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1.
《Journal of pharmaceutical sciences》2019,108(11):3515-3520
Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a “true” value for the size of a particle can be challenging as the output of its measurement will differ because of variations in measurement approaches, instrumental differences and calculation methods. Consequently, for “real” particles, a universal “true” value does not exist and accuracy is therefore not a definable characteristic. Accordingly, precision is then a measure of the ability to reproducibly achieve a measurement of unknown relevance.This article proposes, in place of accuracy, a means to define the “appropriateness” of a measurement in line with the critical quality attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQA; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a critical material attribute.Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed. 相似文献
2.
目的 探讨脂蛋白残粒RLP-c作为新的脂质指标的临床意义。方法 采用免疫分离法测定正常对照组(NC)、冠心病组(CHD)和2型糖尿病组(T2DM)的RLP-c水平,并比较RLP-c与其他脂质指标的相关性。结果 CHD组和T2DM组RLP-c水平明显高于NC组(P<0.01),其水平与甘油三脂(TG)和极低密度脂蛋白胆固醇(VLDL-c)高度相关(P<0.01)。结论 RLP-c可用于对动脉粥样硬化的危险性评估。 相似文献
3.
静脉输液加药后的微粒变化 总被引:7,自引:1,他引:6
本文对我院急诊病人常用的供静脉给药的22种药物、42组配伍情况,制成静脉加药输液,在超净工作台条件下,用KF—4型微粒计数器,测定了168次微粒数,结果显示输液加药后微粒虽有增加,但均在药典规定范围内。输液中加1种、2种、3种药物后所产生的微粒数分别为x_1=5.52(n_1=16);x_2=8.17(n_2=18)、x_3=10.25(n_3=8),经统计处理,三组间无显著差异(P<0.05)。本文对产生微粒的药物、注射器、操作环境等因素进行了分析。 相似文献
4.
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目的比较棉织布与无纺布制作的手术衣和手术洞巾等在手术铺巾时空气中的尘埃粒子数及术中抗渗液性能,为有效控制外科切口感染和预防医患交叉感染提供参考。方法将棉织布与无纺布制作的手术布类各备15包,包内内容均相同,经灭菌处理。应用尘埃粒子计数仪测定两组铺巾时、铺巾后及收巾时空气中的尘埃粒子数,同时在手术过程中观察其抗渗液性能。结果无纺布组在铺巾时、铺巾后及收巾时产生的尘埃粒子数显著少于棉织布组(P〈0.05,P〈0.01);其抗渗液率为100%,而棉织布组为0。结论无纺布抗渗液性能优,可减少手术环境中的尘埃粒子数,从而控制外科切口感染;其阻隔防护效能对患者和医护人员具有双重保护作用。 相似文献
6.
小柴胡汤口服液药效作用的研究 总被引:2,自引:0,他引:2
观察了小柴胡汤口服液的主要药理作用。研究表明,小柴胡汤口服液有显著抑制角叉菜胶诱发的大鼠踝关节水肿(p<0.05),保护四氯化碳所致的大鼠急性肝功能损害,有极显著降低血清SGPT及LDH的作用(P<0.01)。对家兔发热反应也有较好的抑制作用。此外,小柴胡汤口服液对小鼠兔疫反应也有一定的增强作用,可促进小鼠碳粒廓清速率,提高血清溶血素水平及增强鸡红细胞所致的迟发性过敏反应。 相似文献
7.
大气细菌粒子浓度的时间分布特征及最佳采样时间的研究 总被引:4,自引:0,他引:4
用MF-45型和HTK-201型空气微生物采样器分别在北京、天津和沈阳三地观测了不同季节和一天中大气细菌粒子的浓度及其变化。结果表明:京、津二地春季大气细菌粒子浓度高,分别为2053个/m3和2556个/m3;夏季低,分别为995个/m3和1064个/m3。沈阳秋季大气细菌粒子浓度高,为10108个/m3;冬季低,为1294个/m3。一天中,大气细菌粒子浓度呈双峰型变化,6:00~7:00和18:00时大气细菌粒子浓度高,11:00~13:00和1:00~2:00时大气细菌粒子浓度低。根据大气细菌粒子浓度的季节变化和一天中大气细菌粒子浓度的时间分布特征,经过京、津、沈三地一天中分别12次、8次、6次和4次不同采样时间组合的大气细菌粒子浓度的数理统计分析,大气细菌粒子浓度的监测拟集中在一年冬、春、夏、秋四季的中间月份,即1月、4月、7月、10月进行;一天中采样8次的时间序列可为7:00、10:00、13:00、16:00、19:00、22:00、1:00、4:00一天采样4次的时间序列可为5:00、11:00、17:00、23:00。白天采样4次的时间序列可为春、秋季6:00、9:00、12:00、15:00? 相似文献
8.
