一种快速释放枸橼酸环苯替尼的药物制剂及其制备方法

Pharmaceutical preparation for rapidly releasing citric acid benzene ring tinib and preparation method thereof

Abstract

The invention relates to a pharmaceutical preparation for rapidly releasing citric acid benzene ring tinib and a preparation method thereof. The citric acid benzene ring tinib and a medicinal excipient are prepared into tablets; the pharmaceutical preparation comprises the following components by weight percent: 40-65% of citric acid benzene ring tinib; and the medicinal excipient is a disintegrating agent, a filler and a lubricating agent, and contains the components by weight percent: 5-25% of disintegrating agent, 20-50% of filler and 0.5-5% of lubricating agent. The medicine tablet of the citric acid benzene ring tinib provided by the invention can achieve the complete release target after 8 minutes; use of a granulating organic solvent is avoided by adopting a dry granulation method; meanwhile, the granulation time is shortened; and the production safety is greatly improved. The medicine tablet of the citric acid benzene ring tinib provided by the invention belongs to a tetrahydronaphthalene amide compound, and can be used for treating chronic myelogenous granulocyte leukemia, gastrointestinal stromal tumor and the like.
本发明涉及一种快速释放枸橼酸环苯替尼的药物制剂及其制备方法。由枸橼酸环苯替尼和药用赋形剂制成片剂,按重量百分比,含有枸橼酸环苯替尼40%-65%,所述的药用赋形剂是崩解剂、填充剂和润滑剂;按重量百分比为,含有崩解剂5%-25%,含有填充剂20%-50%,含有润滑剂0.5%-5%。本发明所提供的枸橼酸环苯替尼的药物片剂,8min时即可达到完全释放。采用干法制粒,避免了制粒有机溶剂的使用,同时缩短了制粒时间,极大地提高了生产的安全性。本发明提供的枸橼酸环苯替尼的药物片剂,属四氢化萘酰胺类化合物,可用于治疗慢性髓性粒细胞白血病,以及胃肠道间质瘤等。

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