ABSTRACT
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.