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目的制备双氯芬酸钠肠溶微丸并确定其制备工艺。方法利用离心造粒机制备双氯芬酸钠素丸,以丙烯酸树脂Ⅱ号和Ⅲ号为包衣材料,通过微型流化床包衣机对素丸包衣,并以释放度试验和稳定性试验评价其质量。结果所制得的双氯芬酸钠肠溶微丸在人工胃液中2 h内累积释放度小于10%,在人工肠液中45 min内累积释放度为(82.8±1.31)%。产品的稳定性试验结果符合要求。结论采用该法制备的双氯芬酸钠微丸有良好肠溶效果且稳定性较好。
Objective To prepare diclofenac sodium enteric coated pellets and determine its preparation process. Methods Diclofenac sodium pills were prepared by centrifugal granulator. The coating materials of acrylic resin Ⅱ and Ⅲ were coated with the prime pills through a microfluidized bed coater and evaluated by the release test and the stability test quality. Results The cumulative release of diclofenac sodium enteric coated pellets was less than 10% within 2 h in artificial gastric juice and 82.8 ± 1.31% in 45 min in artificial intestinal fluid. Product stability test results meet the requirements. Conclusion Diclofenac sodium pellets prepared by this method have good enteric effect and good stability.