国家药品标准物质保障供应综合数据平台建设

目的：进一步提高国家药品标准物质供应保障的能力和水平,更好支撑药品监管需求和服务行业发展。方法：将信息化管理和分析方法与现有的标准物质管理技术要求相结合,研究建立数字化、可视化的数据共享系统。结果：建成的国家药品标准物质保障供应综合数据平台,可显示各品种的研制生产阶段和效率。结论：该平台试运行一年来已成为指导研制、生产和管理的有力抓手,为对接国际标准ISO 17034奠定了重要基础。     

Comparative study on main compounds in Ginkgo biloba L. base on mathematical statistics

In this paper, an HPLC-DAD-ELSD method was developed to determine main 20 components of Ginkgo bilobaL. leaves from different ages and sources, including six flavonol glycosides, five terpene lactones and nine organic acids. Using statistics method and establishing relevant mathematics models, the measured data has proceeded correlation analysis, principal component analysis, and regression statistics and the results showed generalityand specific characteristics. We defined p-hydroxybenzoicacid, catechinic, KRcG and ginkgolide A as characteristic indexes representing commonnessand specialityof Ginkgo biloba L. leaf. The four characteristic indexes can reflect the quality of Ginkgo biloba L. leaf, and the internal relations between them are significant.The contents of other compounds could define the quantity relation with characteristic markers. It simplified the approach of quality control, and provided a basis for quality control of Ginkgo biloba L.     

右美托咪定对高氧诱导急性肺损伤小鼠的保护作用及Nrf2/HO-1通路的影响

摘 要 目的：探讨右美托咪定对高氧诱导急性肺损伤小鼠的保护作用及核转录因子红细胞系2p45相关因子2（Nrf2）/血红素加氧酶 1（HO-1）通路的影响。 方法: 将100只C57BL/6小鼠随机分为5组：正常对照组、模型组、地塞米松组（100 mg·kg-1）、右美托咪定低（40 mg·kg-1）、高（80 mg·kg-1）剂量组。除正常对照组外,其余各组建立高氧诱导急性肺损伤模型,并于造模成功后腹腔注射相应药物,正常对照组和模型组给予等体积生理盐水,qd,持续7 d。实验结束后,检测小鼠肺/体比值、肺损伤评分、血氧分压（PaO2）,小鼠肺组织中Nrf2、HO-1 mRNA及蛋白表达水平,胱天蛋白酶 1（caspase 1）、白细胞介素 1β（IL 1β）、白细胞介素 18（IL 18 ）蛋白水平。制作肺部HE染色切片,观察肺损伤情况。 结果: 与正常对照组比较,模型组肺/体比值、肺损伤评分、Nrf2 mRNA及蛋白表达水平、IL 1β、IL 18、caspase 1蛋白表达水平明显升高,PaO2、HO-1 mRNA及蛋白表达水平明显降低（P<0.05）;与模型组比较,右美托咪定组肺/体比值、肺损伤评分、Nrf2 mRNA及蛋白表达水平、IL 1β、IL 18、caspase 1蛋白表达水平明显降低,PaO2、HO-1 mRNA及蛋白表达水平明显升高（P<0.05）,且呈剂量相关性;右美托咪定低剂量组与地塞米松组比较差异有统计学意义（P<0.05）。正常对照组肺泡组织结构正常,无炎症细胞浸润、无胶原蛋白沉淀;模型组、右美托咪定低剂量组肺泡壁明显增厚、破裂,可见中性细胞及少量嗜酸性细胞浸润,肺间质可见较多胶原蛋白沉淀;右美托咪定高剂量组及地塞米松组肺泡结构基本正常,有少量中性细胞侵润,几乎无胶原蛋白沉淀。 结论: 右美托咪定对高氧诱导急性肺损伤小鼠的保护作用与抑制Nrf2 mRNA及蛋白表达水平表达,进而抑制IL 1β、IL 18、caspase 1蛋白表达有关。     

基于AMPK/Sirt1通路延龄草总皂苷对脑缺血再灌注继发肺损伤大鼠的保护作用

摘 要 目的：探讨延龄草总皂苷（TST）对脑缺血再灌注大鼠肺组织的影响及其可能机制。 方法: 选取80只雄性大鼠随机分为8组：假手术组、模型组、阳性对照组（尼莫地平,200 mg·kg-1）、TST低（50 mg·kg-1）、中（100 mg·kg-1）、高（200 mg·kg-1）剂量组、腺苷酸活化蛋白激酶（AMPK）/沉默信息调节因子1（Sirt1）通路抑制剂组(1 mg·kg-1)、TST+AMPK/Sirt1通路抑制剂组(200 mg·kg-1+1 mg·kg-1),每组10只。苏木精 伊红（HE）染色检测大鼠肺组织病理变化;检测各组大鼠氧分压（PaO2）;酶联免疫吸附（ELISA）法检测各组大鼠支气管肺泡灌洗液中炎性因子水平;检测各组大鼠肺组织氧化应激水平。蛋白免疫印迹（Western blot）法检测肺组织AMPK、磷酸化AMPK（p AMPK）、Sirt1蛋白表达水平。 结果: 模型组大鼠肺损伤评分较假手术组高,而阳性对照组与TST不同剂量组均较模型组低（P＜0.05）;模型组大鼠PaO2、氧合指数（OI）、超氧化物歧化酶（SOD）、p AMPK及Sirt1蛋白表达水平均较假手术组低,而阳性对照组与TST组（高剂量）较模型组高,AMPK/Sirt1通路抑制剂组与TST+AMPK/Sirt1通路抑制剂组较TST组低,AMPK/Sirt1通路抑制剂组较TST+AMPK/Sirt1通路抑制剂组低（P＜0.05）;模型组IL-18、IL-1β、TNF-α、IL 6、肺组织湿干质量比、MDA、ROS、Ac NF κB p65蛋白表达水平均较假手术组高,而阳性对照组与TST组（高剂量组）较模型组低,AMPK/Sirt1通路抑制剂组与TST+AMPK/Sirt1通路抑制剂组较TST组高,AMPK/Sirt1通路抑制剂组较TST+AMPK/Sirt1通路抑制剂组高（P＜0.05）;阳性对照组与TST组比较差异均无统计学意义（P＞0.05）。 结论: TST可通过激活AMPK/Sirt1通路并减轻肺组织炎性反应及氧化应激反应进而减缓脑缺血再灌注继发肺损伤。     

