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背景:药物以缓释片剂形式存在,可减少用药次数,延长释药时间,有利于其治疗效应的发挥。目的:制备萘普生缓释片,考察其处方工艺因素对体外溶出的影响。设计、时间及地点:以重复测量设计在2005-09于顺德职业技术学院实验室完成实验。材料:萘普生、Ⅱ号丙烯酸树脂、羟丙基甲基纤维素(Hydroxypropyl Methyl Cellulose,HPMC)和硬脂酸由广州市新港化工有限公司提供,乙醇为分析纯。方法:经单因素考察,采用正交试验设计,筛选萘普生缓释片处方(萘普生250g,HPMC(K4M)12.5g,乙醇适量,硬脂酸镁1.2g)。以不同材料(硬脂酸、HPMC、20%丙烯酸树脂Ⅱ、聚维酮K30),不同黏度规格的HPMC(K4M,K15M,K100M),不同硬度的HPMC(2,4,6kg),在相同粒度和相同压力下压片。主要观察指标:不同材料、不同黏度规格的HPMC、不同硬度对释放度的影响。测定并比较萘普生缓释片的释药速度及释放效果。结果:①材料为HPMC的缓释片较符合缓释片标准。用黏度规格为K4M所制缓释片8h释放度符合缓释片标准。硬度为2,4,6kg,压力越大,释放越慢。②所制备的萘普生缓释片在12h内呈现良好的零级释放特征。结论:该处方制出的萘普生缓释片具有理想的缓释效果。
Background: The drug exists in the form of sustained-release tablets, which can reduce the frequency of drug use and prolong the time of drug release, which is beneficial to the treatment effect. OBJECTIVE: To prepare naproxen sustained-release tablets and investigate the effect of prescription factors on in vitro dissolution. DESIGN, TIME AND SETTING: The experiment was conducted in the laboratory of Shunde Vocational and Technical College in 2005-09 with the repeated measurement design. Materials: Naproxen, No. 2 acrylic resin, Hydroxypropyl Methyl Cellulose (HPMC) and stearic acid were supplied by Guangzhou Xingang Chemical Co., Ltd. with ethanol as analytical grade. Methods: By single factor test, the orthogonal design was used to screen naproxen sustained release tablets (Naproxen 250g, HPMC (K4M) 12.5g, ethanol, magnesium stearate 1.2g). HPMC (K4M, K15M, K100M) with different viscosity, HPMC with different hardness (2, 4, 6kg) with different materials (stearic acid, HPMC, 20% acrylic resin Ⅱ and Povidone K30) And under the same pressure tablets. MAIN OUTCOME MEASURES: Effects of different hardness and hardness on release of HPMC with different materials and different viscosities. The release rate and release rate of naproxen sustained-release tablets were measured and compared. Results: ① The material was sustained-release tablets HPMC more consistent with sustained-release tablets standards. The viscosity of K4M sustained-release tablets prepared for 8h release consistent with sustained-release tablets standards. Hardness of 2,4,6 kg, the greater the pressure, the slower the release. The prepared naproxen sustained-release tablets showed good zero-order release characteristics within 12 hours. Conclusion: Naproxen sustained-release tablets produced by this prescription have ideal sustained-release effect.