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盐酸特比萘芬凝胶的制备与质量控制 被引量:6

Preparation and quality control of terbinafine hydrochloride gel
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摘要 目的:研制盐酸特比萘芬凝胶,并建立质量控制方法。方法:用卡波姆940为凝胶基质,制备盐酸特比萘芬凝胶剂,采用高效液相色谱法测定含量。结果:盐酸特比萘芬在0.1~2.5mg·L-1浓度范围内线性关系良好,平均回收率为99.0%,RSD为0.39%(n=3)。结论:该凝胶剂制备工艺简单,性质稳定,质量可控。 OBJECTIVE To study the preparation of terbinafine hydrochloride gel,establish its quality control standard. METHODS The terbinafine hydrochloride gel was prepared with carbopol-940 as base material. The coutent was measured by an HPLC method. Test was carried out to investigate the stability. RESULTS The Terbinafine Hydrochloride had a good linearity, rang from 0. 1-2. 5 mg·L^-1 , while the mean recovery was 99. 0 %, RSD = 0. 390% (n = 3). CONCLUSION The technique is simple in preparing the gel. The gel is stable. The quality can be controlled.
机构地区 天津市长征医院
出处 《中国医院药学杂志》 CAS CSCD 北大核心 2005年第7期642-644,共3页 Chinese Journal of Hospital Pharmacy
关键词 盐酸特比萘芬 凝胶剂 高效液相色谱法 质量控制 terbinafine hydrochloride gel HPLC quality control
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