Empagliflozin pharmaceutical composition and preparation method thereof

• Main Authors: FENG SHANGJUN, WANG HAIBO, MEI GUANGYAO, XU CHENLI, MENG HAIPING, WANG KAIMING, XIAO YANG, JIN HUI
• Format: Patent
• Language: Chinese; English
• Published: 27.10.2023
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention provides a pharmaceutical composition and a preparation method thereof, and particularly provides a pharmaceutical composition of empagliflozin and a preparation method thereof. The pharmaceutical composition is prepared by controlling the raw materials in a proper particle size range and selecting proper types and dosages of auxiliary materials through a wet granulation process. According to the empagliflozin pharmaceutical composition prepared by the technical scheme provided by the invention, the solubility of the medicine can be obviously improved, the tabletting process is ensured to be smooth, and the dissolution rate of a finished product meets the requirements. Finally, the finished empagliflozin pharmaceutical composition has very similar in-vitro dissolution curve and bioequivalence with a reference preparation published by the State Drug Administration. 本发明提供了一种药物的组合物及其制备方法，具体而言，本发明提供了恩格列净的药物组合物及其制备方法。该药物组合物通过对原料控制在合适的粒径范围，并选择合适的辅料种类和用量，采用湿法制粒工艺制得。通过本发明中的技术方案制得的恩格列净的药物组合物可以明显的改善药物的溶解性