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药品抽查检验，不仅可掌握辖区内药品质量总体水平与状态，发现药品研发、生产过程中未考虑到的问题，还可发现蓄意造假、规避检验方式掺假、利用监管薄弱环节售假等事件，打击制售假劣药品的不法分子，确保人民群众用药安全有效。 相似文献
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目的 对贵州省水城县勺米乡与纸厂乡结合部地方性氟中毒(简称地氟病)村聚集性骨软化畸形儿童进行氟(F)、铝(Al)等多种元素测定,结合临床表现进行病因学诊断.方法 2008年11月,对水城县纸厂乡与勺米乡结合部地氟病村寨骨软化畸形少年儿童聚集病例(病例组),在严格质量控制基础上,采集14个病例和同县非地氟病区13个同龄对照(对照组)的任意1次尿和枕部贴皮头发,进行氟(F)、铝(Al)、镉(Cr)、锰(Mn)、铁(Fe)、铜(Cu)、锌(Zn)、砷(As)、硒(Se)、锶(Sr)、钡(Ba)10种元素检测,数据用PEMS 3.1医学软件统计包进行处理.结果 病例组尿中F、Al、Mn、Cu、Sr、Se水平(1.18 mg/L,112.6 μg/L,6.62、29.86 mg/L,177.5、4.23ng/L)与对照组(0.48、47.1、2.04、16.61 mg/L,55.17、15.52 ng/L)比较,差异均有统计学意义(t值分别为4.592、2.486、4.850、2.210、2.078、2.912,P均＜0.05).病例组头发中Al、Mn、As、Sr、Ba、Fe、Se水平(59.27、5.26、0.956、1.497、1.287、297.13、0.454 mg/kg)与对照组(18.69、0.72、1.094、0.621、0.675、69.022、1.323 mg/kg)比较,差异有统计学意义(t值分别为4.583、6.318、3.309、2.704、5.606、6.294,P均＜0.05).病例组尿中F与Al、Zn、As、Se的相关系数(r)均＞0.662(P均＜0.05),Al与Cu、Zn、As、Sr、Ba、Se的r均＞0.674(P均＜0.05),Se与Mn、Ba、Cu、Zn、Sr、As的r均＞0.694(P均＜0.05),Mn、Sr、As、Ba彼此之间r均＞0.550(P均＜0.05).病例组头发中Al与Mn、Cr、Fe、Cu、As、Se的r均＞0.732(P均＜0.05),Ba与Mn、Cr、Fe、Sr,Mn与Cr、Fe,Cr与As,Cu与Sr的r均＞0.686(P均＜0.05);对照组尿Cu与Zn、Se、Ba,Zn与Se、Ba,Cr与Mn、Ba的r均＞0.516(P均＜0.05);对照组头发中Al与Mn、Fe、Cu、As、Se,Se与Fe、Cu、As,Fe与Mn、Cu、As,Cu与Zn、As,Zn与As的r均＞0.739(P均＜0.05).病例组尿F与Se的r(0.762)与对照组(-0.469)比较,差异有统计学意义(u=2.079,P＜0.05).结论 水城县纸厂乡与勺米乡结合部地氟病病村寨骨软化畸形儿童的氟、铝负荷过高,尿和头发多种元素水平及其相关性分析与地方性铝氟中毒Al、F水平引起多种元素水平变化及其相关性呈网络样加强的现象一致,结合病人生活环境,有与铝氟中毒相同的骨X线表现,可诊断为地方性铝氟中毒.病人尿和头发Se水平降低及与F、Al等相关性有显著差异的生物学意义有待进一步探讨.Abstract： Objective To investigate the levels of trace elements such as fluorine(F), and aluminium (Al)etc. of osteomalacia malformation children and to make etiological diagnosis in reference with clinical manifestations.Methods Urine and occipitalia hairs of 14 diseased children(patient group) from endemic fluorosis area and 13 healthy children(control group) from non-endemic area were included in the study on November, 2008, and contents of 10 elements of fluorine(F), aluminum(Al), chromium(Cr), manganese(Mn), ferrum(Fe), cuprum(Cu), zinc(Zn), arsenic (As), selenium(Se), strontium(Sr), and barium(Ba) were tested. The data were analyzed with medical soft package PEMS 3.1. Results Urinary contents of F, Al, Mn, Cu, Sr, and Se(1.18 mg/L, 112.6 μg/L,6.62,29.86 mg/L, 177.5,4.23 ng/L) in patient group were significantly different from those in control group (0.48,47.1,2.04,16.61 mg/L, 55.17,15.52 ng/L, t = 4.592,2.486,4.850,2.210 2.078,2.912, all P＜ 0.05); Hair contents of Al, Mn, As, Sr, Ba, Fe, and Se in patient group(59.27,5.26,0.96,1.50,1.29,297.13,0.45 mg/kg)were significantly different from