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Method To Prepare Pralidoxime chloride powder injection

12:07:00 AM Parvesh Bravo 0 Comments

The pralidoxime methylchloride powder injection contains pralidoxime chloride as active component, its specification is 250mg-Ig/bottle. Its preparation method includes the following steps:

1)   Preparing components according to its formula into aqueous solution, removing heat source, regulating pH value of solution of 1.0-7.0
2)       sterilizing solution and filling
3)       freeze-drying
4)       prefreezing filled semifinished product to -55 deg.C - -35 deg.C, heat-insulating for 1-4 hr, starting vacuum pump, after the degree of vacuum is reached to a certain value, slowly heating to -10 deg.C - 50 deg.C, continuously vacuum-retaining for 3-10 hr, after the water content is evaporated, heating, heat-insulating and drying at 25-30 deg.C for a certain time, taking out; and
5)       sealing and packaging.

Currently, pralidoxime chloride products are water injections with poor stability, short shelf life largely used as a multi-point injection, causing pain medication.


Technical Solution Used In the Method:

The main purpose of the invention is to provide a good stability, high concentrations of the use of state pralidoxime chloride powder and another purpose is to provide a method for preparing a powder of pralidoxime chloride.

This invention employs the following technical solutions: pralidoxime chloride injection, with pralidoxime chloride powder containing as an active ingredient, its specifications for the 250mg ~ 1g / bottle. At a concentration of 500mg / ml, a concentration (250mg / ml) 2 times for existing water injection.

Here, the powder used is a sterile powder. The powder is freeze-dried powder and also contains pH adjusting agent.

The pH adjusting agent is selected from different concentrations of inorganic or organic acids, such as: acetic, lactic, citric, adipic acid, hexanoic acid, fumaric acid, propionic acid, formic acid, malic acid, carbonic acid, hydrochloric acid, tartaric acid , phosphoric acid, metaphosphoric acid, sulfuric acid, nitric acid, succinic acid, boric acid, phytic acid, butyric acid, edetic acid, sorbic acid, salicylic acid, lauric acid, p-aminobenzoic acid, ascorbic acid, benzoic acid, citric acid.

The lyophilized filler is water-soluble filler selected from mannitol, dextrose, sodium chloride, dextran, calcium chloride, citric acid, disodium hydrogen phosphate, gelatin, lactose, maltose, polyvinylpyrrolidone, sorbitol, one or more of sodium hydroxide.

Pralidoxime chloride sterile powder preparation method, the method comprises the of the following steps

1)       a container sterilization
2)       bulk drug treatment: a sterile environment where pralidoxime chloride API crushing, screening take place
3)       The API treated sterile packing to container
4)       sealed packaging.
The aqueous solution of the water is water for injection or a buffer solution pH of less than 7. Eg: ethanol - ammonium acetate buffer, sodium formate buffer, acetate buffer, acetate - lithium salt buffer, acetic acid - acetate buffer, phosphate buffer.The pH of the solution is adjusted to 2.5 to 4.0.

Advantages of this method are:
  • After transforming chlorine dosage phosphorus gives good powder stability
  • facilitate storage
  • when the concentration increases, the injection volume is reduced, so that the site of injection points is also reduced, reducing the suffering of the patients, while beneficial to the emergency rescue the efficacy of quick play. 
  • The preparation obtained through the process is stable in the aspects of content of the preparation and the related substances and low in toxicity and content of the related substances. 
  • Safety and effectiveness of the Pralidoxime Chloride are ensured 
  • Product quality can be guaranteed easily.

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