Quality Control of Tramadol in Kisangani: Development, Validation, and Application of a UV-Vis Spectroscopic Method

Context: Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. Methods: For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg·mL-1 concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. Results: pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg·mL-1 tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. Conclusion: This study showed that the strengthening of analytical strategy in Kisangani is a need.

Optimization of Quality Control Method and Ethanol Extraction Process of Psoralen and Bergapten in Ficus pandurata

[Objectives]To establish a qualitative identification and content determination method for psoralen and bergapten in the roots and leaves of Ficus pandurata,and the multi-indicator scoring method to optimize the ethanol extraction process for the effective parts of F.pandurata.[Methods]Qualitative identification was carried out by thin-layer chromatography(TLC)and content determination was made by high-performance liquid chromatography(HPLC);the content of psoralen and bergapten and extract yield were used as indicators,to investigate the effects of ethanol volume fraction,solid-to-liquid ratio,extraction time and extraction times on the ethanol extraction process of F.pandurata;multi-indicator scoring method was adopted,orthogonal test method was designed to optimize the extraction process,and verification test was performed.[Results]TLC chart of F.pandurata shows clear spots and good separation;the detected concentrations of psoralen and bergapten in the roots are in the range of 1.02-32.64μg/mL and shows a good linear relationship with the peak area(r=0.9997);these components have not been detected in the leaves,and the precision,RSD of stability and repeatability test is less than 2%;the average recovery rate was 99.8%-100.2%,and the RSD value is 1.12%-1.13%(n=6);the optimized extraction process is to use 50%ethanol as the extraction solvent,the solid-to-liquid ratio of 1∶10,reflux extraction of 3 times,and 1.5 h each time;the results of the three batches of verification tests show that the content of the two indicator components obtained is high,and the average value of the total amount is 0.34 mg/g(RSD=0.30%,n=3).[Conclusions]The established quality control method for F.pandurata is simple,easy,accurate and reproducible;the preferred extraction process is stable and feasible,suitable for the extraction and purification of coumarin effective parts in F.pandurata roots,so it is expected to provide references for further development of F.pandurata.

Study on Rear-end Real-time Data Quality Control Method of Regional Automatic Weather Station

[Objective] The aim was to study the rear-end real-time data quality control method of regional automatic weather station. [Method] The basic content and steps of rear-end real-time data quality control of regional automatic weather station were introduced. Each element was treated with systematic quality control procedure. The existence of rear-end real time data of regional meteorological station in Guangxi was expounded. Combining with relevant elements and linear changes, improvement based on traditional quality control method was made. By dint of evaluation and relevant check of element, the quality of temperature and pressure was controlled. [Result] The method was optimized based on traditional quality control method, and it narrowed the effectiveness of real-time data quality control. The quality check of hourly precipitation applied relevant check of hourly minimum temperature, vertical consistency check of radar data, which can effectively improve the accuracy and credibility of hourly precipitation quality control. [Conclusion] The method was on trial for one year in the quality control of real-time data in the regional automatic meteorological station in Guangxi and had gained good outcome.

Analytical Methods in Quality Control of Scientific Publications

Plagiarism, fake or even falsified presentation has become a major plague for scientific publications. This paper is a response to personal appeal by David JW Lane the Editor-in-Chief of Research and Reports in Biodiversity Studies to support and promote the international author standards as developed by COPE for authors and editors-in-chief posted to me April 3rd 2012 (International standards for editors and authors http://www.dovepress.com/rrbscope.t9699812). As corresponding author for more than 100 scientific papers, dozens of scientific reviews, several chapters in scientific books, and author and editor of a book Historical Overview of Chromatography and Related Techniques in Analysis of Antimalarial Drug Primaquine, and as a reviewer of Journal of Chromatography, Journal of Chromatography A, Journal of Chromatography B: Biomedical Sciences and Applications, Lipids, Journal of General Microbiology, Journal of Clinical Microbiology, Journal of Microbiological Methods, Oral Microbiology and Immunology, Analytica Chimica Acta, Mycological Research and Journal of Pharmaceutical and Biomedical Analysis, and member of editorial board of Electronic Components and Systems, American Journal of Analytical Chemistry, ISRN Chromatography and Open Journal of Clinical Diagnostics I was adhered to a new ethical and moral standards in scientific publications. The presented paper is an example of use the analytical methods in visualizing of plagiarism and falsification in the published scientific literature. It is obvious that some of scientific publications need careful quality control. Some papers should have been rejected but were not. These papers clearly pollute the field of scientific information. It is not always easy to demonstrate inappropriate presentation even when many supporting facts are available. The facts should be obvious;there should be no hesitation about the quality or value of a paper presented for consideration to be published. Plagiarism is most common and harmful phenomenon in scientific publications. The plagiarism is based on an original discovery or reproduction of the results from the other authors. The analytical methods used in the quality control of the data can disclose plagiarism. An example is the publication under scrutiny “Applications of GC-EI-MS for the Identification of Positional Isomer in Primaquine, an Antimalarial Drug” by Dongre et al. (2005) Journal of Pharmaceutical and Biomedical Analysis 39, No. 1-2, 111-116.

