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1.
目的 对国内 1 0个厂家生产的 1 2批维脑路通片进行体外溶出度比较 ,并分析各溶出参数 ,以评价产品的内在质量。方法 按中国药典 2 0 0 0年版溶出度测定方法 ,即以水为介质 ,采用转篮法 ,检测波长为 348nm ,用紫外分光光度法测定溶出液的含量。同时对片剂进行溶出度比较 ,计算各时间的累积溶出百分率 ,并提取溶出参数及方差分析。结果 根据威布尔(Weibull)分布模型 ,计算出 (T50 、Td、T80 、m)溶出参数 ,不同厂家产品的溶出参数具有极显著性差异 (P <0 .0 1 )。同一厂家 (SH)不同批号的溶出参数有显著性差异 (P<0 .0 5 ) ,而TJ的不同批号的溶出度参数没有显著性差异 (P >0 .0 5 )。结论 有必要增加对每批维脑路通片进行溶出度检查 ,以控制其质量 ,保证临床疗效  相似文献   

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目的利用六通道光纤药物溶出度测定仪,建立实时、在位监测格列齐特片Ⅱ体外溶出度的测定方法,并比较测定不同厂家共7批格列齐特片Ⅱ的体外溶出参数。方法采用FODT-601检测了格列齐特片Ⅱ的溶出度,并与《中国药典》药品标准溶出度测定结果进行了比较,无显著性差异(P〉0.05)。溶出度测定条件为:测定波长240nm、基线校正波长290nm、温度37℃、转速150r!min、数据采集间隔120s、监测时间180min、溶出介质为磷酸盐缓冲液pH(8.60±0.05)、溶出体积1000ml、转篮法、光纤探头2mm。结果共测定了两个厂家不同批次的格列齐特片Ⅱ在60、180min的溶出度及溶出曲线,其中一个厂家的格列齐特片Ⅱ符合《中国药典》规定,另一个厂家的格列齐特片Ⅱ在180min的溶出度不符合《中国药典》规定。两个厂家的格列齐特片Ⅱ溶出曲线存在非常显著性差异。结论光纤药物溶出度实时测定仪原位、准确、连续、定量地反映了药物的溶出过程,可比较出不同厂家之间同种药品的溶出过程差异。  相似文献   

3.
目的 建立噻奈普汀钠片溶出度测定方法。方法 以水为溶出介质 ,转篮法 ,转速 10 0r/min ,4 5min为取样点 ,检测波长为 2 2 5nm。结果 噻奈普汀钠在 2 .74~ 2 7.4 4 μg·ml-1范围内 ,浓度与吸收度呈良好线性关系 (r =0 .9998)。回收率为 10 0 .1% ,RSD 为 0 .6 1% ,三批溶出度平均值均大于 90 %。结论 本法快速简便 ,为噻奈普汀钠片体外溶出监测提供了方法  相似文献   

4.
目的 优化格替沙星片的溶出度测定条件。方法 采用正交实验对该药片溶出度测定的基本条件 (转速、取样时间、溶出介质 )进行筛选 ,采用紫外分光光度法测定含量。结果 筛选出 80r/min ,45min取样 ,0 .1mol·L-1的盐酸作溶出介质为该药溶出度的最佳测定条件。结论 采用正交实验法筛选出的最佳溶出条件 ,快速、准确。可用于格替沙星片的溶出度测定  相似文献   

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目的 测定法莫替丁片的溶出度。方法 高效液相色谱法 ,以Xterra -C18(3.9× 15 0mm ,5 μm)为色谱柱 ,流动相为庚烷磺酸钠溶液 -乙腈 -甲醇 (2 5∶6∶1) ,流速为 1.0ml/min ;检测波长为 2 5 4nm。结果 本品在 4 0~ 30 0 μg·ml-1范围内线性良好 (r=0 .9998) ,平均回收率为 99.6 5 % ,RSD =0 .4 %。结论 本法可排除辅料对溶出度测定的影响 ,可用于该制剂的质量控制。  相似文献   

6.
目的 建立氯诺昔康片溶出度测定方法。方法 选用中国药典 2 0 0 0年版溶出度测定第二法 ,紫外分光光度法检测。结果 测定波长为 376nm ,浓度在 0 .5~ 1 0 μg·ml-1 范围内 ,与吸收度呈良好的线性关系 (r =0 .9999) ,平均回收率为 1 0 0 .1 3% ,RSD 为 0 .6 8% ,每片溶出量应为标示量的 80 %以上。结论 本法适合于氯诺昔康片的溶出度测定。  相似文献   

