Cephalosporin medicinal composition

A composition and drug technology, applied in the direction of drug combination, active ingredients of heterocyclic compounds, anti-infective drugs, etc., can solve the problems of large differences between batches, large differences in loading volume, and high water content of products, and achieve stable quality and proportion. Stable and uniform effect

Inactive Publication Date: 2013-11-13
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The pharmaceutical compositions of Compound I and Compound II disclosed in the prior art are all obtained by directly mixing the raw materials Compound I and Compound II, and the obtained pharmaceutical compositions have different particle sizes, uneven particle size distribution, and differences in the volume of packaging. Large, high moisture content in the product and large differences between batches, which seriously affect the safety of the preparation product

Method used

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  • Cephalosporin medicinal composition
  • Cephalosporin medicinal composition
  • Cephalosporin medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Three batches of compound I and compound II raw materials purchased from different manufacturers were tested according to the standards of compound I and compound II in the second part of the 2010 edition of "Chinese Pharmacopoeia". Meet the relevant requirements of the standard.

[0061] Take 3 batches of compound I and 3 batches of compound II to pulverize and sieve respectively, each batch screened out D 90 Groups I and D of compounds whose particle sizes are 175 μm, respectively 90 Groups of Compound II whose particle size is 175 μm; 1500 g of Compound I (based on the weight of the free acid of Compound I) and 90 Compound II750g (by weight of compound II free acid) taken by each compound II group with the same particle size was mixed uniformly; to obtain D 90 There are 27 groups of pharmaceutical compositions of Compound I and Compound II with particle sizes 175 μm respectively (the weight of Compound I calculated as Compound I free acid and the weight of Compound...

Embodiment 2

[0063] Prepare according to the preparation method of Example 1 to obtain 27 groups of pharmaceutical compositions of Compound I and Compound II after packaging (compound I in the pharmaceutical composition in terms of Compound I free acid and Compound II in terms of Compound II free acid The weight ratio is 3:1), from the 27 groups of pharmaceutical compositions of compound I and compound II after packaging, 9 groups of pharmaceutical compositions with different particle sizes and moisture were screened for use. The particle size and moisture content of each group of pharmaceutical compositions are as follows: Shown in Table 1; where D 90 Table 2 shows the water content of the nine groups of pharmaceutical compositions of Compound I and Compound II with particle sizes ranging from 95 μm to 175 μm.

Embodiment 3

[0065] Prepare according to the preparation method of Example 1 to obtain the pharmaceutical composition of Compound I and Compound II (the weight ratio of Compound I in terms of Compound I free acid and Compound II in terms of Compound II free acid in the pharmaceutical composition is 4:1 ). Screen out 9 groups of pharmaceutical compositions with different particle sizes and moisture from the prepared pharmaceutical compositions of Compound I and Compound II for subsequent use, and the particle size and moisture content of each group of pharmaceutical compositions are as shown in Table 1; wherein D 90 Table 2 shows the water content of the nine groups of pharmaceutical compositions of Compound I and Compound II with particle sizes ranging from 95 μm to 175 μm.

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Abstract

The invention discloses a cephalosporin medicinal composition, consisting of a compound I, a compound II and water of which the quantity is 1.0-2.8 percent of the weight of the medicinal composition, wherein the D90 granularity of the medicinal composition is 95-175 microns. The medicinal composition is good in stability, content uniformity and packaging uniformity, the quality of the antibacterial medicinal composition is effectively ensured, and the safety of medication is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical compositions, in particular to a pharmaceutical composition composed of compound I and compound II and a powder injection preparation thereof. Background technique [0002] Compound I (its structural formula shown in formula I) is a second-generation cephalosporin, as a broad-spectrum antibiotic, it has strong antibacterial effects on gram-positive bacteria and most gram-negative bacteria, and Hepatotoxicity and nephrotoxicity are low. With the widespread clinical application of compound I, some strains that were originally sensitive have developed resistance to it, resulting in a decline in its antibacterial effect. Studies have found that the main mechanism of bacterial resistance to cephalosporins is to produce specific β-lactamase to decompose the drug. [0003] Compound II (its structural formula is shown in formula II) is a β-lactamase inhibitor, which is usually used as a pharmaceutical prod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61K31/43A61K9/16A61P31/00G01N15/14
Inventor 华怀杰植建琼郭玉倩向俞滔范飞蝶
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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