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Composition of cefpirome sulfate and sodium citrate

A technology of cefpirome sulfate and sodium citrate, which is applied in the directions of drug delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the structural instability of cefpirome sulfate, side reactions and allergies. High reaction rate, difficult to formulate quality standards and other issues

Active Publication Date: 2011-12-28
国药集团致君(苏州)制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because cefpirome sulfate is unstable in structure, it is easy to degrade when meeting water, so it cannot be taken orally, which limits the clinical application of cefpirome sulfate to a large extent, and because its solubility in water is very small (1: 21), reaching Less than the requirement of preparation minimum volume injection, so cosolvent must be used when being prepared into injection, at present, cefpirome sulfate for injection both at home and abroad all adopts sodium carbonate as cosolvent, but in dissolving process, due to acid-base reaction produced A large amount of carbon dioxide creates considerable pressure in the bottle, which can easily cause the liquid medicine to rush out, posing a safety hazard; and due to acid-base reactions, strong local alkalinity can easily promote the degradation of cefpirome and produce related impurities, which cannot be used for a long time Storage and use have a high rate of side effects and allergic reactions, and it is not easy to formulate quality standards

Method used

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  • Composition of cefpirome sulfate and sodium citrate
  • Composition of cefpirome sulfate and sodium citrate
  • Composition of cefpirome sulfate and sodium citrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation of powder injection from cefpirome sulfate and sodium citrate composition: in the aseptic ingredient workshop, weigh 50 kg of cefpirome sulfate and sodium citrate aseptic raw material according to the proportioning scheme in Table 1, pour into the high-efficiency three-dimensional In the motion mixer, set the rotation speed of the three-dimensional powder mixer to 5 rpm, start the powder mixing operation according to the powder mixing packaging standard operating procedures, mix for 60 minutes to 90 minutes until the mixture is uniform, discharge, and pack to obtain powder injections.

[0020] The samples of each ratio were taken to detect the pH value of each sample, and then the infusion solution with the concentration for routine infusion of adult human body was prepared with water for injection, and the water solubility of each sample solution was tested. The specific experimental results are shown in Table 1.

[0021] The pH value of the cefpirome sulfat...

Embodiment 2

[0024] Embodiment 2 Stability study of cefpirome sulfate and sodium citrate composition

[0025] According to the long-term experiment (3 months) of drug registration standard and the accelerated experiment (3 months) experimental operation standard, detect the stability of cefpirome sulfate and sodium citrate composition that above groups are 1, 3, 4 and 7 , and compared with cefpirome sulfate mixed sodium carbonate. Wherein cefpirome sulfate and the relevant impurity content transformed into by cefpirome sulfate adopt high performance liquid chromatography (HPLC) to detect, use waters2487 type high performance liquid chromatography, use octadecyl bonded silica gel as filler; Acetonitrile-pH3.3 phosphate buffer (weigh 3.45g of ammonium dihydrogen phosphate, add water to dissolve and dilute to 1000ml, adjust pH with phosphoric acid)-water (100:800) as mobile phase; detection wavelength is 270nm. Theoretical plate number should be not less than 1500) with cefpirome peak record...

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Abstract

The invention discloses a composition with antibacterial effect. The composition is composed of cefpirome sulfate and sodium citrate. The aseptic powder of cefpirome sulfate and sodium citrate is combined, and sodium citrate is used as cefpirome sulfate. The co-solvent of Pilo, can effectively increase the water solubility of Cefpirome Sulfate, solve the shortcoming of the inconvenient clinical use of Cefpirome Sulfate, Cefpirome Sulfate can play its antibacterial effect well, the composition obtained after the two ratio It has good stability, and the prepared powder injection can be stored for a long time. The antibacterial active ingredient cefpirome sulfate has a stable structure, and it is easy to formulate quality standards, and does not produce impurities with toxic and side effects, and the curative effect is stable and safe.

Description

technical field [0001] The invention relates to a composition, in particular to a composition of antibiotic cefpirome sulfate and sodium citrate. Background technique [0002] Cefpirome Sulfate (Cefpirome Sulfate) is a new type of cephalosporin antibiotics, the drug was first successfully developed by Hoechst (now called Aventis) in Germany, and it was first listed in Mexico and Sweden in 1992 with the trade name Cefrom. It has been successively sold in the United Kingdom, France, Germany, Japan, South Korea and other countries. The chemical name of cefpirome sulfate is: 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy- 8-Oxo-5-thio-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-6,7-dihydro-5H-cyclopentadienopyridine monosulfate Salt. Its structural formula is as follows: [0003] [0004] As a fourth-generation cephalosporin, cefpirome is known to have the strongest antibacterial activity against Gram-positive bacteria among the third- and fourth...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61K47/12A61K9/14A61K9/08A61P31/04
Inventor 王磊杨磊
Owner 国药集团致君(苏州)制药有限公司
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