氧化苦参碱微丸的制备及其性质考察

目的:制备氧化苦参碱微丸并考察其性质。方法:用实验型低温挤出滚圆制粒机制备氧化苦参碱微丸;采用L9(34)正交设计优化工艺条件;考察不同含药量的微丸的粉体学性质及体外溶出度。结果:用挤出滚圆法制备的氧化苦参碱微丸圆整度好,大小均匀;最佳工艺为水∶微晶纤维素=0.90∶1,滚圆速度为35Hz,滚圆时间为5min,挤出速度为40Hz;体外溶出度在30min内达到75%以上。结论:挤出滚圆法制备氧化苦参碱微丸的工艺简便易行,制得的微丸质量好。     

挤出滚圆法在中药微丸中的应用

目的促进挤出滚圆法在制备中药微丸中的推广。方法查阅相关文献,从处方来源、制备工艺、评价指标等方面,对挤出滚圆法制备中药微丸的现状和前景进行分析。结果挤出滚圆法辅料易得,工艺简单,在中药微丸的研究中已得到普遍应用。结论挤出滚圆法是制备中药微丸最可行的方法之一,在中药微丸的研制和生产中具有实用价值。     

探究挤出滚圆法制备中药微丸的效果

目的：研究挤出滚圆法在制备中药微丸中的应用效果。方法查阅相关文献,结合当前该领域研究的成果,从处方来源、制备工艺等方面分析挤出滚圆法在制备中药微丸中的应用效果及前景。结果挤出滚圆法制备中药微丸工艺简单、材料易得,已经得到了较为广泛的应用。结论挤出滚圆法制备中药微丸可行性高,具有很好的实用价值。     

流化床制粒法制备中药纯浸膏包衣微丸的工艺研究

目的:制备半夏泻心汤中药纯浸膏包衣微丸.方法:采用流化床制粒法,考察纯浸膏粉的起母模丸条件、母模丸增大及包衣处理中的处方因素对微丸的形成和收率的影响.结果:在微丸起母模丸阶段,以纯浸膏粉及含醇量30%以上的中药浸膏起模,在母模丸增大阶段采用中药浸膏作为微丸增大剂是可行的,微丸增大后用德固萨作包衣剂,其防潮性能良好.结论:按所选的处方及工艺条件,用流化床制粒法可制得表面光滑、圆整度较高且防潮性能好的半夏泻心汤中药纯浸膏包衣微丸.     

挤出滚圆法制备中药复方当归补血微丸及其性质考察*

目的：应用挤出滚圆法制备中药复方当归补血微丸，研究微丸制备的最佳工艺和处方。方法：用新型的挤出滚圆造粒机制备当归补血微丸；采用单因素考察和正交设计筛选最优处方和工艺条件；考察了微丸的粉体学性质、收率和体外溶出效果。结果：用挤出滚圆技术制备的当归补血微丸圆整度好，大小均匀，收率高，体外溶出迅速。结论：挤出滚圆法可以制备中药微丸。该工艺简便易行，制得的微丸质量好。     

挤出滚圆法制备阿莫西林微丸的处方工艺研究

目的 应用挤出滚圆法制备阿美西林微丸,研究微丸制备的最佳工艺和处方.方法 采用挤出滚圆造粒机制备阿莫西林微丸;采用单因素考察和正交设计筛选最优化处方及工艺条件;评价了微丸的粉体学性质、收率和体外溶出度.结果 用挤出滚圆法制备的阿莫西林微丸在30min内体外溶出均达80%以上,且圆整度好,收率高.结论 挤出滚圆法制备阿莫...     

中心复合设计法优化丹七有效部位缓释微丸

目的:应用挤出滚圆法制备丹七提取物缓释微丸,研究微丸制备的最佳工艺和处方.方法:用挤出滚圆机制备丹七提取物缓释微丸;采用单因素考察和中心复合设计筛选最优处方和工艺条件;考察了微丸粉体学性质、收率和体外溶出度.结果:用挤出滚圆法制备的微丸圆整度好,大小均匀,收率高,药物体外溶出具有明显的缓释作用,体外释放曲线符合Peppas和Higuchi方程.结论:该工艺简便易行.     

