摘要
目的优化盐酸特比萘芬栓剂的生产工艺,并建立质量控制方法。方法以融变时间为优选指标,采用单因素实验与正交实验优选盐酸特比萘芬栓剂的处方组成。通过方法学考察建立了盐酸特比萘芬栓剂的质量控制体系。结果优选出的栓剂基质组成为PEG4000与PEG6000比例为7∶1,熔融温度为100℃。栓剂的性状、鉴别、检查、含量测定等质量可控。结论验证实验说明,该栓剂制备工艺合理、稳定、可行,质量控制方法能较好的控制该制剂的质量。
Objective To optimize the preparation of Terbinafine Hydrochloride Suppositories and to establish its quality control standard.Methods The thaw time of suppositories was selected as index,the preparation of Terbinafine Hydrochloride Suppositories was optimized through the single factor and the orthogonal test.According to the results of methodology,the quality control method was established.Results The optimized components of suppositories base were the mixture of PEG4000 and PEG6000,the ratio between PEG4000 and PEG6000 was 7∶1.The fusion temperature of preparation was 100 ℃.The quality of suppositories can be evaluated by characteristics,identification,and content assay.Conclusion According to the results of verification test,the preparation of the suppositories is reasonable,stable and practicable.The quality can be controlled by the established quality standard
出处
《西北药学杂志》
CAS
2011年第4期283-286,共4页
Northwest Pharmaceutical Journal
关键词
盐酸特比萘芬
栓剂
制备
质量控制
terbinafine hydrochloride
suppositories
preparation
quality control
