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Sodium fusidate freezing-dried powder injection

A technology for sodium fusidate and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of sodium fusidate, can solve the problems of affecting patient medication safety, unqualified product quality, poor long-term stability, etc. Risk, the effect of improving safety

Active Publication Date: 2008-03-19
HAISCO PHARMA GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We conducted a stability study on it. Although this preparation can better solve the problem of precipitation in compatibility, its long-term stability is very poor. The related substances exceed the standard within 3 months or even less, resulting in unqualified product quality, which seriously Affect the patient's drug safety

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Take water for injection, let it cool to 30°C, add glycine, arginine, lactose and mannitol according to the prescription amount described in Table 1, and stir to dissolve. Adjust the pH of the solution to 8.0-9.0, add sodium fusidate in the prescription amount described in Table 1, stir to dissolve, and add water for injection to the full amount. Add special activated carbon for injection to the liquid medicine, stir for 15 minutes, decarbonize and filter. 0.22 ~ 0.45μm microporous membrane fine filter sterilization, filling liquid medicine, half cork, freeze-drying, out of the box, cork and cover. Redissolve in buffer solution (components and contents: disodium hydrogen phosphate 196mg, citric acid 10mg, EDTA-2Na 5mg, 10ml in total), and compatibility with 5% glucose injection and 0.9% sodium chloride injection results in stable selection The final dosage of agents and excipients. The research results are shown in Table 1:

[0016] Table 1 Stabilizer dosage selectio...

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PUM

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Abstract

The invention discloses a sodium fusidate freeze-dried powder injection, including the following components and contents (weight portions) of 450 to 550 of sodium fusidate, 30 to 500 of glycin and 40 to 600 of arginine. The sodium fusidate freeze-dried powder injection has good long-period stability and improves the medication safety for the patient and reduces the medication risk, because certain quantity of stabilizer is added into the sodium fusidate freeze-dried powder injection.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of sodium fusidate. Background technique [0002] Sodium fusidate is an antibiotic with a steroidal skeleton. It is mainly used for staphylococcal infections. It is especially suitable for strains resistant to other antibiotics. It is often used for skin, bone tissue and joint infections and endocarditis. [0003] Since sodium fusidate is compatible with 5% glucose or 0.9% sodium chloride, insoluble flocs will appear, and sodium fusidate is unstable in solution, so the sodium fusidate products currently on the market are all Freeze-dried powder for injection is dissolved in the attached special alkaline buffer salt solvent to solve the problem of product compatibility. However, the long-term stability of the product is poor after freeze-drying, and related substances are likely to exceed the standard in long-term storage, and turbidity is likely to occur when it is used in combination, which dir...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/56A61K47/16A61P31/04
Inventor 杨平鲁方平
Owner HAISCO PHARMA GRP INC
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