Compound preparation used for treating chronic kidney diseases and preparation method thereof

Abstract

The invention relates to a compound preparation used for treating chronic kidney diseases and a preparation method thereof. The preparation has the advantages of beautiful appearance, fast disintegration speed, high dissolution rate and high and stable content of active ingredients. The method that calcium ketonate and amino acid are respectively granulated is adopted, interaction of components is avoided, and the contents of active ingredients can be ensured to be stable. The calcium ketonate part contains anti-viscosity ingredients and an anhydrous wetting agent, the granulation problem caused by the facts that the calcium ketonate is easy to agglomerate due to high viscosity is solved, and meanwhile the disintegration speed and dissolution rate of the preparation are improved, the product quality can be ensured, and the requirement of large scale production can be met.

Description

technical field [0001] The invention relates to a compound preparation for treating chronic kidney disease and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] In recent years, chronic kidney disease (CKD) has a high incidence rate and tends to be younger, and it has been paid more and more attention by people. The progress of CKD is hidden. Once it enters the advanced stage, the cost of treatment drugs and nursing care will surge. Compound α-ketoacid tablets combined with a low-protein diet can delay the progression of renal failure, which is of great value in the treatment of CKD and has gradually become the core means of CKD treatment. [0003] Compound α-keto acid is a compound preparation containing ten active ingredients including 4 kinds of ketoamino acid calcium, 1 hydroxyamino acid calcium and five essential amino acids, which are α-racemic ketoisoleucine calcium, α-ketone Calcium Leucine, Calcium A...

AI Technical Summary

Problems solved by technology

[0004] 1. Calcium ketoacids and amino acids are directly mixed to easily interact, and reactions such as calcium ketoacids and amino acid degradation occur, resulting in a decrease in the content of the main ingredient and an increase in related substances

[0005] 2. Calcium ketoacid has a relatively high viscosity, especially when it meets water, the viscosity is even greater, and wet granulation will cause serious agglomeration, which cannot be made into granules that meet the requirements, which will affect tableting and is not suitable for scale-up production.

[0006] 3. The high viscosity of the material leads to slow disintegration and low dissolution rate of the product

[0007] 200710163357.1 discloses a compound α-keto acid chewable tablet and its preparation method. It adopts the process of mixing and granulating keto acid calcium, amino acid and pharmaceutical excipients. There is no anti-adhesive component in the prescription, and the adhesive contains water, which cannot overcome keto acid High calcium viscosity, easy to form a group of defects

200810224131.2 discloses a compound α-ketoacid dispersible tablet and its preparation method. This process only granulates the main drug components, and the auxiliary materials are directly added to the particles, and then compressed into tablets. This process combines the granular main drug components with powder The excipients are mixed directly, the particle size difference between the two is large, the mixing cannot be guaranteed, and the interaction is easy to occur

In addition, although there is no moisture in the granulation process, the problem of high viscosity in the granulation process cannot be solved because no anti-sticking ingredients are added