反相高效液相色谱法测定阿司匹林可待因片中磷酸可待因和阿司匹林的含量

目的：建立一种用高效液相色谱法检测复方制剂中磷酸可待因和阿司匹林含量的方法。方法：用Ｃ１８ＯＤＳ为固定相。甲醇－００３ｍｏｌ·Ｌ－１醋酸钠（用冰醋酸调ｐＨ至３５）（１∶２５）为流动相。ＵＶ检测波长２８０ｎｍ。结果：该方法回收率为磷酸可待因１００４％,ＲＳＤ＝１３％（ｎ＝６）;阿司匹林９９４％,ＲＳＤ＝０９８％（ｎ＝６）。结论：该法不需经提取分离,溶解后直接进样。简便、快速,准确可靠,适合于生产中使用。     

复方制剂珮夫人小儿咳露中主药成分的含量测定

目的 :建立一种采用高效液相色谱检测复方制剂中氢溴酸美沙芬、愈创木酚甘油醚和马来酸氯苯那敏含量的方法。方法 :采用C1 8色谱柱 ,以 0 .0 0 2 5mol·L- 1 IPR -B6 甲醇溶液∶水 (含 2 %三乙胺 )∶磷酸 (12 0∶10 0∶1)为流动相 ,检测波长为 2 5 7nm。结果 :氢溴酸美沙芬、愈创木酚甘油醚和马来酸氯苯那敏 3种成分的回收率分别为10 0 .5 % ,99.5 % ,10 0 .6% ;RSD分别为 2 .2 % ,1.6% ,1.9% (n =7)。结论 :本方法简便 ,结果准确可靠     

SPE-HPLC法测定菊延保康颗粒剂中3种丹参酮的含量

目的:建立同时测定菊延保康颗粒剂中隐丹参酮、丹参酮Ⅰ和丹参酮ⅡA含量的方法。方法:选用酸性氧化铝固相萃取小柱对样品进行纯化。采用c18色谱柱(4.6 mm×250mm,5 μm),以甲醇-水(72:28)为流动相,流速为1.2 mL·min-1,检测波长为254 nm。结果:隐丹参酮、丹参酮Ⅰ和丹参酮ⅡA进样量依次在0.011-2.70,0.011-2.75,0.015-3.80μg的范围内与峰面积呈良好的线性关系,相关系数依次为0.9996,0.9999,0.9999;平均回收率分别为100.6％,98.4％,99.4％(n=6)。结论:本方法操作简便,结果准确可靠。     

c-myc、P21WAF1和LMP-1在鼻咽癌中表达的意义及其与Ki67的关系

目的:研究原癌基因c-myc、细胞周期调控蛋白(P21WAF1)、EB病毒潜伏膜蛋白1(Latent membrane protein 1)LMP-1与Ki67在鼻咽癌(Nasopharyngeal carcinoma , NPC)中的表达及其相关性和临床意义.方法:应用免疫组织化学Envision二步法检测35例经治疗后,生存时间<5年的鼻咽非角化性癌(Nonkeratinizing carcinoma , NKC),60例生存时间≥5年的NKC及对照组30例鼻咽黏膜慢性炎症组织(non-tumour nasopharyngeal tissue, NP)内c-myc, P21WAF1,LMP-1,Ki67的表达水平.结果:(1)c-myc,LMP-1和Ki67在生存时间<5年组、生存时间≥5年组及NP组中的阳性表达率依次递减(P<0.05);(2) P21WAF1在NKC生存时间<5年组,生存时间≥5年组及NP组中的阳性率依次递增(P<0.05);(3)c-myc的阳性表达与NKC的淋巴结转移有关(P<0.05).LMP-1, Ki67的阳性表达与NKC临床分期密切相关(P<0.05);(4)c-myc和LMP-1共同表达时较两者各自单独表达时, Ki67的强表达率明显增强;(5)c-myc和LMP-1的阳性表达与Ki67的强表达呈正相关关系,P21WAF1的阳性表达与Ki67的强表达呈负相关关系.结论:c-myc,LMP-1的高表达及P21WAF1的低表达与NPC细胞的增殖密切相关,且前两者在NKC发生发展中存在协同作用;通过检测c-myc, P21WAF1,LMP-1及Ki67的表达,有助于对NKC预后的评估.     

SPE—HPLC法测定菊延保康颗粒中蒙花苷的含量

目的:建立测定菊延保康颗粒中蒙花苷含量的方法。方法:选用Oasis HLB固相萃取小柱对样品进行纯化。采用C_(18)色谱柱(4.6mm×250 mm,5μm),以甲醇-0.8%磷酸(1:1)为流动相,流速为1 mL·min~(-1),检测波长为326 nm。结果:蒙花苷进样量在0.0432—2.16μg的范围内与峰面积呈良好的线性关系,r为0.9999,平均回收率为100.4%。结论:本方法操作简便快速,结果准确可靠。     

HPLC法测定野菊花中蒙花苷的含量

建立了HPLC法测定野菊花中蒙花苷含量的方法.采用AICHROM C18(250mm×4.6mm,5μg)色谱柱,以甲醇-0.8%磷酸(9:7)为流动相,流速为1.2ml·min-1,检测波长为326nm.蒙花苷在0.043～2.16μg的范围内具有良好的线性关系,相关系数为0.9999,平均回收率为98.9%(RSD为1.8%).本方法操作简便,灵敏度高,结果准确可靠.     

