CN102274169A - Preparation method of ciprofloxacin lactate sodium chloride injection - Google Patents
Preparation method of ciprofloxacin lactate sodium chloride injection Download PDFInfo
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- CN102274169A CN102274169A CN2011102168056A CN201110216805A CN102274169A CN 102274169 A CN102274169 A CN 102274169A CN 2011102168056 A CN2011102168056 A CN 2011102168056A CN 201110216805 A CN201110216805 A CN 201110216805A CN 102274169 A CN102274169 A CN 102274169A
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- preparation
- sodium chloride
- ciprofloxacin lactate
- injection
- chloride injection
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Abstract
The invention relates to a preparation method of a ciprofloxacin lactate sodium chloride injection, which comprises the following steps of concentration preparation, heating, filtration, dilution preparation, pH value adjustment, filtration, filling, sealing, sterilization, examination, etc. The ciprofloxacin lactate sodium chloride injection prepared by the preparation method has good stability, and can be packaged by plastic bottles completely.
Description
Technical field
The present invention relates to a kind of preparation method of ciprofloxacin lactate sodium chloride injection, relate to a kind of preparation method of ciprofloxacin lactate sodium chloride injection of good stability specifically.
Background technology
Ciprofloxacin lactate is a third generation quinolones broad spectrum antibiotic, and its injection is used for the treatment of clinically by the microbial infection of sensitivity, determined curative effect.Because stability, the dissolubility of ciprofloxacin 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 extensive use of 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 ciprofloxacin lactate.Therefore how to increase deliquescent its stability that guarantees simultaneously of ciprofloxacin 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 preparation method of ciprofloxacin lactate sodium chloride injection, requirement through ciprofloxacin lactate sodium chloride injection that this preparation method makes improving the dissolubility of ciprofloxacin 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 preparation method of ciprofloxacin 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 preparation method helps increasing stability and the homogeneity of ciprofloxacin lactate in sodium chloride solution, avoids ciprofloxacin lactate dissolving not thorough, plastic bottle bottle wall naked eyes sightless concavo-convex on crystallization separate out.
Concrete preparation method is as follows:
(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) dense material after filtration after the carbon removal, is added 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 down slowly adding and claim fixed injection ciprofloxacin 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, and additional water for injection adds active carbon to stipulating scale, adjust pH value with lactate buffer solution, sampling and measuring content and pH value, adjust in accordance with regulations 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, for embedding.
(5) mould bottle transfusion through the system bottle, (one-step method system bottle clean compressed air purge, two step method system bottle compressed air purge washes with water for injection the purge bottle at last.), for fill.
(6) seal after moulding bottle transfusion fill.
(7) mould 115 ℃ of water-bath sterilizations of bottle transfusion 32 minutes.
(8) check.
Described heating steps was kept 5 minutes for feeding is steam heated to 100 ℃.
Described adjusting pH value step is for regulating pH value 3.7～4.3.
The specific embodiment
Further specify the present invention below by embodiment.(all calculating) with single dose
Embodiment:
Preparation method:
1, in handling clean dense preparing tank, add about 1/2 amount water for injection,, gently pour into the 9kg sodium chloride for injection in the dense preparing tank opening under the dense preparing tank stirring state, make its dissolving, prevent from 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, stir, feed Steam Heating in the interlayer and boil, and keep boiling 5 minutes, close vapour.
2, dense material after filtration after the carbon removal, is added 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, about 35L water for injection is added in the clean plastic containers, slowly add total amount 2/3 dense lactic acid and stir evenly, stirring slowly adds down and claims fixed ciprofloxacin lactate, and it is complete to make it dissolving, will dissolve completely slowly to 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, estimate that liquid level is when scale, stop to stir, additional water for injection stops to add water to stipulating scale, adds 0.01% (W/V is with rare stereometer of joining) medicinal charcoal, adjust pH value to 3.7-4.3 with 10% lactate buffer solution, adjust in accordance with regulations 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, for embedding.
5, mould bottle transfusion through the system bottle, (one-step method system bottle clean compressed air purge, two step method system bottle compressed air purge washes with water for injection the purge bottle at last.), (loading amount is controlled at 100ml～102ml) for 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 preparation method of a ciprofloxacin 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 preparation method of a kind of ciprofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: the described dense step of joining is to add sodium chloride for injection.
3. the preparation method of a kind of ciprofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: described heating steps was kept 5 minutes for feeding is steam heated to 100 ℃.
4. the preparation method of a kind of ciprofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: described rare step of joining is to add the injection ciprofloxacin lactate.
5. the preparation method of a kind of ciprofloxacin lactate sodium chloride injection according to claim 1 is characterized in that: described adjusting pH value is for regulating pH value 3.7～4.3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102168056A CN102274169A (en) | 2011-07-27 | 2011-07-27 | Preparation method of ciprofloxacin lactate sodium chloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102168056A CN102274169A (en) | 2011-07-27 | 2011-07-27 | Preparation method of ciprofloxacin lactate sodium chloride injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102274169A true CN102274169A (en) | 2011-12-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011102168056A Pending CN102274169A (en) | 2011-07-27 | 2011-07-27 | Preparation method of ciprofloxacin lactate sodium chloride injection |
Country Status (1)
| Country | Link |
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| CN (1) | CN102274169A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108938636A (en) * | 2018-09-10 | 2018-12-07 | 贵州天地药业有限责任公司 | A kind of preparation method of Ciprofloxacin Lactate and Sodium Chloride Injection |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1115641A (en) * | 1995-07-06 | 1996-01-31 | 东北制药总厂 | Prepn of cyclopropyloxacini injecta |
-
2011
- 2011-07-27 CN CN2011102168056A patent/CN102274169A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1115641A (en) * | 1995-07-06 | 1996-01-31 | 东北制药总厂 | Prepn of cyclopropyloxacini injecta |
Non-Patent Citations (4)
| Title |
|---|
| 刘昌云: "《乳酸环丙沙星注射液的研究》", 《桂林医学院学报》 * |
| 吴培荣: "《乳酸环丙沙星注射液配制方法改进及应用》", 《海峡药学》 * |
| 於传福主编: "《药剂学》", 30 November 1986, 人民卫生出版社 * |
| 邓才彬 主编: "《生物药物制剂工艺》", 31 December 2003 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108938636A (en) * | 2018-09-10 | 2018-12-07 | 贵州天地药业有限责任公司 | A kind of preparation method of Ciprofloxacin Lactate and Sodium Chloride Injection |
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Application publication date: 20111214 |