Empagliflozin tablet and preparation method thereof
The invention relates to an empagliflozin tablet and a preparation method thereof. According to the empagliflozin tablet, a dry granulation process is adopted, and the granularity of raw material medicines, the hardness of dry granulation tablets and the granularity of intermediate particles are con...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | The invention relates to an empagliflozin tablet and a preparation method thereof. According to the empagliflozin tablet, a dry granulation process is adopted, and the granularity of raw material medicines, the hardness of dry granulation tablets and the granularity of intermediate particles are controlled, so that the obtained empagliflozin tablet is stable in content, good in content uniformity and flowability, small in tablet weight difference and small in hardness fluctuation range, and the disintegration time limit, the dissolution curve and the bioavailability of the prepared coated tablet are consistent with those of RLD; the pharmaceutical composition has high bioavailability, and is beneficial to ensuring medication safety and clinical use effect.
本发明涉及一种恩格列净片及其制备方法。本品采用干法制粒工艺,通过控制原料药的粒度、干法制粒片状物的硬度、中间体颗粒的粒度,得到恩格列净片含量稳定、含量均匀度及流动性好,片重差异小、硬度波动范围小、制得的包衣片崩解时限、溶出曲线、生物利用度与RLD一致,具有较高的生物利用度,有利于保证用药安全和临床使用效果。 |
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