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目的:制备灯盏乙素纳米混悬液(SCU-NS),并考察制备过程中的主要影响因素。方法:通过试验确定制备工艺参数,采用单因素试验初选SCU-NS的制备条件,以Zeta电位为评价指标,采用正交试验设计法确定最优处方。结果:所得较优的处方为:0.5 g药物、0.1 g泊洛沙姆188、0.2 g卵磷脂、0.05 g十二烷基硫酸钠(SDS)、0.05 g羟丙甲纤维素E5(HPMC E5),制得的SCU-NS粒径为(122±4)nm,Zeta电位为(-25.5±0.6)m V。透射电镜结果显示SCU-NS呈球形且粒径均一,30 min时的溶出率大于90%。结论:纳米混悬液能显著提高药物的溶出度。
OBJECTIVE: To prepare scutellarin nanosuspension (SCU-NS) and investigate the main influencing factors during the preparation. Methods: The preparation process parameters were determined through experiments. The preparation conditions of SCU-NS were selected by single factor test. Zeta potential was used as evaluation index to determine the optimal prescription by orthogonal design. Results: The best prescriptions were: 0.5 g of drug, 0.1 g of poloxamer 188, 0.2 g of lecithin, 0.05 g of sodium dodecyl sulfate (SDS), 0.05 g of hypromellose E5 (HPMC E5) The particle size of SCU-NS was (122 ± 4) nm and the zeta potential was (-25.5 ± 0.6) mV. Transmission electron microscope showed that SCU-NS was spherical and uniform in size, with a dissolution rate greater than 90% at 30 min. Conclusion: Nano-suspension can significantly improve the dissolution rate of the drug.