UF-100全自动尿沉渣分析仪稀释液的研制和应用

目的 研制适用于Sysmex UF-100全自动尿沉渣分析仪的配套稀释液.使尿沉渣分析仪稀释液试剂国产化.方法 对原装稀释液进行理化分析;根据其电导率,渗透压,pH值配制试剂,采用析因设计与正交实验优化配方,并与原装稀释液进行对比研究.结果 大量临床样本测定结果经统计分析,数据结果均无统计学意义(P＞0.05),相关性良好(r值最小为0.96).结论 临床应用提示:自研试剂完全可以替代进口试剂.     

坦索罗辛联合排石冲剂治疗输尿管下段结石疗效观察

目的分析比较坦索罗辛联合排石冲剂和单纯应用排石冲剂在输尿管下段结石辅助排石中的疗效。方法160例输尿管下段结石患者随机分2组,每组80例。结石直径0．4～1．0cm。组l给予坦索罗辛0．4mg,1次／天,并联合服用排石冲剂1包（12g）冲服,27欠／天;组2仅服用排石冲剂1包（12g）冲服,2次／天。每例患者治疗观察期不超过2周。结果2周内结石排出者组l为63例（78．8％）,组2为50例（62．5％）,两组比较排石率差异有统计学意义（P〈0．05）。平均排石时间组1为4．5d,组2为8d,两组比较差异有统计学意义（P〈0．05）。2周内组2有5例患者因发生肾绞痛而需镇痛药治疗,组1中无肾绞痛发生。2周内两组均未出现明显副作用,无因不能耐受而退出者。结论坦索罗辛和排石冲剂的联合应用可促进输尿管下段和膀胱壁问段结石排出,且和单纯应用排石冲剂相比能缩短排石时间,减少排石过程的疼痛和镇痛药使用。     

某化学发光分析仪HBsAg手工稀释液的制备及应用研究

目的制备雅培i2000SR化学发光分析仪乙型肝炎病毒表面抗原(HBsAg)定量分析手工稀释液。方法利用人血浆(HBsAg、HBV-DNA和抗HIV-1/HIV-2呈阴性)与Beckman Coulter DxI800冲洗缓冲液,按4∶1体积比配制成80%血浆稀释液。分别用自制80%血浆稀释液和原厂HBsAg稀释液对100例HBsAg阳性血清样本进行稀释后上机检测,并将测得结果进行统计学分析。结果原厂HBsAg稀释液与自制80%血浆稀释液对血清样本稀释后所测得HBsAg值比较,前者测得结果绝大多数比后者所测得血清值高,但两者差异无统计学意义(P>0.05)。结论自制80%血浆HBsAg稀释液替代雅培i2000SR HBsAg手工稀释液是可接受的。     

Mg2+在药物无菌检查中的应用

目的 探讨Mg²⁺作为中和剂在无菌检查中的合理应用。方法 添加不同浓度Mg²⁺,观察对培养基、稀释剂和冲洗液性状、以及对微生物生长的影响。结果 以规定验证菌试验,对Mg²⁺最敏感验证菌为铜绿假单孢菌。结论 Mg²⁺作为中和剂应用于无菌检查,其使用方式、使用量(浓度)应进行考察,选择合理的应用方式。     

自制AC-920自动血细胞分析仪试剂的应用和观察

目的 探讨自配血细胞分析仪试剂，运用于进口血细胞分析仪。方法 分析血细胞分析仪原装试剂成分，理化指标；仿制出类似的成分和理化指标，并作一系列比对试验。结果 运用自配血细胞分析仪试剂其各项测试指标：Hb吸收曲线、WBC、RBC、PLT、MCV均与进口试剂相仿。结论 自配血细胞分析仪试剂经两年多的临床运用验证，结果满意。故自配血细胞分析仪试剂可替代进口血细胞分析仪试剂运用于进口血细胞分析仪。     

