and cost is low, has solved the problem that amikacin sulfate injection can not satisfy terminal sterilization, has remedied the deficiencies in the prior art, is applicable to modern production.
Following experimental example is used for further specifying but is not limited to the present invention.
Experimental example 1: contrast experiment
(1) according to " a kind of preparation method of amikacin sulfate injection " (patent No. CN101584658A) disclosed prescription and 1 batch of amikacin sulfate injection of preparation method preparation, lot number: 110801AS, specification 2ml:0.2g, specific as follows:
1, measures 150ml water for injection (account for total amount of preparation 75%), be heated with stirring to 45 ℃;
2, take by weighing 0.18g disodiumedetate and 40g amikacin sulfate, add in the above-mentioned water liquid, be stirred to dissolving fully; With lactic acid adjust pH to 5.50;
3, add the injection water to join 80% of amikacin sulfate injection cumulative volume, regulate pH to 6.00 with lactic acid again;
5, add water for injection again to 200ml, be cooled to 20～30 ℃ simultaneously
6, add 0.1% active carbon and stirred 20 minutes, filter;
7, embedding, 115 ℃, sterilization in 30 minutes.
(2) according to 1 batch of amikacin sulfate injection of amikacin sulfate injection prescription (with embodiment 1) technology preparation disclosed by the invention, lot number: 110801BS, specification 2ml:0.2g, specific as follows:
1, measures 150ml water for injection (account for total amount of preparation 75%), be chilled to 20 ℃～30 ℃, feed nitrogen and make it saturated.
2, add calcium disodium edetate, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the sodium sulfite dissolving, adds to 200ml with the saturated water for injection of nitrogen at last.
3, the medicinal charcoal that adds amount of preparation 0.1% (W/V) stirred 30 minutes.Regulate pH to 5.8 with the 0.1mol/L sodium hydroxide.
4, medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters.
5, fill under nitrogen current is sealed.
6,115 ℃, sterilization in 30 minutes.
The sample that above-mentioned two kinds of preparation methoies are made is according to the inspection of Chinese Pharmacopoeia version amikacin sulfate injection in 2010, and comparing result sees the following form:
The above results shows, adopts the amikacin sulfate injection color of prior art preparation not meet standard code, shows that its disclosed formulation and technology can not make this product tolerance terminal sterilization condition; And the disclosed preparation method of this patent is used 115 ℃, and 30 minutes terminal sterilization conditions can satisfy product quality conformance with standard of the present invention requirement.Proof this patent disclosed method is creative.
Following embodiment all can realize the described effect of above-mentioned experimental example
Embodiment 1:
Amikacin sulfate 100g
Antioxidant 1.5g
Chelating agent 0.1g
Water for injection adds to 1000ml
1, in dilute preparing tank, measure 75% water for injection by prescription, be chilled to 30 ℃, feed nitrogen and make it saturated;
2, adding formula ratio calcium disodium edetate, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio sodium sulfite, adds the 1000ml saturated water for injection of nitrogen at last;
3, the medicinal charcoal that adds amount of preparation 0.1% (W/V) stirred 30 minutes, regulated pH to 5.8 with the 0.1mol/L sodium hydroxide;
4, medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
5, fill under nitrogen current is sealed;
6,115 ℃, sterilization in 30 minutes, namely.
Embodiment 2:
Amikacin sulfate 200g
Antioxidant 3g
Chelating agent 0.2g
Water for injection adds to 1000ml
1, in dilute preparing tank, measure 75% water for injection by prescription, be chilled to 20 ℃, feed nitrogen and make it saturated;
2, adding formula ratio disodium edetate, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio sodium pyrosulfite, adds the 1000ml saturated water for injection of nitrogen at last;
3, the medicinal charcoal that adds amount of preparation 0.1% (W/V) stirred 30 minutes, regulated pH to 5.8 with the 0.1mol/L sodium hydroxide;
4, medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
5, fill under nitrogen current is sealed;
6,115 ℃, sterilization in 30 minutes, namely.
