Abstract：Objective To optimize the formula process of Sitafloxacin Tablets, and determine its scale-up of process parameters through mathematical models. Methods The in vitro dissolution similarity(similarity factor f2≥50) was used as the evaluation index to screen the prescription process, and the scale-up process parameters were determined by mathematical model. Results The preparation formula was Sitafloxacin 50 mg, mannitol 50 mg, corn starch 36 mg, low-substituted hydroxypropylcellulose 18 mg, appropriate amount of 3% hydroxypropyl cellulose aqueous solution, magnesium stearate 1 mg, film coating premix (Opadry), the coating weight gain was 3%; the key processing parameters were the granulation speed of 80 r/min, the granulation time of 2 min. Conclusion The developed sitafloxacin tablets are similar in vitro dissolution curve of the original drug, and the prescription and process parameters are reasonable, which can be used to guide the commercial production of sitafloxacin tablets.
张天可1 黄道明2. 西他沙星片制备与工艺放大研究[J]. 中国医药导报, 2022, 19(13): 38-41,46.
ZHANG Tianke1 HUANG Daoming2. Study on preparation and process pcale-up of Sitafloxacin Tablets #br#. 中国医药导报, 2022, 19(13): 38-41,46.
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