中国药房2011，Vol.22Issue(9)：826-828,3.
他克莫司软膏的基质处方优选及含量测定
Content Determination and Matrix Formula Optimization of Tacrolimus Ointment
摘要
Abstract
OBJECTIVE: To optimize the matrix formula of Tacrolimus ointment and to establish it's method for the content determination. METHODS: The matrix formula of Tacrolimus ointment was optimized by orthogonal experiment using substrate consistency, coating ductility, clarity and microscopic uniformity of droplet distribution as index and with amount of white wax, mineral oil and propylene carbonate as factors. The content of Tacrolimus ointment was determined by HPLC. The separation was carried out on a Venusil ASB C18 column with mobile phase consisted of acetonitrile-0.25％ phosphoric acid (75:25) at a flow rate of 1 mL·min-1. The detection wavelength was set at 210 nm. RESULTS: The optimized formula consisted of white wax 1.5 g, mineral oil 3.0 g, propylene carbonate 0.4 g. The scores of 3 batches of prepared matrix were 8.32, 8.22, 8.27 (10 scale). A good linear relationship of tacrolimus ranged from 10 μg·mL-1 to 100 μg·mL-1 (r=0.999 7). The average recoveries were 99.5％, 100.3％,99.4％ at high, medium and low concentrations (RSD＜1.23％). Detection limit of tacrolimus was 2.1 μg·mL-1 and quantitative limit was 6.5 μg·mL-1. CONCLUSION: The matrix formula of Tacrolimus ointment is reasonable. The established method is simple, rapid and accurate.关键词
他克莫司/软膏/基质处方/正交试验/含量测定分类
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吴燕,张福成,林敏..他克莫司软膏的基质处方优选及含量测定[J].中国药房,2011,22(9):826-828,3.