those of control group( 18.69,0.72,1.09,0.62,0.68,69.02,1.323 mg/kg, t = 4.583,6.318,3.309,2.704,5.606,6.294, all P ＜ 0.05); in patient group, the correlation coefficients of urinary Fe to Al,Zn, As, and Se were all bigger tan 0.662(all P＜ 0.05), those of urinary Se to Mn, Ba, Cu, Zn, Sr, and As were all bigger than 0.694(all P＜ 0.05), those among urinary Mn, Sr, As, and Ba were bigger than 0.550(all P＜0.05), those of hair Al to Mn, Cr, Fe, and Cu were bigger than 0.732(all P＜ 0.05), those of hair Ba to Mn,Cr, Fe, and Sr, and of hair Mn to Cr and Fe, and those between Cr and As, between Cu and Sr were all bigger than 0.686 (all P ＜ 0.05). In control group, the correlation coefficients of urinary Cu to Zn, Se, and Ba, those of Zn to Se and Ba, and those of Cr to Mn and Ba were all bigger than 0.516(all P ＜ 0.05), those of hair Al to Mn,Fe, Cu, As, and Se, and those of hair Se to Fe, Cu, and As, those of hair Fe to Mn, Cu, and As, those of hair Cu to Zn and As, and that between Zn and As were bigger than 0.739(all P ＜ 0.05). The correlation coefficient of urinary F to Se in patient group(0.762) was significantly different from that in control group( - 0.469, u = 2.079,P ＜ 0.05). Conclusions The burden of F and Al of osteomalacia malformation children in endemic fluorosis area of Shuicheng county is too high. The contents of multi-elements in urine and hairs and their correlation are coincident with high levels of Al and F and they cause network increase of multi-element content changes and their correlation. According to bone X-ray features combining with the living environment, the diagnosis of endemic Al-F fluorosis can be made. The biological significance of reducing urinary and hair Se levels and the correlations of F and Al need to be further studied. 相似文献
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目的：建立舒胸片中人参皂苷Rg1、人参皂苷Rb,和三七皂苷R1含量的HPLCI]定方法。方法：采用DiamosilC18柱（4．6X250mm,5gm）,流动相乙腈一水,梯度洗脱,柱温30℃,流速lmL／min,203nm波长下检测。结果：人参皂苷Rg1、人参皂苷Rb1、三七皂苷R,分别在0．442～11．050gg（r=0．9999）、0．344～8．600μg（P=0．9999）、0．208～5．200gg（r=0．9995）范围内线性关系良好,平均回收率分别为98．93％（RSD为1．7％1、98．88％（RSD为1．4％）、98．98％（RSD为1．4％）。结论：以HPLC法检测舒胸片中人参皂苷Rg1、人参皂苷Rb1和三七皂苷R1,方法简便、准确、灵敏度高、重复性好。 相似文献
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药品现场监管是一种以风险为本的监管体系,要求针对药品企业质量风险和隐患科学地制定监管计划,并结合其风险水平合理配置监管资源,实施分类监管措施。本研究通过分析药品现场监管工作的难点,建立了药品企业质量风险专题库、药品企业质量风险监测指标体系,以此构建药品企业质量风险监测业务支撑体系,并依托该支撑体系建立了质量风险分类方法、差异化抽查策略和业务辅助可视化系统,运用该支撑体系获知药品企业风险等级,从而创新了药品现场监管方法,优化了监管策略。以江西省为例,验证了该支撑体系可引导对样本药品企业的风险评估,可在药品现场监管的技术审评、方案编制、现场执行及综合评估过程中提升检查的靶向性,有效提高监管质量和效率。 相似文献
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