硝酸甘油口服控释制剂的研究

STUDIES OF CONTROLLED RELEASE NITROGLYCERIN TABLETS

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 . In this papar we reported the method of developing the cont rolled-release nitro-glycerin tablets(CR tablets). Methods . The dry ingredient was granulated with PVPasabinder. then coated with long chain alcohol (e. g cetostearyl alcohol) and Eudragit E30D aqueous dispersion. respec-tively. The granules were then pressed into tablets and coated with additional amount of Eudragit E30D aqueous dispersion. Results . The results showed that the dissolution data of CR tablets are simillar to those of Nitrong tablets(as control). The percent age of Nitroglyccrin released from the CR tablets at 2h.6h.and 12h were 22.67%, 54. 11%and 77.97%. respectively. It is also stable. ifstored athigh temperature and under strong light for ten days. or on open dishes for 6 weeks. Conclusion . Nitroglyc-erin CR tablets are useful in angina pectoris treatment and will provide the desired controlled release ac-tion.