生脉脉冲控释滴丸的体外释药特性研究

Study on the in vitro Release Characteristics of Shengmai Pulse Controlled Release Dropping Pills

目的:制备生脉脉冲控释滴丸并考察其体外释药特性。方法:将生脉滴丸置于流化床中,以底喷方式依次从溶胀层(含交联羧甲基纤维素钠)到控释层(含乙基纤维素水分散体)进行包衣制备生脉脉冲控释滴丸,采用星点设计及体外释放度试验,考察溶胀层与控释层的不同包衣增重对控释滴丸脉冲释放的影响。结果:溶胀层与控释层的包衣增重分别为20%,10%,得到预期的释药时滞为4 h的生脉脉冲控释滴丸。结论:通过调整包衣增重可得到不同释药时滞的滴丸,具备优良控释制剂的特征。

Objective： To prepare Shengmai pulse controlled release dropping pills and investigate the in vitro release. Methods： Shengmai dropping pills were placed in a fluidized bed and coated respectively with an aqueous solution of a swelling layer （ containing croscarmellose sodium） and a controlled release layer （ containing ethyleellulose aqueous dispersion）. The effects of different coating weight gain on the drug release from the swelling layer and the controlled release layer were studied by central composite design-response surface methodology and in vitro dissolution test. Results： The weight gain of the swelling layer and the controlled release layer was 20% and 10% , respectively, and the expected release time was 4 h. Conclusion： By adjusting the coating weight gain, the drop- ping pills with different release time can be obtained.