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。     

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。     

依那普利非洛地平缓释片水性薄膜包衣工艺研究

目的:探讨依那普利非洛地平缓释片水性薄膜包衣的工艺.方法:以马来酸依那普利含量均匀度、溶出度及包衣合格率为评价指标,采用正交试验法优化水性薄膜包衣的工艺参数.结果:优选包衣液中欧巴代浓度为8%、含药包衣液喷速为30 g·min-1、包衣锅转速为10 r·min-1,此工艺稳定可行.结论:正交设计法可用于依那普利非洛地平缓释片水性薄膜包衣工艺的优化.     

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。     

乳增宁片薄膜包衣的生产工艺研究

目的　探讨乳增宁片薄膜包衣的工艺参数。薄膜包衣较包糖衣工艺简单,耗用工时短,具有用料少、片重增加小、衣层机械强度小、对药物崩解影响小等优点。方法　采用正交设计法进行实验,在现有的设备条件下,素片直接包薄膜衣,确定薄膜包衣的最佳工艺参数,选择最优方案。结果　通过正交实验,确定了薄膜包衣的最佳工艺条件为:包衣液的浓度为16%,喷浆流量为160g/min,片床温度60℃。     

乳增宁片薄膜包衣的生产工艺研究

目的探讨乳增宁片薄膜包衣的工艺参数.薄膜包衣较包糖衣工艺简单,耗用工时短,具有用料少、片重增加小、衣层机械强度小、对药物崩解影响小等优点.方法采用正交设计法进行实验,在现有的设备条件下,素片直接包薄膜衣,确定薄膜包衣的最佳工艺参数,选择最优方案.结果通过正交实验,确定了薄膜包衣的最佳工艺条件为:包衣液的浓度为16%,喷浆流量为160 g/min,片床温度60 ℃.     

乳增宁片薄膜包衣的生产工艺研究

目的探讨乳增宁片薄膜包衣的工艺参数。薄膜包衣较包糖衣工艺简单，耗用工时短，具有用料少、片重增加小、衣层机械强度小、对药物崩解影响小等优点．方法采用正交设计法进行实验，在现有的设备条件下，素片直接包薄膜衣，确定薄膜包衣的最佳工艺参数，选择最优方案．结果通过正交实验，确定了薄膜包衣的最佳工艺条件为：包衣液的浓度为16％，喷浆流量为160g／min，片床温度60℃。     

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。     

乳宁片薄膜包衣生产工艺研究

目的 优选乳宁片薄膜包衣的工艺参数.方法 应用正交实验法,以包衣液浓度、流量、出风温度为考核因素,确定本品种的最佳包衣参数.结果 乳宁片薄膜包衣的最佳工艺条件:包衣液浓度20%,流量110 g·min～170g·min-1,出风温度为38℃～43℃.结论 该工艺适合于大生产.     

保健食品试制过程批生产记录的规范化研究（片剂）

2.2.6包衣部分产品需要有包衣步骤,大多为薄膜包衣。在药品批生产记录中,要求详细记录包衣的配制过程,在包衣设备的参数设置上,要求包括包衣锅转速、包衣锅温度、包衣液进液速度、空气泵流量以及喷头距离片床高度等参数。而保健食品批生产记录中则较少有上述参数的设置情况。     

Influence of the aqueous film coating process on the properties and stability of tablets containing a moisture-labile drug

