Epalrestat pharmaceutical composition and preparation method thereof
The granules of epalstat pharmaceutical composition prepared by extrusion rounding process solve the problems of low dissolution and large differences between tablets in existing epalstat tablets, and achieve the effect of high bioavailability and differences between small tablets.
CN119656162APending Publication Date: 2025-03-21SHENYANG YONGDA PHARMA
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Patent Information
- Application Number
- CN202411888614.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-20
- Publication Date
- 2025-03-21
AI Technical Summary
Technical Problem
The average dissolution of existing epalstat tablets is low, and the dissolution varies greatly between tablets, resulting in low drug bioavailability and affecting clinical effect.
Method used
Epastat pharmaceutical composition granules are prepared by extrusion rounding process, and the composition contains epastat, filler, disintegrant, surfactant and binder. By optimizing the ratio and process parameters, the fluidity and dissolution performance of the granules are improved.
Benefits of technology
The high average dissolution (greater than 95%) and small differences in dissolution between tablets (RSD less than 3%) were achieved, which improved the bioavailability and clinical value of the drug.
✦ Generated by Eureka AI based on patent content.
Abstract
The invention relates to the technical field of medicines, and relates to an epalrestat pharmaceutical composition and a preparation method thereof. According to the technical scheme, the epalrestat pharmaceutical composition is prepared from the following components in percentage by weight: 25 to 65 percent of epalrestat, 25 to 70 percent of filler, 2 to 8 percent of adhesive, 2 to 8 percent of disintegrating agent and 1 to 3 percent of surfactant. The extrusion spheronization process selected by the invention effectively improves the problems of poor particle fluidity and large in-batch difference of the product; according to the epalrestat tablet and the preparation method thereof, the composition and proportion of the raw materials and the auxiliary materials are fully considered, and the raw materials and the auxiliary materials interact under the specific proportion, so that the prepared epalrestat tablet is relatively high in average dissolution rate (greater than 95%) and relatively small in inter-tablet dissolution rate difference (RSD is less than 3%), and the quality of the epalrestat tablet is obviously improved.
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