Compound alpha-ketonic acid tablet and preparation method of same

Abstract

The invention discloses a compound alpha-ketonic acid tablet and a preparation method of same. In the invention, five ketonic acids and five amino acids are subjected to wet-process granulation independently, and then the granules are blended and tabletted, finally the tablets are coated. With organic alcohols as a wetting agent, problems of agglomeration and high viscosity during the granulationare solved, so that security of the medicine is guaranteed. Through specific selection on auxiliary materials, the tablet has excellent dispersibility and binding capability and shows outstanding disintegration capability. The tablet has enough smoothness and hardness and has excellent appearance. By matching the auxiliary materials with the main material, excellent dissolution property of the tablet is guaranteed, and excellent stability during subsequent storage process is achieved. The compound alpha-ketonic acid tablet has excellent appearance, is good in compressibility and dissolubility,has simple and stable processes and is suitable for demands of industrial large-scale production.

Description

technical field [0001] The invention relates to a compound alpha-ketoacid tablet and a preparation process thereof, belonging to the field of medicine. Background technique [0002] Chronic kidney disease refers to chronic kidney structure and dysfunction caused by various reasons. Since the 21st century, the incidence of chronic kidney disease has been increasing day by day, and a large proportion of patients will eventually deteriorate into uremia, which has become a major disease that threatens public health around the world. [0003] Compound α-ketoacid tablets were first listed in Germany by Fresenius Kabi in 1996. The trade name is Kaitong. Preparations, can increase glomerular filtration and urinary albumin excretion. The drug has significant curative effect on chronic kidney disease, and is clinically used for nutrition of patients with chronic renal failure, prevention and treatment of damage caused by protein metabolism disorder caused by chronic renal insufficie...

AI Technical Summary

Problems solved by technology

[0005] Chinese patent application 20071016335.7 discloses a compound α-keto acid chewable tablet, but those skilled in the art know that the compound α-keto acid tablet is a kind of medicine with poor taste, even if it is made into a coated chewable tablet and chewed and crushed in the mouth It will also produce a relatively unpleasant slight odor, and the long-term storage stability is poor, and the adhesive in the prescription contains water, which cannot overcome the defects that calcium ketoacid is highly viscous and easy to form agglomerates. At the same time, the preparation method of this method is cumbersome.

[0006] Chinese patent application 200810224131.2 provides a compound α-ketoacid dispersible tablet and its preparation method. Microcrystalline cellulose, sodium carboxymethyl starch, etc. are used as additional excipients, and the disintegration speed is fast; the dispersible tablet is dissolved in water when used. Drinking, there is still an unavoidable odor, and there is no anti-adhesive component in the prescription, which cannot overcome the problem of high viscosity of calcium keto acid

[0007] At present, there are still many problems in the prescription and process of the existing compound α-ketoacid tablets, which need to be adjusted and improved. Therefore, it is of great practical significance for us to invent a prescription and process for the production of compound α-ketoacid tablets.

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