目的介绍FDA关于普通口服固体制剂生物等效豁免的相关政策。
Objective To introduce FDA's biowaiver policy for IR solid oral dosage forms.
该方法操作简便、准确，有利于有效控制灯盏花素口服固体制剂质量。
The quality control method is simple, accurate and favorable to effective quality control of the oral breviscapine preparation.
本发明制备 的颗粒粒度均匀、流动性好、压缩成形性好，可进一步制成口服固体制剂。
The granules prepared by the method has even granularity, and good liquidity and compression formability, and can be further prepared into oral solid preparation.
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