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。     

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。     

不同包衣增重对泼尼松龙磷酸钠口腔崩解片关键质量属性的影响

目的 考察不同包衣增重对泼尼松龙磷酸钠口腔崩解片粒度、体外溶出曲线及崩解试验的影响.方法 制备包衣增重分别为20％,30％,40％,50％的泼尼松龙磷酸钠口腔崩解片,分别采用100,80,60,50,40目筛考察其粒度分布,并用pH6.8的磷酸盐缓冲液区分不同包衣增重的样品.分别以水、pH1.2的盐酸氯化钠溶液、pH4...     

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。     

流化床包衣法制备甘草酸二铵结肠定位微囊

目的:对甘草酸二铵结肠定位微囊(DCSM)的处方和工艺进行研究。方法:流化床包衣法制备甘草酸二铵结肠定位微囊,以释放度为指标,确定果胶与乙基纤维素水分散体的比例及包衣增重,以微囊收率为指标,采用U8(84)均匀设计试验优化工艺参数。结果:确定果胶与乙基纤维素水分散体的比例为1∶4,包衣增重43%;优化包衣工艺为包衣液浓度4%,进风温度55℃,喷雾压力2.6 kg,输液速度0.6 mL·min-1。结论:DCSM具有良好的体外结肠定位释药特性,可进一步进行体内释药行为考察。     

葛根汤颗粒一步制粒工艺研究

目的考察分析葛根汤颗粒一步制粒的工艺特点及影响因素。方法利用葛根汤颗粒处方中糊精作为一步制粒底料,葛根汤浸膏溶液直接喷雾混合制粒干燥,一步形成颗粒,采用正交试验方法,通过考察葛根汤浸膏溶液相对密度、进风温度、喷浆速度及雾化压力,以成品率、含量和水分作为考察指标,筛选出制备葛根汤颗粒的最优工艺。结果不同的工艺条件对该产品的颗粒成品率有较大影响的,其中浸膏溶液的浓度对成品率的影响最大、其次为进风温度和雾化压力,喷浆速度影响最小。因此确定葛根汤颗粒的工艺条件为葛根汤浸膏溶液相对密度为1.18¹.23,进风温度设定(120±5)℃,雾化压力为0.41.23,进风温度设定(120±5)℃,雾化压力为0.4⁰.6 MPa,喷浆速度为(0.5±0.1)kg·min-1。结论葛根汤颗粒一步制粒法优点明显,值得在生产中推广。     

盐酸胺碘酮包衣脉冲片稳定性初步研究

目的 考察盐酸胺碘酮包衣脉冲片的稳定性.方法 以片剂外观性状、时滞时间、吸湿增重和含量为评价指标,采用光照、高温、高湿、加速试验考察包衣脉冲片的稳定性.结果 光照、高温、高湿条件下该盐酸胺碘酮包衣脉冲片的外观、增重均无明显变化,胺碘酮含量在97.6％以上,时滞时间6h左右;加速试验的6个月内外观无明显变化,增重保持在3.1％以内,胺碘酮含量在98.3％以上,时滞时间6h左右;盐酸胺碘酮包衣脉冲片对光、湿、热稳定.结论 盐酸胺碘酮包衣脉冲片能有效解决对光、湿、热的不稳定性问题.     

影响盐酸吡格列酮载药包衣含量均匀度的关键工艺研究

目的 采用响应面法考察载药包衣关键工艺参数对包衣含量均匀度的影响,并优化载药包衣的工艺条件。方法 以盐酸吡格列酮为模型药物,自制的盐酸二甲双胍渗透泵缓释片芯为基础,用高效包衣机进行载药包衣实验。结果 在实验范围内,各因素对载药包衣含量均匀度影响的大小依次是包衣锅转速、喷液速率、雾化压力,控制包衣锅转速12 r·min^-1,喷液速率12~14 g·min^-1,雾化压力65~75 kPa,包衣片含量均匀度符合中国药典2015年版的要求。结论 模型优化的工艺条件适用于本品的载药包衣,包衣片含量均匀度符合中国药典的要求。     

Box-Behnken效应面法优化盐酸美金刚缓释微丸处方工艺

摘 要 目的：对盐酸美金刚缓释微丸进行处方优化,并考察其体外释放。方法: 采用流化床技术制备盐酸美金刚缓释微丸,以进风温度、雾化压力和喷液流速为考察因素,以上药百分率为评价指标,采用正交试验优选微丸上药工艺参数。采用Box-Behnken效应面法优化缓释包衣处方及包衣增重。以乙基纤维素水分散体的含量、聚乙二醇6000（PEG 6000）含量及包衣增重为因素,以盐酸美金刚2,6,12 h的累计释放度为响应值,采用Box Behnken效应面法优化盐酸美金刚缓释微丸的包衣处方及包衣增重,对盐酸美金刚缓释微丸进行释放度考察。结果: 最佳的微丸上药工艺参数为：进风温度45℃,雾化压力1.0 bar,喷液流速1.5 r·min^-1。最佳缓释包衣处方为：乙基纤维素水分散体含量为8.4%,PEG 6000含量为2.3%,缓释层包衣增重16.7%。盐酸美金刚缓释微丸具有良好的缓释效果。结论:正交试验和Box Behnken效应面法可用于盐酸美金刚缓释微丸处方工艺的优化,所建立的拟合模型具有较好的预测性。     

