替硝唑螺内酯乳膏的制备及质量控制

目的制备替硝唑螺内酯乳膏并建立其质量控制方法。方法以平平加O、十六醇、十八醇为混合乳化剂，替硝唑、螺内酯为主药制备乳膏；采用高效液相色谱法分别测定其主药替硝唑、螺内酯的含量，并考察制剂稳定性及刺激性。结果制备的乳膏质地均匀、细腻、黏稠度适宜；替硝唑、螺内酯检测质量浓度的线性范围分别为30．69～245．52μg／mL（r=0．9994，n=6）和2．55—20．40μg／mL（r=0．9996，n=6）；平均回收率分别为99．96％（RSD=1．19％，n=9）和99．47％（RSD=1．27％，n=9）；离心试验和耐热、耐寒试验及留样观察中各项指标无明显变化，对皮肤刺激性小。结论替硝唑螺内酯乳膏制备工艺简便可行，质量稳定可控。

Preparation and Quality Control of Tinidazole and Spironolactone Cream

Objective To prepare Tinidazole and Spironolactone Cream and to establish its quality control method. Methods The cream was prepared using peregol O, cetylalcohol and stearylalcohol as the mixed emulsifying agents and tinidazole and spironolactone as the main ingredients. The contents of the principal agents tinidazole and spironolactone were determined by HPLC and the stability and the stimulation of this preparation were also determined. Results The cream was well distributed and delicate with good suitable consistency and viscosity. The linear ranges of tinidazole and spironolactone were 30. 69-245.52 μg/mL（ r =0. 999 4, n =6）and 2.55-20.40 μg/mL（ r=0. 999 6, n = 6） respectively, with the average recovery rate of 99. 96% （ RSD = 1. 19%, n = 9） and 99.47% （ RSD = 1.27%, n = 9）, respectively. All the indexes showed no obvious change in the following tests including centrifugalization test, thermoresistant and coldresistant tests as well as sample observation test. The preparation had slight stimulation to skin. Conclusion This preparative technology of Tinidazole and Spironolactone Cream is simple and feasible, and its quality is stable and controllable.