Thiamphenicol aminoacetate hydrochloride sterile freeze-drying preparation for injection and preparation method thereof

A technology of thiamphenicol hydrochloride and thiamphenicol acid, which is applied in the field of sterile freeze-dried preparations of thiamphenicol hydrochloride glycine ester for injection and its preparation, can solve the problems of unfavorable drug stability, damage, unfavorable drug carrying and transportation And other problems, to achieve the effect of good stability, long service life, convenient transportation

Inactive Publication Date: 2009-02-11
沈阳石西投资有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The active drug thiamphenicol hydrochloride glycinate is in a solution state for a long time, and is easily hydrolyzed by natural factors, which is not conducive to the stability of the drug
Solution-type injections are also prone to damage during transportation, which is not conducive to the carrying and transportation of drugs

Method used

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  • Thiamphenicol aminoacetate hydrochloride sterile freeze-drying preparation for injection and preparation method thereof
  • Thiamphenicol aminoacetate hydrochloride sterile freeze-drying preparation for injection and preparation method thereof
  • Thiamphenicol aminoacetate hydrochloride sterile freeze-drying preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] The sterile freeze-dried preparation of thiamphenicol hydrochloride glycinate for injection is prepared from 1.3kg of thiamphenicol hydrochloride glycinate, 300ml of PEKG-400, 300ml of propylene glycol and adding water for injection to 6000ml. Make 1000 bottles, each bottle of freeze-dried preparation contains thiamphenicol hydrochloride glycinate 1.3g (calculated as thiamphenicol 1g)

[0019] The preparation method of thiamphenicol hydrochloride glycinate sterile freeze-dried preparation for injection is:

[0020] (1) Get 1.3kg of thiamphenicol hydrochloride glycine ester (calculated as thiamphenicol 1g) of the prescription amount, add 60% water for injection of the total amount, stir to fully disperse, add 300ml of the prescription amount while stirring PEKG-400 and 300ml propylene glycol, stirred in a 40°C water bath until completely dissolved.

[0021] (2) Add activated carbon for needles according to 0.1% of the solution volume, stir for 30 minutes, filter, add wa...

Embodiment 2

[0025] The sterile freeze-dried preparation of thiamphenicol hydrochloride glycinate for injection is prepared from 0.6 kg of thiamphenicol hydrochloride glycinate, 0.1 kg of mannitol, 100 ml of propylene glycol and adding water for injection to 2000 ml. Make 1000 bottles, each bottle of lyophilized preparation contains 0.6g of thiamphenicol hydrochloride glycinate (0.5g in terms of thiamphenicol)

[0026] The preparation method of thiamphenicol hydrochloride glycinate sterile freeze-dried preparation for injection is:

[0027] (1) Get 0.6kg of thiamphenicol hydrochloride glycine ester, add 70% water for injection in total, stir to fully disperse, add 0.1kg of mannitol and 100ml of propylene glycol in the prescribed amount while stirring, stir in a 50°C water bath until completely dissolved.

[0028] (2) Add activated carbon for needles according to 0.2% of the solution volume, stir for 40 minutes, filter, add water for injection to 2000ml, filter with a 0.22μm microporous mem...

Embodiment 3

[0032] The sterile freeze-dried preparation of thiamphenicol hydrochloride glycinate for injection is prepared from 0.6 kg of thiamphenicol hydrochloride glycinate, 0.2 kg of mannitol and adding water for injection to 5000 ml. Make 1000 bottles;

[0033] Each bottle of lyophilized preparation contains 0.6 g of thiamphenicol hydrochloride glycine ester (0.5 g as thiamphenicol).

[0034] The preparation method of thiamphenicol hydrochloride glycinate sterile freeze-dried preparation for injection is:

[0035] (1) Get 0.6kg of thiamphenicol hydrochloride glycine ester of prescription quantity, add the water for injection of 70% of total amount, stir to fully disperse, add 0.2kg of mannitol while stirring, stir in 30 ℃ of water baths until fully dissolving.

[0036] (2) Add activated carbon for needles according to 0.05% of the solution volume, stir for 30 minutes, filter, add water for injection to 5000ml, filter with a 0.22μm microporous membrane, measure the content, fill in c...

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Abstract

The invention relates to a hydrochloric acid thiamphenicol aminoacetic acid ester asepsis lyophilized formulation for injection, which is characterized by being prepared through the following steps: adding right amount of water with 0.6-1.3kg of hydrochloric acid thiamphenicol aminoacetic acid esterc, 0-0.2kg of mannite, 0-1000ml of solubilizer, after evenly mixing, replenishing water for injection to 2000-10000ml, and then respectively filling 1000 bottles; according to the thiamphenico, the content of the thiamphenico in each bottle is 0.5-1.0g; the solubilizer is at least one of propanediol, polyethylene glycol and Polysorbate-80. The hydrochloric acid thiamphenicol aminoacetic acid ester asepsis lyophilized formulation for injection adopts packages of tube schering bottle for antibiotic, seal of butyl rubber stopper and aluminum cap, thus being capable of overcoming the shortages existing in solution-typed injection. The lyophilized formulation is white block-shaped objects with loosen texture, can be quickly dissolved by being added with little water (3-10ml), and then the solution after dissolution is added into physiological saline for being clinically applied. The lyophilized formulation has good drug stability, long valid useful-life, convenient clinical use, portability and transportation, thus being a new formulation for the clinical use of the hydrochloric acid thiamphenicol aminoacetic acid ester.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to a sterile freeze-dried preparation of thiamphenicol hydrochloride glycinate for injection and a preparation method thereof. Background technique [0002] Thiamphenicol is a synthetic broad-spectrum antibiotic and a substitute for chloramphenicol. Its antibacterial effect in vivo is stronger than that of chloramphenicol, but its toxicity is less than that of chloramphenicol. Thiamphenicol has poor water solubility, and its dosage form and clinical application are limited, so it is esterified to obtain thiamphenicol hydrochloride glycine ester. [0003] Basic pharmacological studies have shown that the drug can be used as a prodrug of thiamphenicol to make various preparations (injections, granules, oral liquids, etc.), and release thiamphenicol after enzymatic hydrolysis in vivo to exert pharmacological effects. Therefore, thiamphenicol hydrochloride glycinate and thiamphenicol h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/22A61K31/16A61K9/19A61P31/04
Inventor 马占芝刘宇姚东民赵鑫
Owner 沈阳石西投资有限公司
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