The Theory and Methods Research on Ecological Quality Control of Enterprises

So far, most theories of economics and management are under the same premisethat the natural resources are never exhausted and regenerated repeatedly. The magic of technologybrought by industrial revolution endowed human with power that they can do anything they want. Italso turns natural resources into industrial energy and enhances the development of human societyand civilization. Human uses direct comparison of input and output and the satisfaction degree ofdemands to measure the production activities, the economic benefit and management performance,regardless of the change of ecology that serves as the natural resources. However, since theecological environment has been changing worse recently and natural disaster happened frequentlyhuman's dream of conquering the nature has been broken. The nature implements reprisal against humanagain and again, and human is faced with the development limit because of the environmentalrestriction.

Quality Control on Crimping of Large Diameter Welding Pipe

Crimping is used in production of large diameter submerged-arc welding pipes. Many researches are focused on crimping in certain manufacturing mode of welding pipe. The application scopes of research achievements become limited due to lack of uniformity in theoretical analysis. In order to propose a crimping prediction method in order to control forming quality, the theory model of crimping based on elastic-plastic mechanics is established. The main technical parameters are determined by theoretical analysis, including length of crimping, base radius of punch, terminal angle of punch, base radius of die, terminal angle of die and horizontal distance between punch and die. In addition, a method used to evaluate the forming quality is presented, which investigates the bending angle after springback, forming force, straight edge length and equivalent radius of curvature. In order to investigate the effects of technical parameters on forming quality, a two-dimensional finite element model is established by finite element software ABAQUS. The finite element model is verified in that its shapes error is less than 5% by comparable experiments, which shows that their geometric precision meets demand. The crimping characteristics is obtained, such as the distribution of stress and strain and the changes of forming force, and the relation curves of technical parameters on forming quality are given by simulation analysis. The sensitivity analysis indicates that the effects of length of crimping, technical parameters of punch on forming quality are significant. In particular, the data from simulation analysis are regressed by response surface method （RSM） to establish prediction model. The feasible technical parameters are obtained from the prediction model. This method presented provides a new thought used to design technical parameters of crimping forming and makes a basis for improving crimping forming quality.

VPLS Based Quality and Cost Control for Tennessee Eastman Process

Product quality and operation cost control obtain increasing emphases in modern chemical system engineering. To improve the fault detection power of the partial least square (PLS) method for quality control, a new QRPV statistic is proposed in terms of the VP (variable importance in projection) indices of monitored process variables, which is significantly advanced over and different from the conventional Q statistic. QRPV is calculated only by the residuals of the remarkable process variables (RPVs). Therefore, it is the dominant relation between quality and RPV not all process variables (as in the case of the conventional PLS) that is monitored by this new VP-PLS (VPLS) method. The combination of QRPV and T2 statistics is applied to the quality and cost control of the Tennessee Eastman (TE) process, and weak faults can be detected as quickly as possible. Consequently, the product quality of TE process is guaranteed and operation costs are reduced.

