A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development

Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a “true” value for the size of a particle can be challenging as the output of its measurement will differ because of variations in measurement approaches, instrumental differences and calculation methods. Consequently, for “real” particles, a universal “true” value does not exist and accuracy is therefore not a definable characteristic. Accordingly, precision is then a measure of the ability to reproducibly achieve a measurement of unknown relevance.This article proposes, in place of accuracy, a means to define the “appropriateness” of a measurement in line with the critical quality attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQA; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a critical material attribute.Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed.     

中药敷脐治疗胸腰椎术后腹胀便秘的效果观察

目的探讨使用大黄厚朴煎剂热敷脐部治疗胸腰椎术后患者腹胀、便秘的疗效。方法选择2005年1月至2006年12月中山大学第二医院骨外科胸腰椎术后出现腹胀便秘的患者80例。分成两组,治疗组用大黄厚朴煎剂热敷脐部;对照组使用开塞露塞肛。观察两组患者肛门排气,排便,腹胀消除及停药复结情况。结果治疗组的总有效率95%,对照组总有效率70%;停药复结情况:治疗组5%,对照组42.5%;腹胀减轻情况:治疗组95%,对照组52.5%。结论大黄厚朴煎剂热敷脐能有效减轻肠胀气,软化大便,对于消除胸腰椎术后患者腹胀便秘明显优于使用开塞露塞肛效果。     

聚酰亚胺纳米杂化材料的制备、结构和性能

介绍了聚酰亚胺（PI）纳米杂化材料的四种制备方法：溶胶－凝胶法、插层法、分散法、相转移分散聚合法。纳米粒子在PI材料中分散性良好。由于纳米粒子本身 性和纳米粒子改变了PI材料的应力作用点，随着SiO2,AIN等纳米粒子含量增加，PI杂化的玻璃化温度、热分解湿度、拉伸强度、断裂伸长率、杨式模量、密度增加，线性膨胀系数减少。对介电性能的影响因不同纳米材料而异。     

改良小儿胸腔镜心脏手术股动静脉插管材料的血液相容性及毒理学研究

目的 通过对改良小儿胸腔镜心脏手术股动静脉插管材料进行血液相容性及毒理学研究,评价其临床应用的可行性.方法 分别进行溶血实验、皮内刺激实验及小鼠全身急性毒性实验,通过测定吸光度值计算溶血率,按照标准制备的材料浸提液注射到兔的皮下和小鼠体内,观察72h兔皮肤病理变化及小鼠的全身反应.结果 改良小儿胸腔镜心脏手术股动静脉插管材料溶血率为1.58%,低于国际标准(5%);实验组兔皮肤无红斑、水肿及坏死;实验组小鼠无死亡、体重下降及明显全身异常反应.结论 所用材料符合医用材料的要求,可用于临床.     

苯胺衍生物掺杂的PMMA薄膜的二次非线性光学性能的稳定性研究

具有A-π-D电子结构的苯胺衍生物掺杂的玻璃态高聚物PMMA的有机薄膜经极化取向后显示很强的二次非线性光学性能,其取向弛豫是实用化的一个有待解决的重要问题。木文通过几种苯胺衍生物以不同百分比与PMMA掺杂,用紫外-可见吸收光谱、二次谐波强度测量、动态力学粘弹谱等方法进行了取向弛豫的机理研究,结果表明分子尺寸和形状以及偶极矩的大小对取向弛豫有显著影响。     

超细α-FeOOH制备过程研究 Ⅰ.制备工艺

以制备晶形、粒度、轴比等满足高性能磁粉要求的铁黄为目标,研究了碱法超细α-FeOOH合成的工艺配方和工艺条件对粒子性能的影响,包括碱比、气量、转速、Fe(OH)_2结晶条件、熟化时间等工艺参数的影响规律。重复稳定地制备出三类超微粒α-FeOOH粒子,其粒度分别为0.18、0.28、0.39μm,分布均匀,无枝叉。     

Polylactic acid (PLA) root replica in ridge maintenance after loss of a vertically fractured incisor

Abstract A periodontally affected tooth was prepared for a special treatment: Calcium hydroxide was introduced into the apical half of the root canal whereas its cervical part was filled with glass ionomer cement. The tooth was shortened subgingivally. After 6 weeks of epithelization over the residual root a palatal full-thickness flap was mobilized. The root was carefully extracted and chairside copy-milled from the biodegradable polylactic acid (PLA) material. The PLA-replica was implanted immediately into the socket and the flap was sutured. Aim of the treatment was to prevent the ridge collapse of the extraction area. Ridge height could be preserved during the 21 months of observation. With time the radiographic density of the cancellous bone increased in the implanted area, indicating that a PLA-replica is replaced by host's bone tissue.     

医用低值材料采供管理的探讨

医疗消耗材料是医疗工作开展的基础，本文从医用低值消耗材料的计划制定、材料采购、库房库存结构、材料供应、成本核算等多方面探讨了如何对医疗消耗材料进行科学管理，这对医院的医疗发展和管理建设有着重要意义。     

具有骨诱导活性的仿生骨基质材料的制备

目的将一种具有与骨形态发生蛋白2相似骨诱导活性的多肽p24共价结合于改性聚（丙交酯-co-乙交酯）基质材料上，以制备出具有骨诱导活性的仿生骨基质材料。方法将活性多肽p24通过交联剂共价结合于改性PLGA材料上作为实验组；以未加交联剂多肽溶液和材料简单混合反应为对照组，通过X射线光电子光谱法和扫描电镜检测交联情况；同时对两组材料进行钙离子吸附实验，初步评价其仿生矿化能力。结果XPS检测结果表明，实验组及对照组材料表面均已结合硫元素，两者含有硫元素含量分别为1.50％及0.09％；钙离子吸附实验结果表明，12h及24h时实验组材料的钙离子吸附量分别为0，126mg及0．231mg；12h及24h时对照组材料的钙离子吸附量分别为0．053、0．102mg。多肽交联之材料较混合之材料的钙离子吸附能力显著增强。结论在改性PLGA三嵌段材料上固定了BMP2活性多肽，为以后发挥其骨诱导活性修复骨缺损奠定了良好基础。