HPLC测定参芪片中人参皂苷Re的含量

建立了测定参芪片中人参皂苷Re含量的HPLC法.采用色谱柱为AT-330C18;流速为1.0mL/min;流动相为乙腈-0.05%磷酸溶液(2080);检测波长为203nm.人参皂苷Re得到了较好的分离,在0.3486～3.486μg范围内呈良好的线性关系.本法简便快捷,结果可靠,可用于参芪片中人参皂苷Re的含量测定.     

More of the Same? Understanding Transformation in Tablet-based Academic Library Instruction

Academic librarians have shared their experiences with tablet computers, but few examine how librarians use tablets in their instruction design. While the education literature provides technology integration models, the nature of library instruction requires adapting these models to the library classroom. After reviewing literature related to tablets in library instruction and a number of technology integration frameworks, this article demonstrates an application of the Substitution, Augmentation, Modification, Redefinition framework to analyze observations of an iPad-equipped classroom at a university library. Demonstrating this use of a framework provides an approach to technology integration and continues the discussion about tablets’ potential to promote innovative pedagogy.     

Tablet use in schools: a critical review of the evidence for learning outcomes

The increased popularity of tablets in general has led to uptake in education. We critically review the literature reporting use of tablets by primary and secondary school children across the curriculum, with a particular emphasis on learning outcomes. The systematic review methodology was used, and our literature search resulted in 33 relevant studies meeting the inclusion criteria. A total of 23 met the minimum quality criteria and were examined in detail (16 reporting positive learning outcomes, 5 no difference and 2 negative learning outcomes). Explanations underlying these observations were analysed, and factors contributing to successful uses of tablets are discussed. While we hypothesize how tablets can viably support children in completing a variety of learning tasks (across a range of contexts and academic subjects), the fragmented nature of the current knowledge base, and the scarcity of rigorous studies, makes it difficult to draw firm conclusions. The generalizability of evidence is limited, and detailed explanations as to how, or why, using tablets within certain activities can improve learning remain elusive. We recommend that future research moves beyond exploration towards systematic and in‐depth investigations building on the existing findings documented here.     

多维片处方研究及工艺探讨

采用单因素试验设计,以溶出度和崩解度为评价指标,筛选多维片处方和工艺,并对其进行稳定性考察。试验结果表明,所制得的片剂释放迅速而且完全,质量稳定,该工艺能够有效地解决多雏片的崩解度和VC含量降解的问题。     

Formulation studies for mirtazapine orally disintegrating tablets

Abstract

Objective: Orally disintegrating tablets (ODTs) recently have gained much attention to fulfill the needs for pediatric, geriatric, and psychiatric patients with dysphagia. Aim of this study was to develop new ODT formulations containing mirtazapine, an antidepressant drug molecule having bitter taste, by using simple and inexpensive preparation methods such as coacervation, direct compression and to compare their characteristics with those of reference product (Remereon SolTab).

Materials and methods: Coacervation method was chosen for taste masking of mirtazapine. In vitro characterization studies such as diameter and thickness, weight variation, tablet hardness, tablet friability and disintegration time were performed on tablet formulations. Wetting time and in vitro dissolution tests of developed ODTs also studied using 900?mL 0.1?N HCl medium, 900?mL pH 6.8 phosphate buffer or 900?mL pH 4.5 acetate buffer at 37?±?0.2?°C as dissolution medium.

Results: Ratio of Eudragit® E-100 was chosen as 6% (w/w) since the dissolution profile of A1 (6% Eudragit® E-100) was found closer to the reference product than A2 (4% Eudragit® E-100) and A3 (8% Eudragit® E-100). Group D, E and F formulations were presented better results in terms of disintegration time. Dissolution results indicated that Group E and F formulations showed optimum properties in all three dissolution media.

Discussion: Formulations D1, D4, D5, E3, E4, F1 and F5 found suitable as ODT formulations due to their favorable disintegration times and dissolution profiles.

Conclusion: Developed mirtazapine ODTs were found promising in terms of showing the similar characteristics to the original formulation.     

Non-invasive and rapid analysis for observation of internal structure of press-coated tablet using X-ray computed tomography

Background: Since the internal structure of a tablet can be measured without destruction of the sample by X‐ray computed tomography (CT), it could be applied to quality control of tablets during the manufacturing process. Aim: A novel, fast, noninvasive tablet observation method was developed to evaluate the internal structure of commercial press-coated tablets by using X-ray CT. Method: Thirty-two CT image slices of four kinds of commercial press-coated tablets (tablets A, B, C, and D) were measured 300 m interval between edges of the tablet by using an X-ray CT. The thinnest layer thickness of the tablets and distance between centers of gravity (DCG) of tables were calculated. Results: The order of the TLT of the tablets was tablet B > tablet C > tablet D > tablet A. The result indicated that the order of DCG was tablet A > tablet D > tablet C > tablet B. Noninvasive observation of the internal structure of commercial, press-coated tablets by X-ray CT has been demonstrated to be useful in quality control of production. Conclusion: The internal structure of press-coated tablets could be observed without pretreatment, without destruction, and very rapidly by X‐ray CT.     

