Sodium phenylbutyrate tablet and preparation method thereof

Abstract

The invention discloses a sodium phenylbutyrate tablet and a preparation method thereof. Described sodium phenylbutyrate tablet is made up of sodium phenylbutyrate and diluent; Described diluent is filler, binding agent and lubricant; In described sodium phenylbutyrate tablet, described sodium phenylbutyrate and The mass ratio of the diluent is 1:0.2-1.5. The preparation method of the sodium phenylbutyrate tablet comprises the steps of: 1) mixing the sodium phenylbutyrate, the filler and the binding agent to obtain a mixture; 2) preparing the mixture granules and dried to obtain sodium phenylbutyrate granules; 3) mixing the sodium phenylbutyrate granules with the lubricant and then compressing into tablets to obtain the sodium phenylbutyrate tablets. Based on the strong hygroscopicity of the raw material of sodium phenylbutyrate itself and its large size (large proportion of the main drug), there are technical difficulties in the preparation. The present invention provides a product with stable quality, suitable hardness, simple and feasible process, and the dissolution level reaches the reference level. Preparations and sodium phenylbutyrate tablets with high bioavailability have filled the blank of sodium phenylbutyrate preparations in my country.

Description

technical field [0001] The invention relates to a sodium phenylbutyrate tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The urea cycle is a metabolic process through which nitrogen is excreted from the human body. There are 6 enzymes involved in this process. Defects in any one of these enzymes will disrupt this metabolic process, resulting in the retention of excess nitrogen (in the form of ammonia) in the body. The six kinds of urea cycle disorders are: carbamoyl phosphate synthase deficiency disease; N-acetylglutamate synthase deficiency disease; ornithine carbamoyltransferase deficiency disease; argininosuccinate synthase deficiency disease; Argininosuccinate lyase deficiency disease and arginase deficiency. [0003] If a newborn baby has one of these rare enzyme deficiencies in the urea cycle, and the enzyme deficiency is severe, it can lead to coma or death within days of birth. Sodium phen...

AI Technical Summary

Problems solved by technology

[0005] In the case of sodium phenylbutyrate granules, the powder dose is measured through one of three different sized measuring spoons, but this method of measuring often results in inaccurate dosing, resulting in inability to take prescribed doses at required intervals. Dosage, especially for young children, often causes nausea, which is not conducive to patient tolerance, while tablets can avoid the above problems

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