Cefpiramide composite

A technology of cefpiramide and its composition, which is applied in the field of pharmaceutical manufacturing, can solve the problems of high energy consumption, difficult quality assurance, unfavorable production and application, etc., and achieve the effects of easy-to-obtain raw materials, good drug stability, and simple operation by nurses

Active Publication Date: 2011-02-09
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The composition prepared by mixing ultra-fine sodium carbonate and cefpiramide evenly has a faster dissolution rate than the composition disclosed in Chinese patent CN163407, but it still takes about 1 minute to dissolve when the temperature is low, and the dissolution rate is still unsatisfactory.
Simultaneously, the preparation cost of superfine sodium carbonate is high, and energy consumption is big, is unfavorable for production application, especially the production of aseptic superfine sodium carbonate, quality is more difficult to guarantee

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1 Investigation of the dissolution rate of the composition of glucose, etc. and sodium carbonate

[0018] The following two sets of samples are used to investigate the dissolution rate of pure sodium carbonate (sample 1) and a mixture of sodium carbonate and (c) (sample 2) using clinically commonly used infusions at different temperatures:

[0019] Sample 1: Weigh 50g of sodium carbonate and pack it in 0.50g / bottle.

[0020] Sample 2: Weigh 50g of sodium carbonate, (c) an appropriate amount of component (see Table 1), mix well, and pack at 0.50g (containing sodium carbonate) / bottle.

[0021] Dissolution method: use common clinical infusion 0.9% sodium chloride injection and 5% glucose injection 10ml to dissolve according to routine operation. The results are shown in Table 1.

[0022] Table 1 Comparison of the dissolution rate of pure sodium carbonate and the mixture of sodium carbonate and (c) at different temperatures

[0023]

[0024] It can be seen from Table 1 tha...

Embodiment 2

[0026] Weigh 190g of sodium carbonate and 500g of dextrose monohydrate, add 1000g of cefpiramide after mixing uniformly, and then mix uniformly, and then divide into cefpiramide powder injection for injection according to the conventional production process of powder injection.

Embodiment 3

[0028] Weigh 190g of sodium carbonate and 50g of sodium chloride, mix well, add 1000g of cefpiramide, mix well, and then divide into cefpiramide powder for injection according to the conventional production process of powder injection.

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Abstract

The invention relates to a cefpiramide composite which is used for the cefpiramide powder-injection in the medicinal manufacture field. The invention discloses the following characteristic of the cefpiramide composite: the composite for the cefpiramide powder-injection which is prepare by the conventional production technology of powder-injection contains two or more of the following components: (a) sterile cefpiramide, (b) sterile sodium carbonate; and (c) sterile anhydrous glucose, dextrose monohydrate, sodium chloride, mannitol, sorbitol, anhydrous lactose or lactose monohydrate, wherein the weight ratio of the component (a) to the component (b) and the component (c) is 1:0.15-0.4:0.03-4.0. The invention has the advantages that the problem that the cefpiramide for injection on the market is difficult to dissolve, especially at a low temperature is solved; the operation of the nurse is easy; and the raw materials are accessible and the drug stability is good.

Description

Technical field [0001] The invention relates to the pharmaceutical manufacturing industry, in particular to the manufacture of cefpiramide powder injection for injection. Background technique [0002] Cefpiramide is a third-generation cephalosporin with a broad antibacterial spectrum. It has been widely used in the clinical treatment of bacterial infections, with definite curative effects and rare but minor adverse reactions. Cefpiramide is insoluble in water and is administered by intramuscular injection, intravenous injection or intravenous drip after being dissolved in the form of its sodium salt in clinical use. [0003] The currently marketed cefpiramide powder injections for injection are all a combination of cefpiramide and sodium carbonate, which mainly suffers from the shortcoming that it is difficult to dissolve in clinical use in infusion such as electrolyte solution or glucose solution according to routine operations, such as at about 25°C , It takes 2 to 3 minutes to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/04A61K31/546A61P31/04A61K9/14A61K47/26
Inventor 谭胜连司徒小燕陈大为
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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