Freeze dried powder injection of cytarabine and its preparation process

A technology for freeze-dried powder injection and fluorouracil, which is applied in the field of fluorouracil freeze-dried powder for injection and its preparation, and achieves the effects of good solubility, ensuring safety and extending the validity period

Inactive Publication Date: 2005-06-01
HAINAN PULIN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The dosage forms of fluorouracil on the market at home and abroad include tablets, oral liquids, ointments and injections, etc. Among them, foreign injections include fluorouracil injection from F.H.Faulding & Co.Ltd.Trading as David Bull Lab in Austra

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0010] Example 1: Add 0.25g of fluorouracil to 4ml of water, adjust the pH to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, then filter with a 0.22μm microporous membrane, and then filter The latter solution is freeze-dried; during freeze-drying, the pre-freezing temperature is -30°C, the pre-freezing time is 4 hours, the sublimation drying temperature is -10°C, the sublimation drying time is 25 hours, the re-drying temperature is 20°C, and the re-drying time For 20 hours, then seal the mouth to obtain a fluorouracil powder injection.

Example Embodiment

[0011] Example 2: Add 0.25g of fluorouracil and 0.1g of Tween into 3ml of water, adjust the pH to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, and then use a 0.22μm microporous filter membrane Filter, then freeze-dry the filtered solution; during freeze-drying, the pre-freezing temperature is -40°C, the pre-freezing time is 4.5 hours, the sublimation drying temperature is -15°C, the sublimation drying time is 27 hours, and the re-drying temperature is 25°C , And the drying time is 25 hours, and then sealed to obtain fluorouracil powder injection.

Example Embodiment

[0012] Example 3: Add 0.25g of fluorouracil and 0.1g of polyethylene glycol to 3ml of water, adjust the pH to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, and then use 0.22μm micropores Filter by membrane, and then freeze-dry the filtered solution; during freeze-drying, the pre-freezing temperature is -25°C, the pre-freezing time is 3 hours, the sublimation drying temperature is -10°C, the sublimation drying time is 20 hours, and the re-drying temperature is At 10°C, the drying time is 30 hours, and then it is sealed to obtain a fluorouracil powder injection.

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PUM

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Abstract

The present invention relates to one kind of freeze dried fluoroplex powder for injection with visceran including fluoroplex, pH regulator, surfactant and/or freeze drying excipient. The preparation process includes adding fluoroplex into water, adding pH regulator under stirring to pH 8.4-9.2 and to clarify, filtering with microporous filtering membrane, freeze drying and sealing. Compared with common water injection of fluoroplex, the freeze dried fluoroplex powder for injection has higher stability, excellent dissolubility, high safety and long effective period.

Description

technical field [0001] The invention relates to a freeze-dried powder injection, in particular to a fluorouracil freeze-dried powder injection and a preparation method thereof. Background technique [0002] Fluorouracil (molecular formula: C 4 h 3 FN 2 o 2 ), fluorouracil (5-Fu) is a broad-spectrum anti-tumor drug discovered in the 1950s, which can interfere with the nucleic acid metabolism of tumor cells through various pathways and metabolites, but its main pathway is: entering 5-Fu in tumor cells -Fu is transformed into fluorouracil deoxynucleotide phosphate (FdUMP), which is a metabolite with anti-tumor activity, and can be covalently combined with reduced tetrahydrofolate and thymidine nucleotide synthase (TS) to form a ternary complex substances, inactivating TS enzymes, thereby inhibiting DNA synthesis. Fluorouracil has clinical inhibitory effect on a variety of tumors, and can treat gastric cancer, liver cancer, pancreatic cancer, breas...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/513A61P35/00
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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