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目的制备复方丹参黏附脉冲微丸。方法使用不同的包衣材料,于载药微丸由内至外依次包溶胀层、控释层和黏附层,考察包衣后对溶出效果的影响并优化包衣处方,评价脉冲微丸的黏附性。结果溶胀层、控释层和黏附层材料类型、包衣增重、增塑剂种类及用量等对黏附脉冲微丸的释药时滞和释药速率均有显著性影响。结论优选的最佳包衣处方,在模拟人体内胃肠道pH值变化条件下时滞达到4.5 h,时滞后1.5 h累积释药80%以上的脉冲释药效果。
Objective To prepare Compound Danshen Adhesion Pulse Pellets. Methods Different coating materials were used to pack the swelling layer, the controlled release layer and the adhesion layer from the inside to the outside of the drug-loaded pellets. The effect of the coating on the dissolution effect and the coating prescription were optimized, and the adhesion of the pulse pellets was evaluated Sex. Results The types of the swelling layer, the controlled release layer and the adhesive layer, the weight gain of the coating, the type and dosage of the plasticizer had significant effects on the release delay and drug release rate of the adhesive pulse pellets. Conclusion The best prescription of the best coating in the human body to simulate the gastrointestinal changes in pH value under the conditions of the time lag 4.5 h, lag time 1.5 h cumulative release of more than 80% of the drug release by pulse.