Cefpiramide composite

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

Active Publication Date: 2012-05-09
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • 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 Dissolution rate investigation of compositions such as glucose and sodium carbonate

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

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

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

[0021] Dissolution method: According to the routine operation, 0.9% sodium chloride injection and 10ml of 5% glucose injection were used for dissolving. The results are shown in Table 1.

[0022] Table 1 Comparison of dissolution rates of pure sodium carbonate and mixtures of sodium carbonate and (c) at different temperatures

[0023]

[0024] It can be seen from Table 1 that the dissolu...

Embodiment 2

[0026] Take by weighing sodium carbonate 190g, glucose monohydrate 500g, add cefpiramide 1000g after mixing homogeneously, then mix uniformly, then pack by powder injection routine production process and make cefpiramide powder injection for injection.

Embodiment 3

[0028] Take by weighing sodium carbonate 190g, sodium chloride 50g, add cefpiramide 1000g after mixing, mix again, then pack by powder injection conventional production process and make injection cefpiramide 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, and is particularly suitable for manufacturing cefpiramide powder 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 effect and rare and mild adverse reactions. Cefpiramide is insoluble in water, and in clinical use, it is dissolved in the form of its sodium salt and administered by intramuscular injection, intravenous injection or intravenous drip. [0003] The cefpiramide powder for injection currently on the market is a combination of cefpiramide and sodium carbonate, which mainly has the disadvantage that it is difficult to dissolve when it is infused with electrolyte solution or glucose solution in clinical use, such as at about 25°C , It takes 2 to 3 minutes to completely dissolve. If the wall is sticky an...

Claims

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Application Information

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