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目的对厄贝沙坦胃滞留夹芯渗透泵片(SOPT)的制备方法进行研究,并考察其体外释放度。方法分别以膨胀速度、水渗透速率、低剪切黏度、屈服应力及释放度为评价指标,确定处方中膨胀剂材料、致孔剂、助悬剂、促渗剂的用量。结果最佳处方:膨胀剂为PEO(Mw 5 000 000)与HPMC混合物(4∶1),用量70 mg;促渗剂氯化钠用量为25 mg;包衣液致孔剂PEG400用量8%;助悬剂PEO(Mw 200 000),用量为厄贝沙坦的1/4。释药行为符合零级方程,具有明显的控释特征。结论 SOPT具有良好的体外控释效果,可进一步进行体内释药行为考察。
Objective To study the preparation of irbesartan gastric retention sandwich osmotic pump slide (SOPT) and investigate its in vitro release. Methods Expansion rate, water penetration rate, low shear viscosity, yield stress and release rate were used as evaluation indexes respectively to determine the dosage of expander materials, porogen, suspending agent and penetration enhancer in the prescription. Results The best prescription: the expansive agent was PEO (Mw 5 000 000) and HPMC mixture (4: 1) in an amount of 70 mg; the penetration enhancer sodium chloride was 25 mg; the coating liquid porogen PEG400 was used in an amount of 8% Suspension PEO (Mw 200 000), the amount of irbesartan 1/4. Drug release behavior in line with the zero-order equation, with obvious controlled release characteristics. Conclusion SOPT has a good in vitro release control effect, which can be further investigated in vivo release behavior.