目的:对鱼腥草素钠(SH)进行颗粒包衣,提高其稳定性。方法:采用羟丙甲基纤维素(HPMC)为包衣材料,用流化床项喷技术对SH颗粒进行包衣,以收率为指标,考察了包衣增重、增塑剂用量、包衣温度、黏合剂等因素对包衣收率的影响,筛选包衣处方及优化制备工艺参数,并通过稳定性考察包衣后鱼腥草素钠的稳定性。结果:优化后的包衣处方是包衣增重为15%,增塑剂用量为5%,包衣温度为60℃。包衣颗粒中SH含量是(86.6±0.4)%(g/g,n=9)。SH包衣颗粒在高温、高湿条件下放置10 d,稳定性很好。结论:SH原料颗粒经过HPMC包衣后能有效提高其稳定性。
OBJECTIVE To prepare sodium houttuyfonate(SH) coating particles which is more stability than SH raw material by particle-coating technique.METHODS Particles were manufactured by rotated spray fluid-bed.The formulation and technology of SH coating particles were investigated.Appling yield rate as main index to evaluate the quality of coating particles,the effect of coating factors including increasing weight of the coating,amount of plasticizer and temperature were investigated.RESULTS The coating factors of optimal formulation,such as increasing weight of the coating,amount of plasticizer and temperature were 15%,5% and 60℃ respectively.SH content of coating particles was(86.6±0.4)%(g/g,n=9).SH coating particles was more stability than SH raw material assessed by drug stability test.CONCLUSION Particle-coating technique is fit for SH coating particles preparation with high stability and repeatability.The stability of SH coating particles was more stability than SH raw material.