乙肝解毒微丸制备工艺研究

目的应用挤出-滚圆法制备中药乙肝解毒微丸,研究微丸制备的最佳处方和工艺。方法采用挤出-滚圆法对润湿剂、药料、乙醇的用量进行筛选,最终筛选出最佳用量。结果用挤出-滚圆法制备的乙肝解毒微丸圆整度好,大小均匀,成品收率高。结论通过加入合适的润湿剂,可以采用挤出滚圆法制备乙肝解毒微丸,该工艺稳定、辅料用量少,挥发性有效成分破坏程度小。     

探究挤出滚圆法制备中药微丸的效果

目的:对应用挤出滚圆法制备中药复方杞芪微丸的效果进行探讨和分析。方法:采用新型挤出滚圆造粒机行复方杞芪微丸制备并对不同处方微丸的体外溶出度、收率以及粉体化学性质进行考察和分析。结果:3种处方微丸质量和收率均非常理想,处方A微丸质量和收率优于处方B和处方C,随着载药量的不断上升,微丸的流动性和圆整度会出现下降,收率会相应降低。3种处方微丸1小时内溶出度均超过80%,胶囊在40min内溶出度即可达到80%,杞芪微丸具有更佳的溶解度,制剂效果更优。结论:应用挤出滚圆法制备中药复方杞芪微丸具有较高的收率和较好的质量,而且具有非常理想的体外溶出效果,值得研究和应用。     

星点设计-效应面法优化黄肝微丸的制备工艺

目的:采用挤出滚圆法制备黄肝微丸,筛选最佳处方工艺.方法:用挤出滚圆造粒机制备黄肝微丸;以微丸的粉体学性质及得率为指标,在单因素试验基础上,通过星点设计-效应面法优化制备工艺.结果:制备黄肝微丸的最佳工艺为:挤出速度33 Hz,滚圆速度29 Hz,滚圆时间为12 min,所得微丸的圆整度好、大小均匀、收率高.验证实验证...     

当归补血微丸的制备及其质量控制

目的制备当归补血微丸并建立其质量控制方法。方法以挤出滚圆法制备当归补血微丸,考察微丸的粉体学性质和溶散时限,并采用高效液相色谱法测定微丸中阿魏酸的含量。结果所制微丸圆整度、流动性好,溶散时限合格。阿魏酸进样量在0.03438μg~1.146μg范围内线性关系良好(r=0.9998),平均回收率为97.0%(RSD=0.664%)。结论该制剂制备方法可行;所建立的含量测定方法准确、灵敏、稳定性好,可用于该制剂的质量控制。     

Optimization and scale-up of a fluid bed tangential spray rotogranulation process

The production of pellets in the pharmaceutical industry generally involves multi-step processing: (1) mixing, (2) wet granulation, (3) spheronization and (4) drying. While extrusion-spheronization processes have been popular because of their simplicity, fluid-bed rotogranulation (FBRG) is now being considered as an alternative, since it offers the advantages of combining the different steps into one processing unit, thus reducing processing time and material handling. This work aimed at the development of a FBRG process for the production of pellets in a 4.5-l Glatt GCPG1 tangential spray rotoprocessor and its optimization using factorial design. The factors considered were: (1) rotor disc velocity, (2) gap air pressure, (3) air flow rate, (4) binder spray rate and (5) atomization pressure. The pellets were characterized for their physical properties by measuring size distribution, roundness and flow properties. The results indicated that: pellet mean particle size is negatively affected by air flow rate and rotor plate speed, while binder spray rate has a positive effect on size; pellet flow properties are enhanced by operating with increased air flow rate and worsened with increased binder spray rate. Multiple regression analysis enabled the identification of an optimal operating window for production of acceptable pellets. Scale-up of these operating conditions was tested in a 30-l Glatt GPCG15 FBRG.     

Feasibility of Eliminating Premixing for the Production of Pellets in a Rotary Processor

This current study aims to explore the feasibility of eliminating the premixing step for making pellets in a rotary processor. Microcrystalline cellulose (MCC) and lactose were used as starting materials. They could be loaded into the rotary processor separately using three different loading configurations (Methods I, II, and III) or as MCC:lactose blend, which was prepared in the separate mixer prior to loading (Method IV). Physical properties of the pellets prepared in Methods I–III were evaluated and compared against those prepared using a premixed blend (Method IV). The effects of loading configuration on pellet quality can be assessed by comparing the pellets prepared in Methods I, II, and III. Physical characterization of pellets included mean size, size distribution, oversized fraction, and shape. No significant difference in pellet properties could be attributed to the effect of premixing. Pellet properties were not significantly affected by the different loading configurations either. This study demonstrated that homogeneous powder blends are not required for the production of pellets in rotary processing. The tumbling action of the powders at the start of rotary processing is sufficient to ensure adequate powder mixing. However, it may be judicious to co-feed the different powders to achieve some preliminary mixing during loading under extreme processing conditions.     