The effects of an aqueous film coating process on the morphology and storage stability of hydroxypropyl methylcellulose-coated tablets containing a moisture-labile model drug (acetylsalicylic acid, ASA) were evaluated using an instrumented side-vented tablet pan coater. Coating parameters studied were inlet air absolute humidity 5 g/m3 and 12 g/m3, spraying air pressure 100 kPa and 500 kPa, pan air temperature 35 degrees C and 55 degrees C, and coating solution flow rate 2.2 g/min and 7.8 g/min. The surface roughness of the coatings was measured with a laser profilometer and the chemical hydrolysis of the model drug ASA with an UV-spectrophotometer. The film-coated tablets were stored at 25 degrees C/60% RH and 40 degrees C/75% RH for three months. The high absolute humidity of the inlet air increased the residual water content and surface roughness of the coated tablets. Using a lower coating solution flow rate, higher spraying air pressure and pan temperature the coatings were smooth and homogeneous. In both ambient and accelerated storage conditions, the roughness of the coatings and the hydrolysis of ASA increased, but this was independent of the film coating process. Uniform and smooth hydroxypropyl methylcellulose coatings can be achieved by improved control of process parameters related to the application of the coating solution and water evaporation of the tablet surface.     

包衣工艺对布地奈德结肠定位片控释衣膜的影响

目的:优化布地奈德结肠定位片控释衣膜的包衣工艺。方法:采用单因素试验考察喷枪位置、喷液速度、喷气雾化压力、片床温度、进风温度及进风流量等包衣参数对定位片微孔型半透膜和肠溶膜包衣的影响。结果:确定喷枪口离片床距离约10～20cm;微孔型半透膜及肠溶膜包衣液的喷射速度分别为3、1mL·min-1,喷气雾化压力分别为2、1.5bar(1bar=105Pa),进风温度分别为50～55、40～45℃,片床温度分别为(40±1)、(30±1)℃,进风流量分别为5、7m3·min-1;采用优化的包衣参数制得的布地奈德结肠定位片半透膜包衣增重10%,肠溶膜包衣增重5%,24h体外累积释放度为(77.5±8.6)%,释药时滞为(6.0±0.5)h。结论:优化后的包衣工艺适合布地奈德结肠定位片控释衣膜包衣。     

An evaluation of process parameters to improve coating efficiency of an active tablet film-coating process

Effects of material and manufacturing process parameters on the efficiency of an aqueous active tablet film-coating process in a perforated pan coater were evaluated. Twenty-four batches representing various core tablet weights, sizes, and shapes were coated at the 350-500 kg scale. The coating process efficiency, defined as the ratio of the amount of active deposited on tablet cores to the amount of active sprayed, ranged from 86 to 99%. Droplet size and velocity of the coating spray were important for an efficient coating process. Factors governing them such as high ratios of the suspension spray rate to atomization air flow rate, suspension spray rate to pattern air flow rate, or atomization air flow rate to pattern air flow rate improved the coating efficiency. Computational fluid dynamics modeling of the droplets showed that reducing the fraction of the smaller droplets, especially those smaller than 10 μm, resulted in a marked improvement in the coating efficiency. Other material and process variables such as coating suspension solids concentration, pan speed, tablet velocity, exhaust air temperature, and the length of coating time did not affect the coating efficiency profoundly over the ranges examined here.     

Modeling the motion and orientation of various pharmaceutical tablet shapes in a film coating pan using DEM

Film coating uniformity is an important quality attribute of pharmaceutical tablets. Large variability in coating thickness can limit process efficiency or cause significant variation in the amount or delivery rate of the active pharmaceutical ingredient to the patient. In this work, the discrete element method (DEM) is used to computationally model the motion and orientation of several novel pharmaceutical tablet shapes in a film coating pan in order to predict coating uniformity. The model predictions are first confirmed with experimental data obtained from an equivalent film coating pan using a machine vision system. The model is then applied to predict coating uniformity for various tablet shapes, pan speeds, and pan loadings. The relative effects of these parameters on both inter- and intra-tablet film coating uniformity are assessed. The DEM results show intra-tablet coating uniformity is strongly influenced by tablet shape, and the extent of this can be predicted by a measure of the tablet shape. The tablet shape is shown to have little effect on the mixing of tablets, and thus, the inter-tablet coating uniformity. The pan rotation speed and pan loading are shown to have a small effect on intra-tablet coating uniformity but a more significant impact on inter-tablet uniformity. These results demonstrate the usefulness of modeling in guiding drug product development decisions such as selection of tablet shape and process operating conditions.     

