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Preparing method of cefodizime sodium for injection

A technology for cefodizime sodium and injection, which is applied in the field of pharmacy, can solve the problems of complex preparation process, poor stability, incapability of industrialized production and the like, and achieves the effect of simple preparation method and good stability

Inactive Publication Date: 2017-01-11
南昌立健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The preparations of cefodizime sodium currently on the market are mainly cefodizime sodium sterile powder for injection. This preparation has poor stability, is very unstable to light and heat, and related substances increase after being placed for a long time, and turbidity appears after dissolution. phenomenon, resulting in many difficulties in its use
[0005] In order to solve its stability problem, Chinese patent ZL200910016147.9 discloses a liposomal freeze-dried preparation of cefodizime and its preparation method, but its preparation process is relatively complicated, wherein a large number of pharmaceutical excipients are added, which leads to The increase in impurity content will greatly increase the hidden dangers of drug safety. Due to the increase in impurities, it is difficult for the content of related substances to meet the requirements of the Pharmacopoeia in the test and cannot be industrialized.
In addition, the preparation yield of liposomes is very low, which causes the cost of medicines to increase greatly, and is not suitable for industrial production.

Method used

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  • Preparing method of cefodizime sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A preparation method of cefodizime sodium for injection, the steps are as follows:

[0025] 1) Weigh the following raw materials in parts by weight: 75 parts of cefodizime sodium, 17 parts of citric acid, 32 parts of potassium clavulanate, 104 parts of hydroxypropyl-β-cyclodextrin, and 550 parts of water;

[0026] 2) Add cefodizime sodium into water, stir and dissolve to obtain the first solution;

[0027] 3) Add both citric acid and potassium clavulanate to the first solution, mix and stir until completely dissolved to obtain the second solution;

[0028] 4) Adjust the pH of the second solution to 6.4 to obtain the third solution, and adjust the pH of the second solution by using sodium hydroxide solution or hydrochloric acid solution;

[0029] 5) Add hydroxypropyl-β-cyclodextrin into the third solution, raise the temperature to 53°C, stir and mix for 1 hour, and naturally cool to room temperature to obtain the fourth solution;

[0030] 6) Add 1% of the total weight ...

Embodiment 2

[0034] A preparation method of cefodizime sodium for injection, the steps are as follows:

[0035] 1) Weigh the following raw materials in parts by weight: 76 parts of cefodizime sodium, 18 parts of citric acid, 35 parts of potassium clavulanate, 108 parts of hydroxypropyl-β-cyclodextrin, and 630 parts of water;

[0036] 2) Add cefodizime sodium into water, stir and dissolve to obtain the first solution;

[0037] 3) Add both citric acid and potassium clavulanate to the first solution, mix and stir until completely dissolved to obtain the second solution;

[0038] 4) Adjust the pH of the second solution to 6.5 to obtain the third solution, and adjust the pH of the second solution by using sodium hydroxide solution or hydrochloric acid solution;

[0039] 5) Add hydroxypropyl-β-cyclodextrin to the third solution, raise the temperature to 54°C, stir and mix for 1.5 hours, and naturally cool to room temperature to obtain the fourth solution;

[0040] 6) Add 1.3% of the total weig...

Embodiment 3

[0044] A preparation method of cefodizime sodium for injection, the steps are as follows:

[0045] 1) Weigh the following raw materials in parts by weight: 78 parts of cefodizime sodium, 19 parts of citric acid, 35 parts of potassium clavulanate, 106 parts of hydroxypropyl-β-cyclodextrin, and 595 parts of water;

[0046] 2) Add cefodizime sodium into water, stir and dissolve to obtain the first solution;

[0047] 3) Add both citric acid and potassium clavulanate to the first solution, mix and stir until completely dissolved to obtain the second solution;

[0048] 4) Adjust the pH of the second solution to 6.5 to obtain the third solution, and adjust the pH of the second solution by using sodium hydroxide solution or hydrochloric acid solution;

[0049] 5) Add hydroxypropyl-β-cyclodextrin into the third solution, raise the temperature to 55°C, stir and mix for 1.5 hours, and naturally cool to room temperature to obtain the fourth solution;

[0050] 6) Add 1.5% of the total we...

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Abstract

The invention discloses a preparing method of cefodizime sodium for injection, wherein the method comprises the following steps of adding cefodizime sodium to water to obtain the first solution after stirring and dissolving; adding citric acid and potassium clavulanate to the first solution to obtain a second solution after it is completely stirred and dissolved; Adjusting the pH of the second solution to 6.4-6. 6 to obtain a third solution; adding hydroxypropyl Beta-cyclodextrin to the third solution, heating to 53-58 oC, stirring and mixing for 1-2 hours, and cooling to room temperature to obtain a fourth solution; adding the activated carbon with the total weight of 1-2% to the fourth solution, stirring and mixing for 20-30min, and removing the activated carbon by coarse filtration to obtain a fifth solution; The fifth solution is filtered through a microporous membrane to obtain an injecta; freeze-drying the injecta to the powder; the preparing of cefodizime sodium for injection enjoys good stability, and the preparing method is simple, safe and reliable, suitable for clinical use, and industrial production can be carried out on a large scale, with a wide range of applications.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation method of cefodizime sodium for injection. Background technique [0002] Cefodizime sodium is a third-generation cephalosporin antibiotic for injection jointly developed by Hearst Company of Germany and Russell Company of France. It is also the first third-generation cephalosporin with immune-enhancing function in the world. First launched in Japan in 1990 under the trade name "Neucef". [0003] Cefodizime is the world's first third-generation cephalosporin with immune-enhancing function. It has a broad antibacterial spectrum and is mainly used clinically for pneumonia, bronchitis, and pharyngitis caused by sensitive bacteria such as Streptococcus and pneumococcus. , tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infection, sepsis, and otitis media, etc., but cefodizime has different effects on Coagulob...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/19A61K47/12A61K47/40A61P31/04A61K31/424
CPCA61K31/546A61K9/0019A61K9/19A61K31/424A61K47/12A61K47/40A61K2300/00
Inventor 郑玲英
Owner 南昌立健药业有限公司
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