Feasibility of eliminating premixing for the production of pellets in a rotary processor

This current study aims to explore the feasibility of eliminating the premixing step for making pellets in a rotary processor. Microcrystalline cellulose (MCC) and lactose were used as starting materials. They could be loaded into the rotary processor separately using three different loading configurations (Methods I, II, and III) or as MCC:lactose blend, which was prepared in the separate mixer prior to loading (Method IV). Physical properties of the pellets prepared in Methods I-III were evaluated and compared against those prepared using a premixed blend (Method IV). The effects of loading configuration on pellet quality can be assessed by comparing the pellets prepared in Methods I, II, and III. Physical characterization of pellets included mean size, size distribution, oversized fraction, and shape. No significant difference in pellet properties could be attributed to the effect of premixing. Pellet properties were not significantly affected by the different loading configurations either. This study demonstrated that homogeneous powder blends are not required for the production of pellets in rotary processing. The tumbling action of the powders at the start of rotary processing is sufficient to ensure adequate powder mixing. However, it may be judicious to cofeed the different powders to achieve some preliminary mixing during loading under extreme processing conditions.     

Some variables influencing rotoagglomeration in the multiprocessor MP-1

Pellets are of great interest to the pharmaceutical industry for variety reasons, e.g. flexibility in dosage form design and drug efficacy improvement. Rotoagglomeration is the novel method for their production using rotoprocessors or rotogranulators allowing one-piece equipment operation. However this process is sensitive and includes numerous variables that have to be optimalized for successful result-spherical pellets of desired properties. This paper is contributing to study some of them: liquid amount, its spray rate and input powder amount and their influence on lactose-microcrystalline cellulose pellet properties.     

The Power-consumption-controlled Extruder: A Tool for Pellet Production

Abstract— Based on the assumption that there is a link between power consumption of an extruder and pellet properties, a control circuit for power consumption was developed. Powder and granulation liquid are feeded separately into a twin-screw extruder. The power consumption is controlled by varying the pump rate at a given powder-feed rate; consequently each level of power consumption results in a specific water content of the extrudate for a particular formulation. The shape of pellets depends almost entirely on the level of power consumption irrespective of formulation. The size of dry pellets is additionally affected by a shrinking factor which depends on the water content. The power-consumption-controlled extruder is an appropriate tool for the production of pellets. The system is able to adapt the water content for a formulation automatically.     

Importance of the Fraction of Microcrystalline Cellulose and Spheronization Speed on the Properties of Extruded Pellets Made from Binary Mixtures*

The aim of the study was to prove the importance of the binary mixture composition and spheronization speed on pellet properties. Extrudates from different binary mixtures of microcrystalline cellulose (MCC) and dicalcium phosphate dihydrate were prepared with a power-consumption-controlled extruder and spheronized at different speeds. The water content of the extrudate for the production of spherical pellets was evaluated. The pellets were characterized in terms of size, shape, porosity, mechanical properties, and disintegration. The fraction of MCC in the binary mixtures had the highest impact on the pellet properties. With an increasing fraction of MCC more water was required for successful pelletization, size and porosity of the pellets decreased, and the surface tensile stress increased. These observations were evaluated using the “sponge” and the “crystallite–gel” models for MCC. The latter led to the conception that an extrudate consists of two phases: a percolating crystallite–gel phase formed by MCC and water during extrusion and a filler phase formed by the second component of the binary mixture. This two-phase concept provides explanations for the extent of shrinking during drying and for the disintegration behavior. The spheronization speed had an influence on the size but not on porosity or surface tensile stress of the pellets. The best results were obtained at intermediate spheronization velocities of 10 and 13.4 m/sec. Fundamental properties of extrudates and pellets can be described by applying a two-phase concept of the crystallite–gel model.     

药用植物根腐病防治的研究进展

根腐病是药用植物生长过程中常见的一种病害,在中药材生产过程中,由于根腐病的危害,会造成不同程度的药材减产,严重影响到中药材生产。本文从药用植物根腐病病原真菌的种类、不同产地对病原真菌种类的影响和病原真菌的生物学特性三方面概述了药用植物根腐病病原真菌的研究现状,综述了药用植物根腐病农业防治、化学防治和生物防治等防治方法的进展,同时提出了药用植物根腐病防治应注意的问题,以确保更加合理有效地防治药用植物根腐病,为中药材生产提供参考依据。