地红霉素肠溶片处方筛选  

Formulation Screening of Dirithromycin Enteric-coated Tablets

作　　者：黄伟静 陈伟翰 李桃英 乔飞 钟国逢 郭婉玲 Huang Weijing;Chen Weihan;Li Taoying;Qiao Fei;Zhong Guofeng;Guo Wanling(Guangzhou Daguang Pharmaceutical Co. Ltd.,Guangzhou 510535,China)

机构地区：[1]广州大光制药有限公司,广州510535

出　　处：《中国药师》2019年第1期184-187,共4页China Pharmacist

摘　　要：目的:筛选体外溶出曲线与参比制剂相似的地红霉素肠溶片处方。方法:以溶出曲线作为筛选指标,采用正交试验和单因素法设计处方筛选试验。结果:地红霉素肠溶片处方中,片芯处方为每片含地红霉素250 mg、微晶纤维199. 6 mg、低取代羟丙甲纤维13 mg、交联羧甲纤维素钠10 mg、羧甲淀粉钠12 mg、碳酸镁250 mg、硬脂酸镁12 mg,隔离层增重为4. 5%,肠溶层增重为6. 5%。结论:筛选得到的地红霉素肠溶片,体外溶出曲线与参比制剂相似,处方工艺重现性好。Objective:To screen the formulation of dirithromycin enteric-coated tablets with in vitro dissolution profile similar to that of reference product.Methods:Orthogonal test and single factor experiment were used to design the formulation of dirithromycin enteric-coated tablets with the dissolution curve as the screening index.Results:As for the formulation of dirithromycin enteric-coated tablets,the tablet core contained 250 mg dirithromycin,199.6 mg microcrystalline fiber,13 mg low-substituted hypromellose,10 mg croscarmellose sodium,12 mg carboxymethyl starch sodium,250 mg magnesium carbonate and 12 mg magnesium stearate.The weight gain of isolation layer was 4.5%and that of enteric layer was 6.5%.Conclusion:With the screened formulation,the dissolution curve in vitro was similar to that of reference preparation with good reproducibility.

关 键 词：地红霉素 肠溶片 处方筛选 参比制剂 溶出曲线 相似因子 

分 类 号：R944.4[医药卫生—药剂学]