摘要
目的筛选合适目数的琥珀酸解决哌柏西利片原料流动性、可压性及溶出度较差的问题。方法以琥珀酸的主要功能性指标及哌柏西利的可压性、溶出曲线、有关物质为评价指标,考察不同目数的琥珀酸对哌柏西利片制备的影响。结果筛分30~40目琥珀酸(粒径约为327.99μm)制备的哌柏西利片混粉流动性及可压性较好,溶出行为与参比制剂相似,产品质量与参比制剂基本一致,且不同批次样品功能性指标具有一致性。结论30~40目琥珀酸(粒径约为327.99μm)适用于制备哌柏西利片。
Objective To screen succinic acid with appropriate mesh number to solve the problems of poor raw material fluidity,compressibility and dissolution of piperacillin tablets,and ensure the drug quality.Methods The main functional indexes of succinic acid,and tablet compressibility,dissolution curve and related substances of piperacillin tablets was used as evaluation indexes.The effect of succinic acid with different mesh numbers on the preparation and production of piperacillin tablets was dertermined.Results The prepared piperacillin tablets had good powder mixing fluidity and compressibility with succinic acid(30~40 mesh,particle size at 327.99μm).The dissolution behavior was similar to the reference preparation,the product quality consistent with the reference preparation,and the functional indexes of different batches of samples were also consistent.Conclusion Succinic acid(30~40 mesh,particle size at 327.99μm)is suitable for the preparation of piperacillin tablets.
作者
钱进
霍立茹
张倩倩
QIAN Jin;HUO Li-ru;ZHANG Qian-qian(Xuzhou Medical University,Xuzhou Jiangsu 221000;Nanjing Gritpharma Co.,Ltd.,Nanjing 211100)
出处
《中南药学》
CAS
2022年第8期1829-1833,共5页
Central South Pharmacy
关键词
琥珀酸
哌柏西利
处方研究
溶出曲线
有关物质
succinic acid
piperacillin
prescription study
dissolution curve
related substance