HPLC法测定硫普罗宁注射液中硫普罗宁的含量

目的：建立高效液相色谱法测定硫普罗宁注射液中硫普罗宁的含量。方法：采用Venusil MP C18色谱柱（150mm×4．6mm,5μm）,水（磷酸调节pH为2．2）-乙腈（90：10）为流动相,流速为1．0ml·min^-1,检测波长为210nm。结果：硫普罗宁在27．01～432．16μg·ml^-1的范围内,线性关系良好（r=0．9999）。平均回收率为99．8％,RSD为1．18％。结论：该方法简便,快速,准确,可用于测定硫普罗宁注射液中硫普罗宁的含量。     

硫普罗宁注射液引起豚鼠全身主动过敏实验

目的:研究硫普罗宁注射液静脉给药对豚鼠引起的全身过敏反应.方法:对硫普罗宁原料、注射液、敷料进行豚鼠的全身主动过敏试验.结果:硫普罗宁原料、注射液豚鼠全身主动过敏试验均产生阳性反应.结论:硫普罗宁注射液对豚鼠有致敏作用.     

硫普罗宁注射液安全性试验

目的评价硫普罗宁注射液的安全性。方法对硫普罗宁注射液进行血管刺激性、溶血性、过敏性试验。结果硫普罗宁注射液对家兔耳缘静脉无明显刺激作用,对家兔红细胞无明显体外溶血及致凝集作用,对豚鼠无致过敏作用。结论硫普罗宁注射液用于注射是安全的。     

硫普罗宁注射液治疗肝纤维化的临床应用

目的观察硫普罗宁注射液治疗肝纤维化的临床疗效。方法将120例患者随机分为治疗组与对照组各60例。2组基础治疗均为静脉滴注维生素C注射液2.0,肌苷注射液0.4,口服拉米呋定片100mg,每天一次。治疗组加用硫普罗宁注射液200mg,每天一次。2组均以3个月为一疗程。结果治疗组显效12,有效37,无效11例,总有效率为81.67%;对照组显效6例,有效30例,无效24例,总有效率为60.00%。2组总有效率比较,差异有非常显著性意义(P<0.01)。结论硫普罗宁注射液主要是通过抑制肝星状细胞增殖的C2-M期而产生抗肝纤维化作用的,从而能较好地改善肝功能和抗肝纤维化的作用。     

硫普罗宁注射液临床作用研究

硫普罗宁(Tiopronin, Tio)是一种新型的含游离巯基的甘氨酸衍生物类药物,化学名为N-(α-颈基丙酰基)-甘氨酸,分子式为C5H9NO3S.临床试验研究证实该药能全面、明显改善病毒性肝炎,酒精性肝损伤的肝功能指标及有关症状,具有疗效确切、安全可靠等特点.     

HPLC法测定硫普罗宁葡萄糖注射液中硫普罗宁的含量

目的:建立高效液相色谱法测定硫普罗宁葡萄糖注射液中硫普罗宁的含量。方法:色谱柱采用Diamonsil-C18,流动相为0.07mol·L-1磷酸二氢钾溶液,流速为1.0mL·min-1,检测波长为210nm。结果:硫普罗宁检测浓度在24.17～56.39μg·mL-1范围内线性关系良好(r=0.9995);平均回收率为99.06%,RSD=0.7%。结论:本方法简便、快速、准确、专属性强,适用于硫普罗宁葡萄糖注射液中硫普罗宁的含量测定。     

硫普罗宁注射液致变态反应2例

患者 1,女, 28岁,哈萨克族。既往无变态反应史。因心悸、消瘦 1个月来本院就诊,以甲状腺功能亢进收治。体检:体温37 6℃,双侧甲状腺Ⅱ度肿大,心率 125次·min 1,心律齐、杂音( -)、双肺、腹均( -),T3 4 4μg·mL 1,T4 3 0μg·mL 1,TSH0 3μU·mL 1,给予他巴唑片 20mg,po,q     

