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Composition of cefmetazole acid and sodium citrate

A technology of cefmetazole acid and sodium citrate, which is applied in the directions of drug delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. High allergic reaction, secondary injury to patients, etc

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

AI Technical Summary

Problems solved by technology

However, cefmetazole sodium itself has no crystal form, so its properties are not very stable. During the freeze-drying process and the subsequent storage process, the structure of cefmetazole acid is easy to change and transform into other substances. In the quality standard control, other relevant The substance content is relatively high, and at the same time, due to the relatively high impurity content, the side effects and allergic reactions are relatively high during clinical use, and it is easy to cause secondary harm to patients

Method used

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  • Composition of cefmetazole acid and sodium citrate
  • Composition of cefmetazole acid and sodium citrate
  • Composition of cefmetazole acid and sodium citrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation of powder injection from the composition of cefmetazole acid and sodium citrate: In the aseptic ingredient workshop, weigh 50 kg of cefmetazole acid and sodium citrate aseptic raw materials according to the proportioning scheme in Table 1, and pour them 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 water for injection was used to prepare a liquid medicine with a concentration for routine infusion of the human body, and the water solubility of each sample solution was tested. The specific experimental results are shown in Table 1.

[0021] Table 1 pH value and water-...

Embodiment 2

[0024] Example 2 Stability Study of Cefmetazole Acid and Sodium Citrate Composition

[0025] According to the long-term test (3 months) and the accelerated test (3 months) test operation standard of the drug registration standard, the stability of the cefmetazole acid and sodium citrate compositions of the above groups of 1, 4, 6 and 7 is detected , and compared with single cefmetazole sodium. Wherein cefmetazole acid and the relevant impurity content transformed into by cefmetazole acid adopt high performance liquid chromatography (HPLC) to detect, use waters2487 type high performance liquid chromatography, use octadecyl bonded silica gel as filler; Ammonium dihydrogen phosphate solution (weigh 5.75g of ammonium dihydrogen phosphate, add 700ml of water to dissolve)-methanol-tetrahydrofuran-10% tetrabutylammonium hydroxide (700:280:20:12.8) (adjust the pH to 4.5±0.1 with phosphoric acid) as Mobile phase; the detection wavelength is 254nm; the column temperature is 30°C as the...

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Abstract

The invention discloses a composition with antibacterial effect. The composition is composed of cefmetazole acid and sodium citrate, the aseptic powder of cefmetazole acid and sodium citrate is combined, and sodium citrate is used as cefmetazole The co-solvent of fenomezolic acid can effectively increase the water solubility of cefmetazole acid, and solve the shortcomings of inconvenient clinical use of cefmetazole acid. Cefmetazole acid can play its antibacterial effect well. The invention has good stability, and the prepared aseptic mixed powder of cefmetazole acid and sodium citrate can be stored for a long time. The antibacterial active ingredient cefmetazole acid has a stable structure, does not produce impurities with toxic and side effects, and has stable and safe curative effect.

Description

technical field [0001] The invention relates to a composition, in particular to a composition of antibiotic cefmetazole and sodium citrate. Background technique [0002] Cefmetazole Sodium (Cefmetazole Sodium) was originally a new type of cephalosporin antibiotic independently developed by Sankyo Company. Sankyo Company obtained a license under the trade name of Cefmetazon in August 1978, and began selling injections in February 1980. Cefmetazole Sodium Chemical name: (6R-cis)-7-[[[(cyanomethyl)sulfur]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-5-tetraazole Azolyl)thio]-methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. The structural formula is as follows: [0003] [0004] Its active ingredient is cefmetazole acid, but because of its low polarity and poor water solubility, it is conveniently used clinically, and its sodium salt is prepared as a preparation. Cefmetazole acid is often added with sodium carbonate or sodium bicarbonate to form a...

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