氯倍他索乳膏的制备和质量控制

Preparation and quality control of clobetasol cream

目的 :制备氯倍他索乳膏并建立其质量控制标准和丙酸氯倍他索的HPLC含量测定方法。方法 :用水包油法制备氯倍他索乳膏 ,按药典要求对该制剂进行质量控制 ,并建立有效的HPLC测定法。结果 :本文的质量控制标准可较好地控制丙酸氯倍他索乳膏的制剂质量。丙酸氯倍他索线性范围为 0 5～ 4 0 μg·mL-1,最低检出浓度 0 0 5 μg·mL-1;检测限 1ng ;日内、日间RSD均 <3 0 % ;平均回收率 :99 18% ;同时测定了 4批制剂 ,标示量在 95 32 %～ 97 5 4 %之间 ,符合质控规定。结论 :本法为氯倍他索乳膏的质量控制和丙酸氯倍他索的含量测定提供简便、可靠、专一的方法 ,适于医院对该制剂进行质量控制。

AIM: To prepare clobetasol cream and create a criteria of preparation,quality control and determination of clobetasol cream. METHODS: The preparation was prepared by o/w (oil in water) method, its quality was controlled by the demand of Chinese Pharmacopeia and the determination of clobetasol was used by high performance liquid chromatography (HPLC). RESULTS: The quality of clobetasol cream can be controlled by the method established in this paper. The linear range of clobetasol was 0 5-4 0 μg·mL -1 , the limit concentration of quantitative was 0 05μg·mL -1 , the average recovery was 99 18%, RSD of inter day and intra day was less than 3 0%. Four batches of preparations had been analyzed, the percents of the stated amounts were between 95 32%-97 54% and coincided with the demands of quality control. CONCLUSION: The method of quality control established in this paper can control the quality of clobetasol cream. This HPLC developed for determination of clobetasol propionate is simple, specific, and accurate, so it is suitable for the quality control of clobetasol cream in hospitals.