防差错系统在软胶囊生产中的应用

随着制造执行系统(manufacturing execution system, MES)在汽车制造业中的广泛运用, 越来越多的行业开始导入MES系统。我国保健食品行业发展迅速, 市场规模不断扩大, 越来越多的企业将MES系统导入到生产过程中, 目前绝大多数企业只停留在MES系统的初级阶段, 用于物料、容器具和人员的追踪等。我司在MES系统的基础上, 对软胶囊生产进行防差错系统开发, 将防差错系统与MES系统全方面的结合, 并运用到软胶囊生产过程中。通过对软胶囊生产工艺分析, 确定各个环节的质量风险点, 增加探头感应器、扫描枪、编程, 赋予设备与物料条形码, 实现配料化胶、压丸、干燥选丸防差错系统的开发。防差错系统的开发应用, 减少了软胶囊生产过程的质量风险点, 避免人为因素带来的质量偏差, 实现生产过程中的局部自动化, 为实现软胶囊连线生产奠定了扎实的基础。     

植物硬空心胶囊成型工艺研究

研究以羧甲基葡甘聚糖-大豆分离蛋白复合物为主料,卡拉胶和K 组成凝固体系制备植物硬空心胶囊的成型工艺。结果表明:当复合物和卡拉胶的质量比例为80∶20,溶胶温度为80℃,K 浓度为0.02 mol/L,保温时间为30 min,溶胶流动性较好,凝胶强度达到6.53 N/cm2,蘸模成型好,胶囊壁厚达标。     

胶囊内窥镜新型外磁场驱动系统模型与仿真

为了克服传统推进式和被动式内窥镜在医用检查时存在的不足,提出了一种由三个同轴圆线圈和两对平行鞍线圈组成的胶囊内窥镜新型外磁场驱动模型。胶囊内窥镜内部嵌入NdFeB永磁体,通过控制外部线圈的电流来驱动永磁体,带动内窥镜在体内运动。在实验过程中,运用ANSOFT电磁场仿真软件分别对三个同轴圆线圈和鞍线圈的磁场分布进行了分析,结果表明,该模块能够产生三维匀强磁场,符合驱动无线胶囊内窥镜在体内运动的要求,并且结构简单紧凑,可控性高,有利于提高检测效率。     

有机溶剂溶解法结合电感耦合等离子体发射光谱法直接测定软胶囊剂型保健食品中的钙和铁

目的 建立电感耦合等离子体发射光谱法(inductively coupled plasma optical emission spectrometry,ICP-OES)测定软胶囊剂型保健食品中的钙和铁含量的方法。方法 软胶囊剂型保健食品经水-硝酸-二甲亚砜混合溶液溶解后,使用电感耦合等离子体发射光谱仪,直接测定其中的钙和铁含量。结果 钙元素方法的检出限为3 mg/kg,定量限为9 mg/kg,钙元素的回收率在92.2%～96.7%之间,相对标准偏差(relative standard deviations,RSDs)在3.2%～8.8%之间。铁元素方法的检出限为0.6 mg/kg,定量限为2 mg/kg,铁元素的回收率在91.8%～96.7%之间,RSDs在1.8%～11.9%之间。实际样品检测时,同时采用了本方法与GB 5009.268—2016《食品安全国家标准食品中多元素的测定》(第二法),两种方法所得结果没有明显差异。结论 本方法在前处理时,不再使用传统的微波消解等方法,操作简单、快捷、准确度高,可以用于软胶囊剂型保健食品中钙和铁的检测。     

Effects of powder flow properties on capsule filling weight uniformity

Filling capsules with the right amount of powder ingredients is an important quality parameter. The purpose of this study was to develop effective laboratory methods for characterizing flow properties of pharmaceutical powder blends and correlating such properties to weight variability in filled capsules. The methods used for powder flow characterization were bulk and tapped density, gravitational displacement rheometer (GDR) flow index, Freeman Technology V.4 (FT4) powder rheometer compressibility, FT4 basic flow energy (BFE), and cohesion parameters [cohesion, (C) and flow factor (ffc)] measured in a shear cell also using the FT4. Capsules were filled using an MG2-G140 continuous nozzle dosator capsule-filling machine. Powder flow properties were the most predominant factors affecting the weight and weight variability in the filled capsules. Results showed that the weight variability decreased with increasing bulk and tapped density, ffc and BFE, while the weight variability increased with increasing compressibility, cohesion and GDR flow index. Powder flow properties of the final blends were significantly correlated to the final capsule weight and weight variability of the filled capsules.     

