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Stable dianhydrogalactol lyophilized powder for injection

A technology of freeze-dried powder injection and water sanitation, which is applied in the field of chemical medicine and can solve the problems of unstable substances, increased content, affecting the safety of medicines, etc.

Active Publication Date: 2017-02-15
GUANGXI WUZHOU PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After research, a new detection method was used to detect related substances, and it was found that within the validity period, the detection data of related substances in dehydrodungol for injection (freeze-dried) is actually not stable, and the content of related substances will decrease as time goes by. increase, which will definitely affect the safety of the drug
[0007] Aiming at the unstable problem of related substances in the existing dehydrodulcitol freeze-dried powder for injection, the present invention is proposed

Method used

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  • Stable dianhydrogalactol lyophilized powder for injection
  • Stable dianhydrogalactol lyophilized powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Weigh dulcitol, add water for injection with 40 times the weight of dulcitol, fully dissolve at 20°C, stir well, and use water for injection to make the total weight 45 times of the weight of dulcitol; Sterilize and filter, fill, and half-stopper; put it in a freeze-drying cabinet, reduce the shelf temperature of the freeze-dryer to -20°C at a rate of 25°C-35°C per hour, and keep it warm for 300 minutes; start vacuuming, when When the vacuum reaches 18pa, start the temperature rise. When the temperature of the shelf reaches 0°C, keep it warm for 900 minutes; keep the vacuum at 18pa, continue to raise the temperature to 40°C, and keep warm for 180 minutes; press the stopper, take it out of the box, and it is ready for injection. Water dulcitol freeze-dried preparation, the moisture content is 1.00%.

Embodiment 2

[0039] Weigh dulcitol, add water for injection of 28 times the weight of dulcitol, fully dissolve at 10°C, stir well, and use water for injection to make the total weight 30 times of the weight of dulcitol; Sterilize and filter, fill, and half-stopper; put it in a freeze-drying cabinet, reduce the shelf temperature of the freeze-dryer to -40°C at a rate of 25°C-35°C per hour, and keep it warm for 180 minutes; start vacuuming, when When the vacuum reaches 25pa, start heating up. When the temperature of the shelf reaches -2°C, keep warm for 2800 minutes; keep the vacuum at 25pa, continue to raise the temperature to 30°C, and keep warm for 240 minutes; press the plug, take it out of the box, and get the product for injection Dehydrodulcitol freeze-dried preparation, the moisture content was 0.03%.

Embodiment 3

[0041] Weigh dulcitol, add water for injection with 15 times the weight of dulcitol, fully dissolve at 10°C, stir well, and use water for injection to make the total weight 30 times of the weight of dulcitol; Sterilize and filter, fill, and half-stopper; put it in a freeze-drying cabinet, reduce the shelf temperature of the freeze-dryer to -60°C at a rate of 25°C-35°C per hour, and keep it warm for 30 minutes; start vacuuming, when When the vacuum reaches 15pa, start heating up. When the temperature of the shelf reaches -2°C, keep it warm for 720 minutes; keep the vacuum at 15pa, continue to raise the temperature to 35°C, and keep warm for 280 minutes; press the stopper and take it out of the box to get the product for injection Dehydrodulcitol freeze-dried preparation, the moisture content is 1.20%.

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Abstract

The invention relates to stable dianhydrogalactol lyophilized powder for injection. The dianhydrogalactol lyophilized powder for injection provided by the invention is good in stability, and the quality effect of the dianhydrogalactol lyophilized powder for injection, after long-term preservation, is significantly better than that of the prior art.

Description

technical field [0001] The invention relates to the field of chemical medicines, in particular to a stable dehydrodungitol freeze-dried powder for injection. Background technique [0002] 1.2; 5.6 Dianhydrog alactito (1.2; 5.6-Dianhydrog alactito.DAD is a hexitol anticancer drug, also known as dehydrated dulcitol (C 6 h 10 o 4 ), dianhydrodulcitol, viconol, anhydrogalactitol. 【Foreign name】Dianhydrogalactitol. It is the transformation product of anticancer drug 1,6-dibromodulcitol. It has good short-term curative effect on chronic myelogenous leukemia, and the remission rate is 86%. It also has a certain effect on lung cancer, multiple myeloma, nasopharyngeal carcinoma, etc. The effective rate on various types of lung cancer is only lower than that of nitrogen mustard, mitomycin C and methotrexate, but its toxicity is relatively mild. [0003] Dehydrodulcitol has broad-spectrum antitumor activity against transplanted tumors in animals. Clinical studies have proved that...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/336A61P35/00
CPCA61K9/19A61K31/336
Inventor 刘冠萍陈明赖树生
Owner GUANGXI WUZHOU PHARMA GRP
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