Icodextrin and its preparation method

Abstract

The invention discloses an icodextrin and a preparing method thereof. The preparing method comprises the first step of mixing cereal starch and water into a solution with the substrate concentration ranging from 20wt% to 50wt%, and adding acid to the mixture of the cereal starch and the water to form a reaction solution, wherein the final concentration of the acid ranges from 0.1% to 1.5% (V / V), the hydrolysis reaction is carried out at the temperature ranging from 70 DEG C to 93 DEG C, the reaction process is monitored at the same time, when the flow-out time duration of the reaction solution, measured with an Ubbelohde viscometer with the internal diameter of a capillary tube being 0.9mm to 1.0mm, is 2-4 minutes, the reaction solution is neutralized to pH7 through the aqueous alkali, the hydrolysis reaction is ended to obtain a product 1, and the reaction duration ranges from 0.5 hour to 4 hours; the second step of carrying out molecular weight screening on the product 1 to obtain a product 2 with the weight-average molecular weight ranging from 13 thousand Da to 19 thousand Da; the product 2 is dried and solidified to obtain the icodextrin. The distribution range of the molecular weight of the icodextrin is narrower, and the molecular weight distribution is more centralized.

Description

technical field

[0001] The invention relates to the field of medicine preparation, in particular to an icodextrin and a preparation method thereof. Background technique

[0002] Icodextrin is the main active ingredient in icodextrin peritoneal dialysis solution, which is used for the treatment of end-stage renal disease. It was first developed by the American ATTELION company and was approved by the FDA in 2002 by Baxter Medical. And Baxter's new peritoneal dialysis fluid, Icodextrin, was approved for marketing in Japan on July 18, 2003. Extraneal has been approved for marketing in 36 countries, including Taiwan and the United States recently. But there is only one simple sentence about the preparation of icodextrin: starch is hydrolyzed under the action of acid to prepare icodextrin. There is currently no patent on the preparation and production process of icodextrin API. In the existing literature about icodextrin peritoneal dialysis solution, respectively described: a k...