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目的:研制一种口服硝酸甘油控释片。方法:以PVP为稳定剂,分别用长链脂肪醇和丙烯酸树脂E30D水分散体包衣,制备硝酸甘油控释片。结果:该片与美国产品Nitrong片(对照品)具有相似的体外释药速率:2h累积释药22.67%,6h释药54.11%,12h释药77.97%。光、热加速试验及开盘试验结果也显示较高的稳定性。结论:硝酸甘油控释片将有利于心绞痛的治疗,并具有满意的控释作用。
Objective: To develop an oral nitroglycerin controlled release tablets. Methods: With PVP as stabilizer, the long-chain fatty alcohol and acrylic resin E30D aqueous dispersions were respectively coated to prepare nitroglycerin controlled-release tablets. Results: The drug release rate of Nitrong tablet was similar to that of the American product Nitrong tablet (control): 22.67% in 2h, 54.11% in 6h and 77.97% in 12h. Light, thermal accelerated test and opening test results also showed higher stability. Conclusion: The controlled release tablets of nitroglycerin will be beneficial to the treatment of angina pectoris and have satisfactory controlled release.