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Composition of sodium fusidafe for injection and preparing method thereof

A technology of sodium fusidate and its composition, applied in the field of pharmaceutical preparations, can solve the problems of high buffer salt consumption, high cost, irritation and pain at venipuncture site, achieve simple process, improve tolerance and reduce production cost Effect

Active Publication Date: 2009-06-03
SHANDONG BESTCOMM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Two different production lines are required for production, and the cost is high
The high amount of buffer salt in the special solvent may cause irritation and pain at the venipuncture site in clinical application, and sometimes cause phlebitis

Method used

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  • Composition of sodium fusidafe for injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Take 4 / 5 of the prescribed amount of water for injection, add the prescribed amount of disodium edetate, and stir to dissolve. Add the prescribed amount of mannitol, disodium hydrogen phosphate and citric acid, stir to dissolve completely, let cool to room temperature, add the prescribed amount of sodium fusidate, stir to dissolve, add water for injection to the full amount. Add special activated carbon for injection to the liquid medicine, stir for 30 minutes, decarbonize and filter. 0.22μm microporous membrane filter to sterilize. Filling liquid medicine, half plug. Freeze-dried, cork and cap.

[0020] The final dosage of buffering agent and metal ion complexing agent is selected according to the results of dissolution, reconstitution and compatibility. The research results are shown in Table 1

[0021] Table 1 Selection results of buffer dosage

[0022] prescription 1 2 3 4 5 6 7 8 fusidic acid

Embodiment 2

[0024] Sodium fusidate for injection prepared according to prescription 6 was placed under high temperature (60°C), high temperature (40°C) and light (45001x) conditions for 10 days respectively, and samples were taken at 5 and 10 days respectively to check the quality The index results are shown in Table 2.

[0025] The results showed that sodium fusidate for injection was placed in high temperature (60°C), light (45001x) and high temperature (40°C) environment for 10 days, and all quality indicators were checked, compared with 0 days, except for high temperature (60°C). The substance increases, the content decreases, and the color changes; except for the light (45001x) related substances increase slightly, other indicators have no obvious changes.

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Abstract

A freeze-dried powder injection of sodium fusidate composition for treating the serious Staphylococcus infection contains sodium fusidate, bisodium hydrogen phosphate and citric acid in weight ratio of 500: (78-113): (4-5.7). The water for injection is used as its solvent.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation containing sodium fusidate for treating various severe staphylococcal infections and a preparation method thereof. Background technique [0002] Fusidic acid (Fusidic Acid, also known as brown mycin), belongs to fusidic acid antibiotics. It was first extracted from Fusidium coccineum fungus in 1962 by the Danish Leo Pharmaceutical Company. The antibacterial mechanism is to interfere with the elongation factor G by inhibiting the translocation of ribosomes, thereby hindering the synthesis of bacterial proteins. This unique mechanism of action avoids cross-resistance with other antibacterial drugs. Although it has been widely used abroad for more than 30 years (the domestic clinical application is less), it still maintains strong antibacterial activity and low drug resistance rate against most Staphylococcus strains, which has attr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/06A61K9/19A61K47/16A61K31/575A61P31/04
Inventor 孟凡清牛传芹刘理南
Owner SHANDONG BESTCOMM PHARMA CO LTD
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