Fusidate sodium composition and preparation of its freeze-drying preparations

A technology of sodium fusidate and its composition, which is applied in the field of pharmaceutical preparations, can solve problems such as poor long-term stability, increased foreign matter, and large material changes, and achieve the effects of improved tolerance, good stability, and simple process

Active Publication Date: 2008-09-17
四川阳光润禾药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparation process of Sodium Fusidate for Injection produced in China is freeze-drying method. There is only Sodium Fusidate as the main drug in its formulation prescription. Each Sodium Fusidate for Injection preparation is attached with a special solvent. The ingredients are disodium hydrogen phosphate and citric acid. During the quality tracking process, it was found that the quality of this product was unstable, and the related substances changed greatly. After compatibility, there were different degrees of opalescence, visible foreign matter increased, and the blood vessels of patients were stimulated. Significantly increased sex and reduced patient tolerance
In addition, Chinese patent application CN1817340A discloses a freeze-dried preparation containing sodium fusidate, in which disodium hydrogen phosphate and citric acid are added, and fusidic acid, disodium hydrogen phosphate, citron The weight ratio of acid is 500: 78~108: 4.5~5.7, and the sodium fusidate lyophilized preparation of this patent application is compared with existing preparation of the same kind, only the buffer pair ( Disodium hydrogen phosphate, citric acid) are add

Method used

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  • Fusidate sodium composition and preparation of its freeze-drying preparations
  • Fusidate sodium composition and preparation of its freeze-drying preparations
  • Fusidate sodium composition and preparation of its freeze-drying preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Each 1000 vials of lyophilized preparation contains the following ingredients:

[0032] Sodium Fusidate 125g

[0033] Mannitol 20g

[0034] Arginine 5g

[0035] Weigh the prescribed amount of mannitol and arginine, add 2000ml of water for injection, stir to dissolve, the temperature of the solution drops below 60°C, then add the prescribed amount of sodium fusidate, stir continuously to dissolve completely, add the prepared total Amount of 0.5% (W / V) activated carbon for injection, stirred and left for 25 minutes, decarburized by filtration, added water for injection to the full amount and set aside. Fine filter the above solution with a 0.22 μm microporous membrane until the filtrate is clear. After the semi-finished product passes the inspection, it is subpackaged and filled into 1,000 10ml vials so that the main drug content is 125mg, and frozen at low temperature (-40°C). 3 hours, primary drying temperature -25°C for 4 hours, 0°C for 7 hours, 18°C ​​for 7 hours, ...

Embodiment 2

[0037] Each 1000 vials of lyophilized preparation contains the following ingredients:

[0038] Sodium Fusidate 125g

[0039] Mannitol 20g

[0040] Arginine 100g

[0041] Disodium edetate 1g

[0042] The raw materials and auxiliary materials of the above prescription were prepared into 1000 bottles of sodium fusidate freeze-dried preparation according to the method of Example 1.

Embodiment 3

[0044] Each 1000 vials of lyophilized preparation contains the following ingredients:

[0045] Sodium Fusidate 125g

[0046] Mannitol 150g

[0047] Arginine 5g

[0048] Disodium edetate 1g

[0049] The raw materials and auxiliary materials of the above prescription were prepared into 1000 bottles of sodium fusidate freeze-dried preparation according to the method of Example 1.

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Abstract

The invention relates to a sodium fusidate combination and the preparation method of freeze dried formulation. Weight ratio of the sodium fusidate, the excipient and the stabilizing agent / pH regulator in the sodium fusidate combination is 25 to 100 : 2 to 100 : 1 to 50, wherein, preferred excipient is glucose and / or mannitol; the stabilizing agent /pH regulator is one from arginine, ethylene diamine tetraacetic acid disodium and EDTA calcium disodium or the mixture. The preparation method is characterized in that: water is used as solvent; the sodium fusidate, the excipient and the stabilizing agent / pH regulator are made into clear and transparent solution before filtered and subpacked, thereby producing freeze dried formulation being suitable for requirement of injection through drying by sublimation, wherein, pH value of the formulation is 7.5 to 9.0 and the formulation of each unit dose comprises 125 to 500mg sodium fusidate. The sodium fusidate combination and the preparation method of freeze dried formulation have the advantages of good stability, convenient use, improvement of drugs tolerance upon patients and simple medical operation, strong practicability, simple technology and good stability of finished product.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a sodium fusidate composition for treating severe staphylococcus infection and a method for preparing the freeze-dried preparation thereof. Background technique [0002] Fusidic acid (Fusidic Acid, also known as brown mycin), the chemical name is 16α-acetoxy-3β, 11β-dihydroxy-4β, 8β, 14α-trimethyl-18-nor-5β, 10α- Cholesta-(17Z)-17(20),24-dien-21-oic acid. In 1962, it was first extracted from the Fusidate coccus fungus in the fermentation broth by the Danish Leo Pharmaceutical Company, and it is now widely used in severe staphylococcal infections, such as sepsis, endocarditis, osteomyelitis, pneumonia, trauma infection and skin infections (impetigo, boils, carbuncles, etc.). In recent years, due to the increasing resistance of staphylococci to antibiotics, the incidence of serious infections is increasing, and the treatment is becoming more and more difficult. Fusidic acid has bee...

Claims

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Application Information

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IPC IPC(8): A61K31/56A61K9/19A61P31/04
Inventor 王颖
Owner 四川阳光润禾药业有限公司
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