中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

Patient preferences and predicted relative uptake for targeted therapies in metastatic colorectal cancer: a discrete choice experiment

Abstract

Objective

Ras wild-type metastatic colorectal cancers (mCRC) may be treated with anti-vascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor (EGFR) agents. We aim to estimate patients’ preferences for mCRC treatment and relative importance of cost, efficacy improvement, avoidance of side effects and therapy convenience, and relative uptake between profiles that resemble Bevacizumab (anti-VEGF) and Cetuximab (anti-EGFR), two commonly prescribed mCRC targeted therapies.     

Quantitative chemical exchange saturation transfer (qCEST) MRI – omega plot analysis of RF‐spillover‐corrected inverse CEST ratio asymmetry for simultaneous determination of labile proton ratio and exchange rate

Chemical exchange saturation transfer (CEST) MRI is sensitive to labile proton concentration and exchange rate, thus allowing measurement of dilute CEST agent and microenvironmental properties. However, CEST measurement depends not only on the CEST agent properties but also on the experimental conditions. Quantitative CEST (qCEST) analysis has been proposed to address the limitation of the commonly used simplistic CEST‐weighted calculation. Recent research has shown that the concomitant direct RF saturation (spillover) effect can be corrected using an inverse CEST ratio calculation. We postulated that a simplified qCEST analysis is feasible with omega plot analysis of the inverse CEST asymmetry calculation. Specifically, simulations showed that the numerically derived labile proton ratio and exchange rate were in good agreement with input values. In addition, the qCEST analysis was confirmed experimentally in a phantom with concurrent variation in CEST agent concentration and pH. Also, we demonstrated that the derived labile proton ratio increased linearly with creatine concentration (P < 0.01) while the pH‐dependent exchange rate followed a dominantly base‐catalyzed exchange relationship (P < 0.01). In summary, our study verified that a simplified qCEST analysis can simultaneously determine labile proton ratio and exchange rate in a relatively complex in vitro CEST system. Copyright © 2015 John Wiley & Sons, Ltd.     

基于BGP、TGF-β1的表达探究蛇床子素对去卵巢致骨质疏松大鼠的作用

目的观察蛇床子素对去卵巢致骨质疏松大鼠的影响。方法选取3月龄雌性SD大鼠30只,随机分为蛇床子素组(A组)、模型对照组(B组)、假手术组(C组),各10只。A、B 2组摘除卵巢构建去势大鼠骨质疏松模型,C组仅进行手术、不摘除卵巢。造模成功后,分别给予相应药物灌胃,连续给药12周,处死。然后测量骨密度,检测治疗后血清BGP、TGF-β1、钙指标。结果B组大鼠股骨骨密度较C组明显降低(P<0.05);经12周治疗,A组股骨骨密度较B组明显升高(P<0.05)。与C组比较,B组大鼠血清中BGP含量升高、TGF-β1降低(P<0.05);与B组比较,A组大鼠血清中BGP降低、TGF-β1含量升高(P<0.05)。与C组比较,B组大鼠血清Ca水平明显降低(P<0.05);与B组比较,A组大鼠血清Ca水平明显升高(P<0.05)。差异均有统计学意义。结论蛇床子素能够有效通过调节大鼠体内激素分泌改善去卵巢大鼠的骨代谢异常,提高骨密度,对骨质疏松症起到一定的防治作用。     

Fast CT-PRESS-based spiral chemical shift imaging at 3 Tesla.

A new sequence is presented that combines constant-time point-resolved spectroscopy (CT-PRESS) with fast spiral chemical shift imaging. It allows the acquisition of multivoxel spectra without line splitting with a minimum total measurement time of less than 5 min for a field of view of 24 cm and a nominal 1.5x1.5-cm2 in-plane resolution. Measurements were performed with 17 CS encoding steps in t1 (Deltat1=12.8 ms) and an average echo time of 151 ms, which was determined by simulating the CT-PRESS experiment for the spin systems of glutamate (Glu) and myo-inositol (mI). Signals from N-acetyl-aspartate, total creatine, choline-containing compounds (Cho), Glu, and mI were detected in a healthy volunteer with no or only minor baseline distortions within 14 min on a 3 T MR scanner.     

铜绿假单胞菌噬菌体PaP3生物学特性的研究

目的测定铜绿假单胞菌噬菌体PaP3的最佳感染复数、一步生长曲线和吸附K值及交叉吸附K值等基本生物学特性。方法按照感染复数（MOI）分别为0．0001、0．001、0．01、0．1、1和10加入噬菌体纯培养液和宿主菌，充分裂解细菌后，测定噬菌体滴度；以MOI=10的比例加入噬菌体及宿主菌，进行一步生长实验；纯化PaP3颗粒，免疫家兔，获得抗血清，通过中和反应实验测定PaP3和其抗血清之间的吸附反应常数K值。同时，利用抗血清交叉中和试验确定本室分离的三株噬菌体之间的血清学关系。结果当MOI=0．001时PaP3感染其宿主菌产生的子代噬菌体滴度最高；根据一步生长实验结果绘制一步生长曲线；通过血清交叉中和反应得出不同的吸附常数。结论PaP3最佳感染复数为0．001，感染宿主菌的潜伏期是20min，爆发期是60min，平均爆发量约为31，其抗血清反应的吸附常数K值为262。     

细菌药敏试验结果的统计分析及反馈

将临床细菌培养及其药物敏感试验结果定期进行统计、分析、反馈，既是医院分级管理和医院感染管理规范的有关内容和要求，更为临床诊断、治疗提供可靠的科学依据。     

C60的化学反应性和高分子化

综述了C_(60)化学研究的进展。C_(60)的化学反应性的研究展现了一个广阔的新领域,并使C_(60)作为一种新型的功能基团引入高分子成为现实。这些进展为进一步深入研究C_(60)尤其是C_(60)的材料化提供了前提。     

尼罗罗非鱼肉营养成分分析

<正> 尼罗罗非鱼(Tilapia nilotica)是我国从非洲引进的热带鱼类,具有刺少肉味鲜嫩、食性广、生长快、繁殖力强、养殖周期短等特点。已快速地养殖到全国各地。作者对利用地热资源人工喂养条件下的尼罗罗非鱼肉的氨基酸和肉内的粗蛋白、脂肪、维生素等成分进行分析,评估尼罗罗非鱼肉的营养价值,从营养学的角度为人们提供科学依据。