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目的制备氢氯噻嗪-羟丙基-β-环糊精(氢氯噻嗪-HP-β-CD)包合物微孔渗透泵片。方法采用中和法制备氢氯噻嗪-HP-β-CD包合物,并通过红外光谱法和核磁共振法对其进行表征;以累积释药百分率为指标,采用单因素法优化包衣膜处方,并对优化处方的体外释药行为进行模型拟合。结果优化后的氢氯噻嗪包合物微孔渗透泵片12 h内符合零级释药模型,累积释放度达到90%。结论以氢氯噻嗪-HP-β-CD包合物为中间体,可制成12 h内零级释药特征显著的微孔渗透泵片。
OBJECTIVE To prepare a micro-porous osmotic pump tablet for hydrochlorothiazide-hydroxypropyl-β-cyclodextrin (hydrochlorothiazide-HP-β-CD) inclusion complex. Methods Hydrochlorothiazide-HP-β-CD inclusion complex was prepared by neutralization method and characterized by infrared spectroscopy and nuclear magnetic resonance method. The cumulative drug release percentage was used as an index to optimize the formulation of coating film by single factor method. The optimized formulation of in vitro release behavior fitting model. Results Hydrochlorothiazide inclusion complex microporous osmotic pump tablets within 12 h consistent with zero release model, the cumulative release of 90%. Conclusion Hydrochlorothiazide-HP-β-CD inclusion complex can be used as an intermediate to produce microporous osmotic pump tablets with zero-order release within 12 h.