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1.
目的:建立HPLC法测定替格瑞洛片中的有关物质的方法。方法:采用Agilent Zorbax SB-C18色谱柱 (4.6 mm × 150 mm, 1.8 μm);以磷酸盐缓冲液-乙腈为流动相,梯度洗脱;流量1.0 mL? min -1;柱温55 ℃;检测波长242 nm。结果:在该色谱条件下,替格瑞洛与各杂质峰分离度良好。结论:建立的方法灵敏度高,专属性强,可用于替格瑞洛片生产中有关物质的检测。  相似文献   

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目的 建立测定替卡西林钠及注射用替卡西林钠克拉维酸钾中有关物质的高效液相色谱梯度洗脱法。方法 采用HPLC梯度洗脱法,色谱柱为Waters XBridgeTM C18柱(4.6 mm×250mm,5μm);以0.01mol/L磷酸氢二铵溶液(pH7.0) 为流动相A,0.01mol/L磷酸氢二铵溶液(pH7.0)-甲醇(50:50)为流动相B,梯度洗脱;流速为1.0mL/min;检测波长为220nm;柱温为30℃。结果 与等度洗脱法比较,梯度洗脱法具有更强的分析杂质的能力,样品中各成分的分离度及检出灵敏度均满足有关物质测定要求。替卡西林杂质A与破坏条件下产生的降解杂质与主成分峰分离较好;替卡西林的最低检出限为4.8ng,克拉维酸的最低检出限为7.3ng;原料药与制剂样品中替卡西林杂质A均<1.5%,最大单个杂质均<2.0%,总杂质均<4.0%。结论 本方法专属性好,灵敏度高,可用于替卡西林钠原料药和注射用替卡西林钠克拉维酸钾中有关物质的测定。  相似文献   

3.
目的 采用HPLC法测定恩替卡韦中的有关物质.方法 采用ODS-AQ C18色谱柱(250 mm × 4.6 mm,5μm),流动相A为乙腈-水(3∶97),流动相B为乙腈,梯度洗脱,流速1.0 mL·min-1,检测波长254 nm,柱温35℃.结果 恩替卡韦与降解杂质能完全分离,分离度为2.99;检测限和定量限分别为20、68 ng·mL-1,精密度良好(RSD=0.73%).结论 所用方法灵敏、准确、操作简便、专属性强,可用于测定恩替卡韦原料药及片剂中的有关物质.  相似文献   

4.
目的:建立超高效液相色谱梯度洗脱法测定注射用头孢替唑钠中的有关物质。方法:采用 Waters Acquity UPLC BEH C18(100 mm ×2.1 mm,1.7μm)色谱柱,以枸橼酸溶液(取枸橼酸3 g 加水溶解并稀释至900 ml)-乙腈(90:10)为流动相 A,乙腈为流动相 B,线性梯度洗脱;流速:0.3 ml/ min;检测波长:254 nm。结果:在0.19~47.08μg/ ml浓度范围内,头孢替唑峰面积与浓度呈良好的线性关系(r =1.0000)。结论:本法简便快速、专属性强,可作为测定注射用头孢替唑钠有关物质的有效方法。  相似文献   

5.
目的建立测定注射用别嘌醇钠有关物质的高效液相梯度洗脱法。方法采用ODS C18色谱柱(250 mm×6 mm,5μm),以1.25 g.L-1磷酸二氢钾-甲醇(体积比为90∶10~70∶30)为流动相进行梯度洗脱,柱温为30℃,流速为1.0 mL.min-1,检测波长为230 nm。结果在上述色谱条件下,5种杂质(1-5)能与别嘌醇得到有效分离,分离度大于1.5;检测限为4.5 ng,精密度良好(RSD为0.71%)。结论高效液相梯度洗脱法可用于测定注射用别嘌醇钠中的有关物质。  相似文献   

6.
目的:建立高效液相色谱( HPLC)法,检测甲磺酸伊马替尼脂质体的含量及有关物质。方法 Kromasil C18柱,流动相 A 为辛烷磺酸钠溶液-甲醇(42:58);流动相 B 为辛烷磺酸钠溶液-甲醇(4:96);梯度洗脱,流速为1.2 mL·min-1,柱温室温,检测波长268 nm。结果在选定的色谱条件下,甲磺酸伊马替尼专属性良好,在线性范围1~100μg·mL-1内线性关系良好,r=0.9991(n=5)。结论该方法用于检测甲磺酸伊马替尼脂质体的含量及有关物质准确、灵敏、可靠。  相似文献   

7.
目的建立高效液相色谱法测定法莫替丁有关物质的方法。方法采用C18色谱柱,流动相采用乙酸盐缓冲液(pH6.0)-乙腈,梯度洗脱,流速为1.5mL·min^-1,检测波长为270nm,柱温为35℃。结果在该色谱条件下,法莫替丁与有关物质分离度良好,能有效检出法莫替丁的降解产物。结论该方法能够检测出法莫替丁的降解情况,对药品质量进行有效控制。  相似文献   

8.
目的 建立检查甲睾酮喷雾剂中有关物质的方法.方法 采用HPLC梯度洗脱法,色谱柱为VP-C18柱(250 mm×4.6 m,5 μm);以甲醇-乙腈-水(33:22:45)为流动相A,乙腈为流动相B,梯度洗脱;检测波长241 nm;柱温35℃;流速1.0 ml·min-1.结果 在选定的色谱条件下,主成分与有关物质能完全分离,各杂质峰分离良好,最低检测限为0.06 ng.结论 所建方法专属性强、灵敏度高、重复性好,可用于检查甲睾酮喷雾剂的有关物质.  相似文献   

