铁皮石斛多糖软膏制备工艺及其质量标准研究

Study on Development and Quality Standard of Dendrobium Candidum Polysaccharide Ointment

目的:制备铁皮石斛多糖软膏并建立其质量控制方法。方法:以铁皮石斛多糖浓缩粉为主药,PEG400和PEG3350为基质,薄荷脑,苯氧乙醇等为辅料采用水包油的方法制备软膏。紫外分光光度法建立铁皮石斛多糖的含量方法,采用加速试验和长期试验进一步考察其稳定性。结果:确定铁皮石斛多糖软膏的最佳制备工艺,PEG400和PEG3350的比例为2∶1时,软膏的黏度最佳,易于涂展;多糖含量在20~100μg/mL呈良好的线性关系,回归方程y=0.0101x+0.0971(r^(2)=0.9997),平均回收率为107.8%,RSD=2.1%。该软膏在高温、高湿、强光下均具有良好的稳定性。结论:该软膏制备工艺简便可行,稳定性良好,可用于铁皮石斛多糖软膏的制备;建立的质量标准专属性强,重复性好,可作为该软膏的质量控制。

Objective To prepare Dendrobium candidum polysaccharide(DOP)ointment and establish its quality standard.Methods The ointment was prepared by oil in water method with Dendrobium officinale polysaccharide concentrated powder as main drug,PEG400 and PEG3350 as matrix,menthol and phenoxyethanol as excipients.The content of DOP in ointment was determined by UV.The stability of DOP ointment was further investigated by the accelerated test and long-term test.Results The optimum preparation technology of DOP ointment was determined.When the ratio of PEG400 and PEG3350 was 2∶1,the viscosity of the ointment was the best and easy to spread.The DOP content showed a good linear relationship in the range of 20~100μg/mL,and the regression equation was y=0.0101x+0.0971(r^(2)=0.9997).The average recovery was 107.8%,RSD was 2.1%.The ointment had good stability under high temperature,high humidity and strong light irradiation.Conclusion The optimized process of the DOP ointment was simple and feasible;the quality standard of the DOP ointment is specific and controllable.