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Preparation method of ciprofloxacin lactate sodium chloride injection

A technology of sodium chloride injection and ciprofloxacin lactate, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve problems such as blood calcium reduction and adverse reactions, Achieve the effect of simple formula, good stability and good reproducibility

Pending Publication Date: 2022-07-22
GUANGZHOU NUCIEN PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, as a strong complexing agent, disodium edetate enters the blood of the human body and complexes with blood calcium, resulting in a decrease in blood calcium in patients taking medication, and adverse reactions may occur

Method used

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  • Preparation method of ciprofloxacin lactate sodium chloride injection
  • Preparation method of ciprofloxacin lactate sodium chloride injection
  • Preparation method of ciprofloxacin lactate sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 Ciprofloxacin lactate and sodium chloride injection and its preparation example

[0030] prescription:

[0031]

[0032] Preparation Process:

[0033] Step a, prepare 0.05% disodium edetate solution, soak the liquid dispensing tank for 40 minutes; then open the feeding valve, discharge the disodium edetate solution to the liquid delivery pipeline, clean the pipeline for 30 minutes, and then use Rinse the pipeline and dosing tank with water for injection until the flushing solution does not contain disodium edetate;

[0034] In step b, lactic acid and hydrochloric acid are added to 5L of water for injection to prepare a solution, and the solution is heat-treated at 121°C for 30 minutes;

[0035] Step c, disperse ciprofloxacin in the water for injection in the dosing tank processed in step a, add the lactic acid solution of step b, stir to dissolve ciprofloxacin;

[0036] Step d, adding sodium chloride to the solution of step c, stirring and dissolving;...

Embodiment 2

[0043] Embodiment 2 Ciprofloxacin lactate and sodium chloride injection and its preparation example

[0044] prescription:

[0045]

[0046] Preparation Process:

[0047] Step a, prepare 0.02% disodium edetate solution, soak the liquid dispensing tank for 60 minutes; then open the feeding valve, discharge the disodium edetate solution to the liquid delivery pipeline, clean the pipeline for 30 minutes, and then use Rinse the pipeline and dosing tank with water for injection until the flushing solution does not contain disodium edetate;

[0048] In step b, lactic acid and hydrochloric acid are added to 5L of water for injection to prepare a solution, which is heat-treated at 115°C for 45 minutes;

[0049] Step c, ciprofloxacin is dispersed in the water for injection in the dosing tank processed by step a, the lactic acid solution of step b is added, and stirring makes ciprofloxacin dissolve;

[0050] Step d, adding sodium chloride to the solution of step c, stirring and diss...

Embodiment 3

[0057] Embodiment 3 product quality and stability research

[0058] The Ciprofloxacin Lactate Sodium Chloride Injection prepared by Example 1 and Example 2 was placed under normal temperature conditions (product storage conditions) for 24 months, and in 0, 3, 6, 9, 12, 18, 24 months Sampling, according to the 2020 version of the Chinese Pharmacopoeia standard to test each quality index of the injection, the results are shown in Table 1 and Table 2 below.

[0059] Table 1 Example 1 finished product and stability results

[0060]

[0061] Table 2 Example 2 finished product and stability results

[0062]

[0063] The results show that the ciprofloxacin lactate sodium chloride injection of the present invention is stored for 24 months under the product storage conditions, and the quality is stable.

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Abstract

The invention provides a preparation method of ciprofloxacin lactate sodium chloride injection, and belongs to the field of pharmaceutical preparations. The preparation method comprises the following steps: cleaning a liquid preparation system and a liquid medicine delivery pipeline by using an edetate disodium solution, then depolymerizing lactic acid under the acidic condition of hydrochloric acid, then fully stirring and uniformly mixing ciprofloxacin as a raw material with the acid-treated lactic acid, sodium chloride and water for injection, adjusting the volume of the prepared liquid, and performing freeze-drying to obtain the ciprofloxacin injection. Finally, the ciprofloxacin lactate sodium chloride injection can be prepared through the steps of ultrafiltration pyrogen removal, sterilization and filtration, potting, sealing performance detection, high-pressure sterilization, inspection and the like. The method has the advantages that the formula is simple, the prepared product does not contain edetate disodium, and the risk of complexing blood calcium is avoided; the pH value of the liquid medicine does not need to be adjusted; the process is simple; and pyrogen is removed by ultrafiltration, so that the medication safety of patients is ensured. The ciprofloxacin lactate sodium chloride injection prepared by the method is good in stability and excellent in product quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of ciprofloxacin lactate sodium chloride injection. Background technique [0002] Ciprofloxacin lactate, the third-generation quinolone broad-spectrum high-efficiency antibacterial drug, is developed and marketed by Bayer, Germany for oral and injection, and is clinically used to treat urogenital infections caused by sensitive bacteria, including Simple and complex urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis or cervicitis; also can treat respiratory infections, including acute exacerbations of bronchial infections and pulmonary infections caused by susceptible gram-negative bacilli; Gastrointestinal infections caused by Shigella, Salmonella, Enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc.; it can also treat typhoid fever, bone and joint infections, skin and soft ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/12A61K47/02A61P31/04
CPCA61K9/08A61K9/0019A61K31/496A61K47/12A61K47/02A61P31/04
Inventor 许小春王兴旺张世喜
Owner GUANGZHOU NUCIEN PHARM CO LTD
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