共查询到19条相似文献,搜索用时 62 毫秒
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目的解决泮托拉唑钠片的薄膜包衣工艺问题。方法采用正交试验法对泮托拉唑钠片的薄膜包衣工艺进行优化改进。结果经片面外观检查,外观合格率达100%。结论经优化改进的工艺完全可行。 相似文献
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目的对硫酸亚铁片的薄膜包衣工艺进行改进。方法采用正交试验法对硫酸亚铁片的薄膜包衣工艺进行优化改进。结果经片面外观检查,外观合格率达100%。结论经优化改进的工艺完全可行。 相似文献
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普乐安片薄膜包衣工艺研究 总被引:3,自引:0,他引:3
王开疆 《中国医药工业杂志》2002,33(10):489-490
采用自配薄膜包衣液及两种市售薄膜包衣材料对普乐安片进行薄膜包衣,比较了包衣材料的防潮性能,并对包衣液的用量进行了筛选。 相似文献
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目的制备感冒通薄膜片.方法以丙烯酸树脂Ⅳ号为成膜材料,通过实验考察感冒通薄膜片的崩解时限、抗磨损及裂纹发生率,进行薄膜包衣工艺的研究.结果感冒通薄膜片各项指标均符合质量要求,感冒通薄膜片采用铝塑包装在温度(40±2)℃、相对湿度75%±5%的条件下加速试验3个月,未发现有裂纹产品.结论本文研究的薄膜包衣液处方及工艺理想. 相似文献
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目的研究盘龙七片的薄膜包衣技术,提高其稳定性。方法针对该品种的自身特点,通过正交实验摸索薄膜包衣工艺的最佳条件,并通过崩解度、耐温、耐湿稳定性实验,考察盘龙七片采用薄膜包衣与糖衣的稳定性。结果薄膜包衣可提高盘龙七片的储存期稳定性。结论盘龙七薄膜衣片质量优于其糖衣片。 相似文献
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Louise Ho Ronny Müller Peter Kleinebudde Thomas Rades Philip F. Taday 《European journal of pharmaceutics and biopharmaceutics》2009,71(1):117-123
The ability of terahertz pulsed imaging (TPI) to be employed as an analytical tool for monitoring a film coating unit operation and to assess the success of a subsequent process scale-up was explored in this study. As part of a process scale-up development, a total of 190 sustained-release tablets were sampled at 10% increments of the amount of polymer applied, from a lab-scale and a pilot-scale coating run. These tablets were subjected to TPI analysis, followed by dissolution testing. Information on tablet film coating layer thickness and variations in coating density were extracted using TPI. It was found that both terahertz parameters were more sensitive and informative to product quality when compared with measuring the amount of polymer applied. For monitoring the film coating unit operation, coating layer thickness showed a strong influence on the dissolution behaviour for both the lab-scale and the pilot-scale batches. An R2 of 0.89, root mean square error (RMSE) = 0.22 h (MDT range = 3.21-5.48 h) and an R2 of 0.92, RMSE = 0.23 h (MDT range = 5.43-8.12 h) were derived from the lab-scale and pilot-scale, respectively. The scale-up process led to significant changes in MDT between the lab-scale and pilot-scale. These changes in MDT could be explained by the differences observed in the film coating density on samples with similar amount of polymer applied between the lab and the pilot-scale. Overall, TPI demonstrated potential to be employed as an analytical tool to help refine the coating unit operation and the scale-up procedure. 相似文献
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《Pharmaceutical development and technology》2013,18(1):2-16
The possibility of continuous processing in pharmaceutical tablet manufacturing is hampered by the viscoelastic recovery of tablets post-compaction. Compacted tablets are typically aged before coating to allow complete viscoelastic recovery so as to avoid subsequent coating defects. There has been little attempt to overcome tablet recovery in order to enable continuous processing and improve manufacturing efficiency. However, with the introduction of improved or newly developed types of tablet-coating equipment, there is renewed interest in the coating of tablets in-line. In-line tablet coating is defined as the coating of tablets immediately after compaction. It is a one-step highly integrated system that circumvents the delay in processing time typically given to allow viscoelastic recovery of tablets. This review aims to summarize the requirements of an in-line tablet-coating system. The possibility of carrying out in-line tablet coating in the near future will also be discussed. 相似文献
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《Asian Journal of Pharmaceutical Sciences》2015,10(3):176-185
Film coating is an important unit operation to produce solid dosage forms, thereby, the monitoring of this process is helpful to find problems in time and improve the quality of coated products. Traditional methods adopted to monitor this process include measurement of coating weight gain, performance of disintegration and dissolution test, etc. However, not only do these methods cause destruction to the samples, but also consume time and energy. There have recently emerged the applications of process analytical technologies (PAT) on film coating, especially some novel spectroscopic and imaging technologies, which have the potential to real-time track the progress in film coating and optimize production efficiency. This article gives an overview on the application of such technologies for film coating, with the goal to provide a reference for the further researches. 相似文献
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目的:优选补气通脉胶囊的制备工艺。方法:以大鼠血液流变学指标考察醇沉条件。以药材的浸泡时间、提取次数、加水量、煎煮时间为考察因素,以黄芪甲苷含量为考察指标优选黄芪最佳提取工艺。以丹参素含量为考察指标优选丹参、川芎、枳壳、红花最佳提取工艺。结果:药材最佳提取方法为采用水提取70%醇沉。黄芪最佳提取工艺为浸泡30 min,煎煮2次,每次90 min,按1∶10加水。丹参、川芎、枳壳、红花最佳提取工艺为煎煮90 min,共煎煮2次,按1∶8加水。结论:该生产工艺方法可行、稳定,符合临床需要。 相似文献
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盐酸环丙沙星阴道泡腾片的制备与质量控制 总被引:3,自引:0,他引:3
目的 :制备盐酸环丙沙星阴道泡腾片并建立该制剂的质量控制标准。方法 :采用正交设计对处方辅料进行筛选 ,考察制剂的稳定性及体外释药性能 ,以紫外分光光度法测定盐酸环丙沙星的含量。结果 :制备工艺可行 ,制剂体外释药性能优于普通片剂、栓剂 ,对光、热稳定 ,对湿度不稳定。结论 :该制剂为一新型局部外用制剂 ,质量控制方法准确可靠 相似文献
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目的 探讨采用包衣预混剂对磷酸川芎嗪片进行薄膜包衣的最佳工艺条件.方法 通过正交优化试验法进行试验,对影响包衣过程中包衣液的浓度、包衣片增重、喷雾速度、雾化压力4个因素进行考察,以加速试验后包衣片增重为考核指标进行考核.结果 选用自制的包衣料,加溶液配成5%的包衣溶液,包衣增重2.5%,喷雾速度350 g/min,雾化压力0.5MPa.结论 此制备工艺可行. 相似文献