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Sodium fusidate freeze-drying powder injection preparation with double auxiliary materials for injection

A technology of sodium fusidate and freeze-dried powder injection, which is applied in the field of freeze-dried sodium fusidate injection for injection with double excipients and its preparation field, and can solve the problems of low product clarity and solution color pass rate, and high drying temperature , Long freeze-drying time and other problems, to achieve the effect of reducing production freeze-drying time, lowering drying temperature, and excellent product quality

Inactive Publication Date: 2018-03-20
刘兴付
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Since the commercially available freeze-dried sodium fusidate powder for injection is produced with a single mannitol, it has long freeze-drying time during production, high drying temperature, high energy consumption, and poor product clarity and solution color pass rate. low disadvantage

Method used

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  • Sodium fusidate freeze-drying powder injection preparation with double auxiliary materials for injection
  • Sodium fusidate freeze-drying powder injection preparation with double auxiliary materials for injection
  • Sodium fusidate freeze-drying powder injection preparation with double auxiliary materials for injection

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Effect test

Embodiment 1

[0024] Embodiment 1, sodium fusidate freeze-dried powder for injection, in 1000 bottles

[0025] Prescription (specification: 125mg / bottle):

[0026]

[0027] Preparation Process:

[0028] a) Dissolve the prescribed amount of mannitol in water for injection, place it in a constant temperature water bath magnetic stirrer and stir at 80°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively The sodium fusidate was kept at 80°C and continued to stir until it was completely dissolved, and the volume was adjusted to 2000ml with water for injection, and the pH value of the solution was adjusted to 7.5.

[0029] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm filter membranes for 30 minutes;

[0030] c) Sampling inspection, put the vial containing the liquid medicine into the vacuum freeze dryer and turn on the machine, quickly cool down to minus 45°C withi...

Embodiment 2

[0031] Embodiment two, sodium fusidate freeze-dried powder for injection, in 1000 bottles

[0032] Prescription (specification: 125mg / bottle):

[0033]

[0034] Preparation Process:

[0035] a) Dissolve the prescribed amount of mannitol in water for injection, place it in a constant temperature water bath magnetic stirrer and stir at 80°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively The sodium fusidate was kept at 80°C and continued to stir until it was completely dissolved, and the volume was adjusted to 2000ml with water for injection, and the pH value of the solution was adjusted to 7.5.

[0036] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm membranes for 30 minutes.

[0037] c) Sampling inspection, put the vial containing the liquid medicine into the vacuum freeze dryer and turn on the machine, quickly cool down to minus 45°C within 55-...

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Abstract

The invention provides a freeze-dried sodium fusidate powder for injection with double auxiliary materials, relates to the field of pharmaceutical preparations and preparation methods, and mainly solves the problem of excipients in the production formula of sodium fusidate freeze-dried powder for injection in the prior art The disadvantages of long freeze-drying time during production, high drying temperature, high energy consumption, and low pass rate of finished product clarity and solution color. The sodium fusidate freeze-dried powder for injection uses double excipients, the excipients include mannitol and hydroxyethyl starch 130 / 0.4, the main drug is sodium fusidate, and the weight ratio of the main drug sodium fusidate to the auxiliary materials 100:100‑100:120, the weight ratio between mannitol and hydroxyethyl starch 130 / 0.4 is 100:70‑100:90. The above main drug and auxiliary materials are used to prepare sodium fusidate freeze-dried powder for injection. The sodium fusidate freeze-dried powder for injection provided by the invention is stable in quality, safe and effective, simple in production process, short in freeze-drying time during production, low in drying temperature, low in energy consumption, high in the clarity of the finished product and high pass rate of solution color .

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to a freeze-dried sodium fusidate powder for injection with double auxiliary materials and a preparation method thereof. Background technique: [0002] The main drug of sodium fusidate freeze-dried powder for injection is an antibiotic with a steroidal skeleton, which produces a bactericidal effect by inhibiting bacterial protein synthesis, and has a strong effect on a series of Gram-positive bacteria Antibacterial effect. Staphylococci, including strains resistant to penicillin, methicillin and other antibiotics, are highly sensitive to this product. It is mainly used for various infections caused by various sensitive bacteria, especially staphylococcus, such as osteomyelitis, sepsis, endocarditis, cystic fibrosis with repeated infections, pneumonia, skin and soft tissue infections, surgical and traumatic infections, etc. . At present, the exci...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/56A61K47/26A61K47/36A61P31/04
CPCA61K31/56A61K9/0019A61K9/19A61K47/26A61K47/36
Inventor 刘兴付
Owner 刘兴付
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