喷雾干燥技术制备麦冬皂苷肠溶微球的处方设计研究

Prescription design of Ophiopogon japonicus saponin enteric microsphere by spray drying technique

目的探索喷雾干燥技术制备麦冬皂苷肠溶微球的处方因素对微球成型性的影响。方法单因素考察肠溶囊材型号、用量、增塑剂种类、抗黏剂类型与用量,采用正交设计对肠溶微球处方进行优选。结果国产丙烯酸树脂和微粉硅胶均能满足制剂需要;最佳处方为药物与囊材比例1∶4,蓖麻油用量1%,微粉硅胶用量1.5%。结论麦冬皂苷肠溶微球质量符合预期要求;国产此类药用辅料有望成为肠溶微球生产的主要原料;处方设计研究为采用喷雾干燥技术实现中药微囊化提供可靠的依据。

Objective To explore the prescription factor on Ophiopogon japonicus saponin enteric microsphere by spray drying technique. Methods Observing the type and content of enteric coating material, the type of plasticizer, the type and dosage of antistickiness material by single factor. Optimizing the prescription by orthogonal test design. Results Both Eudragit Ⅱ and micronization silica gel made in China could meet the need of the preparation. The best prescription included the proportion between drug and enteric coating material （1 ： 4）, the dosage of castor oil （1%）, and the dosage of micronization silica gel （1.5%）. Conclusion O. japonicus saponin enteric microsphere accorded with the expecting demand. The kind of medical subsidiary material made in China will be the main raw material in producing the enteric microsphere. The study of prescription design will provide the basis for realizing microencapsulation in Chinese materia medica.