Embodiment 3:
Amikacin sulfate 400g
Antioxidant 6g
Chelating agent 0.4g
Water for injection adds to 1000ml
1, in dilute preparing tank, measure 80% water for injection by prescription, be chilled to 30 ℃, feed nitrogen and make it saturated;
2, adding formula ratio disodium edetate, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio sodium sulfite, adds the 1000ml saturated water for injection of nitrogen at last;
3, the medicinal charcoal that adds amount of preparation 0.1% (W/V) stirred 30 minutes, regulated pH to 5.8 with the 0.1mol/L sodium hydroxide;
4, medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
5, fill under nitrogen current is sealed;
6,115 ℃, sterilization in 30 minutes, namely.
Claims (10)
1. amikacin sulfate injection is characterized in that this amikacin sulfate injection supplementary material consists of:
Amikacin sulfate 50～400 weight portions
Antioxidant 0.5～10.0 weight portion
Chelating agent 0.05～1.0 weight portion
Water for injection adds to 1000 parts by volume.
2. amikacin sulfate injection as claimed in claim 1 is characterized in that this amikacin sulfate injection supplementary material consists of:
Amikacin sulfate 100～200 weight portions
Antioxidant 1.0～4.0 weight portions
Chelating agent 0.1～0.4 weight portion
Water for injection adds to 1000 parts by volume.
3. amikacin sulfate injection as claimed in claim 1 is characterized in that this amikacin sulfate injection supplementary material consists of:
Amikacin sulfate 100 weight portions
Antioxidant 1.5 weight portions
Chelating agent 0.1 weight portion
Water for injection adds to 1000 parts by volume.
4. amikacin sulfate injection as claimed in claim 1 is characterized in that this amikacin sulfate injection supplementary material consists of:
Amikacin sulfate 200 weight portions
Antioxidant 3 weight portions
Chelating agent 0.2 weight portion
Water for injection adds to 1000 parts by volume.
5. amikacin sulfate injection as claimed in claim 1 is characterized in that this amikacin sulfate injection supplementary material consists of:
Amikacin sulfate 400 weight portions
Antioxidant 6 weight portions
Chelating agent 0.4 weight portion
Water for injection adds to 1000 parts by volume.
6. as the preparation method of the arbitrary described amikacin sulfate injection of claim 1-5, it is characterized in that this preparation method comprises the steps:
(1) in dilute preparing tank, measure 70～80% water for injection by prescription, be chilled to 20 ℃～30 ℃, feed nitrogen and make it saturated;
(2) adding formula ratio chelating agent, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio antioxidant, adds the 1000 parts by volume saturated water for injection of nitrogen at last;
(3) add the medicinal charcoal of amount of preparation 0.1% (W/V), stirred 20～40 minutes, regulate pH to 5.2～6.4 with 0.1mol/L sodium hydroxide or 0.1mol/L hydrochloric acid; Amikacin content should be 95%～105% of labelled amount;
(4) medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
(5) fill under nitrogen current is sealed;
(6) 115 ℃～121 ℃, sterilization in 20～40 minutes, namely.
7. the preparation method of amikacin sulfate injection as claimed in claim 6 is characterized in that this preparation method comprises the steps:
(1) in dilute preparing tank, measure 75% water for injection by prescription, be chilled to 25 ℃, feed nitrogen and make it saturated;
(2) adding formula ratio chelating agent, amikacin sulfate constantly stirs, and after treating to dissolve fully, adds the dissolving of formula ratio antioxidant, adds the 1000 parts by volume saturated water for injection of nitrogen at last;
(3) add the medicinal charcoal of amount of preparation 0.1% (W/V), stirred 30 minutes, regulate pH to 5.8 with the 0.1mol/L sodium hydroxide; Amikacin content should be 95%～105% of labelled amount;
(4) medicinal liquid decarburization under nitrogen current, fine straining are qualified to visible foreign matters;
(5) fill under nitrogen current is sealed;
(6) 115 ℃, sterilization in 30 minutes, namely.
8. as the described amikacin sulfate injection of claim 1-5, it is characterized in that antioxidant is any in sodium sulfite or the sodium pyrosulfite; Chelating agent be in calcium disodium edetate or the disodium edetate any.
