Sodium glycididazole composition and preparation method thereof

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...

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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 time will not only cause glycididazole sodium not to dissolve at room temperature, but also cause the loss of glycididazole sodium, which will affect the therapeutic effect;

[0009] (3) Distilled water needs to be heated and temperature controlled, which is not conducive to industrial production

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