The fenofibrate micronized powders were prepared using lactose and MCC as the main expicients for preparation of fenofibrate tablets.
以乳晶纤维素作为主
料制备非诺贝特的
粉化物,并以此制备片剂,
以预胶化淀粉调节片剂的溶出度。
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(a)There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.
(a) 应制订并遵循详细描述原辅料、药容器及密封件的接收、鉴别、贮存、处理、取样、检验和批准
拒绝的书面操作规程。