Sodium glycididazole composition and preparation method thereof

A technology of sodium glycidiazole and its composition, which is applied in the field of sodium glycidiazole composition and its preparation, can solve problems such as loss of sodium glycidiazole, influence on drug efficacy, and influence on therapeutic effect, and achieve reduction of active ingredients The loss of content, the effect of ensuring the efficacy of the drug, and the effect of ensuring the feasibility

Active Publication Date: 2013-06-05
SHANDONG LUYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] (1) The freeze-dried excipient mannitol and the main drug were dissolved in distilled water at 40°C, which caused the loss of the main drug glycididazole sodium and affected the efficacy of the drug;
[0008] (2) Adding mannitol and glycididazole sodium to distilled water at the same ti

Method used

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  • Sodium glycididazole composition and preparation method thereof
  • Sodium glycididazole composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Dissolve 50g of mannitol with 2000ml of water for injection at room temperature to obtain a mannitol solution, slowly add 250g of glycididazole sodium raw material into the mannitol solution, and slowly stir to dissolve to obtain a medicinal solution, and dissolve sodium bicarbonate with water for injection Obtain 10% sodium bicarbonate solution, use 10% sodium bicarbonate solution to adjust the pH of the medicinal solution to 7.2, add water for injection to 2500ml, filter, fill to make 1000 bottles, freeze-dry, and cap it.

Embodiment 2

[0022] Dissolve 250g of mannitol with 4200ml of water for injection at room temperature to obtain a mannitol solution, slowly add 500g of glycidiazole sodium raw material into the mannitol solution, and slowly stir to dissolve to obtain a medicinal solution, and dissolve sodium bicarbonate with water for injection Obtain 10% sodium bicarbonate solution, adjust the pH of the medicinal solution to 7.0 with 10% sodium bicarbonate solution, add water for injection to 5000ml, filter, fill to make 2000 bottles, freeze-dry, and cap it.

Embodiment 3

[0024] Dissolve 500g of mannitol with 2100ml of water for injection at room temperature to obtain a mannitol solution, slowly add 250g of glycididazole sodium raw material into the mannitol solution, and slowly stir to dissolve to obtain a medicinal solution, and dissolve sodium bicarbonate with water for injection Obtain 10% sodium bicarbonate solution, adjust the pH of the medicinal solution to 7.5 with 10% sodium bicarbonate solution, add water for injection to 2500ml, filter, fill to make 1000 bottles, freeze-dry, and cap it.

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Abstract

The invention relates to the field of a pharmaceutical preparation, and particularly relates to a sodium glycididazole composition and a preparation method thereof. The sodium glycididazole composition includes sodium glycididazole, mannitol, and sodium bicarbonate. The preparation method comprises the steps of dissolving mannitol by injection water under room temperature to obtain mannitol solution; slowly adding the sodium glycididazole material to the mannitol solution, slowly agitating and dissolving to obtain soup, dissolving the sodium bicarbonate by the injection water to obtain the sodium bicarbonate solution; adjusting the pH of the soup to 6.8-7.8 by the sodium bicarbonate solution, supplying the injection water, filtering, bulking, freeze-drying and capping. The sodium glycididazole composition not only is simple in prescription and process, but also is stable in preparation, reduces the cost, is suitable for industrial production, greatly avoids and reduces the loss of the sodium glycididazole, and ensures development of the pesticide effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a glycididazole sodium composition and a preparation method thereof. Background technique [0002] The incidence of malignant tumors is increasing year by year, seriously threatening human health. Radiation therapy is one of the main means of modern tumor treatment, but malignant tumors contain about 10-50% hypoxic cells, which have anti-radiation effect, which seriously affects the effect of tumor radiotherapy. Therefore, it is very important to improve the selectivity of radiation to hypoxic cells in tumor tissue. Tumor radiotherapy sensitizers are a class of drugs that increase the sensitivity of hypoxic cells in tumor tissue to radiation and effectively protect normal cells. They can significantly improve the short-term curative effect of tumor radiotherapy and improve the cure rate. [0003] Glycindiazole sodium is a new type of nitroimidazole compound with obvio...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4178A61K47/10A61P35/00
Inventor 王君莲李菊范艳丽张婷婷孙启泉衣瑞玲
Owner SHANDONG LUYE PHARMA CO LTD
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