康复新液剂型改进及质量评价  

Dosage Form Improvement and Quality Evaluation of the Kangfuxin Ye

作　　者：王成军 何旭 赵翠云 邓叶萍 Wang Chengjun;He Xu;Zhao Cuiyun;Deng Yeping(College of Pharmacy,Dali University,Dali,Yunnan 671000,China)

机构地区：[1]大理大学药学院,云南大理671000

出　　处：《大理大学学报》2024年第8期53-56,共4页Journal of Dali University

摘　　要：目的:将康复新液改为片剂,并进行质量评价。方法:以吸湿量为考察指标,采用L9(34)正交试验法筛选康复新片最佳处方,按照《中华人民共和国药典》(2020年版)三部进行质量评价。结果:康复新片剂由美洲大蠊提取物:辅料(微晶纤维素:乳糖:羟丙基甲基纤维素:微粉硅胶=3:2:1:0.5)按1:3的比例组成,用湿法制粒压片法制备,质量达到相关要求。结论:该处方组成合理,制备工艺简单,稳定性好,质量可控。Objective:To change Kangfuxin Ye into tablets and the quality was evaluated.Methods:With hygroscopic capacity as the index,L9(34)orthogonal test was used to screen the best prescription of Kangfuxin tablets,and the quality was evaluated according to Pharmacopoeia of the People's Republic of China(2020 edition).Results:Kangfuxing tablets was composed of Periplaneta americana extract and excipient(microcrystalline cellulose:lactose:hydroxypropyl methyl cellulose:microsilica gel=3:2:1:0.5)in a ratio of 1:3,and was prepared by wet granulation tablet method,and the quality met the relevant requirements.Conclusion:This prescription has reasonable composition,simple preparation process,good stability and controllable quality.

关 键 词：康复新片 正交试验 吸湿量 制备工艺 质量评价 

分 类 号：TQ460.6[化学工程—制药化工]