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A kind of preparation method of biapenem solid dispersion for injection

A solid dispersion, biapenem technology, applied in the field of preparation of biapenem solid dispersion for injection, can solve the problems of long dissolution time, low solubility, poor stability, etc., achieve stable chemical properties and shorten dissolution time , Improve the effect of drug stability and bioavailability

Active Publication Date: 2015-10-28
AMICOGEN CHINA BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the disadvantages of low solubility in water, long dissolution time and poor stability in aqueous solution of biapenem in the prior art, the present invention provides a preparation method of biapenem solid dispersion for injection, which improves the Stability and bioavailability, and greatly shorten the dissolution time, while improving solubility, requires smaller packaging

Method used

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  • A kind of preparation method of biapenem solid dispersion for injection
  • A kind of preparation method of biapenem solid dispersion for injection
  • A kind of preparation method of biapenem solid dispersion for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0025] (1) First add 1g Poloxamer F68 and 10g PEG-4000 into 1000ml aqueous solution for injection, stir to dissolve, then add 20g biapenem, stir to dissolve, then add 10g mannitol, stir to dissolve, and obtain solution I;

[0026] (2) Add 1 g of activated carbon for needles to solution I, stir at 50°C for 30 minutes, and cool to room temperature to obtain solution II;

[0027] (3) Decarburize the solution II with a 0.45 μm microporous membrane to obtain a filtrate I, and then filter the filtrate I through a 0.22 μm microporous membrane to obtain a filtrate II;

[0028] (4) Fill the filtrate II with 0.3 g of biapenem in each bottle, and freeze-dry to obtain a solid dispersion of biapenem for injection.

Embodiment 2

[0030] (1) First add 5.5g Poloxamer F68 and 105g PEG-4000 into 1000ml aqueous solution for injection, stir to dissolve, then add 30g biapenem, stir to dissolve, then add 15g mannitol, stir to dissolve to obtain solution I;

[0031] (2) Add 1.5 g of activated carbon for needles to solution I, stir at 50°C for 30 minutes, and cool to room temperature to obtain solution II;

[0032] (3) Decarburize the solution II with a 0.45 μm microporous membrane to obtain a filtrate I, and then filter the filtrate I through a 0.22 μm microporous membrane to obtain a filtrate II;

[0033] (4) Fill the filtrate II with 0.3 g of biapenem in each bottle, and freeze-dry to obtain a solid dispersion of biapenem for injection.

Embodiment 3

[0035] (1) First add 10g Poloxamer F68 and 200g PEG-4000 into 1000ml aqueous solution for injection, stir to dissolve, then add 40g biapenem, stir to dissolve, then add 20g mannitol, stir to dissolve, and obtain solution I;

[0036] (2) Add 2 g of activated carbon for needles to solution I, stir at 60°C for 30 minutes, and cool to room temperature to obtain solution II;

[0037] (3) Decarburize the solution II with a 0.45 μm microporous membrane to obtain a filtrate I, and then filter the filtrate I through a 0.22 μm microporous membrane to obtain a filtrate II;

[0038] (4) Fill the filtrate II with 0.3 g of biapenem in each bottle, and freeze-dry to obtain a solid dispersion of biapenem for injection.

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Abstract

The invention belongs to the field of pharmacy, relates to a method for preparing a biapenem solid dispersion, and in particular relates to a method for preparing an injection biapenem solid dispersion. The method comprises the following steps: adding injection water containing PEG-4000 (polyethylene glycol-4000) and poloxamer F68 into biapenem, stirring and dissolving; filtering and sterilizing, filling, and lyophilizing to obtain the biapenem solid dispersion. Compared with an existing sterile subpackaged product, the method provides the injection biapenem solid dispersion with stable property and quick dissolution, so that the medicine solubility can be improved, and the solution time can be greatly shortened, due to the prepared solid dispersion.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a preparation method of a biapenem solid dispersion, in particular to a preparation method of a biapenem solid dispersion for injection. technical background [0002] Biapenem (biapenem) is a new type of 1β-methyl carbapenem antibiotic for injection developed by Lederle Company of Japan and Cyanoamide Company of the United States in 1989. It has been listed in Japan in March 2002 and is widely used clinically. Acute and chronic infections caused by Gram-negative aerobic bacteria, Gram-positive aerobic bacteria and anaerobic bacteria that are more sensitive to apenem, and are mainly used for concurrent intra-abdominal infection and lower respiratory tract infection (including bacterial pneumonia) And concurrent urinary tract infection. In addition, biapenem has a good curative effect in the treatment of plastic surgery infection, gynecological infection and ear, nose and throat infection. T...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4196A61K47/34A61K47/10A61P31/04
Inventor 杜希兵赵新祥胡维智
Owner AMICOGEN CHINA BIOPHARM CO LTD