Avibactam and cefmenoxime compound powder injection for injection and preparation method thereof

A technology of avibactam sodium and cefmenoxime hydrochloride, which is applied in the field of avibactam-cefamenoxime compound powder injection for injection and its preparation, which is easy to use, less resistant to β-lactamase bacteria, and simple in process Effect

Pending Publication Date: 2021-09-21
ZHEJIANG JIANFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the combination of antibiotics with lactamase inhib

Method used

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  • Avibactam and cefmenoxime compound powder injection for injection and preparation method thereof
  • Avibactam and cefmenoxime compound powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Under Class B clean environment conditions, 10 kilograms of cefmenoxime hydrochloride powder and 5 kilograms of avibactam sodium powder were mixed and added to a dry granulator with a roll pressure of 10.2 MPa and a roll speed of 95 rpm to be pressed into thin flakes. Grind into granules, then press into thin flakes with a dry granulator under the same conditions, pulverize into granules, and pulverize with a high-speed pulverizer to obtain 13.621 kg of powder (above 60 mesh), which is divided into 13406 bottles (1 gram per bottle). As detected by HPLC, the content of cefmenoxime hydrochloride was 60.6%, and the content of avibactam sodium was 32.9%. The sample was prepared with water for injection, and the dissolution was completed in 1 minute and 38 seconds.

Embodiment 2

[0019] Under Class B clean environment conditions, 10 kilograms of cefmenoxime hydrochloride powder and 10 kilograms of avibactam sodium powder were mixed and added into a dry granulator with a roll pressure of 11.6 MPa and a roll speed of 105 rpm to be pressed into flakes. Pulverize into granules, then press into flakes with a dry granulator under the same conditions, pulverize into granules, and pulverize with a high-speed pulverizer to obtain 18.948 kg of powder (above 60 mesh), which is divided into 18532 bottles (1 gram per bottle). HPLC detection cefmenoxime hydrochloride 49.1%, avibactam sodium 49.6%. The sample was prepared with water for injection, and the dissolution was completed in 1 minute and 03 seconds.

Embodiment 3

[0021] Under Class B clean environment conditions, 10 kg of cefmenoxime hydrochloride powder and 1 kg of avibactam sodium powder were mixed and added to a dry granulator with a roll pressure of 11.7 MPa and a roll speed of 92 rpm to be pressed into flakes. Pulverize into granules, then press into flakes with a dry granulator under the same conditions, pulverize into granules, and pulverize with a high-speed pulverizer to obtain 10.652 kg (above 60 mesh), which is divided into 20893 bottles (0.5 grams per bottle). HPLC detection cefmenoxime hydrochloride 89.5%, avibactam sodium 9.1%. The sample was prepared with water for injection, and the dissolution was completed in 1 minute and 58 seconds.

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Abstract

The invention relates to an avibactam and cefmenoxime compound powder injection for injection and a preparation method thereof. The compound powder injection is prepared by well mixing cefmenoxime hydrochloride and avibactam sodium, tabletting and crushing. The powder injection disclosed by the invention is easy to disperse and dissolve when being prepared into an injection, is convenient to use, cannot easily generate beta-lactamase bacterial drug resistance while ensuring the content of cefmenoxime, and has a good market application prospect.

Description

technical field [0001] The invention belongs to the field of compound powder injection, in particular to a compound powder injection of avibactam cefmenoxime for injection and a preparation method thereof. Background technique [0002] Cefmenoxime hydrochloride is poorly soluble in water. Generally, sodium carbonate or sodium bicarbonate is added to aid dissolution (such as adding sodium carbonate and ethylenediamine to the cefmenoxime powder injection in patent 201310383089.X). Sodium carbonate and sodium bicarbonate are alkaline soluble in water. Studies have shown that the content of cefmenoxime will decrease in alkaline solution. There is also the preparation of the particle size of cefmenoxime as small as possible (patent 201110040597.9), so that it is easily soluble in water, but the particle size is too small, and it is easy to aggregate after long-term storage, which will affect the dissolution during use. Liu Jiajian et al. (patent 03117380.2) used basic amino aci...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K31/439A61P31/04
CPCA61K9/19A61K9/0019A61K31/546A61K31/439A61P31/04A61K2300/00
Inventor 黄金龙林军庞雄江宏施存元张明寅于敬敬李效超
Owner ZHEJIANG JIANFENG PHARM CO LTD
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