7.
目的:测定不同厂家生产的辛伐他汀片的溶出曲线,并对其进行一致性评价.方法:采用光纤药物溶出度实时测定仪在测定波长238nm处,测定光程为10mm,分别测定5个不同厂家辛伐他汀片的溶出曲线,通过相似因子f2法评价溶出曲线的相似性.结果:不同厂家生产的药品溶出曲线差异较大.结论:本实验选用的方法简便、数据真实可靠,可用于区分体外溶出曲线的相似性,为制剂生物等效性实验提供参考数据.  相似文献   

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目的 建立复方尼群地平片剂中尼群地平的溶出度测定方法。方法  30 %乙醇的 0 .1mol·L-1盐酸溶液 2 5 0ml为溶剂 ,转速 75r/min ,4 5min取样 ,紫外分光光度法于波长 35 6nm处 ,测其吸收度计算容出量。结果 在 12~ 2 8μg·ml-1范围内 ,吸收度与浓度呈良好线性关系 ,A =0 .0 1915 C- 0 .0 2 2 8,r=0 .9999,平均回收率 10 0 .5 % ,RSD为 0 .77% ,3批样品溶出均一性试验结果满意 ,4 5min溶出度均 70 %以上。结论 本法操作简便 ,试剂用量少 ,结果正确。  相似文献   

9.
石杉碱甲片溶出度测定方法的研究   总被引:1,自引:0,他引:1  
目的 建立石杉碱甲片的体外溶出度测定方法 ,以控制其产品质量。方法 溶出介质为 0 .0 1mol·L-1盐酸溶液 10 0ml,温度 37± 0 .5℃ ,转速 10 0r/min ,浆法。采用反相HPLC法测定含量。色谱柱YWGC18柱 ,流动相为甲醇 -水 -三乙胺 (6 0∶4 0∶0 .0 2 ) ,检测波长 310nm。结果 石杉碱甲片在 2 0min时药物已完全溶出。结论 根据溶出度实验结果 ,该方法可作为生产单位控制本片质量的指标之一。  相似文献   

10.
目的 建立复方海螵蛸泡腾片的化学鉴别、含量测定、溶出度测定方法 ,以控制该药的制剂质量。方法 应用化学鉴别法、薄层层析法对所含中药成分进行鉴别。采用HPLC法对所含阿莫西林、甲硝唑进行鉴别试验及含量测定 ,流动相为磷酸盐缓冲液 (pH5 .0 ) -乙腈 (96∶4 ) ;流速为 1ml/min ;检测波长为 2 5 4nm。用药典方法对药物的溶出度进行测定。结果 化学鉴别碳酸钙和延胡索中的生物碱反应为 (+) ,甘草与对照品甘草次酸钠薄层层析结果相符。含量测定 :阿莫西林的标准曲线方程为 :A1=1.6 34× 10 5C - 6 .2 4 2× 10 3 ,r =0 .9997(n =5 ) ;甲硝唑的标准曲线方程为 :A2 =1.2 19× 10 5C +1.5 6 1× 10 3 ,r =0 .994 6 (n =5 ) ;两者在 2 .5~ 30 μg·ml-1范围内线性关系良好。甲硝唑的平均回收率为 98.7% ,RSD 1.4 7% ,阿莫西林的平均回收率为 98.3% ,RSD0 .6 9%。结论 本文建立的三项检查方法 ,快速、简便 ,可以控制复方海螵蛸泡腾片的制剂质量  相似文献   

11.
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-administered instrument measuring outcome after knee injury at impairment, disability, and handicap level in five subscales. Reliability, validity, and responsiveness of a Swedish version was assessed in 142 patients who underwent arthroscopy because of injury to the menisci, anterior cruciate ligament, or cartilage of the knee. The clinimetric properties were found to be good and comparable to the American version of the KOOS. Comparison to the Short Form-36 and the Lysholm knee scoring scale revealed expected correlations and construct validity. Item by item, symptoms and functional limitations were compared between diagnostic groups. High responsiveness was found three months after arthroscopic partial meniscectomy for all subscales but Activities of Daily Living.  相似文献   

