中药“洗眼一号”涂膜剂的制备工艺研究

Research on the preparation of “Ophthalmic Washing Solution No.1” Chinese traditional medicine liniment

[目的]优化中药"洗眼一号"涂膜剂制备工艺的各种因素,建立最佳制备工艺。并且确定其安全性。[方法]采用正交实验法,考察各种辅料的用量,主药浸膏的加入方式等单因素,以涂膜剂的成膜时间、柔韧性、均匀性及流动性等外观形状作为评价指标,确定涂膜剂的最佳制备工艺。[结果]优选的中药"洗眼一号"涂膜剂最佳各组分之比为蒸馏水∶乙醇∶丙酮∶聚乙烯醇(PVA):浸膏=5∶2∶1∶1∶1时,得到的中药"洗眼一号"涂膜剂在成膜时间、柔韧性、均匀性及流动性等外观性状方面为最优。[结论]"洗眼一号"涂膜剂的制备工艺设计合理、简便可行,安全可靠。成膜时间、柔韧性、均匀性及流动性等均符合要求。

[Objective] To optimize the preparation process of different single factors such as dosage of accessories and addition way of medicine extracts in orthogonal experiment, to ensure the safety of 'Ophthalmic Washing Solution No.1' Chinese traditional medicine liniment and establish a best one to ensure the safety. [Methods] To find the best preparation of the liniment by evaluating the filmforming time, flexibility, uniformity and fluidity and acute toxicity test on the basis of Chinese traditional medicine and natural medicine acute toxicity studies technical guidelines. [Results] The ratio in the best preparation of 'Ophthalmic Washing Solution No.1' Chinese traditional medicine liniment which with the best film-forming time, flexibility, uniformity and fluidity was distilled water: ethanol:acetone: PVA: medicine extracts = 5∶2∶1∶1∶1. [Conclusion] The preparation of 'Ophthalmic Washing Solution No.1' Chinese traditional medicine liniment is reasonable, feasible and reliable. The film-forming time, flexibility, uniformity and fluidity can meet the requirements.