猫爪草纳米乳喷喉剂的制备及质量评价

Preparation and quality evaluation of Radix Ranunculi ternati Nano Emulsion Spray

目的研究猫爪草纳米乳喷喉剂的处方与制备工艺,并对其质量进行评价。方法通过绘制纳米乳的伪三元相图筛选制备猫爪草纳米乳喷喉剂所需的油相、乳化剂及助乳化剂,确定最佳处方,并考察其外观、形态、粒径及稳定性。结果根据载药量和空白乳的伪三元相图实验结果最终确定猫爪草纳米乳的最优处方为蓖麻油聚氧乙烯醚(EL-40)-丙三醇-肉豆蔻酸异丙酯(IPM)-水(21.72∶7.24∶10.01∶61.02)。所制得的猫爪草纳米乳喷喉剂为澄清的透明液体,离心后稳定不分层,平均粒径为84±3.12 nm,载药量为20 mg·mL^-1。结论猫爪草纳米乳喷喉剂制备工艺经验证稳定、简便、易行、预测性好,可为猫爪草纳米乳喷喉剂的进一步研发奠定基础。

Objective To study the prescription and preparation process of Radix Ranunculi ternati Nano Emulsion Spray,and to evaluate its quality.Methods The emulsitier,co-emulsifier and oil phase were screened and the Radix Ranunculi ternati Nano Emulsion Spray was prepared by using pseudo-ternary diagram method.Then the optimal prescription was determined and its appearance,morphology,particle size and stability were examined.Results According to the results of pseudo-ternary phase diagram test of drug loading and blank milk,the optimal prescription of the Radix Ranunculi ternati Nano Emulsion Spray was determined as castor oil polyoxyethylene ether(EL-40)-glycerol-isopropyl myristate(IPM)-water(21.72∶7.24∶10.01∶61.02).The preparation was a clear and stable transparent liquid,and non-layered after centrifugation with an average particle size of 84±3.12 nm and a drug loading of 20 mg·mL^-1.Conclusion The preparation process is stable,simple and easy to be predicted,and has a good predictability.The study lays a foundation for the further development of the Radix Ranunculi ternati Nano Emulsion Spray.