顺应论视角下的翻译标准

在“顺应论”的框架内,语言的使用就是在不同意识程度下为适应交际的需要而不断做出选择的过程。从语用顺应理论的视角来看,翻译很难实现对等。原语文本与译语文本的时代差异、语境差异以及语言结构差异都可能造成信息再现的困难。语言顺应的动态性给翻译的启示是：译者完全可以按照跨文化交际的具体语境灵活地采用翻译策略。评判译文的标准是看它是否顺应译文读者的时间、语境和语言结构。     

Cross‐cultural measurement invariance of the General Health Questionnaire‐12 in a German and a Colombian population sample

While the General Health Questionnaire, 12‐item version (GHQ‐12) has been widely used in cross‐cultural comparisons, rigorous tests of the measurement equivalence of different language versions are still lacking. Thus, our study aims at investigating configural, metric and scalar invariance across the German and the Spanish version of the GHQ‐12 in two population samples. The GHQ‐12 was applied in two large‐scale population‐based samples in Germany (N = 1,977) and Colombia (N = 1,500). To investigate measurement equivalence, confirmatory factor analyses were conducted in both samples. In the German sample mean GHQ‐12 total scores were higher than in the Colombian sample. A one‐factor model including response bias on the negatively worded items showed superior fit in the German and the Colombian sample; thus both versions of the GHQ‐12 showed configural invariance. Factor loadings and intercepts were not equal across both samples; thus GHQ‐12 showed no metric and scalar invariance. As both versions of the GHQ‐12 did not show measurement equivalence, it is not recommendable to compare both measures and to conclude that mental distress is higher in the German sample, although we do not know if the differences are attributable to measurement problems or represent a real difference in mental distress. The study underlines the importance of measurement equivalence in cross‐cultural comparisons.     

中药调剂规范化研究(I):大黄不同调剂处理的化学同质性及条件优选

目的:基于化学同质性探讨大黄饮片粒度规格及调剂学处理对临床合理用药的影响规律。方法:比较饮片粒度、提取溶剂、提取时间、提取次数、先下/后下处理方式对大黄蒽醌类成分煎出量的影响。结果:大黄不同粒度饮片水/醇提时总蒽醌提取量最高差别1.9/6.4倍;水/醇提不同时间最高差别2.2/1.8倍;水/醇提不同次数最高差别2.8/1.8倍;水/醇提先下和后下最高差别2.3/1.7倍。从化学同质性来看,所考察不同调剂处理因素得到的提取物均不同质。其中,相同处理方式下醇提样品的蒽醌单体含量明显高于水提样品。水提取时,0.8~1.2 cm的大黄饮片提取量较高,与超微粉碎后提取量相差不大且更经济;大黄先下提取时蒽醌提取量随水提时间延长主要呈增加趋势;后下提取30,60 min时蒽醌提出量均高于先下方式;水提前2次蒽醌提出量超过提取6次总量的50%。而醇提取大黄时,细粉的提取量较高,与1 000目超微粉碎提取量相差不大;后下方式提取量均低于先下方式;醇提30 min后提取量增加不显著;醇提前2次蒽醌提出量超过提取6次总量的70%。综合考虑,大黄水提时后下提取30 min,提取2次为宜;醇提时先下提取30 min为宜,提取2次为宜。结论:不同调剂处理方式对大黄蒽醌成分的提取量有显著影响;亟待建立中药调剂操作规范(good usage practice,GUP)。     

Evaluation of the physicochemical equivalence of three brands of commercially available quinine sulphate tablets from South Western part of Nigeria

Background

The relatively little resistance to quinine globally has led to an increase in its use in P. falciparum malaria especially in multi-drug resistant strains.

Objective

To evaluate the physicochemical and equivalency of three brands of quinine sulphate tablets available in South Western region of Nigeria.

Methods

The pharmaceutical and chemical equivalence of three brands of quinine sulphate tablets were assessed through the evaluation of some biopharmaceutical parameters and active drug content.

Results

All the brands complied with the official specification for uniformity of weight. Two of the brands (A & B) gave similar crushing strengths while the third brand (C) gave a much lower value. Similarly all the brands complied with the official specification of disintegration test but the obtained values were statistically different (p<0.05). The T₇₀ obtained from the dissolution rate profile was less than 45 minutes for the three brands, although A and B were not statistically different but C was statistically from A and B. The quinine content of brands B and C are within the official specification however brand A with percentage content of 110±1.3%w/w, is above the specification while it is statistically different from the other brands.

Conclusion

Brands B and C could be regarded as chemical equivalent, but they are not biopharmaceutical equivalents, on the other hand, brands A and B may be regarded as biopharmaceutical equivalents but not chemical equivalent.     

心康胶囊对血管紧张素Ⅱ所致平滑肌细胞基质金属蛋白酶变化影响随机平行对照等效性研究

[目的]观察心康胶囊对血管紧张素Ⅱ所致平滑肌细胞基质金属蛋白酶变化影响。[方法]将清洁级雄性SD大鼠颈动脉放血处死,取主动脉胸段,常规细胞培养2～3周,待细胞长成致密单层后传代。选择健康雄性SD大鼠15只,笼养3 d后,按7.2g/kg心康生药材灌胃,2次/d,连续7 d,于末次给药后2～3h,股动脉放血无菌分离血清,经56℃、30min灭活后,-70℃保存备用。按随机数字表方法将细胞培养液分组,对照组、血管紧张素Ⅱ(AngⅡ)组、卡托普利(CP)组、氯沙坦(LT)组、心康(XK)组,血管紧张素Ⅱ按不同浓度及不同作用时间进行干预,观测对VSMC MMPs影响。[结果]血管紧张素Ⅱ可诱导血管平滑肌细胞MMPs表达,MMP-9表达较MMP-1和MMP-2出现早;卡托普利、氯沙坦钾、心康对血管紧张素Ⅱ作用有明显抑制,心康更明显。[结论]心康与氯沙坦和卡托普利作用相似且更明显,心康对MMPs作用可能与RAS系统有一定关系。     

What Can Reality Television Teach Us About Psychoanalytic Politics?

