知母皂苷涂膜剂的制备工艺研究

Preparation of Anemarrhenae Rhizoma saponins film

目的:优化知母皂苷涂膜剂的处方工艺。方法:采用L9(34)正交试验法,以聚乙烯醇、1,2-丙二醇、知母皂苷酶水解产物为考察因素,以成膜时间和外观性状为评价指标,对基质与药物的用量进行优化,筛选知母皂苷涂膜剂的最优处方工艺,并对制得的涂膜剂进行质量评价、含量测定和安全性评价。结果:筛选出知母皂苷涂膜剂的最佳处方为:聚乙烯醇1.5 g、丙二醇4 ml、知母皂苷酶水解产物10 mg,所制得的涂膜剂成膜时间短,成膜性好,质量稳定、符合规定,知母皂苷AⅢ含量为(0.27±0.10)mg/ml,且动物实验显示无毒、无皮肤刺激性。结论:该制备工艺简单,成膜性好,制得的知母皂苷涂膜剂质量可控,且安全无刺激。

Objective: To optimize the formulation of Anemarrhenae Rhizoma saponins film. Methods: The L9(34) orthogonal test was performed. The amount of polyvinyl alcohol(PVA), 1,2-propanediol and enzymatic hydrolysates of Anemarrhenae Rhizoma saponins were set as influencing factors. Taking the film forming time and appearance properties as evaluation indexes, the dosage of matrix and drug was optimized to obtain the best formulation of Anemarrhenae Rhizoma saponins film. The quality and safety of the prepared film were evaluated and the content of Anemarrhenae Rhizoma saponins was determined. Results: The optimal formulation of Anemarrhenae Rhizoma saponins film was as follows: PVA 1.5 g, 1,2-propanediol 4 ml and enzymatic hydrolysates of Anemarrhenae Rhizoma saponins 10 mg. The obtained film showed short film forming time and good film forming ability. The film quality was stable and met the requirements of pharmacopoeia. The content of timosaponin AⅢ was(0.27±0.10) mg/ml, and no toxicity and skin irritation were observed in animal experiments. Conclusion: The preparation process is simple, with good film forming ability. The obtained Anemarrhenae Rhizoma saponins film shows stable quality and safety, without irritation.