CN102319203A - Preparation method of levofloxacin lactate and sodium chloride injection - Google Patents
Preparation method of levofloxacin lactate and sodium chloride injection Download PDFInfo
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- CN102319203A CN102319203A CN201110216770A CN201110216770A CN102319203A CN 102319203 A CN102319203 A CN 102319203A CN 201110216770 A CN201110216770 A CN 201110216770A CN 201110216770 A CN201110216770 A CN 201110216770A CN 102319203 A CN102319203 A CN 102319203A
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- sodium chloride
- levofloxacin lactate
- preparing
- injection
- chloride injection
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Abstract
The invention relates to a preparation method of a levofloxacin lactate and sodium chloride injection, and the method comprises the steps such as dense preparing, heating, filtering, diluted preparing, pH value regulating, filtering, filling, sealing, sterilizing, inspecting and the like. The levofloxacin lactate and sodium chloride injection prepared by the preparation method has good stability, and can completely be packaged by adopting a plastic bottle.
Description
Technical field
The present invention relates to a kind of method for preparing of levofloxacin lactate sodium chloride injection, relate to a kind of method for preparing of levofloxacin lactate sodium chloride injection of good stability specifically.
Background technology
Levofloxacin lactate is a third generation quinolones broad spectrum antibiotic, and its injection is used for treatment clinically by the microbial infection of sensitivity, determined curative effect.Because stability, the dissolubility of levofloxacin lactate sodium chloride injection are not fine, all adopt glass bottle packaging at present.But; The plastic bottle packing infusion products than glass bottle packaging infusion products have light weight, convenient transportation, body not cracky, be easy to guarantee product quality, adopt the pull-tab design to open characteristics such as bottle cap is convenient to be widely used in China medical institutions at different levels in recent years, welcome by vast medical and nursing work person; In addition, because plastic bottle body light transmission is weaker than vial,, can further increases product and imitate the phase this storage that concerning the easy analytical product of photaesthesia, is easier to of levofloxacin lactate.Therefore how to increase deliquescent its stability that guarantees simultaneously of levofloxacin lactate sodium chloride injection, making it can adopt plastic bottle packing is present pharmaceutical industry problem demanding prompt solution.
Summary of the invention
Technical problem to be solved by this invention provides a kind of method for preparing of levofloxacin lactate sodium chloride injection; Requirement through levofloxacin lactate sodium chloride injection that this method for preparing makes improving the dissolubility of levofloxacin lactate in sodium chloride solution in; Guarantee the stability of medicine, thereby can use plastic bottle packing.
For solving the problems of the technologies described above, the invention provides a kind of method for preparing of levofloxacin lactate sodium chloride injection, comprise densely join, heating, filtration, rarely join, filter, regulate pH value and fill, seal, sterilize, step such as check.Heating steps in this method for preparing helps increasing stability and the homogeneity of levofloxacin lactate in sodium chloride solution, avoids levofloxacin lactate dissolving not thorough, plastic bottle bottle wall naked eyes sightless concavo-convex on crystallization separate out.
Concrete method for preparing is following:
(1) in handling clean dense preparing tank, add water for injection, opening under the dense preparing tank stirring state; With weighing accurately sodium chloride for injection gently pour in the dense preparing tank, make its dissolving, caking prevents to sink; The medicated powder application water for injection that sticks to tank skin washes down; Treat all to add medicinal charcoal after the dissolving, stir, feed Steam Heating in the interlayer and boil.
(2) with dense material through the filtering charcoal after, add dilute preparing tank, add water for injection simultaneously and open dilute preparing tank and be stirred in dense material and filter afterwards with water for injection and the medicinal liquid of remnants in the dense preparing tank is washed down and add in the dilute preparing tank.
(3) water for injection is added in the clean plastic containers, stir slowly to add down and claim fixed injection levofloxacin lactate, make it dissolving fully.To dissolve completely and slowly add in the dilute preparing tank under the solution stirring.
(4) water for injection filters through dense material and is added to dilute preparing tank; Additional water for injection adds active carbon to stipulating scale, uses caustic lye of soda (2moL/L) or hydrochloric acid solution (2moL/L) adjustment pH value in case of necessity; Sampling and measuring content and pH value; By regulation adjustment qualified after, through titanium rod and 0.45 μ m, that 0.22 μ m micropore filter element is filtered to medicinal liquid is clear and bright, supplies embedding.
(5) mould bottle transfusion through the system bottle, (one-step method system bottle is used the clean compressed air purge to the purge bottle, and two step method system bottle is used the compressed air purge, washes with water for injection at last.), supply fill.
(6) seal after moulding bottle transfusion fill.
(7) mould 115 ℃ of water-bath sterilizations of bottle transfusion 32 minutes.
(8) check.
Said heating steps was kept 5 minutes for feeding is steam heated to 100 ℃.
Said adjusting pH value step is for regulating pH value 3.7～5.3.
The specific embodiment
Further specify the present invention through embodiment below.(all calculating) with single dose
Embodiment:
Method for preparing:
1, in handling clean dense preparing tank, add about 1/2 amount water for injection, opening under the dense preparing tank stirring state; The 9kg sodium chloride for injection is gently poured in the dense preparing tank, made its dissolving, prevent caking; The medicated powder application water for injection that sticks to tank skin washes down, and treats all to add medicinal charcoal 0.05% (W/V is with rare stereometer of joining) after the dissolving, stirs; Feed Steam Heating in the interlayer and boil, and keep boiling 5 minutes, close vapour.
2, with dense material through the filtering charcoal after, add dilute preparing tank, add water for injection simultaneously and open dilute preparing tank and be stirred in dense material and filter afterwards with water for injection and the medicinal liquid of remnants in the dense preparing tank is washed down and add in the dilute preparing tank.
