Azlocillin sodium freeze-dried powder injection for injection prepared from double excipients

A technology for azlocillin sodium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations and preparations, can solve the problems of low qualification rate of finished product clarity and solution color, high drying temperature, long freeze-drying time, etc., so as to reduce the production of freeze-drying Time, excellent product quality, the effect of improving productivity

Inactive Publication Date: 2018-01-30
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 azlocillin sodium freeze-dried powder for injection is produced with a single auxiliary material, mannitol, it has long freeze-drying time during production, high drying temperature, high energy consumption, and low pass rate of product clarity and solution color. Shortcomings

Method used

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  • Azlocillin sodium freeze-dried powder injection for injection prepared from double excipients
  • Azlocillin sodium freeze-dried powder injection for injection prepared from double excipients
  • Azlocillin sodium freeze-dried powder injection for injection prepared from double excipients

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0025] Prescription (specification: 0.5g / bottle):

[0026]

[0027] Preparation Process:

[0028] a) Dissolve the prescribed amount of mannitol in water for injection, place in a constant temperature water bath and stir with a magnetic stirrer at a temperature of 25°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Azlocillin sodium, kept at 25°C and continued to stir until completely dissolved, was fixed to 2000ml with water for injection, and the pH value of the solution was adjusted to 6.5.

[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, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer after half-tightening...

Embodiment 2

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

[0032] Prescription (specification: 0.5g / bottle):

[0033]

[0034] Preparation Process:

[0035] a) Dissolve the prescribed amount of mannitol in water for injection, place in a constant temperature water bath and stir with a magnetic stirrer at a temperature of 25°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Azlocillin sodium, kept at 25°C and continued to stir until completely dissolved, was fixed to 2000ml with water for injection, and the pH value of the solution was adjusted to 6.5.

[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, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer after half-tightening, turn on the ma...

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Abstract

The invention provides an azlocillin sodium freeze-dried powder injection for injection prepared from double excipients, relates to the field of pharmaceutical preparation and preparation method, andmainly overcomes the defects that the excipients in a production formula of an azlocillin sodium freeze-dried powder injection for injection has long freeze-drying time, high drying temperature and high energy consumption in production in the prior art. The azlocillin sodium freeze-dried powder injection for injection uses double excipients including mannitol and hydroxyethyl starch 130/0.4, the main drug is azlocillin sodium, the weight ratio of the main drug to the excipients is (100:100)-(100:130), and the weight ratio of mannitol to hydroxyethyl starch 130/0.4 is (100:50)-(100:80). The azlocillin sodium freeze-dried powder injection for injection is prepared from the main drug and the excipients. The azlocillin sodium freeze-dried powder injection for injection provided by the invention has the advantages of stable quality, safety and effectiveness, simple product production process, short drying time, low drying temperature and low energy consumption in production.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to an azlocillin sodium freeze-dried powder for injection with double auxiliary materials and a preparation method thereof. Background technique: [0002] Azlocillin sodium for injection is a penicillin antibiotic, the third-generation broad-spectrum semi-synthetic penicillin, mainly used for various infections caused by sensitive Gram-positive bacteria and negative bacteria and Pseudomonas aeruginosa infection, including sepsis, meninges Inflammation, endocarditis, suppurative pleurisy, peritonitis and infection of lower respiratory tract, gastrointestinal tract, biliary tract, urinary tract, bone, soft tissue and reproductive organs, gynecological and obstetrical infection, malignant otitis externa, burns, skin and surgical infection, etc. . At present, the auxiliary materials used in the industrial production of azlocillin sodium freeze-dried p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/431A61K47/10A61K47/36A61P31/04
Inventor 刘兴付
Owner 刘兴付
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