通便灵片质量标准研究

目的 制定通便灵片的质量标准.方法 采用薄层色谱法鉴别通便灵片中的番泻叶、当归,采用高效液相色谱法测定本品中大黄酸含量.结果 薄层层析可鉴别出番泻叶、当归,大黄酸在0.13～1.17μg范围内呈良好的线性关系,平均回收率97.08%(RSD=1.91%,n=6).结论 方法简单可控,可有效地控制本品的质量,保证临床疗效...     

高速压片机微电脑控制器的研究

介绍了一种基于８０９８单片机的高速压片机微电脑控制器的设计及软件实现方法。通过对被控对象的分析，建立了系统的数学模型。仿真和实际应用结果表明：该控制器能对压片机实施有效控制，具有实际应用价值。     

Development of sustained-release tablets containing sodium valproate: in vitro and in vivo correlation

We have developed a 200 mg and 400 mg sustained-release sodium valproate tablet that allows effective blood concentration of the active drug with once-a-day dosing. The controlled dissolution or sustained release of the drug was attained by a membrane-controlled system. A single-coating system did not adequately control the dissolution rate, and therefore double-coated tablets were prepared and a human pharmacokinetic study was conducted. With the 200 mg VPA-Na tablets, the nonfasting C_max was only 20% higher than the fasting C_max. An in vitro dissolution test was conducted to predict the effects of food on drug dissolution after administration of this tablet. A relatively good correlation was observed between the absorption profiles and the dissolution profiles of the drug.     

Preparation and Characterization of Annealed‐Enzymatically Hydrolyzed Tapioca Starch and the Utilization in Tableting

Tapioca starch was annealed at 60°C for 90 min followed by hydrolysis with α‐amylase at 60°C at various lengths of time (30, 60 and 120 min) to obtain high‐crystalline starches. The reaction products were subjected to spray drying to obtain annealed–enzymatically hydrolyzed–spray dried tapioca starch (SANET) in the form of spherical agglomerated granules. The properties of SANET were compared with those of annealed–spray dried tapioca starch without enzymatic treatment (SANT) and native–spray dried tapioca starch (SNT). Scanning electron micrographs of the starch samples were used to study the morphological changes and to suggest the mode of enzyme attack during hydrolysis. The á‐amylase preferentially attacked the interior of the starch granules, leaving a deep round hole on the starch granule surface. It was found by X‐ray diffraction that both annealing and amylolysis did not alter the A type diffraction pattern. The% relative crystallinity of SANET was raised with increasing hydrolysis time and with decreasing amylose content. High performance size exclusion chromatography (HPSEC) demonstrated the decrease of the degree of polymerization (DP) of the amylose fraction of SANET after prolonged hydrolysis. For the utilization of SANET as tablet filler, it was directly compressed by a tablet compression machine at 4 kN to obtain tablets. The increased relative crystallinity of starch resulted in increased crushing strength and disintegration time, but in a decreased tablet friability.     

A DEM approach to assess the influence of the paddle wheel shape on force feeding during pharmaceutical tableting

Pharmaceutical tablet quality is tightly controlled to ensure the patient’s safety. Though the tableting process is a well-known and accepted approach, process understanding is frequently built upon long-time experience of the operators. This is also true for the first step in tableting, the die filling where the powder is fed from the hopper through a force feeding system into the rotating dies of the turret. The current study considers a three-chambered force feeder of a FETTE 1200i, with the focus to evaluate the influence of the paddle wheel shape, which may either be of cylindrical or cuboid shaped blades, on tablet quality. A numerical approach utilizing the discrete element method allowed to compute the powder transfer in the tablet press which helps in identifying the optimal paddle wheel shape configuration. For instance, at a low turret – high paddle wheel speed, the cylindrical configuration revealed highest quality with respect to tablet mass, tablet mass variation, and content uniformity. In contrast, the cuboid configuration indicated better quality at a high turret – low paddle wheel speed. In addition, the detailed analysis of macroscopic and microscopic powder flow phenomena within the force feeder was performed which improves general process understanding in pharmaceutical development.     

Study of the effect of liquid bridges on the dynamic behavior of two colliding tablets using DEM

By incorporating a viscous liquid force model into DEM simulations, the effect of liquid bridging between two tablets during a collision was studied. It was shown that when compared to the viscous force, the capillary force is several orders of magnitude smaller. In order to predict the capture of a falling tablet by the liquid bridge, it was necessary to adjust the limiting separation distance used in the viscous force model. Comparison of experimental results with the simulations, using oils with viscosities in the range of 100-1,000 cP, showed that there was a linear relationship between the limiting separation distance and the viscosity of the silicone oils. This viscosity-dependent separation distance varied in the range of 1-6 mm.     

