布洛伪麻混悬液的制备及质控研究  

The preparation and study on quality of suspension of ibuprofen and pseudoephedrine hydrochloride

作　　者：何文[1] 张先洲[1] 姜俊勇[1] 蔡鸿生 

机构地区：[1]湖北医科大学附属第一医院,武汉430060

出　　处：《中国医院药学杂志》1999年第10期584-587,共4页Chinese Journal of Hospital Pharmacy

摘　　要：研制布洛伪麻混悬液，以方便小儿、老人及吞咽困难的患者使用，同时达到快速起效的目的。方法：以布洛芬、盐酸伪麻为主药，以黄原胶、预胶化淀粉、吐温-80等为稳定剂制各布洛伪麻混悬液，对其含量测定方法、粒径大小及分布、沉降容积比，对热、湿、光等的稳定性作了考察，并对其临床疗效作了初步观察。结果：本制剂制备工艺简单，含量测定用HPLC内标法，简便易行，回收率高；平均粒径小于4μp，且分布均匀；加速高心沉降后沉降容积比为0．91，稳定性良好；比布洛伪麻片起效快（P＜0.01）。结论：本制剂丰富了临床制剂品种，使用方便，起效迅速，可作为医院新制剂开发。To develop a suspension of ibuprofen and Pseudoephedrine hydrochloride, which can be easily used bychildren, the elder and other patients who have difficulties in swallow, and can preduce effects quickly. METHODS: The suspensionwas prepared using xanthan gum, pregelatinized starch, Tween-80, etc, as stabilizers. Its properties including conentration, granulesize,talimentation and stability were studied. Its primary clinical tests were also abserved. RESULTS: dricentrations of ibuproha andPseudophedrine hydrochloride were determined easily by HPLC. The suspension had excellent stability and slow sedimentation at am-bient conditions. Its granule size was small and homngenans. Its clinical effects were better than that of tablets(P＜0.01 ). CONCLU-SIONS:The suspension can be easily prepared and usel. Its quality is able to be controlled. It is a useful prepartion for the clinic.

关 键 词：制备 布洛伪麻混悬液 质量控制 

分 类 号：R971.1[医药卫生—药品] R944.16[医药卫生—药学]