9.
目的建立测定注射用替加环素有关物质的梯度洗脱反相高效液相色谱法。方法采用Wa-ters C18色谱柱(5μm,416 mm×250 mm),以磷酸盐缓冲液-乙腈(95∶5)为流动相A,以磷酸盐缓冲液-乙腈(50∶50)为流动相B。梯度洗脱条件:0~40 min,A:85%→57%;40~55 min,A:57%→0%;55~56 min,A:0%→85%;以1.0 mL/min的流速进行梯度洗脱,检测波长为248 nm。结果在上述色谱条件下,替加环素与各中间体杂质及降解杂质均能有效分离,分离度大于2.0;检测限为3.6 ng,精密度良好(RSD为0.7%)。结论本方法操作简便,专属性强,灵敏度高,可用于注射用替加环素有关物质的测定。  相似文献   

10.
对头孢呋辛酯的HPLC含量测定方法进行改进。色谱条件:采用ODS柱,0.01mol/L磷酸盐缓冲液(pH2.0)-乙腈-叔丁基甲醚(80:15:5)为流动相,柱温45℃,检测波长278nm。头孢呋辛酯与有关物质分离良好。头孢呋辛酯在89~268μg/ml范围内呈良好的线性关系,日内RSD为0.4%,含量测定结果与采用欧洲药典方法所得结果相符。提出了头孢呋辛酯有关物质检查的梯度洗脱HPLC法。  相似文献   

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First admissions and readmissions for alcoholism have risen steeply in recent decades. This study looked at readmission histories for four cohorts of alcoholics first admitted to inpatient psychiatric treatment in 1967-68, 1973, 1977 or 1979. Over the twelve years the first cohort was observed, alcoholics on average spent 254 days in treatment and had 2.14 alcohol-related readmissions. However the distributions were very skewed: 50% stayed less than 92 days and 45.6% had no readmissions at all. All four cohorts yielded similar results over comparable time periods and all showed markedly skewed distributions reflecting the diversity of readmission histories among alcoholics. Policy decisions about alcoholism inpatient treatment must take account of this diversity.  相似文献   

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Background: Osteoarthritis (OA) is a frustrating disease for both patient and physician because neither cause nor cure is known and there are currently no disease-modifying drugs. Objective: To review current therapeutic approaches as well as new findings regarding OA pathoetiology that could form the basis of future direction for the development of drugs to prevent or slow down disease progression. Methods: After reviewing disease progression in human OA, as demonstrated by histological analyses, the reasons for cartilage erosion are explored and possible therapeutic approaches are highlighted. Results/conclusions: OA may be an epigenetic disease. This new concept can explain many aspects of the disease and provide reasons why therapeutic approaches until now have met with little success.  相似文献   

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Introduction: The MAPK pathway is a signaling network that plays a key role in many normal cellular processes and in a large number of human malignancies. One of its effectors, MEK, is essential for the carcinogenesis of different tumors. In recent years, several drugs able to inhibit MEK have been assessed in clinical trials. Trametinib has recently become the first MEK inhibitor licensed for cancer treatment (advanced melanoma).

Areas covered: We comprehensively review the safety and clinical efficacy of the family of MEK inhibitors, either alone or in combination with other drugs. We discuss data ranging from the Phase III trial of trametinib in melanoma to the most recent drugs with early signs of antitumor activity. In addition, we explain the reasons for the unsuccessful results of the early trials with MEK inhibitors and provide a view of their role in cancer treatment in forthcoming years.

Expert opinion: MEK inhibitors are a potentially safe and active treatment option for the treatment of many human malignancies. The information provided by a large series of studies currently ongoing will be very valuable in order to optimize their use. Adequate selection of patients is crucial for achieving successful results with these compounds.  相似文献   

18.
The evolution of insulin treatment of diabetes has dramatically changed the natural course of this disease. Modern recombinant DNA technology has brought about many new insulin analogues with improved pharmacokinetics, resulting in better glycemic control. In addition, improved insulin delivery systems, such as insulin pumps and pens, have been introduced to provide convenience and to enhance patient compliance. Efforts are currently being devoted to developing noninvasive insulin formulations, such as oral and pulmonary insulin. A number of products are at different stages of clinical trials. Meanwhile, the quest for a permanent cure for diabetes continues. The frontier of diabetes research has gone through a period of substantial expansion, with the emergence of new areas that include gene therapy, islet cell transplantation and diabetic vaccine. Technological breakthroughs, such as recombinant DNA, nanotechnology, microarray-aided genomics and proteomics, will provide more profound insights into the pathogenesis, and the immunological and biological basis of diabetes. Our growing knowledge in these areas will ultimately contribute to the discovery of preventive methods against or a cure for this disease.  相似文献   

19.
王建民  张琳  史峻义 《中国药房》2008,19(13):993-994
目的:加强门诊调剂室规范化管理,保证药品质量,确保患者用药安全。方法:建立包括管理细则、工作程序、岗位分工及各类药品管理制度在内的系统的管理制度和操作规程。结果与结论:通过实施制度化、规范化管理,有利于规范人员行为,减少药患纠纷,提高患者信任度和满意度,保证患者的用药安全。  相似文献   

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