Development of a design space and predictive statistical model for capsule filling of low-fill-weight inhalation products

The objectives of this study were to develop a predictive statistical model for low-fill-weight capsule filling of inhalation products with dosator nozzles via the quality by design (QbD) approach and based on that to create refined models that include quadratic terms for significant parameters. Various controllable process parameters and uncontrolled material attributes of 12 powders were initially screened using a linear model with partial least square (PLS) regression to determine their effect on the critical quality attributes (CQA; fill weight and weight variability). After identifying critical material attributes (CMAs) and critical process parameters (CPPs) that influenced the CQA, model refinement was performed to study if interactions or quadratic terms influence the model. Based on the assessment of the effects of the CPPs and CMAs on fill weight and weight variability for low-fill-weight inhalation products, we developed an excellent linear predictive model for fill weight (R^2?=?0.96, Q^2?=?0.96 for powders with good flow properties and R^2?=?0.94, Q^2?=?0.93 for cohesive powders) and a model that provides a good approximation of the fill weight variability for each powder group. We validated the model, established a design space for the performance of different types of inhalation grade lactose on low-fill weight capsule filling and successfully used the CMAs and CPPs to predict fill weight of powders that were not included in the development set.     

In vitro and in vivo evaluations of a novel pulsed and controlled osmotic pump capsule

Objective: For better treatment of circadian cardiovascular events, a novel Propranolol hydrochloride (PNH) delayed-release osmotic pump capsule was developed.

Methods: The capsule body was designed of asymmetric membrane and the capsule cap was made impermeable. The physical characteristics of capsule body walls and membrane permeability were compared among different coating solutions.

Results: The formulation with the glycerin and diethyl phthalate (DEP) ratio of 5:4 appeared to be the best. The lag time and subsequent drug release were investigated through assembling the capsule body with capsule caps of different length. WSR N-10 was chosen as the suspending for its moderate expanding capacity. The influence of factors (WSR N-10 content, NaCl content and capsule cap length) on the responses (lag time and drug release rate) was evaluated using central composite design-response surface methodology. A second-order polynomial equation was fitted to the data and actual response values were in good accordance with the predicted ones. The optimized formulation displayed complete drug delivery, zero-order release rate with 4-h lag time. The results of in vivo pharmacokinetics in beagle dogs clearly suggested the controlled and sustained release of PNH from the system and that the relative bioavailability of this preparation was about 1.023 comparing the marketed preparation.

Conclusions: These results indicate that by the adjustment of capsule cap length, PNH could be developed as a novel pulsatile and controlled drug delivery system.     

易碎Be靶丸表面精密抛光技术与理论分析

目的建立一种新的易碎空心微球抛光机模型,并研制出该样机,用于空心Be微球的精密抛光。方法采用限位孔设计解决微球低应力夹持问题,添加不同数量的配重球,用于调整待抛球的滑动摩擦力大小和防止其飞出限位孔。上下盘偏心放置,实现微球无规运动。采用白光干涉仪分析抛光后Be微球的表面粗糙度。结果抛光机模型计算表明,待抛球一直在做周期性的变速和变加速运动,其周期大小由上盘转动频率决定,变加速运动增加了微球的滑动摩擦成分,有利于提高微球抛光效率。此外,待抛球表面抛光轨迹呈现无规行走,这有利于抛光的均匀性。使用该原理抛光机,在24 h内能够将直径1.2 mm、均方根表面粗糙度510 nm的易碎铍(Be)靶丸抛光至85 nm。结论理论和实验共同验证了易碎微球抛光机模型的合理性和可行性,上下盘放置方式、限位孔大小设计和配重球数量等关系着易碎微球的抛光均匀性和抛光效率。     

基于SiP技术的胶囊内窥镜微型电路系统制造

胶囊内窥镜是近年发展起来的微型医疗仪器,其电路构造具有体积小、功能全等特点。文章提出用高密度封装SiP技术实现胶囊内窥镜的电路系统微型化。相对传统的芯片定制方式,采用堆叠式、表面贴装式或倒装焊式等组装方式具有成本低、难度低、开发周期短的优点。SiP封装、埋植式元件基板制造等高密度封装技术的不断发展,使得采用普通商用芯片实现胶囊内窥镜电路系统制造具有可行性。     

一种双向、数字式微型无线内窥镜系统设计

通过分析目前消化道无线内窥镜的发展状况,提出了一种全新的双向、数字化的微型无线内窥镜系统方案设计,该系统具有实时观察病人图像、全消化道检查以及提供三维深度图像数据等功能,并对方案中各硬件模块及其关键技术进行了详细的论述,设计了该系统的FPGA验证环境,验证了整个方案的正确性。系统胶囊内的数模混合芯片已采用0.18μm CMOS工艺流片。