口腔溃复平膜剂的研究

Study on Oral Kuifuping Films

目的 :优选口腔溃复平膜剂 (黄柏、龙胆草、青黛等 )最佳处方 ,建立膜剂中盐酸小檗碱含量的测定方法。方法 :以膜剂外观和融化时间为指标 ,采用L9(34 )正交试验筛选处方 ,反相液相色谱法测定膜剂中盐酸小檗碱的含量。结果 :膜剂最佳处方为 :中药提取液 40mL ,PVA0 588∶PVA1 788为 4∶1 .5 ,甘油含量 8% ,CMC Na0 .2 5g ;测定方法中盐酸小檗碱的平均回收率为 97.7%。结论 :膜剂的外观 (包括可塑性、粘附性及抗拉强度 )和融化时间等指标均符合质量标准的要求 ,采用反相液相色谱法可有效控制溃复平膜剂中盐酸小檗碱的含量。

Objective: To optimize the formulation of Oral Kuifuping Films(Cortex Phellodendri, Radix Gentianae, Indigo Naturalis, etc.)and develop a determination of berberine hydrochloride in the films. Methods: With the exterior quality and melting time as indexes, orthogonal design was used to select the formulation of the films. Berberine hydrochloride in the films was determined by a reversed phase HPLC method. Results: The optimun formulation was composed of 40mL of Chinese herbal extract, PVA 0588 ∶PVA 1788 (4∶1.5),8% glycerine and 0.25g of CMC Na. The recovery of berberine hydrochloride in the reversed phase HPLC was 97.7%. Conclusion: The exterior and melting time of the films are meet the requirements of qulaity standard. The content of berberine hydrochloride in Kuifuping Films can be controlled by the reversed phase HPLC method.