Objective : To measure the functional diameter of alveolar septal microvessels under conditions in which the pulmonary arterial pressure and the lung inflation pressure are equal, at 25 cm H2O (zone I-II border), and to compare these results with those obtained when inflation pressure exceeded arterial pressure by 5 or 10 cm H2O (zone I). Methods : We perfused isolated rat lungs (PA 25, PPA 25, PLA 0 cm H2O) with fluorescent latex particles of specific diameters (0.49, 1.05, 2.0, 4.0, or 10 μm) and then prepared samples for histology. Using a confocal, laser-scanning fluorescence microscope, we measured latex particle densities within the septal plane of individual alveoli. We compared these particle densities with those in arterioles supplying the septa and calculated the density ratio. We fit curves produced by the Verniory equation to these ratios to estimate the septal microvessel functional diameter. Results : Particle densities in septa ranged from 0.06 ± 0.02 particles per μm2 ‘for 0.49-μm-diameter particles to 0.007 ± 0.004 particles per μm2 for 4.0-μm-diameter particles. The 10-μm particles did not enter septa. Calculations based on these data suggest a septal microvessel functional diameter of 6–8 μm. Conclusions : In a previous study, conducted at the same value of Pinflat, but with PPA set at 15 or 20 (5 or 10 cm H2O into zone I), we estimated the capillary diameter to be 1.7 μm. Thus, the septal capillary diameter seems to increase by three- to fourfold as PPA is raised to equal Pinflat. 相似文献
9.
The delivery of particles as small as possible (preferably <5 µm) to the respiratory tract should be the aim of those formulating metered dose inhalers (MDIs). This may be facilitated by the formulation of solution, rather than suspension-type, pressurized aerosol units. Two series of MDIs were compared; one contained suspended micronized disodium fluorescein (0.1%, w/v), while the other contained the same concentration of dissolved salicylic acid. Either oleic acid, L--phosphatidylcholine, or sorbitan trioleate was incorporated at 0.15% (w/v) as suspending agent (disodium fluorescein) or solubilizing agent (salicylic acid). The propellant blend was 70% (w/w) Freon 12 and 30% (w/w) Freon 11 in all cases. This exhibited a vapor pressure of 50.6 psig (444.7 kPa) at 21°C. The output particle size distribution of the aerosol reaching the cascade impactor showed a mass median aerodynamic diameter (MMAD) of approximately 4 and 2 µm for the suspension and solution formulations respectively, regardless of the surfactant used. Larger MMADs were observed for solution aerosols formulated with oleic acid (2.32 µm) compared to those containing L--phosphatidylcholine (1.93 µm) or sorbitan trioleate (2.07 µm). Possible reasons for these observations are discussed. 相似文献
10.
N. El bari P. Montagne M. L. Cuilliere G. Humbert G. Linden J. Duheille 《Food and Agricultural Immunology》1992,4(4):229-240
Rabbit anti‐native bovine ß‐casein antiserum reacted with native ß‐casein and fragments f( 1–105/7) and f( 106–209) formed during ß‐casein proteolysis by plasmin. Agglutination of ß‐casein‐coated microparticles by anti‐native ß‐casein antiserum was weakly inhibited by ß‐casein f(1–105/7) and ß‐casein f( 106–209) (0·04 and 1·4%, respectively, compared with native ß‐casein). Immunoreactivity of these ß‐casein peptides in microparticle‐enhanced nephelometric immunoassay was more preserved in the whole ß‐casein than in its isolated fragments. The protein concentration producing 50% inhibition of the ß‐casein‐coated microparticle agglutination with anti‐native ß‐casein antiserum increased during ß‐casein denaturation. A microparticle‐enhanced nephelometric immunoassay, quantifying changes of this inhibiting protein concentration, permitted detection of alteration of the immunoreactivity of ß‐casein during its plasmin proteolysis and heat denaturation, providing an adequate test for the integrity of the whole molecule. 相似文献