酶联免疫法与胶体金法检测肺炎衣原体IgM抗体抗干扰能力的比较

目的:评价酶联免疫法和胶体金法用于肺炎衣原体IgM抗体(CP-IgM)检测抗干扰能力的差异。方法:检测方法的优劣一定程度上源于该方法抗干扰能力的强弱,体现在准确率、敏感性、特异性等相关指标上,选取219例临床疑为肺炎衣原体感染患者血清作为研究样本,分别采用酶联免疫法和胶体金法检测肺炎衣原体IgM抗体。比较两种方法检测结果的真阳性例数、真阴性例数、假阳性例数、假阴性例数,并计算两种方法相应的准确率、敏感性、特异性,进而评价两种检测方法的抗干扰能力。结果:酶联免疫法检测肺炎衣原体IgM抗体比胶体金法的真阳性例数与真阴性例数多;而假阳性例数和假阴性例数均少;酶联免疫法的准确率、敏感性、特异性均高于胶体金法(P<0.05)。结论:酶联免疫法检测肺炎衣原体IgM抗体的抗干扰能力比胶体金法更强,检测结果准确性更高。     

酢浆草体外抗炎抗氧化检测方法的建立和优化

目的优化和建立酢浆草体外抗炎抗氧化活性的检测方法。方法建立抗氧化、蛋白酶活性抑制和蛋白变性抑制活性的检测方法。比较醇提水沉法和水提醇沉法、不同保存条件下药物的活性。结果优化检测方法后,不同浓度酢浆草样品的检测结果具有高度相关性,表明检测方法高度稳定且准确可靠。经醇提水沉法和水提醇沉法后,酢浆草的抗氧化活性为100%,蛋白变性抑制活性为90%,酶活性抑制活性为50%,两者出峰位置基本一致。醇提水沉法更易快速获得澄清的提取溶液。室温和4℃冷藏时,蛋白变性抑制成分第3天时均下降40%,第7天时下降至无活性;酶活性抑制成分在冷藏时下降比室温条件慢,在第7天时分别下降30%和60%;抗氧化成分在2种保存条件下均有较高活性。结论所建立的方法可用于体外检测酢浆草的抗炎活性。     

五味子甲素研究进展

五味子甲素为五味子木脂素类有效成分。该文对近年来关于五味子甲素的研究情况作一系统综述,包括其药理作用、提取工艺、测定方法,为进一步研究、开发和合理应用五味子甲素提供参考。     

胰岛素生物检定的快速测定方法的建立

目的:建立胰岛素生物测定的快速检测方法。方法:血糖试纸上的葡萄糖脱氢酶将血液中的葡萄糖转化为葡萄糖酸内脂。这种作用会产生直流电,血糖仪以此判读血糖值。使用血糖仪快速测定小鼠血糖。结果:血糖仪能够快速测定小鼠血糖值,与全自动生化分析仪测定结果高度相关,效价偏差率<5%,结果无显著性差异(P>0.05)。结论:经方法学验证,本法可用于胰岛素生物活性的快速测定。     

Bioanalytical method by HPLC-FLD for curcumin analysis in supplemented athletes

In sports, curcumin, a substance derived from the rhizome of Curcuma longa (turmeric) plant with antioxidant effect 8 times greater than vitamin E, has attracted the attention of scientists because of its potent antioxidant action, since in athletes subjected to intense exercise the—endogenous mechanisms of neutralization of reactive species are saturated. However, the pharmacokinetic characteristics of curcumin do not favor its medicinal use due to its low absorption, accelerated metabolism and rapid systemic elimination. Thus, the determination of plasma levels in supplemented patients is a crucial step in their pharmacodynamic evaluation. Therefore, the objective of this work was to develop and validate an analytical method by HPLC-FLD for curcumin evaluation in plasma of supplemented athletes. Luna column (C18; 150 × 4 mm; 3 µm), acetonitrile: acetic acid pH 3.2 (45:55 to 60:40) as mobile phase, flow rate of 1 mL min⁻¹, excitation at 429/285 nm and emission at 529 nm and injection of 10 µL were the chromatographic conditions used. Plasma samples were extracted using ethylacetate and methanol (95: 5, 500 µL) and estradiol (30 µg mL⁻¹) as internal standard, with subsequent stirring (3 min) and centrifugation (8 min) (triple extraction). The organic fraction was evaporated under N₂ (20 min) and the dried residue reconstituted in acetonitrile. The method was linear between 44 and 261 ng mL⁻¹, showing intra-day (2.05.6%) and inter-day (4.0–5.1%) precision with accuracy and selectiveness (curcumin t_R = 8.7 min and internal standard t_R = 13.9 min with relative recovery of 83.2%). So, it can be successfully used for curcumin evaluation in plasma samples from supplemented athletes, as well as being an alternative and advantageous method to UV–Vis and MS/MS in bioavailability studies.     

