Erlotinib hydrochloride composition tablet and preparation method thereof

2016 
The invention discloses an erlotinib hydrochloride composition tablet and a preparation method thereof. The erlotinib hydrochloride composition tablet comprises the following ingredients in percentage by weight: 20-38% of erlotinib hydrochloride crystals, 30-50% of pregelatinized starch, 25-45% of calcium sulfate, 1-5% of ethyl cellulose, 6-12% of beta-cyclodextrin, 0.2-3% of Tween, 5-10% of crosslinked sodium carboxymethyl starch, 0.5-1.5% of sodium stearyl fumarate and 0.2-2% of micropowder silica gel. A preparation process route of the erlotinib hydrochloride composition tablet is stable, simple and easy to operate, set technological parameters can effectively control each reaction, and sample detection results show that an erlotinib hydrochloride crude drug is stable in crystal form and relatively good in purity and quality requirements of a final product can be met. A synthesis and production technology of the erlotinib hydrochloride composition tablet is simple, stable and feasible and is applicable to mass production; and quality is controllable, and stability is relatively good.
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