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《齐鲁药事》2014,(6)
目的建立测定人参多糖注射液中细菌内毒素含量的方法。方法建立动态浊度法测定细菌内毒素标准曲线,通过测定供试液中外加内毒素的回收率进行干扰试验,确定样品检测浓度线性范围,并定量测定样品中的细菌内毒素。结果内毒素检测浓度线性范围为0.031 252.0 EU·mL-1(r=-0.998 9);样品在稀释36倍及以下时,对试验无干扰作用,细菌内毒素回收率在50%2.0 EU·mL-1(r=-0.998 9);样品在稀释36倍及以下时,对试验无干扰作用,细菌内毒素回收率在50%200%范围内,样品中的内毒素含量可定量测定。结论动态浊度法可用于人参多糖注射液中细菌内毒素的定量检测。 相似文献
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目的:建立测定多西他赛注射液中细菌内毒素含量的方法。方法:采用动态浊度法。确立细菌内毒素检查的标准曲线及稀释倍数,通过测定供试液中外加内毒素的回收率进行干扰试验,确定样品检测浓度线性范围,并定量测定样品中的细菌内毒素。结果:内毒素检测浓度线性范围为0.03125~2.0EU·mL-1(r=-0.9999);样品在稀释12~96倍时对试验无干扰作用;细菌内毒素回收率为50%~200%;3批样品的内毒素定量测定结果符合规定。结论:动态浊度法可用于多西他赛注射液中细菌内毒素的定量检测。 相似文献
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卢文斌 《中国现代应用药学》2012,29(3):271-273
目的 应用动态浊度法鲎试验定量测定黄芪注射液中的细菌内毒素含量。方法 通过干扰试验确定样品检测浓度,并建立标准曲线对不同的样品进行细菌内毒素的定量测定。结果 样品用BET水制成1∶5稀释液,对鲎试验检查无干扰,细菌内毒素回收率在50%~200%之间。样品中的内毒素含量可定量测定,检测结果与凝胶法检测的结果有一定的相关性。结论 动态浊度法可用于黄芪注射液中细菌内毒素定量检测。 相似文献
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利尿配方注射液中细菌内毒素定量测定的研究 总被引:1,自引:0,他引:1
目的 应用动态比浊法鲎试验定量测定利尿配方注射液的细菌内毒素含量。方法对样品中定量添加标准内毒素进行干扰试验,通过回收率定最佳检测浓度再进行三个批号样品的正式干扰试验,样品中定量添加标:住内毒素,其回收率均在为50%~200%内。结果标准内毒素使用5.00,0.500,0.0500Eu/mL,将样品制备成最佳浓度为定量添加标准内毒素,无干扰作用,可用于有效的日常检查。结论动态比浊法鲎试验可以高效地测定利尿配方注射液细菌内毒素含量。 相似文献
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目的应用动态浊度法定量测定注射用还原型谷胱甘肽中细菌内毒素的含量。方法通过干扰试验确定样品检测浓度,建立标准曲线并对样品进行细菌内毒素的定量检测。结果注射用还原型谷胱甘肽稀释至质量浓度为1mg/mL时,对鲎试剂检查无干扰作用,细菌内毒素的回收率均在50%~200%范围内。结论用动态浊度法测定注射用还原型谷胱甘肽中的细菌内毒素含量,方法可行。 相似文献
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应用动态浊度法鲎试验定量测定骨肽注射液中细菌内毒素含量。通过对样品进行干扰预试验,筛选出骨肽注射液最佳稀释倍数为40并进行了干扰试验,样品中定量加入内毒素0.5EU·ml^-1,回收率为50%-200%,可用于日常检测。 相似文献
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目的:建立测定硫酸异帕米星注射液中细菌内毒素含量的方法。方法:采用动态浊度法,将样品作系列稀释,通过干扰试验确定样品检测浓度,并建立标准曲线对样品进行细菌内毒素的定量检测。结果:硫酸异帕米星注射液稀释至6.25mg·mL-1时对鲎试剂检查无干扰作用,细菌内毒素的回收率均在50%~200%范围内。结论:本方法可用于测定硫酸异帕米星注射液中细菌内毒素的含量。 相似文献
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动态浊度法定量测定碘海醇中细菌内毒素的含量 总被引:1,自引:1,他引:0
目的应用动态浊度法鲎试验定量测定供注射用的碘海醇原料中的细菌内毒素含量。方法通过干扰试验确定样品检测浓度,并建立标准曲线对精制程度不同的样品进行细菌内毒素的定量测定。结果样品在10mg·mL^-1时,对鲎试验检查无干扰作用,细菌内毒素回收率在50%~200%范围内。样品中的内毒素含量可定量测定。检测结果与热原检测的结果有一定的相关性。结论动态浊度法可用于碘海醇中的细菌内毒素定量检测。 相似文献
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显著性检验是最基本的统计假设检验,它的基本思想是小概率原理;区间检验是传统显著性检验的延伸,它用来检验两个总体的差异是否在某范围之内;置信区间检验是先找到药物疗效差值的置信区间,通过置信区间下限或(和)上限与界值的关系来判断两种药物非劣效、等效、优效的关系。通过公式推导发现,区间检验与显著性检验的主要区别是前者的假设中包含了有临床意义的界值△,而区间检验和置信区间检验是一致的,可以用置信区间检验实现区间检验的目的。 相似文献
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《Statistics In Biopharmaceutical Research》2013,5(2):115-125
This article compares the performance of many two-sample tests of significance that might be used to test the equality of means when the effect of the treatment is variable. Of the 19 tests that were compared, the normal scores test is recommended for general use in testing the null hypothesis of no treatment effect against the alternative that the distributions are stochastically ordered when the ratio of the larger standard deviation to the smaller standard deviation does not exceed 1.3. The Baumgartner-Weiß-Schindler tests and an adaptive test also have higher power than the pooled t-test, the unequal variance t-test, and the rank-sum test for many distributions. In the simulation studies, data in the first sample are generated from nine distributions, including long-tailed and skewed distributions. Data in the second sample are generated by adding a random treatment effect to a random variable that was generated from the same distribution that was used in the first sample. Because we restricted our power studies to treatment effects that are positive or zero, the population distributions will be stochastically ordered. The results of these studies demonstrate that the normal scores test is often more powerful than the t-tests and the rank-sum test. If the ratio of the standard deviations does exceed 1.3, then one of the t-tests is recommended. 相似文献