9. the preparation method of amikacin sulfate injection as claimed in claim 6 is characterized in that wherein said antioxidant is any in sodium sulfite or the sodium pyrosulfite; Chelating agent be in calcium disodium edetate or the disodium edetate any.
10. the preparation method of amikacin sulfate injection as claimed in claim 7 is characterized in that wherein said antioxidant is any in sodium sulfite or the sodium pyrosulfite; Chelating agent be in calcium disodium edetate or the disodium edetate any.
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| CN201510554115.XA CN105213300B (en) | 2011-12-27 | 2011-12-27 | A kind of amikacin sulfate injection and preparation method thereof |
| CN201110443918XA CN103181890A (en) | 2011-12-27 | 2011-12-27 | Amikacin sulphate injection and preparation method for same |
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| CN201110443918XA CN103181890A (en) | 2011-12-27 | 2011-12-27 | Amikacin sulphate injection and preparation method for same |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622814A (en) * | 2013-11-06 | 2015-05-20 | 河南辅仁怀庆堂制药有限公司 | New freeze-drying technology of amikacin sulfate for injection |
| CN106361694A (en) * | 2016-11-29 | 2017-02-01 | 无锡福祈制药有限公司 | Arbekacin sulphate injection and preparation method thereof |
| CN111110627A (en) * | 2018-10-30 | 2020-05-08 | 齐鲁制药有限公司 | Amikacin sulfate injection and preparation method thereof |
| CN115282116A (en) * | 2022-08-19 | 2022-11-04 | 浙江和沐康医药科技有限公司 | Amikacin injection and preparation method thereof |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997897B (en) * | 2016-06-15 | 2018-04-17 | 马鞍山丰原制药有限公司 | A kind of amikacin sulfate lyophilized formulations and preparation method thereof |
| CN107638386B (en) * | 2017-10-27 | 2020-10-30 | 丽珠集团丽珠制药厂 | Kanamycin sulfate injection and preparation method thereof |
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| CN101584658A (en) * | 2009-07-03 | 2009-11-25 | 上海恒丰强动物药业有限公司 | Preparation method of amikacin sulfate injection |
| CN102048685A (en) * | 2009-11-02 | 2011-05-11 | 海口市制药厂有限公司 | Pefloxacin mesylate injection and preparation method and application thereof |
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- 2011-12-27 CN CN201510554115.XA patent/CN105213300B/en active Active
- 2011-12-27 CN CN201110443918XA patent/CN103181890A/en active Pending
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| CN101584658A (en) * | 2009-07-03 | 2009-11-25 | 上海恒丰强动物药业有限公司 | Preparation method of amikacin sulfate injection |
| CN102048685A (en) * | 2009-11-02 | 2011-05-11 | 海口市制药厂有限公司 | Pefloxacin mesylate injection and preparation method and application thereof |
Non-Patent Citations (1)
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622814A (en) * | 2013-11-06 | 2015-05-20 | 河南辅仁怀庆堂制药有限公司 | New freeze-drying technology of amikacin sulfate for injection |
| CN106361694A (en) * | 2016-11-29 | 2017-02-01 | 无锡福祈制药有限公司 | Arbekacin sulphate injection and preparation method thereof |
| CN111110627A (en) * | 2018-10-30 | 2020-05-08 | 齐鲁制药有限公司 | Amikacin sulfate injection and preparation method thereof |
| CN111110627B (en) * | 2018-10-30 | 2022-12-02 | 齐鲁制药有限公司 | Amikacin sulfate injection and preparation method thereof |
| CN115282116A (en) * | 2022-08-19 | 2022-11-04 | 浙江和沐康医药科技有限公司 | Amikacin injection and preparation method thereof |
| CN115282116B (en) * | 2022-08-19 | 2023-04-18 | 浙江和沐康医药科技有限公司 | Amikacin injection and preparation method thereof |
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| CN105213300B (en) | 2019-09-10 |
| CN105213300A (en) | 2016-01-06 |
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Application publication date: 20130703 |