硫普罗宁注射液有关物质的分离与测定

目的优化反相高效液相色谱法分离测定硫普罗宁注射液有关物质并进行方法学验证。方法以各杂质峰的对称性、相对保留时间及分离度等因素为指标,优化了pH、流动相缓冲盐浓度、温度等因素,建立HPLC色谱条件:色谱柱:Waters Symmetry-C18柱;流动相:0.05moL.L-1磷酸二氢钾溶液(用磷酸调pH值至3.2)-乙腈(95∶5);检测波长:210nm;柱温:30℃;流速:1.0mL.min-1。结果优化后的方法具有简便快速、灵敏度高、专属性强的特性;杂质A、B及杂质C、杂质D的相对响应因子(相对于硫普罗宁)分别为0.73、2.32和1.18;硫普罗宁注射液中含有这4个杂质,且含量均大于0.1%。结论采用加相对响应因子的1%主成分自身对照法以及杂质对照外标法更能准确反映杂质含量。     

硫普罗宁联合复方丹参注射液治疗慢性乙型肝炎

目的 :观察硫普罗宁联合复方丹参注射液治疗慢性乙型肝炎 (乙肝 )的疗效。方法 :慢性乙肝患者 12 5例分为两组。治疗组 70例 ,以硫普罗宁 2 0 0mg ,po ,tid ;复方丹参注射液 2 0mL加入 10 %葡萄糖注射液 2 5 0mL ,静脉滴注 ,qd。对照组 5 5例 ,以硫普罗宁 2 0 0mg ,po ,tid。两组患者均加维生素C注射液 2g ,维生素K1 注射液 2 0mg ,加入 10 %葡萄糖注射液 2 5 0mL ,静脉滴注 ,qd。疗程均为 3个月。结果 :治疗组显效 5 4例 (77.2 % ) ,有效 12例 (17.1% ) ,无效 4例(5 .7% ) ,总有效率 94.3 %。对照组显效 3 0例 (5 4.5 % ) ,有效 14例 (2 5 .5 % ) ,无效 11例 (2 0 % ) ,总有效率 80 .0 %。治疗组总有效率优于对照组 (P <0 .0 5 )。结论 :硫普罗宁联合复方丹参注射液治疗慢性乙肝具有协同作用 ,可加快肝功能恢复     

应用腘窝淋巴结实验评价干扰素的免疫毒性

目的用小鼠腘窝淋巴结实验(Popliteallymphnodassay,PLNA)以及检测淋巴细胞表面分子来预测干扰素的免疫毒性,探讨该方法的预测价值。方法采用小鼠腘窝淋巴结实验方法测定腘窝淋巴结重量及细胞指数,淋巴细胞亚群测定采用流式细胞技术法。结果干扰素可引起小鼠腘窝淋巴结肿大,并造成腘窝淋巴结CD4+/CD8+T细胞比例改变。结论本实验中干扰素的测试结果呈阳性,提示用腘窝淋巴结实验对干扰素(Interferon,IFN)的免疫毒性进行初步评估。     

高效液相色谱法测定注射用硫普罗宁中硫普罗宁含量

目的建立测定注射用硫普罗宁中硫普罗宁含量的高效液相色谱法。方法采用waters C18色谱柱(150 mm×4.6 mm,5μm),水(磷酸调节pH为2.2)-乙腈(90∶10)为流动相,流速为1.0 mL/min,检测波长为210 nm。结果硫普罗宁质量浓度在25.01～400.16μg/mL的范围内与峰面积线性关系良好(r=0.999 9),平均回收率为100.01%,RSD为0.55%(n=9)。结论该方法简便、快速、准确,可用于测定注射用硫普罗宁中硫普罗宁的含量。     

HPLC法测定硫普罗宁注射液的有关物质

目的:建立高效液相色谱法测定硫普罗宁注射液中的有关物质。方法:采用C18柱,以水(磷酸调节pH值为2.2)-乙腈(90∶10)为流动相,检测波长为210 nm。结果:硫普罗宁与其降解产物在该色谱条件下能够有效分离,检测限为0.11μg.mL-1,重复性试验RSD为0.8%。结论:该方法简便、快速、灵敏、准确,可用于测定硫普罗宁注射液中的有关物质。     

注射用硫普罗宁细菌内毒素检查法的建立

目的:建立注射用硫普罗宁细菌内毒素检查方法.方法:参照<中国药典>2010年版二部细菌内毒素检查法进行试验.结果:将硫普罗宁稀释至1 mg·mL-1时对细菌内毒素和鲎试剂的反应无干扰作用.结论:该品种可采用细菌内毒素检查法控制药品质量.     

