Freeze dried arsenic trioxide injection and its preparation process

Abstract

The invention provides a process for preparing arsenic trioxide freeze-drying power injection which comprises the steps of, (1) weighing arsenic trioxide, placing into sterile container, charging right amount of sterility water for injection, obtaining suspending liquid, (2) heating and stirring the suspending liquid to dissolution, cooling down to room temperature, split charging the solution into 10 ml bottles, low-temperature freeze drying, sterility cover stressing. The invention also provides an arsenci trioxide freeze-drying power injection prepared through the production process.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to arsenic trioxide freeze-dried powder injection. Background technique [0002] At present, the role of arsenic trioxide in treating leukemia and other solid tumors has been widely recognized internationally, so arsenic trioxide has become a hot spot in the treatment of leukemia and solid tumors. [0003] Studies have shown that oral administration of a small amount of arsenic (the lethal dose is 70-180 mg / time) can promote the body's protein synthesis, stimulate bone marrow hematopoiesis, benefit the body's growth and reproduction, and may kill tumor cells through protoplasm poisoning (see: Guo Xiaozhuang, Toxic Dictionary of Chinese Herbal Medicine, Tianjin Science and Technology Translation Press, 1992). [0004] Arsenic trioxide has a significant effect on untreated, relapsed and refractory acute promyelocytic leukemia (APL), with complete remission rates (CR) of 87.9%, 88.4% and...

AI Technical Summary

Problems solved by technology

[0013] (1) The damage rate is high, and there is a high damage rate in production, transportation, storage and use;

[0014] (2) The current arsenic trioxide injection is prone to crystallization when the temperature is lower than 16 degrees Celsius, especially when the temperature is lower than 5 degrees Celsius, which not only causes unstable properties, but also affects the curative effect;

[0015] (3) Once the water injection ampoule is opened, it must be used up at one time, and sometimes it is easy to cause waste. For the sake of economy, patients sometimes keep the unused water injection for use after opening, which increases the incidence of side effects such as infusion reactions.