Metformin hydrochloride tablet and preparation method thereof

• Main Authors: QU YONGZHAN, LI WENBO, SHEN YUNFENG, HE XIRUI, CHEN BINGYUE, WEI JIA
• Format: Patent
• Language: Chinese; English
• Published: 10.09.2019
• 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 relates to the technical field of pharmaceutical preparations, in particular to a metformin hydrochloride tablet and a preparation method thereof. The components of the metformin hydrochloride tablet comprise metformin hydrochloride, a binder, a framework film material and a lubricant, wherein the framework film material is selected from at least one of sodium stearate, magnesium stearate, stearic acid and the like. The preparation method of the tablet is a one-step granulation method. The in-vitro dissolution condition of the provided metformin hydrochloride tablet is highly similar to that of an original triturate, the tablet has excellent inter-batch stability, and the in-batch and inter-batch dissolution uniformity and inter-batch reproducibility of the tablet are superior to those of the original triturate. 本发明涉及药物制剂技术领域，具体涉及一种盐酸二甲双胍片及其制备方法。该盐酸二甲双胍片的成分包括盐酸二甲双胍、粘合剂、骨架膜材料和润滑剂，骨架膜材料为硬脂酸钠、硬脂酸镁、硬脂酸等中的至少一种。其制备方法为一步制粒法。本发明提供的盐酸二甲双胍片与原研制剂的体外溶出情况相似度高，且批间稳定性优异，优于原研制剂的批内、批间溶出均一性及批间重现性。