局部淋巴结试验与局部封闭斑贴试验应用于化妆品皮肤变态反应评价的比较

目的 通过局部淋巴结试验法和局部封闭斑贴试验应用于化妆品皮肤变态反应的比较,探讨局部淋巴结试验应用于化妆品成品的可行性.方法 采用局部淋巴结试验与体内局部封闭斑贴试验对标准的阳性物以及市面上的2种染发剂进行评价.结果 局部淋巴结试验表明,2种染发剂的SI值＜1.8,均为阴性,判断结果与局部封闭斑贴试验结果一致.结论 局...     

Interlaboratory Evaluation of the Local Lymph Node Assay with 25 Chemicals and Comparison with Guinea Pig Test Data

Abstract

Summary: The murine local lymph node assay (LLNA) has been developed as an alternative method for the identification of skin sensitizing chemicals. Measurement is made of the proliferation of lymphocytes within lymph nodes draining the site of exposure to the test chemical. This report describes a collaborative study in which 25 test chemicals were evaluated in each of four participating laboratories and the results compared with existing data from guinea pig predictive tests. Nineteen chemicals were predicted to be sensitizers in the guinea pig. Of these, 14 were correctly identified in the LLNA (9 by all laboratories and 5 by two or three laboratories). Five chemicals predicted to be contact allergens by guinea pig tests failed to elicit positive LLNA responses. With adoption of a 5 day rather than a 4 day exposure period to the test chemical and administration of maximum soluble test concentrations, positive reactions could be obtained with each of the chemicals initially negative in the LLNA. The LLNA and guinea pig tests were in agreement for all three chemicals predicted to be nonsensitizers in the guinea pig. Positive LLNA responses were obtained with four chemicals (including a re-evaluation of one initially negative in the LLNA) for which guinea pig results were equivocal in three cases and negative in another. These results suggest that the LLNA may provide a rapid and reliable elective prescreen for the identification of contact allergens.     

硫普罗宁的合成工艺研究

目的:改进硫普罗宁的合成工艺.方法:以丙酸为起始原料,经溴化、取代、缩合、置换、水解反应合成硫普罗宁,对置换剂硫代苯甲酸的合成方法进行了改进.结果:对各步反应条件进行了优化,总收率达到66.1%,高于文献报道的38.2%.结论:合成工艺操作简便,提高了收率,降低了成本,适合工业化生产.     

Immune modulation by cadmium and lead in the acute reporter antigen-popliteal lymph node assay.

Immune modulation by heavy metals may cause serious adverse health effects in humans, although the mechanisms involved are not well understood. Both cadmium and lead are important environmental and occupational toxins. Therefore, in the current study, the costimulatory/adjuvant effects and the T-cell-activating potential of these metals (i.e., CdCl2 and PbCl2), are examined. These immune-modulating properties are critical in the development of conditions such as allergy, hypersensitivity, and autoimmunity. Using the direct popliteal lymph node assay (PLNA) and reporter antigen-popliteal lymph node assay (RA-PLNA) both metals were examined individually for immunotoxicity. Mercury (i.e., HgCl2) was included for comparative purposes as its effects in the RA-PLNA are well documented. Seven days following a single footpad injection containing metal and/or RA (trinitrophenyl-ovalbumin [TNP-OVA] or TNP-Ficoll), BALB/c mice were sacrificed and the popliteal lymph nodes (PLNs) removed. PLN cellularity, TNP-specific antibody-secreting cells (ASCs), and lymphocyte subsets were assessed. All three metals strongly stimulated T- and B-cell proliferation and ASC production following coinjection with the RA TNP-OVA. In each case, ASC production was skewed towards the IgG1 isotype. In addition, all three metals induced IgG production to TNP-Ficoll (although relatively weakly in the case of Cd). These results show that each of these metals can provide adjuvant signals to promote lymphocyte proliferation and enhance adaptive immune responses to unrelated antigens. Skewing of immune responses towards T helper type 2 responses suggests that each of these metals can enhance allergic and hypersensitivity reactions to environmental antigens. Furthermore, the induction of IgG responses to TNP-Ficoll, a T-cell-independent antigen, indicates that each of these metals can activate neoantigen-specific T cells. T-cell activation by metals can lead to metal hypersensitivity and has been implicated in the development of autoimmunity. This is the first report of immune modulation by CdCl2 and PbCl2 in the RA-PLNA.