Over the past years, gene therapeutics have held great promise for treating many inherited and acquired diseases. The increasing number of approved gene therapeutics and developing clinical pipelines demonstrate the potential to treat diseases by modifying their genetic blueprints in vivo. Compared with conventional treatments targeting proteins rather than underlying causes, gene therapeutics can achieve enduring or curative effects via gene activation, inhibition, and editing. However, the delivery of DNA/RNA to the target cell to alter the gene expression is a complex process that involves, crossing numerous barriers in both the extracellular and intracellular environment. Generally, the delivery strategies can be divided into viral-based and non-viral-based vectors. This review summarizes various bioanalysis strategies that support the non-virus-based gene therapeutics research, including pharmacokinetics (PK)/toxicokinetics (TK), biodistribution, immunogenicity evaluations for the gene cargo, vector, and possible expressed protein, and highlights the challenges and future perspectives of bioanalysis strategies in non-virus-based gene therapeutics. This review may provide new insights and directions for the development of emerging bioanalytical methods, offering technical support and a research foundation for innovative gene therapy treatments.

Staphylococcus aureus contamination in food supplements poses substantial challenges to public health and largescale production but the sensitive detection in a timely manner remains a bottleneck. Drawing inspiration from the sea hedgehog, gold nanostars (AuNSs) were leveraged to design an ultrasensitive surface-enhanced Raman scattering (SERS) biosensor for the determination of Staphylococcus aureus in food supplements. Besides the surface enhancement furnished by the AuNSs, Raman reporter molecules and specific aptamers sequentially selfassembled onto these AuNSs to construct the "three-in-one" SERS biosensor probe for label-based quantitation of Staphylococcus aureus. Following incubation with contaminated health product samples, the gold nanostars@Raman reporter-aptamer specifically recognize and assemble around Staphylococcus aureus cells, forming a distinctive sea hedgehog structure. This unique configuration results in an amplified Raman signal at 1338 cm- 1 and an enhancement factor of up to 6.71 x 107. The entire quantitative detection process can be completed within 30 min, boasting an exceptional limit of detection as low as 1.0 CFU mL-1. The method exhibits a broad working range for the determination of Staphylococcus aureus, with concentrations spanning 2.15 CFU mL-1 to 2.15 x 105 CFU mL-1. Furthermore, it demonstrates outstanding precision, with relative standard deviation values consistently below 5.0%. As a showcase to validate the practicality of the SERS method, we conducted tests on determining Staphylococcus aureus in a herbal food supplement, i.e., Ginkgo Biloba extract (GBE); the results align closely with those obtained through the conventional lysogeny broth agar plate method, pointing to the potential applicability in real-world scenarios.

三叶青是一种葡萄科崖爬藤属植物,因其具有抗肿瘤、抗病毒、镇痛、解热、消炎、免疫调节等作用,被称为"植物抗生素".不同产地的三叶青有效化学成分会存在差异,对临床疗效也会产生影响.现阶段市场上的三叶青品质参差不齐,不同产地的三叶青质量差异大,无法建立统一的评价标准,对三叶青的栽培和品质鉴定造成了一定的困难.因此,如何区分出三叶青的产地是三叶青中药道地性和品质评价的前提,也是三叶青研究中的重中之重.本研究综述了三叶青的化学成分、药理活性、产地分布、产业问题以及产地溯源技术,以期为三叶青的品质评价与产地溯源体系提供参考.

枇杷作为蔷薇科枇杷属的植物,是我国重要的药食同源品种,享有"全身是宝"的美誉,其主要化学成分为挥发性成分、三萜酸、黄酮和多糖4大类成分,现代药理研究表明其具有抗氧化、止咳平喘、降脂降糖等作用.然在其栽培和采收过程中,大量的非药用部位未得到合理利用,不仅资源未得到充分利用,而且还增加了处理成本和环境污染.基于已公开发表的文献,对枇杷药用部位和非药用部位化学成分、药理作用及其资源利用现状进行整理和总结,旨在为枇杷的非药用部位的深入研究、资源价值发现与资源产业化开发利用提供参考,同时为中药生态农业的生态功能提升及通过生态功能助力经济功能发展提供思考和借鉴.

The formation and accumulation of payload-containing catabolites (PCCs) from a noncleavable antibody-drug conjugate (ADC) in targeted and normal tissues are directly associated with the therapeutic effect and toxicity of the ADC, respectively. Understanding the PCC forma-tion is important for supporting the payload design and facilitating pre -clinical evaluation of ADCs. However, detection and identification of PCCs of a noncleavable ADC are challenging due to their low concen-trations and unknown structures. The main objective of this study was to develop and apply a generic liquid chromatography-high-resolution mass spectrometry (LC-HRMS) method for profiling PCCs in vitro. Non -cleavable ADCs, ado-trastuzumab emtansine (T-DM1) and ADC-1, were incubated in liver lysosomes, liver S9, and/or cancer cells followed by data acquisition using LC-HRMS. Profiling PCCs mainly relied on proc-essing LC-HRMS datasets using untargeted precise and thorough background subtraction (PATBS) processing and targeted product ion filtering (PIF). As a result, 12 PCCs of T-DM1 were detected and struc-turally characterized in human liver lysosomal incubation, a majority of which consisted of 4-[N-maleimidomethyl]cyclohexane-1-carboxylate (MCC)-DM1 and a few amino acids. Additionally, the incubation of ADC-1 in human, rat, and monkey liver S9 and cancer cells generated one major and three very minor PCCs, verifying the payload design. The results demonstrate that PATBS enabled the comprehensive profiling of PCCs regardless of their molecular weights, charge states, and fragmen-tations. As a complementary tool, PIF detected specific PCCs with supe-rior sensitivity. The combination of the in vitro metabolism systems and the LC-HRMS method is a useful approach to profiling in vitro PCCs of noncleavable ADCs in support of drug discovery programs. SIGNIFICANCE STATEMENT Profiling in vitro payload-containing catabolites (PCCs) of a non -cleavable antibody-drug conjugate (ADC) is important for optimiza-tion of the payload design and preclinical evaluation of ADC. However, currently used analytical approaches often fail to quickly provide reliable PCC profiling results. The work introduces a new liquid chromatography high resolution mass spectrometry method for comprehensive and rapid detection and characterization of PCCs released from a noncleavable ADC in liver lysosomes and S9 incubations.

