克拉霉素片处方和工艺研究  

Clarithromycin Tablets Prescription and Process Research

作　　者：王亚龙[1] 毛万祥 郑晓斌 蓝美英 王则澡 钟贞[1] 曹珺 WANG Ya-long;MAO Wan-xiang;ZHENG Xiao-bin;LAN Mei-ying;WANG Ze-zao;ZHONG Zhen;CAO Jun(Livzon(Group)Pharmaceutical Factory,Zhuhai 519000,China)

机构地区：[1]丽珠集团丽珠制药厂,广东珠海519000

出　　处：《海峡药学》2024年第12期1-4,共4页Strait Pharmaceutical Journal

基　　金：广东省2021~2022年度平台基地及科技基础条件建设项目(粤科资字〔2022〕57号),项目名称:广东省特色药物研发企业重点实验室(2022年度),项目编号:2022B1212020007。

摘　　要：目的开发克拉霉素片的处方工艺。方法将pH 6.8磷酸盐缓冲液介质溶出曲线作为考察指标,利用全析因设计和单因素设计等试验方法,对克拉霉素片处方中原料粒径、辅料用量进行筛选研究,同时对制备工艺参数进行相关研究。结果利用筛选研究后的处方工艺制成片剂,根据体外溶出曲线测试表明,自制制剂与参比制剂在测试的各种介质中均溶出行为相似。结论筛选出了适宜的原料药粒径范围、崩解剂总比例和崩解剂内外加比例以改善克拉霉素片的溶出度,经过大量的处方和工艺筛选研究,确定了处方工艺稳定可控、适合商业化生产的制备方法。OBJECTIVE To develope the formulation&process for clarithromycin tablets.METHODS The dissolution curve in pH 6.8 phosphate buffer medium was used as the investigation index,and the particle size of API and used amount of excipient in the formulation of clarithromycin tablets were screened and studied by using test methods such as total factorial design and single-factor design,and the process parameters were studied at the same time.RESULTS Tablets were manufactured using the formulation&process obtained in screening studies,and in vitro dissolution curve testing showed the similar dissolution behavior between homemade and reference preparations in various media tested.CONCLUSION The appropriate API particle size range,total disintegrant ratio and disintegrant internal and external ratio were screened to improve the dissolution of clarithromycin tablets,and after a large number of formulation&process screening studies,the stable and controllable formulation&process suitable for commercial production were finally determined.

关 键 词：克拉霉素片 处方工艺研究 溶出曲线 

分 类 号：R94[医药卫生—药剂学]