Sodium glycididazole composition and preparation method thereof

Abstract

The invention relates to the field of pharmaceutical preparations and particularly relates to a sodium glycididazole composition and a preparation method thereof. The sodium glycididazole composition comprises sodium glycididazole, mannitol and sodium bicarbonate, wherein the mass ratio of the sodium glycididazole to the mannitol is 1: (0.5-1.25), and the mass ratio of the sodium glycididazole to the sodium bicarbonate is 1: (0.0008-0.004). The preparation method comprises the following steps: dissolving the mannitol and the sodium bicarbonate with 30-40 DEG C injection water to obtain a solution, slowly adding the sodium glycididazole raw material into the solution, stirring to dissolve, supplementing the injection water, uniformly mixing, and storing, filtering, filling, carrying out freeze drying and capping under the condition that the medicinal liquor is rapidly cooled to 10-20 DEG C, thus obtaining the sodium glycididazole composition. The pharmaceutical composition is simple in process, stable in preparation and suitable for industrial production; according to the sodium glycididazole composition and the preparation method thereof, the degradation of the sodium glycididazole and the contents of impurities in the medicinal liquor are greatly reduced, the exertion of the pharmaceutical effect is ensured and the clinical medication safety is improved.

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 radiation has low selectivity to tumor cells and normal cells. While killing tumor cells, normal cells are also damaged, resulting in systemic toxicity. Therefore, it is particularly important to improve the selectivity of radiation to hypoxic cells in tumor tissue. [0003] 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. Since the 1950s, nitroimidazole compounds have been scre...

AI Technical Summary

Problems solved by technology

[0007] (1) Add mannitol and glycididazole sodium to distilled water at the same time, prolong the dissolution time of glycididazole sodium, cause the loss of glycididazole sodium, and affect the therapeutic effect;

[0008] (2) After the lyophilized excipient mannitol and the main drug were dissolved in distilled water at 40°C, the temperature was not lowered, which led to the rapid degradation of the main drug glycididazole sodium in the subsequent production process, affecting the efficacy of the drug; and without cooling treatment The high content of impurities in the liquid medicine affects the efficacy of the medicine;

[0009] (3) Sodium bicarbonate is used as a pH regulator, and it is added in a solution state to adjust the pH of the liquid to 7.0-7.5. The addition method is cumbersome, and the dosage is not fixed, so it is inconvenient to operate during the production process

[0011] (1) Sodium bicarbonate is used as a pH regulator, and it is added in a solution state to adjust the pH of the liquid to 7.0-7.5. The addition method is cumbersome, and the dosage is not fixed, so it is inconvenient to operate during the production process;

[0012] (2) No cooling treatment was carried out, resulting in a high content of impurities in the obtained liquid medicine, which affected the efficacy of the medicine

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