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Clindamycin phosphate freeze-dried powder needle and preparation thereof

A technology of clindamycin phosphate and freeze-dried powder injection, which is applied in freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., can solve the problems of cumbersome steps and increased substances, and achieve simple formula, few side effects, and full appearance Effect

Inactive Publication Date: 2008-11-12
BEIJING JINGWEI SHUNKANG MEDICAL TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this process is actually a sterilized solvent crystallization powder injection, the steps are very cumbersome, and step (6) needs to be dried at 60-80°C, and as mentioned above, clindamycin phosphate can be produced at 60°C Degradation, which will inevitably lead to the increase of related substances (impurities)

Method used

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  • Clindamycin phosphate freeze-dried powder needle and preparation thereof
  • Clindamycin phosphate freeze-dried powder needle and preparation thereof
  • Clindamycin phosphate freeze-dried powder needle and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Under the condition of air cleanliness level 100,000 and local level 100, add 370.25 clindamycin phosphate (equivalent to 300g clindamycin) into 1200ml water for injection. Slowly add 280ml of 2mol / l sodium hydroxide solution while stirring to make it completely dissolved, so that the pH of the solution is between 6.10 and 6.30, add 0.03% g / mL of medicinal activated carbon, stir and adsorb for 30 minutes, Remove carbon by filter membrane, add water for injection to the filtrate to 2000mL, stir fully for 20 minutes to mix the solution evenly, and carry out terminal filtration sterilization on the prepared solution through a 0.22μm microporous filter membrane to obtain the filtrate; put the filtrate into 1000 bottles In the injection bottle, put the injection bottle containing the filtrate into the material tray and put it on the partition in the freeze-drying box in time, and pre-freeze: the temperature is -45 ° C, and the time is 4 hours; after the drug is frozen, the co...

Embodiment 2

[0056] Under the condition of air cleanliness level 100000 and local level 100, add 740.5 clindamycin phosphate (equivalent to 600g clindamycin) into 2400ml water for injection, the water for injection must be cooled to below 20 ℃ in advance, Slowly add 560ml of 2mol / l sodium hydroxide solution while stirring to make it completely dissolved, so that the pH of the solution is between 6.10 and 6.30, add 0.03% g / mL of medicinal activated carbon, stir and adsorb for 30 minutes, Filter membrane to remove carbon, add water for injection to the filtrate to 4000mL, stir fully for 20 minutes to mix the solution evenly, and filter the prepared solution through a 0.22μm microporous membrane to obtain the filtrate; put the filtrate into the injection bottle In the process, put the injection bottle containing the filtrate into the material tray and put it on the partition in the freeze-drying box in time, and pre-freeze: the temperature is -45°C, and the time is 4 hours; after the drug is f...

Embodiment 3

[0058] Under the condition of air cleanliness level 100,000 and local level 100, add 300 grams of lindamycin phosphate to 1200 ml of water for injection. The water for injection must have been cooled to below 20°C in advance, and slowly add 2 mol / l of hydroxide while stirring. Sodium solution 250ml, make it dissolve completely, make the pH of the solution between 6.10~6.30, add 0.03% g / mL of medicinal activated carbon, stir and absorb for 30 minutes, filter through 0.45μm microporous membrane to remove carbon, add the filtrate for injection Water to 2000mL, fully stirred for 20 minutes to mix the solution evenly, and the prepared solution was sterilized by terminal filtration through a 0.22 μm microporous membrane to obtain the filtrate; put the filtrate into 1000 bottles of injection bottles, and the Put the injection bottle into the material tray and put it on the partition in the freeze-drying box in time, and pre-freeze: the temperature is -45°C, and the time is 4 hours; af...

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Abstract

The invention provides a clindamycin phosphate freeze-dried powder injection, which is prepared by the steps that: clindamycin phosphate solution is added with NaOH and is freeze-dried, wherein, the weight ratio of clindamycin phosphate to the NaOH is between 12 and 18 to 1, and the preferred weight ratio is 16.5 to 1. The clindamycin phosphate freeze-dried powder injection has simple formula and less auxiliary materials, overcomes side effects due to the fact that the auxiliary materials are excessively added, and ensures that patients are safer for use.

Description

technical field [0001] The invention relates to clindamycin phosphate for injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Clindamycin phosphate, the English name is Clindamycin phosphate, the chemical formula is 6-(1-methyl-4-propyl-2-pyrrolidine carbonyl amido)-1-1thio-methyl-7-chloro -6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate, the structural formula is: [0003] [0004] Clindamycin phosphate is a chemically semi-synthesized clindamycin derivative. It has no antibacterial activity in vitro, and when it enters the body, it is rapidly hydrolyzed into clindamycin to display its pharmacological activity. Therefore, the antibacterial spectrum, antibacterial activity and therapeutic effect are the same as Clindamycin is the same, but its ester solubility and permeability are better than clindamycin, and it can be administered orally, intramuscularly or intravenously. C...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7056A61P31/04
Inventor 罗韬
Owner BEIJING JINGWEI SHUNKANG MEDICAL TECH DEV
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