人白细胞介素-6重组蛋白的制备

目的利用大肠杆菌原核表达系统制备人白细胞介素-6(IL-6)重组蛋白,并对蛋白进行纯化,为后期制备IL-6标准物质和质控品提供候选物质基础。方法以现有IL-6原核表达质粒6His-IL-6-pET-28a(+)为模板,通过PCR扩增目的片段,并在其N端添加His标签。通过酶切连接的方式,将该段基因克隆至pRSFDuet载体,随后转化BL21感受肽获得表达菌株。利用异丙基硫代半乳糖苷(IPTG)进行诱导,得到IL-6重组蛋白,利用镍柱亲和层析技术对蛋白进行纯化,并比对两个表达菌株的蛋白表达量,选择高表达菌株进行后续实验。结果成功构建6His-IL-6-pRSFDuet原核表达质粒,根据蛋白表达比对情况选择6His-IL-6-pET-28a(+)质粒进行后续实验,确定最适IPTG诱导浓度(0.2 mmol/L)、诱导温度(20℃)、诱导时间(20 h)等条件,在BL21中高效表达重组IL-6蛋白,纯化后的蛋白不仅可通过临床检测,且稀释倍数与检测结果之间呈线性关系。结论成功获得低成本、高浓度、高纯度的IL-6重组蛋白,为后续IL-6标准物质和质控品的制备奠定了基础。

Dynamic estimation and reliability control of quality assurance for bored piles

A systematic method was proposed to estimate the occurrence probability of defective piles(OPDP) from a site according to quality assurance inspection. The OPDP was firstly suggested as the criterion to weight the performance of a pile foundation. Its prior distribution and updating distribution were deduced to follow Beta distributions. To calibrate the OPDP, a dynamic estimation model was established according to the relationships between prior mean and variance and updating mean and variance. Finally, a reliability-control method dealing with uncertainties arising from quality assurance inspection was formalized to judge whether all the bored piles from a site can be accepted. It is exemplified that the OPDP can be substantially improved when more definite prior information and sampling formation become available. For the example studied herein, the Bayesian estimator of updating variance for OPDP is reduced from 0.0037 to 0.0014 for the first inspection, from 0.0014 to 0.0009 for the second inspection, and with less uncertainty by incorporating experience information.

Optimal control of a quality supervision profit model for the electronic intermediary

Online customers execute transactions without inspecting products could expect to encounter risks of receiving products with unsatisfactory qualities,especially in food trans-actions.Thus quality supervision plays a key role in the establishment of trust as well as in the management of risk between online customers and sellers.Most papers in this field are in qualitative nature.In this paper,a quality supervision profit(QSP)model is formulated as a discrete-time optimal control problem.It is a quantitative approach,and it broadens the scope.of current research in the area.The quality efort level of online sellers(QELa)and the quality supervision level of the electronic intermediary(QSLm)are considered together with their cor-responding profit in the proposed model.The aim is to optimize an overall profit.A case study arising from Suichang's food traceability system(FTS)of farm produce online transaction is carried out in details.The results reveal that QELs,QSLm and the profit distribution coeffi-cient have a strong influence upon the profits of both sides.Finally,some concluding remarks,including potential further research topics,are given.

HPLC Profiling for Quality Control of Secondary Metabolites of Aqueous and Hydroethanolic Extract of Gardenia aqualla Stapf &Hutch

WHO strategy on traditional medicine is based on security and quality of phytomedicine. Commonly adulterated affecting mostly metabolic and sexual dysfunction drugs. Control quality of those phytomedicines requires development of strategy and techniques applicable to them. Among the techniques, Reverse Phase Liquid Chromatography is the most used and has been developed in these studies to assess a protocol to characterize Gardenia aqualla leaves extract. The method consists in determining chromatographic conditions using organic and pH gradient models based on water and acetonitrile combined with pH modifiers made up of formic acid (AF) and ammonium hydroxide (NH3). Results show that extracts contain mainly acidic compounds quickly eluted by NH3 and more retained by AF. Optimal pH range for separation is 3 - 7 corresponding to 1.59 mM of NH3 and 6.55 mM of AF. In these conditions, elution of many polar compounds could be effective using a C18 based-deactivated column in a short period of time.

