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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 Australia, the specification is 10ml: 500mg, In China, there are fluorouracil injections from Shanghai Xudong Haipu Pharmaceutical Co., Ltd., the specification is 10ml: 250mg, and there is no report or listing of fluorouracil freeze-dried pharmaceutical composition

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

Embodiment 2

[0011] Embodiment 2: Get 0.25g fluorouracil and 0.1g Tween and join in 3ml water, under stirring, adjust the pH value to 9.0 with saturated sodium hydroxide, and stir into a clear and transparent solution, and then use a 0.22 μm microporous membrane Filter, and then freeze-dry the filtered solution; when 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 then dried for 25 hours, and then sealed to obtain fluorouracil powder injection.

Embodiment 3

[0012] Example 3: Add 0.25g fluorouracil and 0.1g polyethylene glycol into 3ml water, adjust the pH value to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, and then use a 0.22μm micropore Filter the filtered solution, and freeze-dry the filtered solution; 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 10°C, and then dried for 30 hours, and then sealed to obtain 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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