不同包装和贮藏条件下酸枣仁的质量比较

目的:确定酸枣仁适合的贮藏条件、包装材料和包装方式,为保障酸枣仁质量提供参考。方法:选用同一批酸枣仁样品,分别采取塑料编织袋包装、塑料袋包装、塑料袋真空包装、铝塑复合袋包装、铝塑复合袋真空包装和牛皮淋膜纸袋包装,贮藏在阴凉库(温度≤20℃、相对湿度为45%~75%)和药品稳定性试验箱[温度为(40±2)℃、相对湿度为(75±5)%]中,以性状及水分、黄曲霉毒素、酸枣仁皂苷A、斯皮诺素含量为考察指标,开展为期6个月的阴凉长期稳定性试验和加速稳定性试验研究。结果:6个月阴凉长期稳定性试验结果显示,不同包装条件下酸枣仁样品的性状以及水分、黄曲霉毒素、酸枣仁皂苷A含量均符合2015年版《中国药典》(一部)(后文简称"药典")酸枣仁项下规定;斯皮诺素含量均不符合药典的规定(不低于0.080%),但其中铝塑复合袋真空包装样品中斯皮诺素含量(0.079%)与药典要求接近。6个月加速稳定性试验结果显示,牛皮淋膜纸袋包装、塑料编织袋包装样品发霉严重,塑料袋包装、塑料袋真空包装样品表面颜色变暗,铝塑复合袋包装样品颜色稍变暗,但铝塑复合袋真空包装样品外观基本无变化;塑料编织袋包装、牛皮淋膜纸袋包装样品中水分含量超过了药典要求最高值(9.0%);仅在贮藏2个月时,编织塑料袋包装样品被检出黄曲霉毒素B1含量为8.64μg/kg,超出药典规定;各包装样品中酸枣仁皂苷A含量虽有下降,但均满足药典要求;仅塑料袋真空包装样品中斯皮诺素含量(0.084%)满足药典要求,其次属铝塑复合袋真空包装样品中含量(0.071%)相对较高。结论:酸枣仁以铝塑复合袋真空包装后置于阴凉干燥处为宜。     

Study of the stability of packaging and storage conditions of human mesenchymal stem cell for intra-arterial clinical application in patient with critical limb ischemia

Critical limb ischemia (CLI) is associated with significant morbidity and mortality. In this study, we developed and characterized an intra-arterial cell suspension containing human mesenchymal stem cells (hMSCs) for the treatment of CLI. Equally, the stability of cells was studied in order to evaluate the optimal conditions of storage that guarantee the viability from cell processing to the administration phase. Effects of various factors, including excipients, storage temperature and time were evaluated to analyze the survival of hMSCs in the finished medicinal product. The viability of hMSCs in different packaging media was studied for 60 h at 4 °C. The best medium to maintain hMSCs viability was then selected to test storage conditions (4, 8, 25 and 37 °C; 60 h). The results showed that at 4 °C the viability was maintained above 80% for 48 h, at 8 °C decreased slightly, whereas at room temperature and 37 °C decreased drastically. Its biocompatibility was assessed by cell morphology and cell viability assays. During stability study, the stored cells did not show any change in their phenotypic or genotypic characteristics and physicochemical properties remained constant, the ability to differentiate into adipocytes and osteocytes and sterility requirements were also unaltered. Finally, our paper proposes a packing media composed of albumin 20%, glucose 5% and Ringer’s lactate at a concentration of 1 × 10⁶ cells/mL, which must be stored at 4 °C as the most suitable to maintain cell viability (>80%) and without altering their characteristics for more than 48 h.     

iPod Touch在住院病人用药管理中的应用

目的分析口服药物按次包装结合iPod Touch在病房应用的效果。方法选取2013年1-12月妇科住院患者共1200例,随机分为对照组和实验组。对照组共600例患者,以传统的药盒摆药,统计口服药物11258份;实验组600例,运用自动摆药机摆药,采用一次性透明薄膜袋按次包装摆药,并结合iPod Touch的使用,统计口服药物11310份。对两组在药物安全管理、护理满意率等方面进行评价。结果实验组在药物安全管理、护理满意度等方面均较对照组有提高,差异有统计学意义（P＆lt;0.01）。结论口服药物按次包装联合iPod Touch的使用能提高药物安全管理,减少差错的发生,提高护理满意率,提升护理服务水平。     

