星点设计-效应面法优化发酵虫草菌粉全粉末压片-中国现代应用药学.pdf

星点设计-效应面法优化发酵虫草菌粉全粉末压片工艺  陈丽华1 1 1 2 ，岳国超 ，管咏梅 ，杨明 (1.江西中医药大学现代中药制剂教育部重点实验室，南昌 330004 ；2.江西济民可信金水宝 制药有限公司，南昌 330096) 摘要：目的 研究发酵虫草菌粉全粉末直接压片的成型工艺，提升产品质量。方法 根据全粉末压片的要求，以微粉的 流动性和可压性为评价指标对各类直压辅料进行筛选；运用星点设计-效应面法，以混合粉末的堆密度、崩解时间、硬度 为考察指标优选最佳处方。结果 优选的最佳处方为微粉硅胶用量为 10% ，Flowlac100 ∶AvicelPH102 为 3 ∶1 ， Plasdone®S-630 的用量为3.03% ，期望值达到95% 以上。结论 该工艺处方合理，片剂成形性好，质量稳定，可有效解 决发酵虫草菌粉直接压片成形性差的问题。 关键词：发酵虫草菌粉；全粉末压片；星点设计-效应面法；微粉硅胶 中图分类号：TQ460.6 文献标志码：B 文章编号：1007-7693(2013)11-1192-05 Optimization of the Fermented Cordyceps Powder Directly Compress Tablets by Central Composite Design-response Surface Methodology 1 1 1 2 CHEN Lihua , YUE Guochao , GUAN Yongmei , YANG Ming (1.Key Laboratory for Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Ch inese Medicine, Nanchang 330004, China; 2.Jiangxi Jimingkexin Jinshuibao Co., Ltd, Nanchang 330096, China) ABSTRACT: OBJECTIVE To study the direct powder tableting technique of fermented Cordyceps powder for promoting the quality of the product. METHODS On the basis of the requirements to the direct powder tableting, the most suitable excipients from all kinds of direct compress excipients were evaluated by the micro powder’s flowability and compressibility. Utilizing the central composite design-response surface method, the ratio of the best prescription was elected through the index of the mixed powder’s bulk density, the disintegrating time and the hardness of the tablet. RESULTS The optimized prescription seems to be made up with silica gel 10%, Flowlac100:AvicelPH102 3 ∶1 and Plasdone®Sbest-630 3.03%, the expected value was more than 90%. CONCLUSION With good formability and stable quality, the prescrip