Gout is an inflammatory and metabolic disease characterized by arthritis and elevation of the serum uric acid (SUA) level. More and more studies have shown that high body mass index (BMI) has become one of the most important risk factors for gout. We used the data of gout burden attributed to high body mass index (BMI) from global burden of disease (GBD) study 2019 to provide insights for reducing the global burden of gout. From 1990 to 2019, the prevalence and DALYs of gout caused by high BMI worldwide has been increasing. The burden of gout caused by high BMI is heavier in the elderly group and countries and regions with high SDI. Developing a weight management plan and lifestyle habits for groups severely affected by gout will effectively reduce the local disease and economic burden.

•Saffron as a high value spice is prone to mislabeling of origin.•Stable isotopes and bioelements are used to discriminate Iranian and Chinese saffron.•Chemometric models show good country and regional discrimination of saffron.

目的 为了提高中药炮制学课程的教学效果,改变传统的讲授式教学方法,引入BOPPPS教学模式,结合云班课进行课程教学改革.方法 以2016级中药学本科27名学生为研究对象,采用课前线上云班课自主学习导入、课堂线下云班课辅助教学和课后线上云班课总结巩固知识的方法,构建包含诊断评价、形成评价和总结评价的中药炮制学全过程教学评价体系.结果 认为云班课和BOPPPS模式激发课程学习兴趣的学生占比92.59％(25/27);喜欢云班课和BOPPPS模式的占比85.19％(23/27);学生参与的8次作业平均得分均在80分以上,这些统计结果说明学生认真完成了云班课上的作业,并能够较好地掌握本课程的重点难点.结论 在中药炮制学教学中应用云班课和BOP-PPS模式有助于构建此课程全过程教学评价体系,推动中药炮制学教学模式的改革.

以浙江工业大学中药炮制学课程教学为例,探讨在传统中药炮制学课程教学基础上,如何结合时代需求,深度挖掘本课程中的思政教育内容,讲好中国的炮制故事,让学生在学好炮制专业知识的同时,将自己的理想目标统一到为实现中国第二个百年奋斗目标上来,达到润物细无声、当春乃发生的效果.

目的 建立UPLC-MS/MS方法测定固培牛樟芝粉末中4种黄曲霉素含量,考察方法的适用性和可行性.方法 Acquity BEH C18色谱柱(2.1 mm×50 mm,1.7μm),流动相乙腈-0.1％ 甲酸水.采用不同浓度黄曲霉素B1、B2、G1、G2对照品溶液进样,获得校正曲线,进行方法学考察,测定固培牛樟芝粉末中的黄曲霉素B1、B2、G1、G2含量.结果 本测定方法的精密度、稳定性、重复性及加样回收率良好,采用该法对6批固培牛樟芝粉末进行分析,结果表明:固培牛樟芝粉末样品中不含黄曲霉素.结论 U PLC-M S/M S方法分析时间短,结果可靠,可用于固培牛樟芝粉末中黄曲霉素的质量控制.

为了构建斑马鱼骨质疏松模型,研究牛膝生、盐炙品对骨质疏松症的治疗作用,并探讨其作用机制.采用泼尼松龙诱导斑马鱼骨质疏松模型,加入生、盐牛膝水提液干预培养,利用茜素红染色法对干预后的斑马鱼骨质疏松模型骨矿化量改善情况进行定量分析,采用Western Blot方法分析不同组别斑马鱼TGF-β/Smad信号通路蛋白水平变化.结果 表明:牛膝生、盐炙品均能显著提高斑马鱼骨质疏松模型的骨矿化量,显著上调TGF-β1、p-Smad 2/3及Smad 4蛋白表达水平,下调Smad 7蛋白表达水平,盐牛膝的调控力度大于生牛膝.因此生、盐牛膝发挥抗骨质疏松作用机制可能与其调控TGF-β/Smad信号通路有关,盐牛膝的治疗效果优于生牛膝.

目的 为了探讨基于智能终端的蓝墨云班课在中药炮制学教学中的应用及其效果.方法 在2016级中药学本科生中应用蓝墨云班课辅助中药炮制学翻转课堂教学,通过多次课堂测验、投票问卷、不同时间点教学反馈等方式,全面评价教学效果.结果 基于智能终端的蓝墨云班课能有效激发学生对中药炮制学的学习兴趣,增强学生学习热情和自主学习能力,同时能促进师生互动,明显改善教学效果.结论 蓝墨云班课可建立全过程教学评价体系,推动中药炮制学教学模式改革.