High-efficiency sample preparation with dimethylformamide for multi-element determination in pharmaceutical materials by ICP-AES

The pressure to reduce cycle times of sample analysis has made it increasingly important to improve sample throughput during pharmaceutical process development. For ICP-based analyses, sample preparation is often the bottleneck of the entire analytical scheme due to the tedious digestion procedure and lacking a universal diluent for organic compounds. In this work, N,N-dimethylformamide (DMF) was used as a “universal” organic diluent so that the sample preparation can be simplified as a “dilute-and-shoot” procedure. An optimized interface with a commercial membrane desolvation unit was implemented, which enabled the introduction of organic solvents into an ICP-AES without organic loading. Mixed standard solutions of 15 elements (Al, Co, Cr, Cu, Fe, Mn, Mo, Ni, Pd, Pt, Rh, Ru, W, Zn, and Zr), which covered the majority of processing metals routinely monitored in pharmaceutical development, were prepared for the study and stability of each element in a multi-element DMF solution was investigated. It was found that the addition of a stabilizing agent (EDTA) was necessary to ensure that all the elements at concentrations of 0.10–0.50 μg/mL remained physically stable in solution (recovery better than 95%) for 2 weeks. It was also important to use an internal standard (yttrium) in order to compensate for signal drift and matrix effects from different sample matrices. A 2–10-fold increase of sensitivity (due to enhanced analyte transport efficiency) and acceptable levels of precision (RSD < 3%) and recoveries (91–111%) were achieved. The LOQs of all 15 elements were less than 10 μg/L in the solution, which translates to less than 5 μg/g or μg/mL in pharmaceutical samples tested. This technique would minimize the effort required for sample preparation, thus reducing the cycle time by approximately 60–90% in the entire analytical scheme for samples that are difficult to be dissolved in nitric acid. This will provide opportunities for a new level of sample handling and automation for metal analysis in pharmaceutical process development.     

Can simultaneous contact allergies to phenyl glycidyl ether and epoxy resins of the bisphenol A/F‐types be explained by contamination of the epoxy resins?

Background: Simultaneous contact allergies to epoxy resins based on diglycidyl ether of bisphenol A (DGEBA‐R) or epoxy resins of the bisphenol F‐type and the reactive diluent phenyl glycidyl ether (PGE) have been reported. The reason might be cross‐reactivity, exposure to an epoxy resin system with PGE as a component, or contamination by PGE in the epoxy resin. Aims: To study contamination by PGE, 20 commercial epoxy resins were analysed for the presence of PGE. To study contact allergy to PGE and its relation to epoxy resins by inserting PGE in the standard series. Results: Among 2227 patients, 7 reacted to PGE. Of 23 (30%) patients, 7 with contact allergy to DGEBA‐R and 7/19 (37%) with contact allergy to an epoxy resin of the bisphenol F‐type reacted to PGE. All 7 patients with contact allergy to PGE reacted both to the DGEBA‐R and to the epoxy resin of the bisphenol F‐type. PGE was found in 90% of the investigated resins. The amounts of PGE ranged between 0.004% w/w and 0.18% w/w. Conclusion: Most probably, the presence of PGE as a contaminant in epoxy resins is of minor importance for the sensitization, but possibly the contamination of PGE might elicit contact dermatitis in individuals with a high reactivity to PGE.     

参苏冲剂对小鼠巨噬细胞功能和淋巴细胞转化率的影响

本实验观察了参苏冲剂对小鼠巨噬细胞功能和淋巴细胞转化率的影响,结果表明,参苏冲剂能提高小鼠的淋巴细胞转化率,并能显著促进巨噬细胞的功能。     

自蔓延熔附成型陶瓷涂层的组织结构及性能分析

采用铝热反应熔附成型技术在普通碳素钢管内壁涂覆一层较为均匀致密的陶瓷层。分析了烯释剂添加量和粉体充填密度对反应蔓延速度以陶瓷涂层厚度的影响。