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In ophthalmologic studies, bilateral correlated data often arise when information involving paired organs (e.g., eyes) are measured from each subject. Adjusted chi-square approach for testing the equality of proportions has been proposed in the literature. In this article, we investigate and derive three alter- native testing procedures for the problem. Our simulation results show the score testing procedure usually produces satisfactory type I error control with higher power, and therefore is recommended. Examples from ophthalmologic studies are used to illustrate our proposed methods. 相似文献
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目的在综合分析中国药品上市后抽验模式现状及问题的基础上,提出药品上市后抽验的建议。方法通过文献研究的方法,发现中国药品上市后抽验模式中存在的问题,并提出相关建议。结果与结论在药品抽验中引入以风险为基础的抽验模式,将药品上市后抽验结果与药品监管相衔接。 相似文献
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Quinine hydrochloride was assayed for genotoxic activity by using 4 different test systems with distinct genetic endpoints. No indications for point mutations were observed in the Ames system. In 3 cytogenetic tests performed on small rodents, Chinese hamsters showed no genotoxic activity, while inbred strains of mice revealed a dose dependent increase of SCEs, enhanced incidence of micronuclei and elevated chromatid breaks. 相似文献
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目的:研究刹毒草口服液对小鼠的药理作用。方法:用小鼠分别进行爬杆实验、炭粒廓清实验、耳肿胀实验和墨汁推进实验,观察刹毒草口服液对小鼠的抗疲劳作用、非特异性免疫功能的影响、抗炎作用和抗腹泻作用。结果:刹毒草口服液能显著延长小鼠爬杆时间,有较好的抗疲劳作用;高剂量刹毒草口服液能显著提高小鼠对惰性炭粒的吞噬指数及吞噬活性,可提高小鼠免疫功能;刹毒草口服液3个剂量组均对二甲苯致小鼠耳炎症有较好的抑制作用,且能显著降低墨汁推进的速率,有较好的抗腹泻作用。结论:刹毒草口服液具有一定抗疲劳、抗炎、提高非特异性免疫功能和抗腹泻作用。 相似文献
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The primary objective of the dose-escalation trial for NGX267 was to estimate the maximally tolerated dose (MTD) and to gather detailed clinical and pharmacokinetic observations near the MTD. The MTD was defined based on the weighted average of moderate and severe adverse events. An adaptive design was employed to concentrate dosage assignments at or near the MTD. Favoring the acquisition of data near the MTD, at the expense of information at lower dosage levels, resulted in a shorter trial and no loss of the type of information required to inform subsequent studies where larger normal volunteer or patient samples are evaluated. 相似文献
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目的:建立氢溴酸山莨菪碱注射液的细菌内毒素检查方法。方法:按《中国药典》2010年版(二部)附录相关方法确定本品细菌内毒素限值,分别进行细菌内毒素检查凝胶法和动态浊度法的干扰试验。结果:凝胶法结果表明,样品稀释2倍(5 mg/ml)时对试验无干扰作用;动态浊度法结果表明,本品稀释2倍(5 mg/ml)时外加内毒素的回收率在50%200%之间。每1 mg氢溴酸山莨菪碱中含内毒素应小于0.35 EU。结论 :本文初步建立的氢溴酸山莨菪碱注射液细菌内毒素检查方法,可为《中国药典》增订该制剂的细菌内毒素检查项提供参考。 相似文献
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Summary We study several tests for the coefficient of the single right‐hand‐side endogenous variable in a linear equation estimated by instrumental variables. We show that writing all the test statistics—Student's t, Anderson–Rubin, the LM statistic of Kleibergen and Moreira (K), and likelihood ratio (LR)—as functions of six random quantities leads to a number of interesting results about the properties of the tests under weak‐instrument asymptotics. We then propose several new procedures for bootstrapping the three non‐exact test statistics and also a new conditional bootstrap version of the LR test. These use more efficient estimates of the parameters of the reduced‐form equation than existing procedures. When the best of these new procedures is used, both the K and conditional bootstrap LR tests have excellent performance under the null. However, power considerations suggest that the latter is probably the method of choice. 相似文献