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Objective To investigate endovascular treatment of traumatic direct carotid-cavernous fistulas (CCF) and their complications such as pseudoaneurysms. Methods: Over a five-year period, 22 patients with traumatic direct CCFs were treated endovascularly in our institution. Thirteen patients were treated once with the result of CCF occluded, 8 twice and 1 three times. Treatment modalities included balloon occlusion of the CCF, sacrifice of the ipsilateral internal carotid artery with detachable balloon, coll embolization of the cavernous sinus and secondary pseudoaneurysms, and covered-stem management of the pseudoaneurysms. Results All the direct CCFs were successfully managed endovascularly. Four patients developed a pseudoaneurysm after the occlusion of the CCF with an incidence of pseudoaneurysm formation of 18.2% (4/22). A total number of 8 patients experienced permanent occlusion of the ICA with a rate of ICA occlusion reaching 36.4% (8/22). Followed up through telephone consultation from 6 months to 5 years, all did well with no recurrence of CCF symptoms and signs. Conclusion Traumatic direct CCFs can be successfully managed with endovascular means. The pseudoaneurysms secondary to the occlusion of the CCFs can be occluded with stent-assisted coiling and implantation of covered stents.  相似文献   

15.
Acute limping may be the result of multiple pathologies in children. The differential diagnosis varies based on the age of the child. Irrespective of age, the initial imaging work-up includes AP and frog leg radiographs of the pelvis and ultrasound; MRI may sometimes be helpful. In children less than 3 years, infections and trauma are most frequent. MRI is the imaging modality of choice when osteomyelitis is clinically suspected. Between the ages of 3 and 10 years, transient synovitis of the hip and Legg-Calvé-Perthes disease are main considerations but infection, inflammation and focal bony lesions are also considered. In children over 10 years, slipped capital femoral epiphysis also is considered.  相似文献   

16.
Introduction Ankle sprains are the most common musculo-skeletal injury that occurs in athletes,particularly in sports that require jumping and landing on one foot such as soccer,and basketball(1-4).These injuries often result in significant time loss from participation,long-term disability,and have a major impact on health care costs and resources(5-8).  相似文献   

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KEY POINTS ·High-intensity interval training(HIT)is characterized by repeated sessions of relatively brief,intermittent exercise.often performed with an“a11 out”effort or at an intensity close to that which elicits peak oxygen uptake(i.e.,≥90%of VO2 peak).  相似文献   

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In response to the ENFSI and EDNAP groups’ call for new STR multiplexes for Europe, Promega® developed a suite of four new DNA profiling kits. This paper describes the developmental validation study performed on the PowerPlex® ESI 16 (European Standard Investigator 16) and the PowerPlex® ESI 17 Systems. The PowerPlex® ESI 16 System combines the 11 loci compatible with the UK National DNA Database®, contained within the AmpFlSTR® SGM Plus® PCR Amplification Kit, with five additional loci: D2S441, D10S1248, D22S1045, D1S1656 and D12S391. The multiplex was designed to reduce the amplicon size of the loci found in the AmpFlSTR® SGM Plus® kit. This design facilitates increased robustness and amplification success for the loci used in the national DNA databases created in many countries, when analyzing degraded DNA samples. The PowerPlex® ESI 17 System amplifies the same loci as the PowerPlex® ESI 16 System, but with the addition of a primer pair for the SE33 locus. Tests were designed to address the developmental validation guidelines issued by the Scientific Working Group on DNA Analysis Methods (SWGDAM), and those of the DNA Advisory Board (DAB). Samples processed include DNA mixtures, PCR reactions spiked with inhibitors, a sensitivity series, and 306 United Kingdom donor samples to determine concordance with data generated with the AmpFlSTR® SGM Plus® kit. Allele frequencies from 242 white Caucasian samples collected in the United Kingdom are also presented. The PowerPlex® ESI 16 and ESI 17 Systems are robust and sensitive tools, suitable for the analysis of forensic DNA samples. Full profiles were routinely observed with 62.5 pg of a fully heterozygous single source DNA template. This high level of sensitivity was found to impact on mixture analyses, where 54–86% of unique minor contributor alleles were routinely observed in a 1:19 mixture ratio. Improved sensitivity combined with the robustness afforded by smaller amplicons has substantially improved the quantity of data obtained from degraded samples, and the improved chemistry confers exceptional tolerance to high levels of laboratory prepared inhibitors.  相似文献   

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