The fenofibrate micronized powders were prepared using lactose and MCC as the main expicients for preparation of fenofibrate tablets.
以乳糖和

维素作为

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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All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
(d) 任何人无论何时(体检或监督观察)发现有可能影响药品安全性或质量的明显疾病或
放性损伤,都应避免直接接触各种原辅料、药品容器、密封件、中间产品和药品,直至健康状况改善或由合格的医务人员
定其对药品的安全性和质量不会造成危害为止。应告知所有人员就任何对药品可能有不利影响的健康状况向监督人员报告。
(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、药品容器及密封件的接收、鉴别、贮存、处理、取样、检验和批准或拒绝的书面操作规程。