6-苄氨基嘌呤处理对鲜切西兰花硫代葡萄糖苷代谢的影响

为探讨6-苄氨基嘌呤(6-Benzylaminopurine,6-BA)处理对鲜切西兰花中硫代葡萄糖苷(简称硫苷)代谢的作用机理,该研究首先鉴定得出西兰花花球中分别以萝卜硫苷和萝卜硫素为主的12种硫苷和6种水解产物,然后以30 mg/L的6-BA溶液对鲜切西兰花进行处理,研究外源6-BA处理对其硫苷含量、黑芥子酶活性、硫苷水解产物及其代谢途径关键基因表达水平等的影响。结果表明,6-BA处理通过延缓西兰花花球叶绿素含量下降从而延迟其黄化进程;同时,显著提高了脂肪族硫苷合成相关基因MYB28、CYP79F1、CYP83A1、ST5b、FMO_(GS-OX1),和吲哚族硫苷合成关键基因MYB51、CYP79B2及CYP83B1的表达水平(P<0.05),其中6-BA处理组FMO_(GS-OX1)的表达量在贮藏第6天时为对照组的1.93倍,MYB51的表达量为对照组1.41~1.91倍,CYP79B2的表达量在4 d后高出对照组41.90%~93.75%;由此,6-BA处理保持了其组织较高的萝卜硫苷、3-甲基亚磺酰丙基硫苷、吲哚甲基硫苷和4-甲氧基吲哚甲基硫苷的含量,总硫苷含量为对照组的2.46~4.79倍;此外,6-BA处理的西兰花花球组织黑芥子酶活性和其基因MYR的表达水平在4~8 d期间分别高出对照组15.32%~90.22%和25.86%~33.73%,并显著提高了其组织萝卜硫素等异硫氰酸酯水解产物的含量(P<0.05),其中萝卜硫素含量高于对照组17.58%~25.39%,但对硫苷水解关键基因ESP的表达量并无显著影响(P>0.05)。因此,6-BA处理可通过提高硫苷合成相关基因和水解关键基因来保持鲜切西兰花花球中硫苷的含量和异硫氰酸酯的水平,为西兰花功能活性成分的保持提供理论和技术支持。

生姜中6-姜酚的提取方法比较及质量控制研究

目的建立生姜中6-姜酚的提取与质量控制方法。方法分别采用4种溶剂回流提取,考察溶剂对6-姜酚提取率的影响。采用HPLC法测定提取物及生姜中6-姜酚的含量。结果以正己烷、乙醚、乙酸乙酯、丙酮为溶剂,6-姜酚提取率分别为43.1%、59.2%、83.1%、85.6%。鲜姜中6-姜酚的平均含量为0.549mg·g-1,RSD为0.23%。结论本研究提供了一种较好的生姜中抗晕活性成分的提取和质量控制方法。

新生儿干血片葡萄糖-6-磷酸脱氢酶测定的影响因素分析

目的探讨新生儿干血片葡萄糖-6-磷酸脱氢酶(G6PD)筛查过程中可能影响G6PD测定结果的因素。方法观察采血季节、新生儿性别及分娩方式、血样采集后样本的贮存条件及时间、干血片取样部位、加酮试剂后血片是否去除和加酮试剂后仪器测定时间等因素对检测结果的影响。结果采血季节、新生儿的分娩方式(顺产及剖宫产)、样本贮存条件及时间、加酮试剂后血片的处理方式及仪器测定时间的不同均可引起G6PD结果的差异。新生儿性别及干血片取样部位对G6PD的测定结果没有影响。结论影响新生儿干血片G6PD筛查试验结果的因素众多,选择最佳检测条件,才能较好保证筛查试验质量。

2,6-二氯异烟酸处理对芒果果实采后品质的影响

为了研究2,6二氯异烟酸(INA)处理对芒果果实贮藏品质及抗病性的影响,将绿熟芒果(Mangifera indica L.cv.Zihua)在负压(0.08MPa)状态下分别用20和100mg/LINA溶液和清水(对照)中渗透处理2min,然后在常压下浸泡10min,晾干后于13℃,相对湿度85%～95%放置,测定芒果果实在贮藏中的腐烂率、色泽、内含物等指标变化。试验结果表明,20和100 mg/L INA处理能够有效降低芒果果实的腐烂率和腐烂指数;延缓了芒果果皮色泽的转黄以及果实硬度、抗坏血酸含量的下降,对果实可溶性固形物和可滴定酸含量无明显影响。说明INA处理能够延缓芒果果实后熟衰老,抑制果实贮藏期品质的下降。

饲粮n-6/n-3多不饱和脂肪酸比例对畜禽健康和产品品质的影响

现今人类膳食中n-6多不饱和脂肪酸(PUFA)大多都是过量的,但n-3 PUFA却严重不足。研究表明,n-6/n-3 PUFA比例平衡对畜禽健康和产品品质有着重要意义,n-6/n-3 PUFA比例平衡成为当下最受关注的问题。本文综述了n-6/n-3 PUFA比例平衡的营养生理作用以及对畜禽产品品质的影响及如何改善畜禽产品中的n-6/n-3 PUFA比例。