氧化苦参碱肠溶包衣微丸的制备

目的:制备氧化苦参碱肠溶包衣微丸。方法:采用单因素试验考察包衣锅转速、包衣锅温度和喷枪压力对包衣条件的影响,并比较各种树脂包衣液的性质,选出适宜的包衣材料;采用包衣锅法制备微丸;以体外释放度评价包衣效果。结果:包衣条件为包衣锅转速50r.min-1、包衣温度30℃、喷枪压力0.10MPa;包衣材料为湖州Ⅲ号聚丙烯酸树脂;制备的微丸体外释放度符合2005年版《中国药典》(二部)要求。结论:所选方法可制备出体外释放良好的氧化苦参碱肠溶包衣微丸。     

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.     

盐酸鲁拉西酮片的溶出度研究

目的:考察并比较自制盐酸鲁拉西酮片与原研片的溶出度。方法:溶出度测定采用桨法,以pH 3.8 McIlvaine缓冲溶液900 ml为溶出介质,转速为50 r/min,温度为(37±0.5)℃;采用反相高效液相色谱法测定盐酸鲁拉西酮的含量,色谱柱为C8,流动相为0.05 mol/L磷酸盐缓冲液(pH 3.0)-乙腈(60∶40),检测波长为230 nm,流速为1.2 ml/min,柱温为40℃。对5批自制片与1批原研片的溶出行为采用相似因子法和威布尔法进行评价。结果:盐酸鲁拉西酮检测质量浓度线性范围为10¹00μg/ml(r=0.999 9),平均回收率为99.88%(RSD=0.55%,n=3)。5批自制片与原研片的相似因子均大于85,威布尔法中各溶出参数比较差异无统计学意义(P>0.05)。结论:建立的溶出度测定方法简便、快速、准确、可靠;自制片与原研片体外溶出度一致。     

人凝血因子Ⅷ生产冷沉淀制备工艺的优化

目的：通过优化冷沉淀制备过程中的工艺条件,获得最佳的人凝血因子Ⅷ生产用冷沉淀的制备工艺。方法主要对溶解过程中的夹层循环水温度、搅拌转速和离心过程中的离心机转速、出液温度和进液速度等影响因素进行考察,以人凝血因子Ⅷ效价为衡量指标进行研究。结果通过该试验研究,获得的最佳制备工艺为：循环水温度大于25～30℃,搅拌转速100 r/min,离心机转速14000 r/min,出液温度0～2℃,每台进液速度为3 kg/min。结论通过该试验研究,获得了最佳的人凝血因子Ⅷ生产用冷沉淀的制备工艺,为提高人凝血因子Ⅷ的质量和产量奠定了基础。     

A thermodynamic model for organic and aqueous tablet film coating

A tablet film-coating model for aqueous- and/or organic-based systems is shown to predict exhaust stream conditions thereby facilitating process optimization and scale-up. This coating model uses the First Law of Thermodynamics and conservation of mass principles to complete a material-energy balance on the coating unit operation for a closed, non-isolated system. Heat loss from the coating pan is incorporated into the model through a parameter called a heat loss factor (HLF) that is directly related to the heat transfer coefficient and pan surface area. For a mixed organic-aqueous coating formulation, the outlet air temperature and humidity are most notably affected by the coating composition and the inlet drying air temperature, which controls the evaporative cooling rate. The coating solution temperature and inlet air relative humidity do not significantly influence the exhaust air temperature, Tair,out. The HLF was determined to be 24 to 62 cal/min degrees C for the LDCS-20 to HCT-30, 360 cal/min degrees C for the HCT-60, 0 cal/min degrees C for the HC-130L and 945 to 1322 cal/min degrees C for the Accela-Cota-48 to Compulab-36 coating pans. This model successfully predicts Tair,out within 3 degrees C for a given coating pan, and within 6 degrees C scaling up from one to 220 kg pans for both organic- and aqueous-based coatings. The model is also useful for probing process and formulation variable sensitivity critical to establishing process robustness.