Injection preparation containing anhydrogalactitol and preparation method thereof

A technology of dehydrated dulcitol and preparations, which is applied in the field of pharmaceutical preparations and can solve problems such as toxic and side effects

Inactive Publication Date: 2009-06-03
TIANJIN JINGUIGU XYLITOL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After the patient is weak, malnourished, and has undergone multiple long-term chemotherapy or after th

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]Take 3g of dehydrated dulcitol, put it in a container, add 0.1g of polyvinylpyrrolidone as a solubilizer, 80ml of water for injection, 0.2g of sodium hydroxide, stir to dissolve, add 1mol / L of citric acid to adjust the pH to 7-9.0 , add 28g of mannitol, stir to dissolve, add water to 100ml. Add 0.5g of activated carbon, stir at 30°C for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 1ml tubes, pre-freeze for 2 hours, and dry under reduced pressure for 12 hours until After the temperature of the sample reached room temperature, it was dried for another 5 hours to obtain a white loose block, which was sealed to obtain anhydrous dulcitol freeze-dried powder injection.

Embodiment 2

[0034] Take 50g of dehydrated dulcitol, put it in a container, add 2g of PEG-60000, 180ml of water for injection, stir to dissolve, adjust the pH to 5.0-9.0 with 1mol / L hydrochloric acid or sodium hydroxide, add 80g of mannitol, 20g of sorbitol , stir to dissolve, add water to 2000ml. Add 0.5g of activated carbon, stir at 30°C for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 2ml tubes, pre-freeze for 2 hours, and dry under reduced pressure for 18 hours until After the temperature of the sample reached room temperature, it was dried for another 5 hours to obtain a white loose block, which was sealed to obtain anhydrous dulcitol freeze-dried powder injection.

Embodiment 3

[0036] Take 10 g of dulcitol and 0.3 g of xylitol, add it to 440 ml of water for injection in which 5 g of sodium lauryl sulfate has been dissolved, add 2 g of sodium thiosulfate and stir to dissolve, add sodium bicarbonate to adjust the pH to 5.5-8.5, Add 0.5g of activated carbon, stir and adsorb at room temperature for 30 minutes, remove carbon, add water to 500ml, fine filter, fill with 5ml each, and sterilize to obtain dehydrated dulcitol injection.

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PUM

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Abstract

The invention relates to an anhydrogalactitol injection preparation and a preparation method thereof. The preparation is characterized by being made from anhydrogalactitol, a water soluble filler, a pH regulator, water for injection and an osmoregulator, wherein, the anhydrogalactitol is 0.001-50% by weight, and the other is pharmaceutic adjuvants or water. The anhydrogalactitol injection preparation has good stability and high bioavailability, thus solving the injection requirements of treating clinical acute granulocytic leukemia and chronic granulocytic leukemia.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to an injection-administered preparation containing an active ingredient anhydrodulcitol and a preparation method thereof. Background technique [0002] Leukemia is a malignant disease of the hematopoietic system, characterized by extensive and uncontrolled proliferation of a large number of leukemia cells in the body, appearing in the bone marrow and many other organs and tissues, and entering the peripheral blood. Acute leukemia is characterized by rapid onset, rapid progress, and dangerous condition, which seriously endangers human health. With the advancement of medicine, most patients with acute leukemia can achieve remission after active treatment. Now remission of leukemia is no longer the ultimate goal of treatment. How to improve the cure rate so that most leukemia patients can be cured has become the focus of current hematology research . [000...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/08A61K31/336A61P35/00
Inventor 马永华邱洪江
Owner TIANJIN JINGUIGU XYLITOL
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