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Ortho diphenylhydratoin freeze dried powder for injection and its preparation method

A technology of fosphenytoin sodium and freeze-dried powder injection, which is applied in the field of fosphenytoin sodium freeze-dried powder injection and preparation, which can solve the problems of easy generation of fine precipitation, increased toxic and side effects, and reduced content of the main drug, so as to facilitate storage and transportation and sales, preparation stability, and the effect of extending the validity period

Inactive Publication Date: 2004-12-22
陈庆财 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the hydrolysis reaction of phosphate ester, the stability of this kind of injection is reduced, fine precipitation is easily produced, the content of the main drug is reduced, the curative effect is reduced, and the toxic and side effects are increased.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Example 1: 50mg / bottle specification, 1000 freeze-dried powder injection formulations

[0015] Fosphenytoin Sodium 50g

[0016] Tromethamine 25g

[0017] Water for injection is added to 2000ml, which is made into 1000 pieces.

[0018] According to the formulation prescription of Example 1, weigh 50g of fosphenytoin sodium, put it in a container, add 1800ml of water for injection, and add 25g of tromethamine, heat and stir until dissolved, let it cool, and adjust the pH to 8.6~ with 1mol / L phosphoric acid 9.0, add 0.9g of charcoal for needles, stir at 50-80°C for 30 minutes, after decarbonization, measure the content of intermediates, and add water for injection to 2000ml, under sterile conditions, use a 0.22μm microporous membrane filter to sterilize, The filtrate was divided into 10ml vials, 2ml per bottle, stoppered, freeze-dried, filled with N 2 , Cork, Pack.

[0019] Wherein, fosphenytoin is the main drug, and tromethamine is the stabilizer. According to the lit...

Embodiment 2

[0021] Embodiment 2: 150mg / bottle specification, 1000 freeze-dried powder injection formulations

[0022] Fosphenytoin Sodium 150g

[0023] Tromethamine 70g

[0024] Water for injection is added to 2000ml, which is made into 1000 pieces.

[0025] According to the formulation prescription of Example 2, weigh 150g of fosphenytoin sodium, put it in a container, add 1800ml of water for injection, and add 70g of tromethamine, heat and stir until dissolved, let it cool, adjust the pH to 8.6~ with 1mol / L phosphoric acid 9.0, add 0.9g of charcoal for needles, stir at 50-80°C for 30 minutes, after decarbonization, measure the content of intermediates, and add water for injection to 2000ml, under sterile conditions, use a 0.22μm microporous membrane filter to sterilize, The filtrate was divided into 10ml vials, 2ml per bottle, stoppered, freeze-dried, filled with N 2 , Cork, Pack.

Embodiment 3

[0026] Embodiment 3: 750mg / bottle specification, 1000 freeze-dried powder injection formulations

[0027] Fosphenytoin Sodium 750g

[0028] Tromethamine 300g

[0029] Water for injection is added to 8000ml, and it is made into 1000.

[0030] Its preparation process is as follows:

[0031] According to the ingredients of the preparation prescription in Example 3, take 750g of fosphenytoin sodium and put it in a container, add 6500ml of water for injection, and add 300g of tromethamine, heat and stir until dissolved, and after cooling, adjust the pH to 8.6~ with 1mol / L phosphoric acid 9.0, add 3.25 g of charcoal for needles, stir at 50-80 ° C for 30 minutes, decarbonize, measure the content of intermediates, add water for injection to 8000 ml, and filter bacteria with a 0.22 μm microporous membrane under sterile conditions, and separate the filtrate Packed in 20ml vials, 8ml per bottle, stoppered, freeze-dried, filled with N 2 , Cork, Pack.

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PUM

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Abstract

A fosphenytoin sodium injection in the form of freeze dried powder for preventing and treating epilepsy is prepared from fosphenytoin sodium, pharmacologically acceptable auxiliary, and water for injection through mixing fosphenytoxin sodium with water for injection and aminobutanetriol, heating while stirring, regulating pH value 8.0-10.0, adding charcoal for injection, heating while stirring, removing charcol, sterilizing and freeze drying.

Description

technical field [0001] The invention belongs to fosphenytoin sodium pharmaceutical preparations, in particular to a fosphenytoin sodium freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Epilepsy is a common central nervous system dysfunction disease. Phenytoin has been the main anti-epileptic drug since it was launched in the 1930s. It is also used to treat neuralgia such as trigeminal nerve, glossopharyngeal nerve and sciatic nerve. [0003] Phenytoin is a weak acid with a pKa of 8.3, and Na + Phenytoin sodium is formed, and clinical phenytoin sodium has two major dosage forms, oral and injection, but oral dosage forms are mostly used. The main reason for limiting the clinical use of phenytoin injections is that the intramuscular injection of phenytoin forms deposits at the injection site due to its low water solubility, resulting in slow and irregular drug absorption. Intravenous injection of phenytoin is very irritating to...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/675A61P25/08
Inventor 陈庆财赵俊
Owner 陈庆财
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