Oxaliplatin lyophilized powder injection and preparing method thereof

Abstract

The invention relates to oxaliplatin freeze-dried injection, which is characterized in that the invention is prepared by the method that aqueous solution is freeze-dried. The aqueous solution contains oxaliplatin, mannitol and citrate, wherein, the concentration of the oxaliplatin in the aqueous solution is 2.5 to 6.25 mg / ml; the concentration of the mannitol in the aqueous solution is 25 to 200 mg / ml; and the concentration of the citrate in the aqueous solution is 2 to 20 mg / ml. And sodium citrate can also be added into the aqueous solution so as to adjust the pH of the aqueous solution. Thepreparation processes are as following: the oxaliplatin is placed inside the container, 80 percent amount of water for injection is added, and then the water for injection is mixed so that the oxaliplatin can be dissolved and mixed evenly in the water for injection; after that, the mannitol and the citrate are added into the water for injection, and then the water for injection is mixed so that the mannitol and the citrate can be dissolved and mixed evenly in the water for injection; the content of the intermediate is measured; if the content of the intermediate is qualified, the volume of the water for injection is fixed to full amount; in the aseptic condition, the water for injection is filtered until to be clear by a microporous membrane of 0.22 microns; the filtered solution is filled into an aseptic silin bottle; part of the aseptic silin bottle is plugged with a butyl rubber closure; and then the aseptic silin bottle is filled in the tray to be sent into the freeze dryer to be freeze-dried; the mouth of the aseptic silin bottle is rolled; the quality of the filtered solution is inspected; and the aseptic silin bottle is packaged.

Description

technical field [0001] The present invention relates to oxaliplatin freeze-dried powder injection, and the oxaliplatin freeze-dried powder injection prepared by the technical solution of the present invention can be used as a therapeutic drug for colorectal cancer metastasis patients after failure of fluorouracil treatment. Background technique [0002] Since the second half of the 20th century, the incidence and death of cancer have been increasing year by year, especially since the 1970s, the number of cancer cases has increased at an average annual rate of 3-5%, and cancer death has become one of the seven major causes of death for human beings. one. According to the WHO report, the number of cancer deaths in 1997 was about 6.2 million, ranking third among human deaths after infectious diseases and cardiovascular diseases. WHO held a tumor control planning conference in London. Karol Sikora (France, Lyon), the director of the program, estimated that by 2020, there will b...

AI Technical Summary

Problems solved by technology

Oxaliplatin has a large filling volume and is easy to precipitate due to its poor solubility. Adding mannitol can stabilize the solution to a certain extent, but it also brings problems at the same time. Due to the high solid content and large In the production process of oxaliplatin freeze-dried powder injection, there is a high rate of bottle frying, which greatly reduces the product yield and causes a lot of waste on production capacity, raw materials and inner packaging materials. Saliplatin is highly toxic, and the drug leaked with the bomb bottle is likely to cause harm to the operator, and it also brings difficulties to the production site, increasing the risk of cross-contamination

Based on the above shortcomings, the existing technology generally seeks solutions through strict and even harsh freeze-drying parameter control and prolonging the freeze-drying time, the effect is not ideal, waste of energy, and poor reproducibility

Other known technologies also do not propose suggestions for improving the above defects

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