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Novel antibiotic composition for preventing and treating aerobic bacterium and anaerobic bacterium mixed infection and preparation method thereof

A technology of mixed infection and composition, which is applied in the field of medicine, can solve the problems of uneven quality, inconsistent control level, and inconsistent curative effect of metronidazole injection, so as to avoid unqualified clarity, improve solution stability, and sterilize the effect Good results

Active Publication Date: 2018-05-25
海南广升誉制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, the combined application needs to be purchased separately for clinical use, and no combined package of cefuroxime sodium for injection and metronidazole injection appears on the market or in medical institutions
The quality of cefuroxime sodium for injection and metronidazole injection produced by different manufacturers is not uniform, and the control levels of key quality indicators of the drugs such as content and related substances are inconsistent. Patient medication poses safety hazards

Method used

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  • Novel antibiotic composition for preventing and treating aerobic bacterium and anaerobic bacterium mixed infection and preparation method thereof
  • Novel antibiotic composition for preventing and treating aerobic bacterium and anaerobic bacterium mixed infection and preparation method thereof
  • Novel antibiotic composition for preventing and treating aerobic bacterium and anaerobic bacterium mixed infection and preparation method thereof

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preparation example Construction

[0059] The preparation method of described cefuroxime sodium for injection comprises the following steps:

[0060] Step 1: refining the raw material of cefuroxime sodium to reduce remaining process impurities in the synthesis, and controlling the total amount of impurities to be less than 0.5%.

[0061] Since cefuroxime sodium in the present invention is an injection, it directly enters the patient's body through intramuscular injection, intravenous injection or intravenous infusion, so the requirements for its safety are relatively high.

[0062] In the present invention, cefuroxime sodium is refined again to improve the purity of cefuroxime sodium. The water used in the present invention is sterile water for injection.

[0063] In the refining step, cefuroxime sodium is added into the reaction tank, and a mixed solvent is added to dissolve it completely. The cefuroxime sodium includes water, and further, it also contains one of ethanol, acetone, dichloromethane and n-propan...

Embodiment 1

[0178] (1) Preparation of Cefuroxime Sodium for Injection:

[0179] Put 1 kg of cefuroxime sodium bulk drug (Sinopharm Group Zhijun Pharmaceutical Co., Ltd.) in the reaction tank, add acetone: dichloromethane: 8L of mixed solvent with a ratio of 7:2:1 of water for injection, stir and dissolve, add Use 24g of activated carbon for needles, stir for 20min and then filter with a filter membrane of 0.22μm.

[0180] Add 2L of acetone to the solution in portions under stirring, and cool the solution to 5°C at a cooling rate of 5°C / h, grow crystals for 1 hour, filter the precipitate, and dry in vacuum until the water content is 2.5%.

[0181] Put the precipitate in the DECO-PBM-V-2L ball mill of Deco, and carry out aseptic grinding in a 100-level purification environment, wherein the speed is 650r / min, and the grinding time is 15min; nitrogen-filled grinding; all the ground The powder was sieved through a 100 mesh nylon sieve.

[0182] The cefuroxime sodium powder was vacuum-dried a...

experiment example 1

[0196] Get the cefuroxime sodium for injection that makes in embodiment 1, use Karl-Fisher's coulometric titrator to measure the moisture content in the sample, the result is as follows:

[0197]

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PUM

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Abstract

The invention relates to a cefuroxime sodium and metronidazole medicinal composition for preventing and treating infection or suspected aerobic bacterium and anaerobic bacterium mixed infection, in particular to combination application package. The cefuroxime sodium and metronidazole medicinal composition comprises cefuroxime sodium for injection and a metronidazole injection. For most aerobic bacterium and anaerobic bacterium mixed infection, an effect can be achieved by dissolving 0.75 g of the cefuroxime sodium in the metronidazole injection (0.5 g / 100 ml) and injecting once every 8 hours.For more serious or specific aerobic bacterium and anaerobic bacterium mixed infection, 1.5 g of the cefuroxime sodium is dissolved into the metronidazole injection (0.5 g / 100 ml) and injected once every 8 hours. When the cefuroxime sodium and metronidazole medicinal composition is used for preventing injection in surgeries (such as colon surgery and gynecologic surgery), a single dose of 1.5 g ofthe cefuroxime can be given, and the cefuroxime sodium can be dissolved in the metronidazole injection (0.5 g / 100 ml) for treating, or the dose of 0.75 g of the cefuroxime and the metronidazole are given for treating twice. The combination application package provided by the invention greatly facilitates a clinical medication requirement.

Description

technical field [0001] The present invention relates to a novel antibiotic composition for preventing and treating the mixed infection of aerobic bacteria and anaerobic bacteria and its preparation method, specifically refers to the pharmaceutical composition of cefuroxime sodium and metronidazole and its use, especially relates to a The invention relates to a combined application package of a sterile injection prepared from cefuroxime sodium sterile powder for injection and metronidazole, belonging to the technical field of medicine. Background technique [0002] Cefuroxime sodium is a second-generation cephalosporin antibiotic. It is a bactericidal cephalosporin antibiotic. Its mechanism of action is to inhibit the synthesis of bacterial cell walls by binding to bacterial proteins. Cefuroxime has broad antibacterial activity against pathogenic bacteria and is stable to many β-lactamases, especially plasmid-mediated enzymes common in Enterobacteriaceae. [0003] In vitro t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4164A61K31/546A61P31/04
CPCA61K31/4164A61K31/546A61K2300/00
Inventor 俞玉萍
Owner 海南广升誉制药有限公司
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