乙型肝炎病毒拉米夫定耐药株的重组逆转录病毒载体及其包装细胞系的建立

目的构建1.3拷贝乙型肝炎病毒(HBV)拉米夫定耐药株的重组逆转录病毒载体及其包装细胞系。方法在野毒株1.3拷贝HBV载体的基础上采用定点突变的方法将rtL180M,rtM204V位点突变,构建拉米夫定耐药病毒株,并通过PCR、限制性内切酶酶切,分别以正向和反向将野毒株和耐药株分别连接于逆转录病毒载体pLNCX2的相应酶切位点,构建成重组逆转录病毒载体,经双酶切及PCR扩增鉴定。重组载体转染包装细胞,筛选培养细胞克隆并进行病毒滴定。结果通过双酶切、PCR扩增、测序鉴定证实成功构建了1.3拷贝HBV拉米夫定耐药株的逆转录病毒载体。成功建立包装细胞系并测得病毒滴度均为1×105cuf/ml。结论含正向及反向1.3拷贝HBV拉米夫定耐药的重组逆转录病毒载体及其包装细胞系构建成功,可以用于拉米夫定耐药细胞模型研究。     

床边备用气管切开包不同包装材料的性价比分析研究

目的对比分析床边备用气管切开包不同包装材料的性价比,寻求性价比高的灭菌包装材料及包装方法。方法对气管切开包选用两组不同包装材料及包装方法：对照组为纸塑袋包装,实验组为无纺布包装（发放时加自封袋）。相同的灭菌方式,对比分析各自的使用成本和包装性能。结果两组包装材料的单次使用成本：对照组为3．35元,实验组为4．15元;但实验组在床边备用期间包装质量的合格率明显高于对照组,两组比较差异有显著意义（P〈0．05）。结论针对床边备用气管切开包其储存条件的不确定性,正确、合理地选择灭菌包装材料及包装方法极为重要;只有确保灭菌物品的包装质量及其连续稳定性,才能更好地保证灭菌质量、控制医院感染、维护医疗护理安全。     

HIV-1假病毒包装方法的探讨

目的：通过不同方案包装HIV-1假病毒,确定获得高重复性、高稳定性和高滴度假病毒的方法。方法从转染效率影响因素出发,通过不同的转染方案,利用pNL4-3 LucR-E-质粒与VSV-G质粒共转染293细胞包装病毒,分别于48 h和72 h收取假病毒并重新感染293细胞,48 h后测荧光素酶报告基因。结果成功包装出HIV-1假病毒,不同包装方案的病毒滴度不同,测得报告基因最高接近107 RLUs。结论应用PEI转染试剂、大提质粒pNL4-3︰VSV-G为4︰1时,转染效率最高,包装的假病毒滴度最高。     

医疗器械灭菌包装设计的几个基本要求

医疗器械灭菌包装（MDSP）的基本原理及在实践中的实现。     

Efficient replication of full-length murine leukemia viruses modified at the dimer initiation site regions

Retroviruses encapsidate two copies of full-length viral RNA molecules linked together as a dimeric genome. RNA stem loop structures harboring palindromic (or "kissing") loop sequences constitute important cis-elements for viral dimerization known as dimer initiation sites (DIS). In murine leukemia virus (MLV), a 10-mer and a 16-mer palindrome (DIS-1 and DIS-2, respectively) located in the viral leader region mediate dimerization in vitro and affect dimer stability of vector RNA in vivo. We have investigated the effect on viral replication of introducing deletions or nucleotide substitutions within these palindromes in a full-length MLV genome. Our results demonstrate that viruses modified at the dimer initiation site regions are viable and show wild-type levels of RNA encapsidation. One mutant lacking the DIS-1 palindrome was severely impaired and displayed an increased cellular ratio of spliced versus genomic RNA that most likely contributes to the inefficient replication. The implications for development of DIS-modified retrovirus-based vectors are discussed.     

Characterisation of influenza A viruses with mutations in segment 5 packaging signals

Influenza A virus vRNA segments contain specific packaging signals at their termini that overlap the coding regions. To further characterise segment 5 packaging signals, we introduced synonymous mutations into the terminal coding regions of the vRNA and characterised the replicative fitness of the resulting viruses. Most mutations tested were well-tolerated, but a virus with alterations to NP codons 464-466, near the 5′-end of the vRNA, produced small plaques and replicated to around one-tenth of the level of wild type virus. The mutant virus supported normal levels of NP and segment 5 vRNA synthesis but packaged reduced levels of both segment 5 and segment 3 into virus particles. This suggests an interaction between segments 3 and 5 during influenza A virus assembly.