共查询到20条相似文献,搜索用时 94 毫秒
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魏宝康 《中国医药工业杂志》2013,44(7)
利用离心造粒机,通过粉末层积法,以微晶纤维素为稀释剂,羟丙甲纤维素(HPMC) E5水溶液为黏合剂制备辛伐他汀微丸,再将微丸灌装胶囊.考察了微晶纤维素用量、黏合剂浓度对辛伐他汀载药微丸的粉体学性质和收率的影响,以及原药粒径对溶出度的影响.所得优化处方与市售胶囊(理舒达)在4种介质中的溶出行为相似. 相似文献
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快速搅拌制备肠必清微丸的工艺研究 总被引:7,自引:2,他引:5
目的:制备肠必清微丸。方法:采用正交试验设计,考察肠必清处方提取物配比微晶纤维素作赋形列比例、润湿剂乙醇浓度、粘合剂PVP浓度及快速搅拌制粒时间对微丸质量的影响。结果:优选出快速搅拌制备肠必清微丸工艺,提取物配比赋形剂比例为2:1,乙醇浓度为90%,PVP浓度为3%,搅拌时间为15min。结论:其工艺制备微丸符合设计要求,适合工业化生产。 相似文献
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目的筛选含油中药浸膏片赋形剂。方法以外观、硬度、崩解度、脆碎度等为指标评价赋形剂对片剂成型性的影响。结果稀释剂选用糖粉,吸收剂选用辅料X,粘合剂选用微晶纤维素,崩解剂选用低取代羟丙基纤维素片剂成型性好。结论以上赋形剂适合于该片剂。 相似文献
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目的:优化去甲斑蝥素骨架型缓释微丸的制备工艺,并考察制剂体外释药特性.方法:采用挤出-滚圆技术制备去甲斑蝥素骨架型缓释微丸,以多因素综合评价指标,正交设计与多元回归分析相结合优化处方工艺.结果:以微晶纤维素(MCC)9.877%、乙基纤维素(EC)-硬脂酸(1:1.5)、黏合剂1%羟丙甲纤维素(HPMC)13 mL,80℃烘干制得的去甲斑蝥素骨架型缓释微丸具有较好的缓释效果.结论:采用挤出-滚圆技术,通过缓释材料制备的去甲宽蝥素骨架型缓释微丸,其体外释药缓慢、持续、平稳. 相似文献
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目的:研制苯磺酸左旋氨氯地平片,并以原研药为对照,考察其体外溶出性能。方法 :以溶出度为考察指标,优选苯磺酸左旋氨氯地平片干粉直接压片的处方工艺,在四种溶出介质下考察仿制药的溶出,以确定处方工艺的合理性。结果:处方组成除活性成分苯磺酸左旋氨氯地平外,优选微晶纤维素、甘露醇和磷酸氢钙为填充剂,交联聚维酮为崩解剂,硬脂酸镁为润滑剂,并采用粉末直接压片工艺。结论:优选的处方工艺可行,在四种溶出介质下,仿制药与原研药溶出基本一致。 相似文献
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Low and high degree of polymerization (DP) cellulose II powders have been prepared from Avicel PH-102 and Solka Floc 40NF (low and high DP cellulose I powders, respectively), respectively, by treatment with sodium hydroxide (5N) for 24h and their powder and tableting properties investigated. Cellulose II powders, compared to the respective cellulose I counterpart, exhibited lower crystallinity, true density, and specific surface area. They were denser and showed higher moisture uptake. The Heckel analyses revealed both low and high DP cellulose II powders to be less ductile than the low DP cellulose I powder and more ductile compared to the high DP cellulose I powder. The crushing strengths of low and high DP cellulose II powders were comparable to that of the high DP cellulose I powder but lower than the low DP cellulose I powder. When compressed to comparable crushing strengths, the low and high DP cellulose II compacts disintegrated faster in comparison to the corresponding cellulose I compacts. Low DP cellulose I and II powders, compared to the high DP cellulose I counterparts were more sensitive to magnesium stearate. Magnesium stearate decreased the disintegration times of low DP cellulose I compacts but had no effect on the low and high DP cellulose II and high DP cellulose I compacts. In conclusion, low and high DP cellulose II powders, despite their different powder properties, show similar tableting properties, leading to the formation of rapidly disintegrating compacts. The low and high DP cellulose I excipients, in contrast, differ in their powder properties as well as tableting characteristics. 相似文献
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氯雷他定片的制备及质量控制 总被引:1,自引:0,他引:1
目的:制备氯雷他定片并建立其质量控制方法。方法:将氯雷他定与十二烷基硫酸钠、淀粉、微晶纤维素等辅料混合制备片剂。采用紫外分光光度法测定氯雷他定含量。结果:氯雷他定检测浓度线性范围为4~28μg/ml(r=0.9 999),平均回收率为99.9%,相对标准偏差为0.3%。结论:该制剂制备工艺简单,质量控制方法可行。 相似文献
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目的:制备盐酸坦索罗辛缓释微丸。方法:采用离心造粒粉末层积法制备盐酸坦索罗辛微丸。通过考察主机转速、喷浆泵转速、供粉速度、喷枪雾化条件、抛光时间、包衣增重对微囊收率的影响,确定各因素较佳水平;制备微晶纤维素空白丸芯和盐酸坦索罗辛含药微丸,并在此基础上进行丙烯酸树脂水分散体包衣,对包衣微丸的释药特征进行探讨。结果:微丸成丸的最佳工艺参数为主机转速200r·min-1,喷浆泵转速20r·min-1,供粉速度50r·min-1,喷气压力0.5MPa,喷气流量10~15L·min-1,抛光时间5min,包衣增重11%。3批样品经放大试验,测得微晶纤维素空白丸芯、含药微丸、包衣微丸的收率分别是97.5%、95.4%、96.8%。缓释微丸胶囊体外释药行为较好地符合零级方程。结论:采用离心造粒法在优化的工艺条件下可制得符合要求的盐酸坦索罗辛缓释微丸。 相似文献
