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Cefotetan disodium for injection, and preparation method thereof

A technology of cefotetan disodium and cefotetan, which is applied in the field of cefotetan disodium for injection and its preparation, and can solve the problems of inability to obtain impurity content, potential safety hazards for patients, and high impurity content, etc.

Inactive Publication Date: 2011-11-23
从淑芳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But from several examples that the present invention provides, it can be seen that the related substances of the filtrate after the prescription dosing of cefotetan disodium of the present invention without adding glucose are all as high as more than 5%. It can be seen that the pharmaceutical composition The resulting freeze-dried product contains a lot of impurities, and as time goes by, the content of impurities will further increase, bringing safety hazards to patients
[0006] And because cefotetan disodium is very poor in stability, it degrades rapidly after encountering water in the production, storage and use process, even if the above-mentioned addition can be used to strengthen the stable adjuvant of cefotetan disodium, it can not be obtained that the impurity content is small and the stability is very high. Cefotetan Disodium for Injection

Method used

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  • Cefotetan disodium for injection, and preparation method thereof
  • Cefotetan disodium for injection, and preparation method thereof
  • Cefotetan disodium for injection, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] prescription:

[0083] Preparation Process:

[0084] (1) The cefotetan that takes prescription quantity is added in the cooling water for injection (0~5 ℃) of 80% of total volume, stir, make it become suspension;

[0085] (2) Take by weighing the sodium bicarbonate of recipe quantity, slowly join in above-mentioned suspension, fully stir, make solution clarification;

[0086] (3) Measure the pH of the solution (in the range of 4.5 to 5.5), and adjust the pH with 0.1mol / L dilute hydrochloric acid if necessary;

[0087] (4) Add cooled water for injection (0-5°C) to 100%;

[0088] (5) Add 0.1% activated carbon, stir, let stand for 20 minutes, filter for decarbonization, and filter with a 0.22 μm filter membrane;

[0089] (6) Intermediate detection;

[0090] (7) Fill the above solution in a volume of 4ml / bottle (specification: 1g), stopper halfway, freeze-dry, and stopper and cap.

[0091] (8) All the above-mentioned freeze-dried products are inspected, and cefotetan...

Embodiment 2

[0093] prescription:

[0094] Preparation process: the same as in Example 1, except that it is filled in step (7) at a capacity of 8ml / branch (specification: 2g).

Embodiment 3

[0096] prescription:

[0097] Preparation Process:

[0098](1) The cefotetan that takes prescription quantity joins in the water for injection of 0 ℃ of 80% of total volume, stirs, and makes it become suspension;

[0099] (2) Take by weighing the sodium bicarbonate of recipe quantity, slowly join in above-mentioned suspension, fully stir, make solution clarification;

[0100] (3) Measure the pH of the solution (in the range of 4.5 to 5.5), and adjust the pH with 0.1mol / L dilute hydrochloric acid if necessary;

[0101] (4) Add water for injection at 0°C to 100%;

[0102] (5) Add 0.1% activated carbon, stir, let stand for 20 minutes, filter for decarbonization, and filter with a 0.22 μm filter membrane;

[0103] (6) Intermediate detection;

[0104] (7) Fill the above solution according to the amount of 4ml / cartridge (specification: 1g), half-stopper, freeze-dry, and stopper and cap; wherein the freeze-drying method is: start the freeze-drying machine, after pre-freezing at...

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Abstract

The invention relates to cefotetan disodium for injection, and a preparation method thereof. The cefotetan disodium for the injection is prepared from cefotetan, sodium bicarbonate, dilute hydrochloric acid and water for the injection, wherein the use amount of the sodium bicarbonate is 24.5-28.5% of the use amount of the cefotetan, preferably, 26.5%. The invention further provides the cefotetan disodium for the injection prepared from the cefotetan crystal, and the preparation method thereof. The cefotetan disodium for the injection provided by the present invention has good stability, small related substance content, such that the potential safety hazard problem due to large impurity content is avoided; the cefotetan disodium prepared from the cefotetan crystal provided by the present invention has good stability and small related substance content, meanwhile, because the prepared cefotetan disodium contains the cefotetan crystal, the prepared cefotetan disodium has strong antibacterial characterization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to cefotetan disodium for injection and a preparation method thereof. Background technique [0002] At present, many cephalosporin antibiotics have been listed and widely used in clinical practice, playing an important role in the treatment of infectious diseases. However, upon analysis, most of the listed cephalosporin antibiotics are cephalosporins. From the first generation of cephalexin and cefadroxil to the new generation of cefotaxime, ceftriaxone, cefpirome, etc., although each generation of cephalosporin antibiotics has its own characteristics, the common defect of this class of antibiotics is that it is harmful to certain The β-lactamase produced by some bacteria is unstable, so the therapeutic effect on infections caused by some strains that can produce β-lactamase is affected. Since the discovery of cephamycin C in Streptomyces, some cephamycin antibiotics hav...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/19A61P31/04
Inventor 朱正兵石均平
Owner 从淑芳
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