信息化控制系统平板电脑设计与应用

通过对平板电脑多角度分类,对平板电脑完成任务分析,选择一款满足使用在具有高粉尘、烟雾、高温、低温、潮湿、高振动、高腐蚀等非常恶劣工程条件下的平板电脑。叙述了具体的设计考虑、给出了对所选电脑的环境试验考核指标。通过环境试验考核、实际运行,统计了样本数量足够多,可靠工作时间足够长的运行数据。大量样本的使用统计数据表明,正确设计选用了一款合适使用于恶劣工程环境的平板电脑。供工业控制设计同行借鉴。     

In Vitro and In Vivo Release of Naltrexone from Biodegradable Depot Systems

ABSTRACT

The aim of this study was to prepare poly(d, l-lactide) (PLA) microspheres containing naltrexone (NTX) by a solvent evaporation method, and to evaluate both in vitro and in vivo release characteristics and histopathological findings of tissue surrounding an implant formulation in rats.

This method enabled the preparation of microspheres of regular shape and relatively narrow particle size distribution. The in vitro release profiles of NTX from PLA microspheres showed the release of NTX did not follow zero-order kinetics. An initial burst release was observed, subsequently followed by a nearly constant rate of 0.4% per day after ten days. The cumulative amount of NTX released at the end of 60 days was 80%. Compressed microspheres showed near zero-order sustained release of NTX for 360 days. The plasma NTX levels in rats showed that for compressed microspheres NTX concentrations were constant and exceeded 2 ng/mL for 28 days. Throughout the 28 days of study, the implantations cause a minor inflammatory response, which can be regarded as a normal defence mechanism. The sustained release performance of NTX from the biodegradable depot systems may provide a reliable, convenient, and safe mechanism for the administration of NTX for the long-term treatment of opioid dependence.     

Adoption of three new types of computers in Taiwan: Tablet PCs,netbooks, and smart phones

Tablet PCs, netbooks, and smart phones are similar to one another in that they possess the basic functions of computers, but they differ in what functions they emphasize. Rogers’ diffusion of innovation model has been widely recognized as a powerful model for predicting technology adoption. This study adopted Rogers’ model to examine the adoption intentions of the three new types of computers. A telephone survey was conducted to collect data. This study made 1757 telephone calls, from which 1100 valid calls were obtained, representing a response rate of 62.61%. The data analysis demonstrates that the findings are generally congruent with the predictions of Rogers’ model. However, this study’s results also reveal one limitation of Rogers’ model, its pro-innovation bias, which explains why the diffusion of netbooks was incongruent with Rogers’ model.     

Bioequivalence Evaluation of Two Formulations of Doxazosin Tablet in Healthy Thai Male Volunteers

ABSTRACT

The bioequivalence of two doxazosin 2 mg tablets was determined in 24 healthy Thai male volunteers after one single dose in a randomized cross-over study with a one week washout period. The study was conducted at Faculty of Pharmaceutical Sciences and Health Sciences Research Institute, Naresuan University, Phitsanulok, Thailand. Reference (Cardura®, Heinrich Mack Nachf. GmbH & Co. GK, Illertissen, Germany) and test (Dozozin-2®, Umeda Co., Ltd., Bangkok Thailand) were administered to volunteers after overnight fasting. Blood samples were collected at specified time intervals and plasma was separated. The validated HPLC method with fluorescence detection was used for quantification of doxazosin in plasma samples. The pharmacokinetic parameters, T_max, C_max, AUC_t, AUC_∞, T_1/2, λ_z, Cl and V_d, were determined from plasma concentration time profile of both formulations by using non-compartment analysis. The calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two brands. The analysis of variance (ANOVA) using log-transformed C_max, AUC_t, and AUC_∞ did not show any significant difference between two formulations. The point estimates and 90% confidence intervals for C_max, AUC_t and AUC_∞ were within the acceptance range (0.80–1.25), satisfying the bioequivalence criteria of the Thailand Food and Drug Administration Guidelines. These results indicate that Dozozin-2® is bioequivalent to Cardura® and, thus, may be prescribed interchangeably.