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Ceforanide C-type crystal composition used for injection and its preparation method

A technology for cefret and injection, which is applied in the field of cefret C-type crystalline composition for injection and preparation thereof, and achieves the effects of being conducive to the protection of the natural environment, high purity and convenient operation

Inactive Publication Date: 2012-02-15
SICHUAN INDAL INST OF ANTIBIOTICS CHINA NAT PHARMA GROUP CORP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Up to now, there have been no relevant reports on the crystal form of cefrelide and cefreteride for injection, so it is extremely important to choose an appropriate preparation process to obtain drugs with superior crystal forms

Method used

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  • Ceforanide C-type crystal composition used for injection and its preparation method
  • Ceforanide C-type crystal composition used for injection and its preparation method
  • Ceforanide C-type crystal composition used for injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: Preparation of Cefereide Type A crystals:

[0050] According to the patent application number 200910223572.5 in the example 9 obtained cefereide N,N-dimethylbenzylamine salt (CRD-H DMBA) compound [2] 65.48g, placed in a 1000ml three-necked bottle, add 328ml Deionized water (w / v=1:5), stir to dissolve, keep warm in a water bath (30°C), when most of the solids are dissolved, add 3.0g NaHCO 3 Stirring, vacuum extraction of CO 2 Gas to make it completely dissolved, measure the pH value of the solution, and adjust the solution to PH=7.5±0.2 with a little 2N hydrochloric acid. Then decolorize with 6.5g of activated carbon in vacuum pumping, filter the solution through water-soluble filter membranes with pore diameters of 0.45μm and 0.22μm respectively, then wash twice with 100ml of deionized water, combine the washings to obtain crystallization solution; Internally, use 2N hydrochloric acid to adjust the pH value of the isoelectric point to crystallize, that i...

Embodiment 2

[0054] Embodiment 2: Preparation of L-lysine type B crystals:

[0055] Dissolve 25.0 g of commercially available spray-dried L-lysine (alkali) in 125 ml of deionized water, add 5.0 g of activated carbon, and stir at room temperature for 60 minutes for decolorization. Sterile filtration, washing and filtering twice with 25ml deionized water and combining the filtrate washings, and placing them in a constant pressure dropping funnel for later use.

[0056] Treat with activated carbon, filter aseptically, place 3000ml of filtered isopropanol in a 1 liter three-neck bottle and seal it, drop the above L-lysine solution into the isopropanol at a constant speed of 40 drops per minute After the dropwise addition, stir at room temperature to make it precipitate and turn into crystals. When the process is observed with a polarizing microscope, it can be seen that the product is in a state of solution from hygroscopicity to non-hygroscopic under microscope inspection, and crystals are ob...

Embodiment 3

[0058] Embodiment 3: Preparation of cefereide type C crystalline composition for injection:

[0059] The cefereide type A crystals and L-lysine type B crystals obtained in Example 1 and Example 2 were respectively pulverized with a pulverizer, passed through a 180-200 mesh sieve, and set aside.

[0060] Mix according to the molar ratio of cefereide type A crystal and L-lysine type B crystal at 1:1~1:1.2, fully mix in the three-dimensional powder mixer, and then pack in 1.3g-1.32g per bottle molded glass bottle, that is, the target object.

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Abstract

The invention provides a ceforanide C-type crystal composition used for injection and its preparation method, and discloses a crystal preparation method for high-purity ceforanide hydrochloride A-type crystal, namely (6R,7R)-3-[[[1-(carboxymethyl-1H-tetrazole-5-group] sulfur] methyl butyl-7-[[[2-(aminomethyl)-phenyl]2 acyl] amino]8-oxo-5-thia-1-azabicyclo[4,2,0] octyl-2-vinyl-formic acid and L-lysine B-type crystal respectively, crystal morphology parameters of the ceforanide A-type crystal and the L-lysine B-type crystal, and morphology parameters and medicinal application of ceforanide C-type crystal of sterile mixed powder consisting of the ceforanide A-type crystal and the L-lysine B-type crystal for injection for the first time.

Description

technical field [0001] Cefereide for injection is a known antibiotic widely used in clinic, and the present invention belongs to the discovery of a new crystal form in the field of its preparation. However, this crystalline form has not been discovered and disclosed yet, and when this form is dissolved in water for injection, it has the same curative effect as clinical application. Background technique [0002] Ceforanide (Ceforanide molecular formula C20H21N7O6S2 molecular weight 519.56 CAS registration number [60925-61-3]), this drug composition is composed of L-lysine as a co-solvent for injection (Ceforanide for Injection synonym Radacef, commodity Name Precef, chemical number BL-S786), is actually a mixed powder of two sterile raw powders of cefereide and L-lysine, which is manufactured by Bristol-Myers-Squibb (BMS for short) ) research and development, launched in the United States in 1984. [0003] At present, in the open literature about the preparation method of c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/18A61P31/04
Inventor 刘家健游莉李波邓盛齐邵瑞杰
Owner SICHUAN INDAL INST OF ANTIBIOTICS CHINA NAT PHARMA GROUP CORP
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