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Biapenem crystalline compound and composition powder-needle thereof

A biapenem and compound technology, applied in the field of biapenem crystalline compound and its composition powder injection, can solve the problems of high price and the like, and achieve the effects of good stability, good stability and improved drug safety

Active Publication Date: 2013-07-10
SHANDONG LUOXIN PHARMA GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, domestic biapenem is mainly imported, and the price is expensive

Method used

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  • Biapenem crystalline compound and composition powder-needle thereof
  • Biapenem crystalline compound and composition powder-needle thereof
  • Biapenem crystalline compound and composition powder-needle thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Preparation of biapenem crystalline compound: take 1 kg of crude biapenem, add water for injection with a volume 11 times the weight of crude biapenem, and heat to 57°C; Activated carbon with 0.5 times the weight of apenem was decolorized for 30 minutes, filtered, and the filtrate was stirred at 57°C and added with ethanol whose volume was 3.3 times the weight of the crude product of apenem. After stirring for 10 minutes, the volume was added dropwise at a constant speed within 4 to 5 minutes For isopropanol with 1.7 times the weight of the crude product of biapenem, stop heating, stir and cool down. The stirring and cooling is to cool down to 45°C for 15 minutes under stirring at a rotating speed of 20rmp, and then cool down to 14°C under stirring at a rotating speed of 12rmp for 35min, and stand still for 13 hours. Filter, wash twice with 9:1 ethanol:water solution for injection, 0.3 times each time, and dry to obtain the crystalline compound of biapenem with a yield o...

Embodiment 2

[0048]Preparation of biapenem crystalline compound: take 1 kg of crude biapenem, add water for injection whose volume is 11 times the weight of crude biapenem, and heat to 55°C; Activated carbon with 0.5 times the weight of apenem was decolorized for 30 minutes, filtered, and the filtrate was stirred at 55°C and added with ethanol whose volume was 2.5 times the weight of the crude product of apenem. After stirring for 10 minutes, the volume was added dropwise at a constant speed within 4 to 5 minutes For isopropanol with 1.7 times the weight of the crude product of biapenem, stop heating, stir and cool down. The stirring and cooling is to cool down to 43°C for 15 minutes while stirring at a rotating speed of 22rmp, then cool down to 14°C for 35min while stirring at a rotating speed of 11rmp, and let it stand for 13 hours. Filter, wash twice with 9:1 ethanol:water solution for injection, 0.2 times each time, and dry to obtain the crystalline compound of biapenem with a yield of ...

Embodiment 3

[0051] Preparation of biapenem crystalline compound: take 1 kg of crude biapenem, add water for injection with a volume 11 times the weight of crude biapenem, and heat to 57°C; Activated carbon with 0.5 times the weight of apenem was decolorized for 30 minutes, filtered, and the filtrate was stirred at 57°C and added with ethanol whose volume was 4.1 times the weight of the crude product of apenem. After stirring for 10 minutes, the volume was added dropwise at a uniform speed within 4 to 5 minutes For isopropanol with 1.7 times the weight of the crude product of biapenem, stop heating, stir and cool down. The stirring and cooling is to cool down to 46°C for 15 minutes while stirring at a rotating speed of 19rmp, then cool down to 12°C for 35min while stirring at a rotating speed of 13rmp, and let it stand for 15 hours. Filter, wash twice with 9:1 ethanol:water solution for injection, 0.2 times each time, and dry to obtain the crystalline compound of biapenem with a yield of 94...

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Abstract

The invention relates to a biapenem crystalline compound, which is measured by using a powder X-ray diffraction measurement method. An X-ray powder diffraction pattern indicated by a diffraction angle of 2 theta + / -0.2 degree shows feature diffraction peak at the positions of 5.9 degrees, 6.5 degrees, 10.5 degrees, 14.8 degrees, 15.6 degrees, 16.3 degrees, 17.4 degrees, 19.8 degrees, 22.9 degrees, 23.7 degrees, 25.1 degrees, 28.4 degrees and 34.7 degrees. The invention further relates to a biapenem composition powder-needle comprising the biapenem crystalline compound. Components of the composition powder-needle are 95 to 100 parts of the biapenem crystalline compound and 0.1 to 1 part of sodium benzoate.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a biapenem crystalline compound and its composition powder for injection. Background technique [0002] Biapenem (Biapenem) is a 1β-methyl carbapenem antibiotic for injection developed by Lederle Company of Japan. It is clinically applicable to the treatment of secondary infection of chronic bronchitis, pneumonia, pulmonary suppuration, pyelonephritis, complicated cystitis, peritonitis and uterine adnexitis. [0003] This product is stable to DHP-1, and its activity against aerobic G+ bacteria is slightly lower than that of imipenem, and its activity against Pseudomonas aeruginosa and anaerobic bacteria is 2 to 4 times stronger than that of imipenem; it inhibits drug-resistant Pseudomonas aeruginosa Bacillus is 4 to 8 times stronger than meropenem, stable to β-lactamase, and has inhibitory effect. The total effective rate was 87.7%, the bacterial clearance rate was 85.6%, adverse reacti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D519/06A61K31/4196A61K9/14A61P31/04
Inventor 刘明霞刘新泉朱全明
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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