摘要
目的制备治疗儿科疾病的罗红霉素中空栓剂并对其质量控制进行研究。方法以半合成脂肪酸甘油酯为基质,罗红霉素为主药制备制剂,用分光光度法对成品质量进行控制,通过长期留样试验考察药品的稳定性。结果制剂在6个月内性质稳定,符合临床治疗需要。结论该制剂制备工艺简单,成品质量可控,性质稳定,可以推广应用。
Objective To prepare Roxithromycin Hollow Suppositoiry and to study its quality control in order to treat paediatric diseases. Methods The preparation was made with semi- synthesis fatty glyceride as drug excipient and the ruxithromycin as primary drug. The concentration of roxithromycin was analyzed with ultraviolet- visible spectrophotometer. Stability property was observed through the long-term test, Results The preparation was stable in 6 months and corresponded completely with the need for clinical treatment. Conclusion Roxithromycin Hollow Suppository is stable, the quality can be controlled by effective standard procedure. The preparative method is simple, feasible and the products fit for wider application in clinic.
出处
《中国药业》
CAS
2007年第23期38-39,共2页
China Pharmaceuticals
关键词
罗红霉素
中空栓剂
制备
质量控制
稳定性
roxithromycin
hollow suppository
preparation
quality control
stability
