An HPTLC method for the determination and the purity control of ciprofloxacin HCl in coated tablets

A high-performance thin-layer chromatographic method (HPTLC) has been developed for the determination and the purity control of a synthetic fluoroquinolone antibiotic ciprofloxacin hydrochloride in coated tablets when desfluoro compound, ethylene diamine compound, by-compound A and fluoroquinolonic acid are considered as impurities. Silica gel F₂₅₄ was used as a stationary phase and a mixture of acetonitrile, ammonia 25%, methanol and methylene chloride (1:2:4:4, v/v/v/v) as a mobile phase. The method was validated in terms of linearity (range), selectivity (placebo and related compounds), precision, accuracy (Recovery), system suitability (repeatability, peak symmetry, resolution) and impurities limit of detection (LOD). The analysis of variance (ANOVA) and t-test were applied to correlate the results of ciprofloxacin hydrochloride determination in coated tablets by means of the HPTLC method and the official British Pharmacopoeia (BP 1999) high-performance liquid chromatographic (HPLC) method.     

Unified Sample Size Calculations Using the Competing Probability

Sample size formulas are functions of two categories of quantities. The first category does not depend on the analysis variables and contains randomization ratio, Type I error rate, and power. The second category depends on the analysis variables and includes means and standard deviations for the two-sample t-test, competing probabilities for the Wilcoxon–Mann–Whitney test, and median survival times for the logrank test. Quantities in the second category depend on subject matter knowledge and are much harder to specify than those in the first category. In addition, these quantities have different interpretations. In this article we propose using the competing probability as the only second category quantity when calculating sample sizes for the aforementioned three commonly used tests in clinical trials. Doing so unifies the interpretation of and sheds new light on the two-sample t-tests and the logrank tests in terms of sample size calculations.     

医院数字减影设备质量控制的探索与研究

目的定期检测数字减影血管造影（DSA）设备的主要性能指标,并从检测数据中得出规律性因素,从而保证设备的良好性能。方法选取同一厂家相同型号的两台DSA,按照我院2007《中国人民解放军总医院DSA质量检测技术规范》进行质量检测,并对其检测数据运用独立样本t验统计分析。结果两台DSA设备由于所处工作负荷状态不同,其空气比释动能率、管电压精度等检测项目差异有统计学意义（P〈0.01）。结论质量检测是质量控制的重要环节,通过对检测数据进行统计分析,有助于评估设备运行的实际工作状态,并及时发现问题,有针对性的处理解决。     

More on the means comparison with unequal variances problem

Scheffe gave an exact solution to the problem of comparing two means from normal populations with unequal variances that is useful for general analysis of variance problems. The behavior of the usual t-statistic that assumes equal variances is contrasted to Satterthwaite's approximate t- statistic and Scheffe's method. An interesting relationship is uncovered between Scheffe's and Satterthwaite's solutions.     

双样本t检验和配对检验的异同性

概述:临床研究中经常遇到比较实验组和对照组之间的结果.双样本t检验(又称为独立样本t检验)和配对t检验可能是运用于比较两个样本之间均值的最广泛的统计方法.然而,这两种方法的运用会产生混淆,从而导致使用不当.本文中,我们讨论了这两种t检验之间的异同性,并运用三个范例来阐述双样本t检验和配对t检验的计算过程.     

多种统计方法比较黄连姜制工序中影响生物碱含量的因素

目的：测定黄连不同姜制品中6种生物碱的含量,采用多种统计方法对数据进行分析,找出姜制工序中影响姜黄连质量的因素。方法：采用高效液相色谱法测定黄连不同姜制品中药根碱、非洲防己碱、表小檗碱、黄连碱、巴马汀及小檗碱的含量。运用主成分分析、聚类分析、LSD（Least-Significant Difference）检验、独立t检验对结果进行分析。结果：黄连经姜炙后,表小檗碱、黄连碱含量略有上升,药根碱、非洲防己碱、巴马汀、小檗碱含量略有下降,传统姜炙品中各成分含量均高于烘制品。聚类分析发现榨汁组和煮汁组可以聚为一类;烘法和炙法具有明显不同的聚类,对黄连姜制品中的6种生物碱之和进行LSD检验,亦表明烘法与炙法具有显著性差异。对榨汁组进行独立t 检验,结果表明姜汁与黄连饮片拌匀或闷润至透心在6种生物碱上无显著性差异,LSD与独立t 检验的结果与聚类分析的结果一致。结论：采用同一批次黄连炮制所得的姜制品中,姜的来源、不同方法制备的姜汁及闷润过程对6种生物碱影响不大,加热方式可能是影响姜黄连质量的因素。考虑到润至透心需加入大量水稀释姜汁,炒干所需工时较长,故辅料姜汁与黄连饮片拌匀吸尽即可。     

假设检验在供应商变更中的应用

目的：运用假设检验的方法,以确认供应商变更前后药品质量是否有显著性差异。方法：使用minitab软件,运用假设检验和p值比较法,对原料供应商变更前后的药品质量进行显著性差异分析。结果与结论：通过反复使用数理统计学中的假设检验,可以在不同显著性水平上判断数据的显著性差异,得出科学的结论,为药品生产过程中的质量保证提供科学合理的帮助。     

高频电刀的电气安全检测分析

本研究利用相关分析与独立样本t检验对三种型号的高频电刀电气安全数据进行统计分析,验证各检测参数之间的关系及不同品牌参数间的差异。结果表明,地线出现故障时的对地漏电流会以其他方式或通过其他路径流入大地;对地漏电流、外壳漏电流、患者漏电流及患者辅助漏电流之间相互影响,相互作用。     

医疗设备通用电气安全检测数据的分析研究

目的:研究分析医疗设备通用电气安全质量控制工作中积累的检测数据,从中得出数据规律性因素和部分统计学特征。方法:运用多种数理统计手段,以监护仪通用电气安全测量数据为例,分析测量环境对数据的影响,并分析原因所在。结果:统计结果表明,医院中不同的供电环境对测量数据存在较大影响,不同型号设备的参数之间存在显著差异。结论:数据统计分析是质量管理中不可或缺的环节,分析结果能够全方位反映医疗设备质量状况,能够为设备的质量管理提供第一手资料。