Abstract

The coincidence of hearing two different patients describe watching the same reality television show as a way of comforting themselves during the 2016 election campaign leads the author to reflect on how this particular show came to occupy the place of thirdness in ongoing sessions. Thinking together about this reality show added a new dimension that made it possible for patient and therapist to emerge from a merged state of disbelief into an exploration of the meaning of what seemed an unimaginable political reality, and the exercise of individual agency. In the second part of the article, the author reviews the unfortunate history that has frequently emerged when psychoanalytic institutions attempt to coexist with totalitarian regimes. Pointing out that within-group differences can prove as full of rancor and shame-inducing behavior as between-group differences, the author turns again to the reality television show to provide some answers to this perennial problem.     

磷酸卡维地洛缓释微丸的制备及其在比格犬体内的药动学

目的:评价自制磷酸卡维地洛缓释微丸在Beagle犬中的等效性。方法:〗流化床包衣法制备磷酸卡维地洛缓释微丸;试验采用两周期交叉试验设计,将6条Beagle犬,雌雄各半,分为两组,分服试验制剂磷酸卡维地洛或参比制剂磷酸卡维地洛;采用HPLC-FD法比较给药后原研和自研制剂在Beagle犬体内不同时间点的血药浓度。计算药动学参数并根据试验制剂和参比制剂AUC计算相对生物利用度。同时对主要药动学参数进行方差分析、双单侧t检验和[1-2α]置信区间分析,评价试验制剂和参比制剂的生物等效性。结果:磷酸卡维地洛在1~300 ng·mL^-1范围内线性关系良好(r=0.999 3),定量下限为1ng·mL^-1。提取回收率均高于50%,日内、日间RSD均小于12%,专属性良好,在本实验涉及的条件下样品稳定。磷酸卡维地洛缓释微丸试验制剂和参比制剂主要药动学参数t_1/2、t_max、C_max、AUC_0-t、AUC_0-∞无明显差异,与参比制剂相比较试验制剂相对生物利用度为(96.8±8.7)%。结论:自研制剂与原研制剂在Beagle犬体内生物等效。     

三叶青藤叶配方颗粒与饮片化学等量性及抗炎等效性研究

目的 基于特征图谱探究三叶青藤叶配方颗粒与饮片汤剂间的相关性和等量性，评价二者的抗炎药理等效性。方法 建立三叶青藤叶饮片汤剂、中间体及配方颗粒的HPLC特征图谱共有模式；基于特征图谱与主要效应组分含量，建立等效比数学模型，计算迁移率，综合分析比较配方颗粒与饮片汤剂间的共有特征组分群的相似性及其含量的等量关联性。采用大鼠棉球肉芽肿增生炎症模型的抗炎抑制作用的药效实验，考察三叶青藤叶配方颗粒与饮片汤剂的等同药效相关性。结果 基于HPLC特征图谱共有模式，辨识归属特征共有峰10个，汤剂与配方颗粒的相似度>0.900；由饮片煎煮对照汤剂各组分平均迁移率仅14.97%~23.89%，由饮片经优化工艺制得配方颗粒各组分平均迁移率为54.61%~92.30%。3批次配方颗粒与饮片平均等量等效比为3.72，以平均值的80%计，配方颗粒与饮片的等效比是2.98倍，提示1 g三叶青藤叶配方颗粒相当于饮片3 g。与模型组相比，配方颗粒与饮片汤剂均能显著减少大鼠肉芽肿的质量（P<0.05），对大鼠棉球肉芽肿炎症组织增生的抑制率，低、高剂量组的配方颗粒分别为15.70%，37.27%，饮片汤剂分别为14.59%，35.73%，二者均具有抗炎作用且呈剂量依赖性，二者对肉芽肿炎症抑制率在统计学上无显著性差异，提示配方颗粒与饮片汤剂（1：3）之间具有等同的药效相关性。结论 三叶青藤叶配方颗粒与饮片汤剂的共有药效组分群相似，配方颗粒与饮片的量效关联性为1：3，以此量效比例用药，二者具有等同的药效相关性。     

外用半固体制剂的体外释放试验和等效性评价

外用半固体制剂包括乳膏剂、软膏剂和凝胶剂等。药物活性成分（active pharmaceutical ingredient，API）的释放对于外用半固体制剂的质量影响至关重要，药物释放在很大程度上取决于其配方组成和制备过程。体外释放试验（in vitro release test，IVRT）可用来评估API的释放速率，检测由于制剂变化或API理化性质的差异而可能引起的释放速率之间的不同。已有大量研究表明，IVRT方法参数的差异会影响IVRT结果，因此保持IVRT方法参数的一致性才能保证结果的可靠。本文讨论了IVRT方法开发和验证，及关于半固体制剂仿制药等效性评价的实验和数据统计分析方法。