环丙沙星片薄膜包衣制备工艺研究

目的：探讨环丙沙星片薄膜包衣的优良工艺。方法：使用L9（34）正交试验筛选包衣液浓度、喷液流量、片床温度和包衣锅转速4个工艺对薄膜包衣的影响,探讨环丙沙星片薄膜包衣制作优良工艺。结果：以10%浓度LE薄膜包衣剂,预热时间为6min,喷液流量为10g/min,片床温度为50℃,包衣锅转速为7r/min进行包衣滚筒制作的片剂外观和增重符合规定要求。结论：通过正交试验,能够获得环丙沙星薄膜包衣制备的最佳工艺流程。     

大黄酸肠溶片的制备

目的：研制大黄酸肠溶片。方法采用正交试验设计法,以包衣效率为指标,考察雾化压力、蠕动泵转速、枪床距离3个因素,优化大黄酸肠溶片的包衣工艺。结果最佳工艺参数,雾化压力4．5kg／cm2、蠕动泵转速1．5mL? min －1、枪床距离30cm。结论所制备的肠溶片符合设计要求,适合临床应用。     

骨得健颗粒一步制粒工艺研究

目的对一步制粒法制备骨得健颗粒的工艺进行优化。方法以颗粒的得率、水分和含量为考察指标,采用正交实验法对影响骨得健颗粒一步制粒过程的因素进行考察。结果 3个考察因素中喷雾速度对结果影响显著,最佳工艺条件为:喷液速度为10 mL·min-1,雾化压力为1.4 bar,进风温度为80℃。结论该工艺合理可行,产品稳定性好,为工业化生产提供了实验依据。     

Formulation and processing factors influencing the adhesion of film coats to tablet cores

The effect of six factors: spray gun, formulation, inlet temperature, atomizing air pressure, fan air pressure, and gun-bed distance, on the final adhesion of the film coat to the tablet core were assessed. The method used was based on an experimental design, Resolution IV, that allowed the main effects to be free from any two factor interactions. Using a specially designed adhesion tester, values for the maximum force of adhesion, elongation, and area under the curve were obtained. The results obtained show that the effect of all the process parameters on the three adhesive responses measured vary according to which adhesive property is considered. An increase in the fan air pressure decreased the elongation, and increased the area under the curve while the maximum force of adhesion remained unchanged. Both atomizing air and inlet temperature affect the adhesive responses, but they are dependent on the formulation and spray gun used. The gun-bed distance has no influence on the adhesion for the distances used in this study.     

Effects of process parameters on solid self-microemulsifying particles in a laboratory scale fluid bed

The purpose of this study was to select the critical process parameters of the fluid bed processes impacting the quality attribute of a solid self-microemulsifying (SME) system of albendazole (ABZ). A fractional factorial design (2^4–1) with four parameters (spray rate, inlet air temperature, inlet air flow, and atomization air pressure) was created by MINITAB? software. Batches were manufactured in a laboratory top-spray fluid bed at 625-g scale. Loss on drying (LOD) samples were taken throughout each batch to build the entire moisture profiles. All dried granulation were sieved using mesh 20 and analyzed for particle size distribution (PSD), morphology, density, and flow. It was found that as spray rate increased, sauter-mean diameter (D_s) also increased. The effect of inlet air temperature on the peak moisture which is directly related to the mean particle size was found to be significant. There were two-way interactions between studied process parameters. The main effects of inlet air flow rate and atomization air pressure could not be found as the data were inconclusive. The partial least square (PLS) regression model was found significant (P?<?0.01) and predictive for optimization. This study established a design space for the parameters for solid SME manufacturing process.     

Formulation and Processing Factors Influencing the Adhesion of Film Coats to Tablet Cores

The effect of six factors: spray gun, formulation, inlet temperature, atomizing air pressure, fan air pressure, and gun-bed distance, on the final adhesion of the film coat to the tablet core were assessed. The method used was based on an experimental design, Resolution IV, that allowed the main effects to be free from any two factor interactions. Using a specially designed adhesion tester, values for the maximum force of adhesion, elongation, and area under the curve were obtained. The results obtained show that the effect of all the process parameters on the three adhesive responses measured vary according to which adhesive property is considered. An increase in the fan air pressure decreased the elongation, and increased the area under the curve while the maximum force of adhesion remained unchanged. Both atomizing air and inlet temperature affect the adhesive responses, but they are dependent on the formulation and spray gun used. The gun-bed distance has no influence on the adhesion for the distances used in this study.     

流化床制粒制备甘芝口含片

目的：制备甘芝口含片。方法：采用流化床制粒,以颗粒流动性、含片崩解时限及外观性状为考察指标,通过正交试验优选最佳制粒工艺参数。结果：最佳工艺参数为A1B2C3D3,即进风温度为45～50℃、物料温度40～45℃,雾化压力0.8～1.0bar,料液流速5～7ml/min。结论：该制备工艺简单,方法可行,可应用于大生产。     

External Characteristics of Unsteady Spray Atomization from a Nasal Spray Device

The nasal route presents an enormous opportunity to exploit the highly vascularized respiratory airway for systemic drug delivery to provide more rapid onset of therapy and reduced drug degradation compared with conventional oral routes. The dynamics of atomization at low injection pressure is less known as typical spray atomization studies have focused on industrial applications such as fuel injection that are performed at much higher pressure. An experimental test station was designed in house and an alternative method to characterize the external spray is presented. This involved the use of high-speed camera to capture the temporal development of the spray as it is atomized through actuation of the spray device. An image-processing technique based on edge detection was developed to automate processing through the large number of images captured. The results showed that there are three main phases of spray development (prestable, stable, and poststable) that can be correlated by examining the spray width. A comparison with a human nasal cavity is made to put into perspective the dimensions and geometry that the spray atomization produces. This study aimed to extend the current existing set of data to contribute toward a better understanding in nasal spray drug delivery.