3, an amount of water for injection is added in the clean plastic containers, stir slowly to add down and claim fixed levofloxacin lactate, make it dissolving fully.To dissolve completely and slowly add in the dilute preparing tank under the solution stirring, stir.
4, water for injection filters through dense material and is added to dilute preparing tank, estimates liquid level when scale, stops to stir; Additional water for injection stops to add water to stipulating scale, adds 0.01% (W/V is with rare stereometer of joining) active carbon; Use caustic lye of soda (2moL/L) or hydrochloric acid solution (2moL/L) adjustment pH value to 3.7-5.3 in case of necessity; By regulation adjustment qualified after, through titanium rod and 0.45 μ m, that 0.22 μ m micropore filter element is filtered to medicinal liquid is clear and bright, supplies embedding.
5, mould bottle transfusion through the system bottle, (one-step method system bottle is used the clean compressed air purge to the purge bottle, and two step method system bottle is used the compressed air purge, washes with water for injection at last.), (loading amount is controlled at 100ml～102ml) to supply fill.
6, seal after moulding bottle transfusion fill.
7, mould 115 ℃ of water-bath sterilizations of bottle transfusion 32 minutes.
8, check.
Claims (5)
1. the method for preparing of a levofloxacin lactate sodium chloride injection, comprise densely join, heating, filtration, rarely join, regulate pH value, filtration and fill, seal, sterilize, step such as check.
2. the method for preparing of a kind of levofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: the said dense step of joining is to add sodium chloride for injection.
3. the method for preparing of a kind of levofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: said heating steps was kept 5 minutes for feeding is steam heated to 100 ℃.
4. the method for preparing of a kind of levofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: said rare step of joining is to add the injection levofloxacin lactate.
5. the method for preparing of a kind of levofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: said adjusting pH value is for regulating pH value 3.7～5.3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110216770A CN102319203A (en) | 2011-07-27 | 2011-07-27 | Preparation method of levofloxacin lactate and sodium chloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110216770A CN102319203A (en) | 2011-07-27 | 2011-07-27 | Preparation method of levofloxacin lactate and sodium chloride injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102319203A true CN102319203A (en) | 2012-01-18 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201110216770A Pending CN102319203A (en) | 2011-07-27 | 2011-07-27 | Preparation method of levofloxacin lactate and sodium chloride injection |
Country Status (1)
| Country | Link |
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| CN (1) | CN102319203A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105412006A (en) * | 2015-12-08 | 2016-03-23 | 广东艾希德药业有限公司 | Ofloxacin and sodium chloride injection and preparation method thereof |
| CN106176591A (en) * | 2016-08-26 | 2016-12-07 | 广西裕源药业有限公司 | A kind of production method of levofloxacin hydrochloride and sodium chloride injection |
| CN109431993A (en) * | 2018-12-21 | 2019-03-08 | 江西润泽药业有限公司 | A kind of levofloxacin Lactate sodium chloride injection and preparation method thereof |
| CN111252278A (en) * | 2020-01-17 | 2020-06-09 | 上海华源安徽锦辉制药有限公司 | Production process of plastic bottle infusion solution |
| CN112957322A (en) * | 2021-03-23 | 2021-06-15 | 回音必集团江西东亚制药有限公司 | Levofloxacin lactate and sodium chloride injection and preparation method thereof |
| CN113304107A (en) * | 2021-06-09 | 2021-08-27 | 苏州天马医药集团天吉生物制药有限公司 | Levofloxacin lactate injection and preparation method thereof |
-
2011
- 2011-07-27 CN CN201110216770A patent/CN102319203A/en active Pending
Non-Patent Citations (4)
| Title |
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| 刘方,李文仕: "《氧氟沙星注射液的制备及质量控制》", 《右江民族医学院学报》 * |
| 於传福主编: "《药剂学》", 30 November 1986 * |
| 谢东: "《氧氟沙星注射液制备工艺的改进及稳定性观察》", 《医学理论与实践》 * |
| 邓才彬 主编: "《生物药物制剂工艺》", 31 December 2003 * |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105412006A (en) * | 2015-12-08 | 2016-03-23 | 广东艾希德药业有限公司 | Ofloxacin and sodium chloride injection and preparation method thereof |
| CN106176591A (en) * | 2016-08-26 | 2016-12-07 | 广西裕源药业有限公司 | A kind of production method of levofloxacin hydrochloride and sodium chloride injection |
| CN109431993A (en) * | 2018-12-21 | 2019-03-08 | 江西润泽药业有限公司 | A kind of levofloxacin Lactate sodium chloride injection and preparation method thereof |
| CN109431993B (en) * | 2018-12-21 | 2021-04-27 | 江西润泽药业有限公司 | Levofloxacin lactate and sodium chloride injection and preparation method thereof |
| CN111252278A (en) * | 2020-01-17 | 2020-06-09 | 上海华源安徽锦辉制药有限公司 | Production process of plastic bottle infusion solution |
| CN112957322A (en) * | 2021-03-23 | 2021-06-15 | 回音必集团江西东亚制药有限公司 | Levofloxacin lactate and sodium chloride injection and preparation method thereof |
| CN112957322B (en) * | 2021-03-23 | 2023-08-15 | 回音必集团江西东亚制药有限公司 | Levofloxacin lactate sodium chloride injection and preparation method thereof |
| CN113304107A (en) * | 2021-06-09 | 2021-08-27 | 苏州天马医药集团天吉生物制药有限公司 | Levofloxacin lactate injection and preparation method thereof |
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Application publication date: 20120118 |