泮托拉唑钠片的薄膜包衣工艺改进

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。     

硫酸亚铁片的薄膜包衣工艺改进

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。     

番茄红素片薄膜包衣工艺研究

目的研究欧巴代Ⅱ薄膜衣料用于番茄红素片的包衣方法。方法用正交试验确定最佳工艺条件,以提高包衣片的稳定性。结果最佳条件为:包衣液质量浓度180g.L-1,包衣增质量3%,包衣锅转速70r.min-1,喷液速率2g.min-1。结论在优选的工艺条件下生产的番茄红素片各项质量指标均合格,提高了番茄红素片储存期的稳定性。     

三七止血片薄膜包衣工艺研究

目的通过对三七止血片薄膜包衣工艺研究,确定其最佳工艺条件。方法用正交试验法,以片芯硬度、主机转速、片床温度、包衣液流量作为考察因素,以崩解时限、包衣合格率作为指标,选用L9(34)正交表进行试验,筛选出三七止血片薄膜包衣的最佳包衣工艺。结果确立了三七止血片薄膜包衣工艺条件。结论该包衣工艺科学合理,能保证产品质量。     

牛黄化毒片薄膜包衣工艺研究

目的：优选牛黄化毒片薄膜包衣的最佳工艺条件。方法：选定包衣液的浓度、片床温度、包衣液流量和包衣锅转速四个因素进行正交方法考查,以包衣片外观合格率为考查指标,用L9（34）正交表进行试验研究,优选出最佳包衣工艺。结果：最佳工艺条件为包衣液的浓度为6%,片床温度为40～50℃,包衣液流量为110 ml/min,包衣锅转速为4～6r/min。结论：该包衣工艺科学合理,生产效率高,为牛黄化毒片的最佳包衣工艺。     

普乐安片薄膜包衣工艺研究

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。     

决明降脂片薄膜包衣工艺的探讨

目的:探讨用不同的包衣预混剂对决明降脂片进行薄膜包衣的最佳工艺条件。方法:用正交试验法进行试验,对影响包衣的衣料种类、衣料浓度、衣料增重、喷雾速度4因素进行考察,以加速试验后水分增重为考核指标进行考核。结果:选用上海卡乐康包衣技术有限公司提供的包衣料,加水配成15％的包衣溶液,喷速为1.25g·min~(-1),包衣增重为4.0％。结论:用最佳组合参数能有效地将决明降脂片进行包衣。     

感冒通片的薄膜包衣工艺研究

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.     

盘龙七片薄膜包衣工艺研究

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。     

芒果苷片薄膜包衣工艺的研究

目的：探讨芒果苷片薄膜包衣工艺的最佳工艺参数。方法：采用比较法和正交试验设计法，以包衣片外观合格率、硬度、增重、耐湿度、溶出度等作为考核指标，确定薄膜包衣的最佳工艺参数。结果：最佳包衣工艺参数为：包衣液浓度为13％，主机转速为12r·min^-1，片床温度45℃。结论：此工艺稳定可行。     

海绵剂成型工艺的选择

目的：优选海绵剂的成型工艺。方法：采用正交设计法,以海绵剂的厚薄均匀度,柔软度,海绵的吸水量,表面色泽为考察指标,对海绵剂中辅料明胶、羧甲基纤维素钠（CMC—Na）、10％甲醛的投料比例进行优选研究。结果：海绵剂最佳辅料投料比例为：明胶：CMC—Na：10％甲醛为3：1：7。结论：海绵剂的成型工艺切实可行,为工业生产提供了依据。     

Terahertz pulsed imaging as an analytical tool for sustained-release tablet film coating

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.     

The reality of in-line tablet coating

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.     

正交试验优选愈肝宁贴剂制备工艺

目的:优选愈肝宁贴剂的制备工艺。方法:以用膏量、固化时间、干燥温度、干燥时间为考察因素,以初黏力、剥离强度和皮肤残留现象为指标,用正交试验法优选出最佳制备工艺。结果:以用膏量(7.6±0.1)g·100cm-2、固化时间24h、干燥温度60℃、干燥时间3.5h为最佳制备工艺,并符合质量控制方法。结论:优选的最佳工艺方案可行,所制备的愈肝宁贴剂质量稳定。     

Study progression in application of process analytical technologies on film coating

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.     

基于正交试验设计的黄芩苷微丸制备工艺研究

目的：优选黄芩苷微丸的制备工艺。方法采用正交试验设计法,考察挤出速度、滚圆速度、滚圆时间对黄芩苷微丸的影响。结果所制备的微丸圆整度好,大小均匀;最佳制备工艺为挤出速度35Hz,滚圆速度为45Hz,滚圆时间为6min,体外溶出度在30min内达到80％以上。结论所优选的制备工艺简单易行,所制备的微丸释放效果良好。     

正交试验优选补气通脉胶囊制备工艺

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。     

盐酸环丙沙星阴道泡腾片的制备与质量控制

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     

磷酸川芎嗪片薄膜包衣工艺的探讨

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.