共查询到20条相似文献,搜索用时 62 毫秒
1.
2.
3.
4.
5.
6.
7.
8.
9.
比较了国内指导原则《药物重复给药毒性试验技术指导原则》和《药物毒代动力学研究技术指导原则》与ICHS4和ICH S3A的对应关系及差异,并对ICH S4及ICH S3A在我国实施的可行性及存在的技术困难和法规障碍进行了讨论,最后根据CDE和ICH指导原则的差异对比情况对我国实施ICH S4及ICH S3A给出了建议,以期为国内重复给药毒性试验及药物毒代动力学研究提供借鉴。 相似文献
10.
本文通过综述国外医药管理机构ICH/FDA/EMA/WHO对复方药物非临床试验指导原则的内容,比较了不同机构对复方药物非临床评价要求,包括复方药物的类型、不同类型复方药物非临床要求的一般原则、研究方案,以及动物种属、特殊毒理试验的要求、复方剂量配比原则等内容,以期为国内复方药物的非临床评价提供借鉴。 相似文献
11.
比色法与液相色谱法对罗红霉素溶液稳定性研究的比较 总被引:4,自引:0,他引:4
罗红霉素 (roxithromycin)为大环内酯类抗生素红霉素的一种衍生物 ,其体外抗菌作用与红霉素相当 ,在临床上广泛用于敏感细菌引起的感染[1] 。本品于 1987年首先在法国上市 ,目前已在我国和其他80多个国家和地区得到广泛应用。到目前为止 ,罗红霉素体内外样品的测定方法有微生物法[2 ] 、液相色谱法[3 ,4 ] 和比色法[5,6] 。罗红霉素的体外溶出度测定 ,可用人工胃液[6] 、不同 pH值的磷酸盐缓冲液[5~ 7] 作为介质。比色法是大环内酯类抗生素通用方法 ,由于用同一显色剂罗红霉素与其分解产物显同一颜色 ,用比色法测定罗红霉素… 相似文献
12.
13.
R. J. Dearman D. A. Basketter L. Blaikie E. D. Clark J. Hilton R. V. House 《Toxicology mechanisms and methods》2013,23(2):69-85
The mouse IgE test is a novel method for the prospective identification of chemicals that have the potential to cause allergic sensitization of the respiratory tract. Activity is measured as a function of increases in the concentration of total serum IgE induced by topical exposure of mice to chemicals; those chemicals that elicit a substantial elevation in IgE are classified as respiratory allergens. The present investigations were designed to evaluate further the utility of the mouse IgE test. For this purpose theassay was conducted in each of fiveindependent laboratories using trimellitic anhydride (TMA), a known cause of respiratory sensitization and occupational asthma, and 2,4-dinitrochlorobenzene (DNCB), a potent contact allergen that is considered not to cause sensitization of the respiratory tract. For these investigations BALB/c mice were used, which are currently the strain of choice for the mouse IgE test. In four of five laboratories, exposure of mice to TMA caused a statistically significant increase in the serum concentration of IgE. Under the same conditions of exposure, DNCB failed in all laboratories to induce a significant change in IgE levels compared with vehicle-treated controls. In three of five laboratories, the concentration of total serum IgE was greater in TMA- than in DNCB-treated mice. The concentration of IgE in the sera of mice exposed to vehicle alone was not significantly different from that found in untreated (naive)animals. Although thedifferential ability, in some instances, of TMA and DNCB to provoke increases in serum IgE is consistent with the results of previous investigations, it was found in all five laboratories that there existed considerable variation among individual mice within experimental groups with respect to IgE levels. These data mirrored an increasing variability in serum IgE concentrations among BALB/c strain mice found in one of the participating laboratories. For this reason mice of another strain (C57BL/6) were evaluated in the mouse IgE test by the same laboratory. The data presented here reveal that C57BL/6 mice display more stable serum IgE levels and a lower constitutive level of serum IgE but nevertheless exhibit differential responses to TMA and DNCB, with only the former causing a substantial increase in IgE concentrations. Collectively these results suggest that although the mouse IgE test continues to show some promise as an approach to the identification of chemical respiratory allergens, there is a need for careful consideration of thestrain of mouseused beforetheassay can be considered fully optimized. 相似文献
14.
目的:分析和比较维、汉民族酒精依赖患者的人格特征和心理卫生状况。方法:运用明尼苏达多项人格测验(MinnesotaMultiphasicPersonalityInventory,MMPI)问卷进行调查、统计分析及比较。结果:维、汉族酒精依赖患者的MMPI临床量表中除L、K、Ma、Si外,其他临床量表得分与对照组均有统计学意义(P〈0.05);维、汉民族两组酒精依赖患者MMPI的临床量表中Pd、si得分比较有统计学意义(P〈0.05)。结论:在新疆地区生活的维、汉民族酒精依赖患者与正常组在人格方面均存在显著的特征;但维、汉民族之间的酒精依赖患者人格差异性并不显著。 相似文献
15.
16.
17.
18.
均匀设计法筛选中药巴布剂基质的研究 总被引:30,自引:0,他引:30
采用均匀设计法,以粘着强度为指标,筛选中药巴布剂基质,以所得回归方程对基质组成比例进行优化,确定基质的最佳配比为明胶-西药著胶-聚乙二醇400-聚丙烯酸-甘油-氧化锌=3.0:4.0:5.0:4.0:4.0:0.3。 相似文献
19.
盐酸左旋咪唑和甲苯咪唑均为抗肠道蠕虫类药物。本实验根据我国新药审批的有关要求来检测这二类药物的致突变作用,该实验通过诱发CHL 细胞染色体畸变的体外试验和小鼠骨髓细胞染色体的体内试验这两条途径来检测。实验结果表明:在体内试验中,甲苯咪唑(400-1600mg/kg)与阴性对照组(N.S)相比,有非常显著性差异(p<0.01);在体外试验中,甲苯咪唑(0.39-0.78μg/ml)培养24h 和48h 对CHL 细胞所诱发的染色体变化率显阳性。说明甲苯咪唑具有损伤小鼠骨髓细胞染色体和诱发CHL 细胞染色体畸变的遗传物质存在。而盐酸左旋咪唑的体内、体外试验显示阴性。 相似文献
20.
目的獉獉:研究中文版尼古丁依赖检测量表(FTND)在吸烟美沙酮维持治疗(MMT)门诊患者中使用的信效度。方法獉獉:在深圳市三家MMT门诊选取217位吸烟MMT门诊患者自评完成一般情况问卷、FTND量表和Russell吸烟原因问卷(RRSQ);间隔2周后对其中60名患者进行FTND量表重测;采用信度分析、相关分析和因子分析评价量表的信效度。结果獉獉:FTND量表的Cronbachα系数为0.638,两周重测信度系数为0.797(P<0.01);FTND量表总分与RRSQ依赖分和每日吸烟量的校标关联效度系数分别为0.404和0.637(P均<0.01);因子分析提取了两个公因子,累积解释总变异的55.039%。结论獉獉:中文版FTND量表在吸烟MMT患者中具有较好的重测信度、校标关联效度和结构效度,但其内部一致性未达心理测量学要求,需要进一步修订。 相似文献