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Timo Pesonen Petteri Paronen Terttu Puurunen 《International journal of clinical pharmacy》1989,11(1):13-19
A novel form of cellulose powder was evaluated as a filler-binder in tablets. The particle, powder, flow and binding properties of this experimental cellulose material were compared with those of two commercial microcrystalline celluloses, Avicel® PH 101 and Emcocel®. The effect of various storage conditions on the physical stability of tablets compressed from celluloses was also evaluated. The particle size and shape of experimental cellulose powder differed markedly from those of microcrystalline celluloses. Experimental cellulose contained mainly large and roughly spherical agglomerates of particles, among which were few smaller regularly shaped particles. Because of spherical particle shape, the experimental cellulose powder flowed better than microcrystalline celluloses, which consisted of much more irregularly shaped particles. Experimental cellulose formed stronger tablets than microcrystalline celluloses. It also acted more effectively than microcrystalline celluloses as a binding material in tablets containing poorly compressible ascorbic acid and acetaminophenone. This may be due to the extensive surface area of the particles of experimental cellulose powder. The specific surface area of this material was over 50 times as great as that of microcrystalline celluloses. This indicates an extremely porous structure of cellulose agglomerates. Tablets containing experimental cellulose powder were able to resist a permanent loss in tablet strength at different storage conditions better than tablets containing microcrystalline celluloses. According to the results of this study an experimental agglomerated form of cellulose powder is a very advantageous material as a filler-binder for direct compression of tablets. 相似文献
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目的:制备卡马西平(CBZ)口腔速崩片并评价其质量。方法:选用CBZ为主药,微晶纤维素(MCC)、交联羧甲基纤维素钠(CCNa)为崩解剂,以直接粉末压片法制备片剂;以MCC、CCNa、乳糖用量为考察因素,崩解时间为考察指标设计正交试验筛选处方;采用紫外分光光度法测定制剂中主药的含量,同时以崩解时间、溶出度及稳定性等指标进行质量评价,并与普通片剂比较溶出度,与原料药比较稳定性。结果:优选处方为MCC75mg、CCNa9mg、乳糖30mg。所制制剂含量均匀度符合规定,崩解时间为(21±3)s,溶出迅速,2min内累积溶出率达81.46%;普通片剂90min累积溶出率为71.46%。与原料药比较,该制剂在高温下吸收峰略有变化。结论:该制剂制备方法简单,质量稳定可控,应于低温干燥环境下贮存。 相似文献
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The stability of crystalline acetylsalicylic acid (ASA) powder in binary mixtures with cellulose powders was investigated to reveal information about the influence of the cellulose structural properties on the moisture-induced ASA degradation. Different cellulose powder samples were manufactured and characterized by X-ray diffraction and N2 BET gas adsorption. The degradation patterns in ASA/cellulose mixtures were monitored as a function of salicylic acid increase versus time under various relative humidity conditions at 50 degrees C. The crystallinity index of cellulose samples varied between approximately 49 and 95%. The results indicated that cellulose powder with the lowest crystallinity index exhibited lower degradation rates than the samples with the higher crystallinity index. It should be noted that higher ASA degradation rates were observed in the samples with comparably lower moisture contents. This effect was most pronounced in the 1:3 (w/w), ASA/cellulose mixtures, whereas in 3:1 (w/w), ASA/cellulose mixtures the effect was less obvious. The findings emphasise the importance of cellulose structural organisation when governing the moisture's partition between cellulose and ASA during the hydrolytic degradation. 相似文献