复方螺内酯乳膏的制备及质量控制.pdfVIP

曾明辉 , 朱九群, 余继英, 童荣生( 四川省医学科学院 四川省人民医院药剂科, 成都市 6100 72) R9272; R986 A 100 1- 0408( 2008) 04- 0285- 03 目的: 制备复方螺内酯乳膏并建立其质 控制方法方法: 以十二烷基硫酸钠和聚山梨酯- 80 为混合乳化剂制备乳膏; 采 用高效液相色谱法分别测定其中主药的含 结果: 所制备乳膏质地均匀细腻黏稠度适宜; 盐酸克林霉素螺内酯检测浓度的线 性范围分别为 100~ 800 g mL - 1( r = 0999 0) 10~ 20 0 g mL - 1( r = 0 999 5) , 平均回收率分别为 10074% ( RSD = 150%) 10028% ( R SD = 16 1%) 结论: 本制剂制备工艺简便可行,质 稳定可控 复方螺内酯乳膏; 盐酸克林霉素; 高效液相色谱法; 制备; 含 测定 Preparation and Quality Control of Compound Spironolactone Cream ZENG M ing- hui, ZH U Jiu- qun, YU Ji- ying, T ONG Rong - sheng( Dept of Pharmacy, Sichuan Provincial Peoples Hospital, Sichuan M edical Science Academy , Chengdu 610072, China) ABSTRACT OBJECT IVE : T o re are Com ound S ironolact one Cream and t o est ablish a method f or its ualit cont rol p p p p q y METHODS : The cream w as prepared using sodium dodecylsulfat e(SDS) and polysorbate- 80 as m ixed emulsif ying agents w ith the content s of t he principal agents - Spironolactone( Sp) and Clindamycin hydrochloride ( Cd) determined by HPLC RE SULTS : T he cream w as w ell - dist ribut ed and delicate w it h ood suitable consistenc and viscosit T he linear ran es of g y y g Clindam cin H drochloride and S ironolactone w ere 100~ 80 0( r = 0999 0) and 10~ 200 mL - 1( r = 0999 5) , re y y p g spectively, w ith average recoveries at 10074% ( R SD = 150%) and 10028% ( R SD = 16 1%) , respectivelyCONCLUSION: The re arat ion t echnolo of this cream is sim le and feasible and it s ualit is st able and controllable p p gy p q y KEY WOR S S ironolact one; Clindam cin h drochloride; HPLC; Pre arat ion; Content determinat ion p y y p 20 L , ,