全身运动评估家庭录像法在早产儿神经发育随访中的可行性研究

目的了解全身运动(general movements,GMs)评估的家庭录像法在早产儿神经发育随访中的可行性和稳定性。方法对家长进行早期筛查随访重要性教育和取得合格家庭GMs录像的相关培训,在家中摄录GMs,通过网络传至GMsQQ群进行评估随访,对家庭录像从录像质量、次数及评估者间信度进行分析,了解家庭录像法评估的可行性,调查未参加家庭GMs录像的原因。结果 GMs家庭录像质量能接近临床标准化录像水平,且能序列录像,评估者间信度较好。结论 GMs评估家庭录像法具有可行性,可作为标准化GMs评估的补充方法,适合在经济欠发达地区推广。     

2021-09期目录

Objective To investigate the predictive effect of thyroglobulin antibody (TgAb) level after operation and the trend of TgAb change after 131I treatment on the curative effect of 131I treatment in patients with differentiated thyroid carcinoma (DTC). Methods A total of 95 patients with DTC who were positive for TgAb and who underwent total thyroidectomy and 131I treatment in the Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology from December 2016 to May 2018 were retrospectively analyzed. The patients included 16 males and 79 females, aged 11?63 (37.74±11.27) years old. 131I treatment was administered 2–6 months after surgery. Based on the response to therapy assessment system of DTC in the American Thyroid Association Management Guidelines and according to the images, the curative effect was divided into three groups, namely, structural excellent response group (A group, 54 cases), structural incomplete response group (B group, 19 cases), and structural indeterminate response group (C group, 22 cases). The following parameters were observed among the three groups: TgAb level before 131I treatment; percentage change at 1.5 months, 3–6 months, and 6–12 months; and rate of change of TgAb. The factors that might affect the curative effect were analyzed. Receiver operating characteristic (ROC) curves were drawn with the following: the TgAb level before 131I treatment; percentage change of TgAb at 1.5 months after treatment; and percentage change of TgAb at 3–6 months after treatment. The best critical value for predicting therapeutic effect was determined, and the diagnostic efficiency was calculated. The measurement data were compared through variance analysis or Kruskal-Wallis rank sum test. Chi-square test or Fisher's exact text were used to compare the count data among the groups. The multivariate Logistic regression analysis was used to analyze the factors that may affect the curative effect. Results The univariate regression analysis results showed that the mean age (F=3.48, P=0.03), lymph node metastasis rate (χ2=10.28, P<0.01), TgAb level before 131I treatment (χ2=16.03, P<0.01), 131I dose (Fisher's exact text, P=0.002), percentage changeand and rate of change of TgAb (except percentage change at 6?12 months) at 1.5 months, 3?6 months, and 6?12 months were significantly different among the three groups (χ2=8.55–22.79, all P<0.05). The multivariate Logistic regression analysis result showed that TgAb levels before 131I treatment were significantly different among the three groups (β=?0.006, OR=0.994; P<0.01), percentage change of TgAb at 1.5 months (β=0.327, OR=1.387; P=0.046), and percentage change of TgAb at 3?6 months (β=2.521, OR=12.439; P=0.041) had statistical significance. The optimal cut-off value of TgAb level on ROC curve was 201.4 U/mL with a sensitivity of 74.1% and specificity of 68.3%. The area under ROC curve (AUC) was 0.740. The optimal cut-off values of the percentage change of TgAb in 1.5 months and for 3–6 months after treatment were 9.7% and 19.2%; the sensitivities were 72.2% and 61.0%; the specificities were 87.0% and 58.5%; and the AUCs were 0.660 and 0.752, respectively. Conclusions Postoperative TgAb level enabled the prediction of the therapeutic effect of 131I. Patients with lower TgAb level showed better therapeutic effect. The decrease of TgAb after treatment was more significant than before treatment, suggesting that the 131I therapeutic effect was satisfactory.     

探讨定量构效关系模型在药物及其杂质毒性预测方面的应用

随着定量构效关系（QSAR）模型从二维至多维的不断发展,它被越来越广泛地应用于各个领域,同时也为药品的监管提供了新的参考方案。QSAR模型对于杂质的毒性预测可应用于药品的研发和质量控制过程,有利于控制药品的安全风险,缩减企业的研发成本。QSAR模型的应用程序也在不断优化,以确保QSAR模型可以不断地适用于新药及未知杂质的毒性研究。本文从QSAR模型的建模基础及发展历程出发,对近年来该模型在药物及其杂质毒性预测方面的应用研究报道进行了归纳总结。     

日本蓝皮书的介绍及启示

目的：介绍日本仿制药上市后质量动态信息的最新查询途径,为建立我国相关橙皮书提供借鉴。方法：介绍日本蓝皮书的背景、结构和内容,并以熊去氧胆酸片为例,详细介绍日本蓝皮书的使用方法。结果与结论：仿制药质量再评价工作在日本开展了近20年,淘汰了约10%的不合格药品。对于仿制药质量再评价的跟踪和实施、市场抽验及药品质量研讨会有效保证了口服固体仿制药药品质量的一致性和有效性,日本蓝皮书是对该项工作成果的集中系统整理,对我国开展仿制药一致性评价工作具有积极的启示。