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Applications of convection heat transfer method in dianhydrodulcitol freeze drying powder preparation process

A technology of dehydrating dulcitol and convective heat transfer, which is applied in the field of heating and drying process, can solve problems such as ineffective application, and achieve the effects of smooth sublimation, improved drying efficiency, and stable quality

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

Due to practical problems, these concepts have not been effectively applied to industrial production in the end.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1) Dosing and pre-freezing: add dulcitol to tert-butanol containing 99.9% of 2-methyl-2-propanol and 0.1% of water, and dissolve it at 35°C to make a 20% solution. Filtrate, divide the filtrate into open containers, place in a freeze-drying cabinet, keep cooling down to 10°C within 0.25h, and maintain at this temperature for 0.25h;

[0036] 2) Freezing and system balance: after the end of pre-freezing, continue to cool down within 1 hour, lower the temperature in the freeze-drying cabinet to -5°C, and maintain this temperature for 0.5 hours, and reduce the pressure in the freeze-drying cabinet Adjust to 2Pa~10Pa;

[0037] 3) Sublimation: intermittently inject steam that is 0.00025 times the volume of the cavity into the cabinet intermittently, control the vacuum degree at 250Pa, and keep it for 3h;

[0038] Keep the above conditions unchanged, increase the temperature of the inner layer of the freeze-drying cabinet from the base temperature of -5°C to 0°C within 3 hour...

Embodiment 2

[0043] 1) Dosing and pre-freezing: Take dehydrodungalcitol crystals and add tert-butanol, dissolve at 30°C to form a solution containing 6% dehydrodunglitol, filter, pack the filtrate into open containers, and place In the freeze-drying cabinet, keep cooling down to 5°C within 0.5h and maintain at this temperature for 0.5h;

[0044] 2) Freezing and system balance: after pre-freezing, continue to cool down within 0.75 hours, reduce the temperature of the plate layer in the freeze-drying cabinet to -15°C, and maintain it at -15°C for 0.5h, and then maintain the plate layer Keep the temperature constant, vacuumize and depressurize to 5Pa;

[0045] 3) Sublimation: intermittently inject steam that is 0.00015 times the volume of the cavity into the cabinet intermittently, control the vacuum at 150Pa, and keep it for 3h;

[0046] Keep the above conditions unchanged, raise the temperature of the inner layer of the freeze-drying cabinet from the base temperature of -15°C to 2°C within 3...

Embodiment 3

[0051] 1) Dosing and pre-freezing: Take dehydrodungalcitol crystals and add glacial acetic acid, dissolve at 25°C to form a solution containing 8% dehydrodungalcitol, filter, divide the filtrate into open containers, and place in the freezer In the dry cabinet, keep cooling down to 0°C within 1 hour and maintain it at this temperature for 1 hour;

[0052] 2) Freezing and system balance: After pre-freezing, continue to cool down within 0.75 hours, reduce the temperature of the inner layer of the freeze-drying cabinet to -15°C, and maintain it at -15°C for 1 hour, and then maintain the layer temperature Unchanged, vacuumize and depressurize to 5Pa;

[0053] 3) Sublimation: keep the temperature of the plate layer constant, continuously pass into the cabinet the instantaneous steam of 0.001 times the volume of the cavity, control the vacuum degree at 500Pa, and keep it for 3h;

[0054] Keep the above conditions unchanged, increase the temperature of the inner layer of the freeze-...

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Abstract

The present invention relates to applications of a convection heat transfer method in a dianhydrodulcitol freeze drying process. According to the present invention, by using the convection heat transfer type freeze drying preparation method of the dianhydrodulcitol freeze drying powder, drying is performed according to the predetermined freeze-drying process to obtain the freeze drying product of the dianhydrodulcitol or the composition thereof, the melting point is high and is in the range of 99.5-103.5 DEG C, the time for achieving the complete freeze-drying state is short, the freeze drying product is the loose amorphous body, the melting point is not changed after the freeze drying product is stored for 200 days at a room temperature in a sealed manner, and the quality stability of the freeze drying product of the present invention is significantly superior to the quality stability of the dianhydrodulcitol freeze drying powder prepared in the prior art.

Description

technical field [0001] The invention relates to the field of chemical medicines, in particular to a heating and drying process when a convective heat transfer method is applied to the preparation of dehydrodungitol freeze-dried powder by a freezing method. Background technique [0002] 1,2-5,6 Dianhydrog alactito (1,2-5,6-Dianhydrog alactito.DAD is a hexitol anticancer drug, also known as dehydroducitol (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 light. [0003] During the freeze-drying process of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/336A61K9/19A61P35/00B01D7/00
Inventor 黄宇声刘冠萍徐卓张栩颜陈勇贤英越陈苑君易燕群
Owner GUANGXI WUZHOU PHARMA GRP
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