喷雾制粒法制备溃疡片及质量标准的研究  

Study on the Quality Control for Ulcer Tablet and its Preparing by Spraying

作　　者：闫锋[1] 刘荣[1] 程远瑞[1] 

机构地区：[1]中国人民解放军总医院第309临床部药剂科,北京100091

出　　处：《解放军药学学报》2005年第4期314-315,共2页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的采用喷雾制粒法制备溃疡片;对其质量进行控质。方法利用喷雾干燥制粒机,温度控制在90℃左右,采用流化喷雾制粒法制粒压片;利用原有的质控标准进行检测。结果含量测定结果表明,温度对其含量没有影响,新、老方法平均百分含量分别为:47.04%、46.50%;该制剂的崩解时限和微生物限量检查均符合其检验标准。结论喷雾制粒法制备溃疡片,提高了片剂质量,改善了生产条件,结果令人满意。Aim To prepare ulcer tablet by spraying and develop its quality control. Methods The flowing and spraying machine was uesed at 90℃, and the tablets were determined. Results The content was not affected by temperature. The average contents with the new method and the old were 47.04% and 46.50% respectively. The examination of dissolution and microbial limit passed. Conclusion It improves the quality of tablet prepared by flowing and spraying. The method is acceptable.

关 键 词：原生药粉末直接压片 流化喷雾制粒法制粒压片 质量观察 

分 类 号：R943[医药卫生—药剂学]