New synthesis process of icodextrin API

Abstract

The invention relates to the field of medicine preparation, in particular to a new synthesis process of icodextrin raw material drug, which uses cornstarch as the starting material, hydrolyzes it to a certain extent by adding hydrochloric acid, and ultrafilters it with an ultrafiltration membrane with a molecular weight cut-off of 5000; adds activated carbon , by adjusting the pH value and controlling the temperature, spray-drying can obtain qualified products for each quality control index, especially for endotoxin control. The addition method and decarburization procedure, and the product with endotoxin controlled at less than 1.2 EU / g can be obtained by adjusting the temperature and pH value.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a novel synthesis process of icodextrin bulk medicine. Background technique [0002] Icodextrin is a water-soluble glucose polymer in which starch derivatives are linked by α(1-4) and less than 10% α(1-6) glycosidic bonds, with a weight-average molecular weight of 13,000-19,000 Daltons. [0003] The combination of icodextrin and other electrolytes is clinically used for peritoneal dialysis. It was first developed by ATTELION Company of the United States, and was approved by FDA in 2002 by Baxter Medical Company. Baxter's new peritoneal dialysis fluid, Icodextrin, was approved to go on the market in Japan on July 18, 2003, under the trade name: Extraneal. Extraneal is the first dialysate of a new type of osmotic agent for peritoneal dialysis patients, and it has been approved for marketing in 36 countries. At present, there is no production and marketing of icodextrin peritone...

AI Technical Summary

Problems solved by technology

There is only one patent in China, CN201310453098, which reports the synthesis method of icodextrin, but it only compares the range of molecular weight with the reference preparation, and does not study other quality control indicators, especially for endotoxin control. involved, and the control of endotoxin is precisely the difficulty in the production of icodextrin raw materials

In addition, the foreign production process and the process reported in the domestic patent CN201310453098 all need to use two sets of ultrafiltration membrane bags and ultrafiltration equipment. The ultrafiltration membrane bags and equipment are expensive, and the two sets of ultrafiltration processes are very cumbersome in actual production operations.