双源64层CT的质量控制检测

目的目前CT的质量控制方法主要针对于单源CT。本研究通过西门子双源64层CT的实际质量控制操作,探讨日常工作中64层CT的质量控制方法。方法使用美国模体实验室Catphan500CT的检测模体和瑞典Barracuda X线机多功能质量检测仪对64层CT的层厚、空间分辨力、密度分辨力、CT值线性、均匀性、噪声和CT剂量指数(computed tomo-graphy dose index,CTDI)进行检测。结果经统计学分析,现阶段辐射剂量在正常范围内(F=34.362,P<0.05),常规算法下空间分辨率为8～9 LP/cm,密度分辨率为3@0.5%～3@0.3%;CT线性为1.56E-0.4至1.68E-0.4,均匀性为2.0 Hu;噪声为0.19～0.39。所测结果均在正常范围内,所检双源CT各指标均合格。结论通过对噪声、CT线性、对比度分辨率等图像性能参数的检测可有效保证系统性能良好和维持最优化的图像质量。对CT剂量的检测,可及时了解辐射危险水平,进而优化扫描方案,在保证诊断的前提下降低患者受照剂量。

福建省新生儿筛查中心参加台湾葡萄糖-6-磷酸脱氢酶室间质量评价分析

目的分析参加台湾葡萄糖-6-磷酸脱氢酶（G6PD）室间质量评价结果,以了解该项目的质控质量。方法收集2011-2012年参加台湾预防医学基金会组织的室间质量评价的单位中使用与福建省新生儿筛查中心相同实验方法的实验室（2011年14家、2012年18家）12个批次120个样本的测定结果,并对结果进行定量及定性的描述和分析。定量分析采用评价限法和Z比分数法,定性分析公式为该项目的可接受结果数/该项目总测定样本数×100%。结果评价限法分析显示12个批次中有11次结果可接受率〉80%;而Z比分数法分析12个批次结果可接受率均〉80%。定性分析显示可接受率为100%。结论定量分析评价中,Z比分数法即使在测量值较低浓度值样本的,也能有较好的评价能力,是评价限法的补充。

HPLC法同时测定复方四嗪利血平片中盐酸肼屈嗪、维生素B 6和磷酸氯喹的含量及含量均匀度

目的建立能同时测定复方四嗪利血平片中盐酸肼屈嗪、维生素B 6和磷酸氯喹的含量及含量均匀度的HPLC法。方法采用Agilent Zorbax Eclipse XDB C 18色谱柱(250 mm×4.6 mm,5μm);以0.06 mol·L^-1磷酸二氢钾溶液-甲醇(90∶10,pH值为3.0)为流动相A,乙腈为流动相B,梯度洗脱;流速为1.0 mL·min^-1;柱温为30℃;检测波长为271 nm。结果系统适用性实验均符合要求,各成分间的分离度均大于1.5,盐酸肼屈嗪、维生素B 6和磷酸氯喹的线性范围分别为19.40~58.20(r 2=0.9999),21.42~64.27(r 1=1.0000)和50.73~152.19μg·mL^-1(r 3=0.9999);平均回收率分别为99.09%,100.99%和99.50%,RSD值分别为1.1%,1.1%和1.2%(n=9)。结论该方法可同时测定复方四嗪利血平片中盐酸肼屈嗪、维生素B 6和磷酸氯喹的含量及含量均匀度,为该产品的质量控制提供参考。

6-[^(18)F]氟-L-多巴的质量控制

6 - [18F]氟 -L -多巴 (18FDOPA ,I)为L -多巴的类似物 ,是研究大脑突触前多巴胺能神经功能的正电子显像剂。为在临床上安全有效地使用18FDOPA ,对合成的18FDOPA进行了较系统的质量控制研究 ,并建立了手性流动相HPLC法测定18FDOPA对映纯度 ,合成的18FDOPA各项质控指标符合药典的要求。本研究为研制新型PET显像剂提供了质量控制模式 ,为测定18FDOPA和其他L -型氨基酸的对映纯度提供了廉价而实用的方法。