阿莫西林胶囊仿制药与原研药溶出行为研究及有区分力溶出方法的建立

Objective To establish a discriminative method for the dissolution curve of amoxicillin capsules. Methods The effects of different stirring device, different stirring speeds, different dissolution media on the dissolution behavior of different manufacturers' amoxicillin capsules (250mg) were investigated by dissolution profile and f2 similarity factor. Results The dissolution test of amoxicillin capsules (250 mg) was carried out by a paddle method (with sinker) with the rotation speed of 100 r/min, temperature of 37 °C, and water as dissolution medium, which could easily and effectively distinguish the dissolution behavior of amoxicillin capsules from various manufacturers. Conclusion This method provides a reference for the further quality consistency evaluation of amoxicillin capsules.     

16S rDNA序列分析法在注射剂微生物污染鉴定及溯源分析中的应用

目的 对一次注射剂无菌检查阳性结果进行溯源。方法 采用16S rDNA序列分析法对污染菌A1和污染调查中采集的16株葡萄球菌进行鉴定和同源性分析,并将分析结果用脉冲场凝胶电泳进行验证。结果 A1的鉴定结果为科氏葡萄球菌;科氏葡萄球菌科氏亚种菌株的核糖体16S亚基序列完全相同;结合PFGE分析显示A1来自无菌检查使用的隔离器污染。结论 制药企业可以使用16S rDNA序列分析法进行生产和检验中污染菌的鉴定和溯源,但对于与如科氏葡萄球菌科氏亚种一样核糖体16S亚基序列完全相同的菌株,需要结合其他同源性分析方法进行最终的判定。     

香叶木素固体脂质纳米粒的制备及质量评价

目的 制备香叶木素固体脂质纳米粒并对其进行质量评价。方法 采用溶剂注入法制备香叶木素固体脂质纳米粒,用 Box-Benhnken效应面法优化处方,并通过包封率、微观形态、粒径分布和Zeta电位对香叶木素固体脂质纳米粒的质量进行评价。 结果 香叶木素固体脂质纳米粒最优处方组成：表面活性剂浓度3.39%,棕榈酸浓度0.116%,脂药质比为21:100,制备的香叶木素 固体脂质纳米粒外观澄清透明,带淡蓝色乳光;平均粒径为(91.73±3.18)nm(n=3),PDI为0.228,电位为(-11.46±0.74)mV(n=3);包 封率为95.13%,载药量为9.04%;透射电镜照片显示纳米粒大小均一,呈球形或类球形。 结论 该处方可用于香叶木素固体脂 质纳米粒的制备,工艺简单,稳定可行。     

基于德尔菲法构建中药饮片处方点评内容

目的： 基于德尔菲法构建中药饮片处方点评内容,促进点评工作开展。方法： 在文献检索的基础上形成调查问卷,采用德尔菲法对22名专家共进行二轮问卷调查,然后对调查结果分析,计算积极系数、权威系数、均值、等级和、满分比、变异系数和协调系数等指标,评价专家评分的一致性,并结合均值和满分比对点评内容的重要性进行排序。结果： 专家的积极系数为100%,权威系数均在0.7以上。最终形成21条点评内容,变异系数在0.060~0.401之间,协调系数为0.321（P<0.01）,评分具有一致性,重要性排序有效可信。结论： 利用德尔菲法构建中药饮片处方点评内容,进行重要性排序,有利于点评工作开展。