3D Printing technologies for drug delivery: a review

With the FDA approval of the first 3D printed tablet, Spritam®, there is now precedence set for the utilization of 3D printing for the preparation of drug delivery systems. The capabilities for dispensing low volumes with accuracy, precise spatial control and layer-by-layer assembly allow for the preparation of complex compositions and geometries. The high degree of flexibility and control with 3D printing enables the preparation of dosage forms with multiple active pharmaceutical ingredients with complex and tailored release profiles. A unique opportunity for this technology for the preparation of personalized doses to address individual patient needs. This review will highlight the 3D printing technologies being utilized for the fabrication of drug delivery systems, as well as the formulation and processing parameters for consideration. This article will also summarize the range of dosage forms that have been prepared using these technologies, specifically over the last 10 years.     

Novel taste-masked orally disintegrating tablets for a highly soluble drug with an extremely bitter taste: design rationale and evaluation

The purpose of this study was to evaluate the taste masking potential of novel solid dispersions (SDs) using Eudragit^® EPO as the excipient when incorporated into the orally disintegrating tablets (ODTs) for delivering a highly soluble drug with an extremely bitter taste. The pyridostigmine bromides (PB) SDs (PBSDs) were prepared by solvent evaporation–deposition method. The physicochemical properties of PBSDs were investigated by means of differential scanning calorimetry and Fourier transformed infrared spectroscopy. The dissolution test showed that only about 8% of PB was released from PBSDs in the simulated salivary fluid in 30 s. Therefore, PBSDs were considered taste-masked and selected for formulation of PBODTs. A central composite design was employed for process optimization. Multiple linear regression analysis for process optimization revealed that the optimal PBODTs were obtained, when the microcrystalline cellulose and crospovidone were 17.16 and 5.55 (%, w/w), respectively, and the average in vivo disintegration time was 25 s. The bitterness threshold of PB was examined by a sensory test, and the threshold value was set as 3?mg in each tablet. Taste evaluation of PBODTs in 18 volunteers revealed considerable taste masking with bitterness below the threshold value. PBODTs also revealed rapid drug release (around 99%, 2?min) in the simulated gastric fluid. The mean PB plasma concentration–time profiles of PBODTs and that of the commercial tablets were comparable, with closely similar pattern. Bioequivalence assessment results demonstrated that PBODTs and the commercial tablets were bioequivalent. In conclusion, PBODTs are prepared successfully, with taste masking and rapid disintegration in the oral cavity.     

波生坦片在中国健康受试者中的生物等效性研究

目的:评价中国健康受试者单剂量口服波生坦片受试制剂和参比制剂的人体生物等效性。方法:采用随机、开放、双序列、双周期交叉设计,24例中国健康男性受试者,分别在空腹和餐后情况下,单剂量口服波生坦参比和受试制剂各125 mg。采用高效液相色谱-串联质谱法测定血浆中的波生坦及其活性代谢物羟基波生坦的浓度,以WinNonlin软件按非房室模型计算药代动力学参数,进行生物等效性评价。结果:空腹试验,受试和参比制剂波生坦主要药代动力学参数：Cmax分别为(2.72±1.09)、(2.59±1.02) μg/mL,AUC0-t分别为(13.51±4.55)、(12.61±4.25) μg·mL-1·h,AUC0-∞分别为(14.04±4.46)、 (13.02±4.24) μg·mL-1·h,tmax分别为(3.75±0.81)、(3.98±0.76) h,t1/2分别为(2.70±0.88)、(2.77±0.91) h。餐后试验受试和参比制剂波生坦主要药代动力学参数：Cmax分别为(2.84±0.68)、(2.95±0.99) μg/mL, AUC0-t分别为(14.66±4.27)、(15.34±6.09) μg·mL-1·h, AUC0-∞分别为(15.04±4.41)、(15.68±6.19) μg·mL-1·h,tmax分别为(3.98±1.05)、(3.98±1.21) h,t1/2分别为(2.55±0.65)、(2.71±0.63) h。空腹和餐后试验,两制剂波生坦的AUC0-t、AUC0-∞、Cmax经对数转换后行方差分析,两制剂在给药顺序、制剂间及周期间均无统计学差异(P＞0.05)。在α=0.05水平上行双单侧t检验,AUC0-t、AUC0-∞、Cmax的90%置信区间均在80%～125%的等效区间范围内。结论:波生坦片受试制剂与参比制剂在空腹和餐后条件下均具有生物等效性。     

NIR光谱法快速分析总黄酮醇苷和萜类内酯

采用NIR法和化学计量学方法构建了银杏叶片中的总黄酮醇苷和萜类内酯含量的定量分析模型。通过PLS建立数学模型,并对预测集样品进行预测。39份样品经交叉验证建立校正模型,RSMECV分别为0.104和0.063。R分别为0.978 8和0.961 9。用13份样品进行预测,R达0.919 9和0.931 8,RSMEP分别为0.107和0.105。该方法简便快速,结果准确,可应用于不同批次银杏叶片样品的进行快速检查或质量控制。