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A kind of drug combination of cefmetazole sodium for injection

A cefmetazole sodium and amorphous technology, which is applied in the field of pharmaceutical preparation, can solve problems such as poor reconstitution clarity and poor stability of cefmetazole sodium, and achieve the effects of good fluidity, easy industrial production, and simple technology

Active Publication Date: 2020-05-05
CHONGQING SHENGHUAXI PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome the poor stability of Cefmetazole Sodium for Injection in the prior art, the deficiencies such as poor reconstitution clarity, the purpose of the present invention is to provide good stability, good reconstitution clarity, simple preparation method, easy industrial production Cefmetazole sodium composition for injection, and preparation method thereof

Method used

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  • A kind of drug combination of cefmetazole sodium for injection
  • A kind of drug combination of cefmetazole sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Suspend 50g of cefmetazole sodium in water: N , N -In 250ml of a mixed solvent of dimethylacetamide=1:1, slowly heat to 30°C under nitrogen protection, the system is dissolved, add 0.5g of activated carbon for needles, stir at 30°C for 10min, filter aseptically, and cool the filtrate 20±2℃, dropwise add sterile filtered butanone / ethanol (volume ratio 0.5:5) to make a mixed solution 5000ml, drop the mixed solvent at 25ml / min, stir at 800r / min, and cool to- Crystallize at 5~5℃ for 2h, filter with suction in a sterile environment, wash the filter cake with a small amount of ethanol, and vacuum dry at 32~35℃ for 8-12h to obtain the following figure 1 The shown aseptic cefmetazole amorphous powder is 40g, the yield is 80%, and the purity is 99.8%.

Embodiment 2-3

[0032] According to the general method described in Example 1, the yield of amorphous cefmetazole obtained by changing various technical conditions, and the purity is shown in Table 1:

[0033] .

Embodiment 4

[0034] Example 4 Formulation Example Cefmetazole Sodium Composition Sterile Powder for Injection

[0035] Specification: 1.0g (in C 15 H 17 N 7 O 5 S 3 meter)

[0036] prescription:

[0037] 1000g of amorphous cefmetazole sodium aseptic powder prepared according to Example 1

[0038] Sodium salicylate 0.5g

[0039] Glucose 3g

[0040] Vitamin C 3g

[0041] In a sterile environment, mix 1000g of the qualified amorphous cefmetazole sodium aseptic powder prepared in accordance with Example 1, 0.5g sodium salicylate, 1g glucose and 3g vitamin C as excipients for injection. , In a sterile environment, divided into 1000 bottles of 8ml vials, each bottle weighing 1.0g (by C 15 H 17 N 7 O 5 S 3 Cefmetazole sodium sterile powder for injection is obtained by pressing plug, capping, light inspection, inspection, labeling and packaging.

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Abstract

The invention relates to a cefmetazole sodium composition used for injection. The cefmetazole sodium composition sterile powder contains 99.1-99.75 wt% of cefmetazole sodium sterile powder, 0.05-0.1% of sodium salicylate, 0.1-0.5% of glucose, and 0.1-0.3% of vitamin C, wherein the cefmetazole sodium sterile powder is amorphous cefmetazole sodium. The invention further relates to preparation of the cefmetazole sodium amorphous powder used for injection. The preparation is characterized by heating and dissolving cefmetazole sodium in a proper water / N,N-dimethylacetamide mixed liquid which is a benign solvent, performing degerming and filtering, adding a butanone / ethanol mixture which is an inert solvent drop by drop at a certain stirring speed and flow speed, performing cooling for crystallization, and performing filtering and drying to obtain the amorphous cefmetazole sodium sterile powder. The invention provides a preparation method of amorphous cefmetazole sodium sterile powder and a pharmaceutical composition contains the cefmetazole sodium. The pharmaceutical composition overcomes the defect that cefmetazole sodium used for injection in the prior art is poor in stability and redissolution clarity, and provides a new medicine selection of cefmetazole sodium.

Description

Technical field [0001] The invention belongs to the neighborhood of medicine preparation technology, and particularly relates to a method for preparing a drug combination of cefmetazole sodium for injection and amorphous cefmetazole sodium for injection as the active ingredient. Background technique [0002] Cefmetazole Sodium, CAS: 56796-39-5, the structural formula is as follows: [0003] [0004] Cefmetazole sodium is a second-generation semi-synthetic cephalosporin. It was developed by Japan's Sankyo Company. It was listed in 1980 and entered China in 1992. It is clinically used for respiratory infections, biliary tract infections, peritonitis, and urinary system infections caused by sensitive bacteria. And other diseases. [0005] The currently marketed cefmetazole sodium is a sterile powder of cefmetazole sodium for injection. Generally, it is a sterile subpackaged preparation of ordinary cefmetazole sodium for injection or a sterile freeze-dried powder prepared by ultra-low ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/546A61K47/12A61K47/26A61K47/22A61P31/04
CPCA61K9/0019A61K9/19A61K31/546A61K47/12A61K47/22A61K47/26
Inventor 曾秀秀胡朝惠
Owner CHONGQING SHENGHUAXI PHARMA CO LTD