Anti-infective pharmaceutical composition containing cefminox

A technology of cefminox and cefminox sodium, applied in the field of medicine, can solve problems such as unsatisfactory effects, aggravated kidney damage, and accumulation

Inactive Publication Date: 2010-07-21
深圳四环医药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The requirements for the production environment of sterile packaging products are relatively high. Because the raw material of cefminox sodium is unstable, especially in aqueous solution, it is easily degraded when dissolved in infusion, resulting in insoluble matter; and cefminox sodium is cleared through the kidneys, clinically Studies have confirmed that in patients with renal impairment, the clearance rate of cefminox sodium is significantly reduced, which is likely to cause accumulation in the body and aggravate the damage to the kidneys. Therefore, in the process of clinical application, it brings safety problems
[0004] Product stability and nephrotoxicity problems limit the wide application of this product. Although many manufacturers add a large amount of stabilizers in the production process to improve drug stability, the effect is still unsatisfactory

Method used

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  • Anti-infective pharmaceutical composition containing cefminox
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  • Anti-infective pharmaceutical composition containing cefminox

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0017] The preparation of the composition aseptic powder injection of embodiment the present invention

[0018] Prescription 1

[0019] Cefminox Sodium 500g

[0020] Na 2 HPO 4 0.4g

[0021] NaH 2 PO 4 0.1g

[0022] Arginine 50g

[0023]

[0024] A total of 1000 sticks were prepared

[0025] Prescription 2

[0026] Cefminox Sodium 1000

[0027] Na 2 HPO 4 0.3g

[0028] NaH 2 PO 4 9.7g

[0029] Arginine 10g

[0030]

[0031] A total of 1000 sticks were prepared

[0032] Prescription 3

[0033] Cefminox Sodium 2000g

[0034] Na 2 HPO 4 80g

[0035] NaH 2 PO 4 120g

[0036] Arginine 200g

[0037]

[0038] A total of 1000 sticks were prepared

[0039] Prescription 4

[0040] Cefminox Sodium 500g

[0041] Na 2 HPO 4 1g

[004...

experiment example 1

[0065] The investigation of experimental example 1 cefminox sodium solution stability

[0066] Test sample 1, listed cefminox sodium sterile powder injection;

Embodiment 1

[0067] Sample 2, the composition of the present invention, is taken from Example 1 prescription 2;

[0068] Sample 3, the composition of the present invention, is taken from Example 1 prescription 4;

[0069] Sample 4, the composition of the present invention, is taken from prescription 5 of Example 1.

[0070] (1) The influence of pH value on the stability of cefminox sodium

[0071] The experimental method simulates the concentration of routine clinical drugs, prepares a compatible solution of cefminox sodium and sodium chloride infusion with a concentration of 5 mg / mL, and puts it in a biochemical incubator (25±2°C) at 0, 1, 2, 4, 6. Observe the appearance of the solution for 8 hours and measure the pH value. Simultaneously draw the above solution, dilute it into a dilute solution with a concentration of 25 μg / mL, take water as a blank, measure the absorbance at 272nm wavelength, calculate the content of cefminox sodium, and use The content of 0h is 100%, and the relative...

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PUM

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Abstract

The invention belongs to the technical field of medicines, discloses an anti-infective pharmaceutical composition containing cefminox, and relates to a preparation method of the pharmaceutical composition and an application of the medicine in preparing the medicines for treating infectious diseases. By the combination of the cefminox, Na2HPO4 / NaH2PO4 and arginine, the invention solves the problem of the prior art that the cefminox is easy to hydrolyze and is unstable after storage and clinical dosage. The pharmaceutical composition has stable property, convenient storage and improved clinical medication safety.

Description

1. Technical field [0001] The invention belongs to the technical field of medicine, and relates to an anti-infective pharmaceutical composition containing cefminox, which consists of cefminox sodium, Na 2 HPO 4 / NaH 2 PO 4 And arginine composition, also relate to its preparation method. 2. Background technology [0002] Cefminox sodium (Cefminox sodium) is a new generation of cephalosporin developed by Meiji Company in Japan. Now it has been produced in my country. It has broad-spectrum antibacterial activity against Gram-positive bacteria and Gram-negative bacteria, especially Escherichia coli , Klebsiella, Haemophilus influenzae, Proteus and Bacteroides fragilis have a strong antibacterial effect. It is suitable for inflammations such as pneumonia, pharyngitis and urinary tract infection. The clinical dosage of cefminox sodium is large, the curative effect is definite, and the market prospect is good. [0003] The dosage form of cefminox sodium listed for intravenous ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/02A61K47/16A61K9/14A61P31/04
Inventor 郭维城车冯升孟宪慧贾中新霍彩霞
Owner 深圳四环医药有限公司
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