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.     

辛味中药在治疗消渴证中的应用价值及中药五味理论现代研究的思考

辛味是中药五味学说中的重要性味之一,通常具有“发散”“行气”和“行血”的作用,且辛味中药在传统医学临床应用中占有较大比例。结合中药辛味的功效内涵及传统中医理论对消渴证的认识,阐述辛味中药与消渴证治疗之间的内在联系,总结辛味中药对“消渴三消”的治疗意义与价值。并在此基础上,对中药五味理论的现代研究趋势和发展方向进行思考,为同行研究提供参考。     

提升“湘九味”品牌价值 高质量发展湖南中药材产业

湖南省历经8年聚力打造“湘九味”中药材品牌，已逐渐形成品牌品种引领的产业链发展模式。为达成湖南省中药材产业链千亿发展目标，梳理了“湘九味”品牌培育历程，厘清并阐释了相关概念，分析了产业发展现状及问题，研判了大健康应用背景下未来的中药材产业的发展趋势，并提出相关发展建议。     

Academic–Industrial Collaboration: Toward the Consilience of Two Solitudes

Current major advances in drug discovery can be traced back to pioneering contributions originating from academics over a century ago. Living in a symbiotic yet noninvasive coexistence, the academic community and the pharmaceutical industry have strived, each in their own way, to develop the modern medicines that benefit humankind today. The subject is presented from a historical and personal perspective.     

中药对大鼠辐射损伤防护作用的实验研究

目的探讨中药当归、川芎、黄芪、丹参提取液对大鼠放射性骨髓损伤的防护作用.方法雄性SD大鼠60只,随机分为正常对照组、模型组、中药组,每组6只,在相同条件下饲养2周,模型组和中药组大鼠给予6.0 Gy 60Co γ射线一次性全身照射,继续饲养1周处死全部动物并取材.用骨髓细胞计数法计数骨髓有核细胞数,用Western blot法测定血管内皮生长因子（vascularendothelialgrowth factor,VEGF）、血小板衍生生长因子（ptatelet derived growth factor,PDGF）的蛋白含量.结果与正常对照组比较,模型组大鼠的骨髓有核细胞数、VEGF、PDGF蛋白含量明显减少（P＜0.01）,与模型组比较,中药组大鼠的骨髓有核细胞数、VEGF、PDGF蛋白含量明显增加（P＜0.01或P＜0.05）.结论中药当归、黄芪、川芎、丹参对大鼠放射性骨髓损伤有一定防护作用.     

芪月降脂片制剂处方的优化

[目的 ]优化芪月降脂片的制剂处方 .[方法 ]采用正交设计和多指标综合评分法对已筛选出的药剂辅料进行处方优化 .[结果 ]最佳制剂处方为糖粉 50 g ,辅料X 50g ,微晶纤维素 75g .[结论 ]该处方合理 ,成型性好     

克氏螫虾与中国对虾微量元素与氨基酸含量的比较

对克氏螯虾和中国对虾的不同部位所含游离氨基酸和重要微量元素进行了比较。结果表明,克氏螯虾某些部位中游离氨基酸和微量元素的含量高于中国对虾。提示克氏螯虾可能具有与中国对虾相似的药用价值。     

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。