Fe/Zn-modified tricalcium phosphate (TCP) biomaterials: preparation and biological properties

Bone repairing materials play an essential role in the repair treatment of bone defects. The presence of calcium phosphate invertebrates is of significance for bone repairing processes. However, the mechanical properties and osteogenic activities of many current calcium phosphate materials are not ideal, which limit their biological applications. Therefore, it is an effective alternative strategy to study the modification of calcium phosphate biomaterials to address these limitations. In this research, in order to enhance the biological performance of tricalcium phosphate (β-TCP), metal species (Fe and Zn) modified β-TCP materials through the co-precipitation method were successfully developed. The physical, chemical and biological properties of the binary composites were carefully studied for the first time. The bioactivities of the Fe-TCP and Zn-TCP were evaluated by simulating body fluid (SBF) immersion experiments, blood compatibility, and cytotoxicity tests. The findings demonstrated that the metal-TCP with excellent cytocompatibility and osteogenic properties shows good potential in medical applications.

Fe/Zn-TCP biomaterials were prepared and their bioactivities to enhance the synthetic bone-repair materials were studied in comparison.     

Tissue‐engineered trachea from a 3D‐printed scaffold enhances whole‐segment tracheal repair in a goat model

Traditional treatment therapies for tracheal stenosis often cause severe post‐operative complications. To solve the current difficulties, novel and more suitable long‐term treatments are needed. A whole‐segment tissue‐engineered trachea (TET) representing the native goat trachea was 3D printed using a poly(caprolactone) (PCL) scaffold engineered with autologous auricular cartilage cells. The TET underwent mechanical analysis followed by in vivo implantations in order to evaluate the clinical feasibility and potential. The 3D‐printed scaffolds were successfully cellularized, as observed by scanning electron microscopy. Mechanical force compression studies revealed that both PCL scaffolds and TETs have a more robust compressive strength than does the native trachea. In vivo implantation of TETs in the experimental group resulted in significantly higher mean post‐operative survival times, 65.00 ± 24.01 days (n = 5), when compared with the control group, which received autologous trachea grafts, 17.60 ± 3.51 days (n = 5). Although tracheal narrowing was confirmed by bronchoscopy and computed tomography examination in the experimental group, tissue necrosis was only observed in the control group. Furthermore, an encouraging epithelial‐like tissue formation was observed in the TETs after transplantation. This large animal study provides potential preclinical evidence around the employment of an orthotopic transplantation of a whole 3D‐printed TET.     

超声引导下经皮穿刺植入放射性125I粒子治疗腹部恶性肿瘤

目的探讨超声引导下经皮穿刺植入放射性¹²⁵I粒子治疗腹部恶性肿瘤的临床效果。 方法选取2014年1月至2016年12月在吉林大学中日联谊医院诊治的142例腹部恶性肿瘤患者,其中,42例肝癌,53例胰腺癌,27例腹膜后原发肿瘤,20例腹腔转移癌。均行超声引导下放射性¹²⁵I粒子腹部肿瘤内植入术,统计术前疼痛者,判断术后缓解程度。CT对比手术前后肿瘤长径,并随访有无手术相关并发症。 结果（1）疼痛缓解有效率：87.35%（肝癌85.71%,胰腺癌90.00%,腹膜后肿瘤85.00%,腹腔转移癌84.62%）;（2）肿瘤局部控制有效率：76.06%（肝癌83.33%,胰腺癌73.58%,腹膜后肿瘤70.37%,腹腔转移癌75.00%）;（3）并发症：15例发热、腹腔积液及腹胀各5例、2例胃潴留（一过性）。发生率：19.01%（肝癌19.05%,胰腺癌18.87%,腹膜后肿瘤18.52%,腹腔转移癌20.00%）。 结论对于丧失手术切除机会的腹部恶性肿瘤患者而言,超声引导经皮穿刺放射性¹²⁵I粒子肿瘤内植入术可有效缓解疼痛、较好控制肿瘤的局部生长,并发症少,疗效肯定。超声作为其影像学引导手段,有实时显示、操作简便、定位准确等优势,值得推广应用。