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Method for preparing freeze-dried preparation of combretastatin A4 disodium phosphate

A technology of compredin disodium phosphate and freeze-dried preparations, which is applied in freeze-dried transportation, medical preparations containing active ingredients, pharmaceutical formulas, etc., to achieve the effect of plump appearance and stable quality

Active Publication Date: 2013-07-03
PKU HEALTHCARE CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can obtain a stable freeze-dried preparation, it needs to use cosolvents, pH regulators and stabilizers

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Weigh 50g of CA4P, add water for injection to dissolve, add 0.02% activated carbon and let stand for adsorption for 30 minutes, use 0.45μm composite cellulose microporous filter membrane for coarse filtration, add water for injection to dilute to 1000ml, shake well, and then use 0.22μm composite cellulose Fine filter with a cellulose microporous membrane to detect the concentration of CA4P; divide the fine filtrate into 7ml brown vials. Further process the medicine, pre-freezing: take 120 minutes to cool down from room temperature to -45~-60°C, and then keep it for 240 minutes; primary drying: take 240 minutes to raise the final temperature of step a to -5°C, then keep it at 450 Minutes, the vacuum degree is controlled at 10 Pa; Secondary drying: First, adjust the final temperature of the primary drying to a temperature of -5°C to 10°C in 180 minutes and keep it for 210 minutes; then, use 60 minutes to keep it for 150 minutes Adjust the temperature to 10 ℃ ~ 30 ℃, keep ...

Embodiment 2

[0036]Weigh 100g of CA4P, add water for injection to dissolve, add 0.05% activated carbon and let it stand for adsorption for 30 minutes, use a 0.45μm composite cellulose microporous filter membrane for coarse filtration, add water for injection to make up to 1000ml, shake well, and then use 0.22μm composite cellulose Fine filter with a cellulose microporous membrane to detect the concentration of CA4P; divide the fine filtrate into 7ml brown vials. Further processing of the medicine, pre-freezing: take 180 minutes to cool from room temperature to -50°C, and then keep it for 180 minutes; primary drying: take 180 minutes, raise the final temperature of step a to -5°C, keep it for 420 minutes, vacuum The temperature is controlled at 10 Pa; Secondary drying: First, adjust the final temperature of the primary drying to -5°C ~ 10°C in 180 minutes, and keep it for 210 minutes; then, use 60 minutes to adjust the temperature for 180 minutes To 10 ℃ ~ 30 ℃, keep for 180 minutes, the va...

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PUM

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Abstract

Studies show that combretastatin A4 disodium phosphate is low in light stability and is easily subjected to cis-trans isomerism to form invalid trans-isomer, and an aqueous solution of the combretastatin A4 disodium phosphate is more instable than solid powder of the combretastatin A4 disodium phosphate. The invention aims to provide a method for preparing a freeze-dried preparation of the combretastatin A4 disodium phosphate, which comprises the following steps of: 1) preparing liquor; 2) freeze-drying, namely a, pre-freezing, b, performing primary drying, and c, performing secondary drying;and 3) packaging, performing quality inspection, and thus obtaining a finished product. Compared with the prior art, the method has the advantage that: a stable combretastatin A4 disodium phosphate preparation can be prepared under the condition that a cosolvent, a PH regulator and a stabilizer are not used.

Description

technical field [0001] The invention relates to the preparation of a stable preparation of medicine, in particular to a preparation method of a freeze-dried preparation of comprelidine disodium phosphate. Background technique [0002] It was discovered more than a hundred years ago that tumor tissue is richer in blood vessels than normal tissue. In 1971, Folkman first proposed that tumor growth is dependent on blood vessels. This view is supported by more and more evidences, and this field has become a hot spot in tumor research and a new strategy for tumor treatment. It has become an important way to prevent and treat tumors by targeting each link of angiogenesis and the biochemical changes in the process of angiogenesis to develop angiogenesis inhibitors and control tumor growth and metastasis. Choosing a reasonable treatment timing and treatment plan will become the determinant of its curative effect, and the combined use with traditional chemotherapy and radiotherapy w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/661A61P35/00A61P35/04
Inventor 赵洪武赵德贺清凯李明川唐凤
Owner PKU HEALTHCARE CORP LTD