【摘要】 目的:制备氢地油乳剂并建立其质量控制方法。方法:采用乳化法,以盐酸丁卡因为主药制备氢地油乳剂;采用紫外分光光度法测定其中盐酸丁卡因的含量;考察3批样品的稳定性。结果:所制制剂为白色乳状物;盐酸丁卡因检测浓度的线性范围为3.168～9.504μg.mL-1(r=0.9999),平均回收率为99.68%(RSD=0.49%)。3批样品经留样试验考察,质量稳定。结论:该制剂制备方法简便,含量测定准确,质量在保质期内稳定可控。更多还原

【Abstract】 OBJECTIVE:To prepare qingdiyou emulsion and to establish its quality control.METHODS:Qindiyou emulsion was prepared by emulsification by using tetracaine hydrochloride as principal agent.The content of tetracaine hydrochloride was determined by UV spectrophotometry.The stability of 3 batches of samples was investigated.RESULTS:The preparation was white emulsion.The linear range of tetracaine hydrochloride was 3.168～9.504 μg·mL-1(r=0.999 9),with an average recovery rate of 99.68%(RSD=0.49%).The 3 batches of sample preparations were proved to be stable in quality.CONCLUSION:This method is simple in operation,accurate in content determination,and stable and controllable in quality within expiration date.更多还原