复方螺内酯乳膏的制备及质量控制

目的:制备复方螺内酯乳膏并建立其质量控制方法。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量。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10.0～80.0μg.mL-1(r=0.9990)、1.0～20.0μg.mL-1(r=0.9995),平均回收率分别为100.74%(RSD=1.50%)、100.28%(RSD=1.61%)。结论:本制剂制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of Compound Spironolactone Cream

OBJECTIVE： To prepare Compound Spironolactone Cream and to establish a method for its quality control. METHODS： The cream was prepared using sodium dodecylsulfate（SDS） and polysorbate- 80 as mixed emulsifying agents with the contents of the principal agents - Spironolactone（Sp） and Clindamycin hydrochloride （Cd） determined by HPLC. RESULTS： The cream was well - distributed and delicate with good suitable consistency and viscosity. The linear ranges of Clindamycin Hydrochloride and Spironolactone were 10.0-80.0（r = 0.999 0） and 1.0-20.0 μg . mL^-1（r = 0.999 5）, respectively, with average recoveries at 100.74% （RSD ： 1.50% ） and 100.28% （RSD ： 1.61% ）, respectively. CONCLUSION： The preparation technology of this cream is simple and feasible and its quality is stable and controllable.