对《中国药典》中注射用水重金属检测的商榷

《中国药典》2 0 0 0年版 (下简称 2 0 0 0年版药典 )中注射用水检测项下较 1995年有较大改进 ,对硝酸盐、亚硝酸盐、氨、重金属等项的限度或方法进行了修改[1 ] 。现就笔者遇到的下列问题进行讨论。1　限度值过宽问题2 0 0 0年版药典规定 ,注射用水重金属限度为 0 .0 0 0 0 5 % ,若按体积重量换算 ,约相当于供试量的 5× 10 7。尤其是对大输液而言 ,用水量较大 ,注射用水质量的优劣直接影响着大输液的质量。其重金属限度 0 .0 0 0 0 5 % ,显然宽于大多数大输液的重金属限度规定。如氯化钠注射液、复方氯化钠注射液 ,重金属限度均规定为 3…     

影响注射用水质量的因素分析

注射用水是制备各种大输液制剂以及各类小针剂的主要溶媒,在质量上有着特别严格的要求。药典规定本品应为无色澄明的液体,无臭,无味。pH值应为5．0～7．0。100ml中不挥发物不得超过1．0rag,无热原,氯化物、硫酸盐与钙盐、氨、二氧化碳、易氧化钧、重金属等项应符合药典规定标准。供配制大输液及小水针剂用的注射用水。应于蒸馏出后12h内使用。注射用水质量对注射剂药物的安全、有效是非常重要的。影响注射用水质量有以下几个方面的因素。     

注射用水的馏制、储存及设备

中国药典2000年版把注射用水描述为“纯化水经蒸馏所得的水”,并把细菌内毒素限度由0.5EU·ml-1修改为0.25EU·ml-1;重金属限度也明确量化为0.000 05％。虽纯化水规定了蒸馏、离子交换和反渗透三种制备方法,但注射用水只限定为纯化水经蒸馏所得的水。注射用水的化学纯度由纯化水     

关于影响大输液澄明度因素的探讨

大输液质量的好坏直接影响病人的健康,而澄明度是衡量大输液质量的重要指标。影响输液澄明度的微粒是指直径在1～50urn的不能机体代谢的异物,对人体健康在宏观及微观上都有影响。我国药典规定输液中检查微粒限度的方法为目测灯检法,但此法只能检出大约50urn直径的粒子。我院制剂室配制大输液十余年时间,每批大输液均经过目测灯检法检查澄明度,发现影响大输液澄明度的因素有多方面,现总结如下。l注射用水的质量注射用水是灭菌制剂的主要溶媒,其质量对成品质量关系重大。我院制剂室采用多效重蒸馏器生产注射用水。Fe卅很容易进入注射…     

电导仪监控大输液注射用水的质量

电导仪监控大输液注射用水的质量沈承武，王复馨，陈丽萍（山东省立医院济南２５００２１）目前制备大输液所用的注射用水，在生产过程中每日只作几个主要项目，如ｐＨ、氯化物、氨、重金属等的检查，热原作定期检查，每月按药典规定进行全检。工作虽不复杂，但显繁琐，且...     

《中国药典》2000年版微生物限度检查法中存在的几个问题

《中国药典》 2 0 0 0年版一、二部附录中都收载了药品的微生物限度检查法和微生物限度标准 ,这说明了药品卫生质量的重要性和国家对其重视的程度 ,标志着我国药品卫生质量标准水平已达到一个新的阶段。与 1995年版药典相比 ,该版药典在卫生学检查方面是比较系统和完善的。微生物限度检查改变了按 1995年版药典方法检查 ,按 1986年部颁《药品卫生标准》来判断的状况。但笔者在研读过程中仍发现有以下几个问题值得商榷。1　部分剂型微生物限度检查项规定不明确在药典 (一部 )制剂通则中 ,共列出 2 5个非规定灭菌剂型 ,除可不作微生物限度检查…     

注射用水制备系统的验证

目的 :按照GMP的要求 ,验证注射用水制备系统各步骤的产水质量 ,介绍该系统维护措施。方法 :依据中国药典 2 0 0 0年版测试系统制水质量标准实施。结果 :制备的注射用水符合标准。其化学指标 ,符合中国药典 2 0 0 0年版注射用水项下的各项规定要求 ,菌落数为零 ,细菌内毒素不大于 0 .2 5EU·ml- 1,电导率 <1.5 μs·cm- 1。结论 :济南山泉制药厂制水系统能制备出合格的注射用水     

LT法检测6种大输液热原的研究

细菌内毒素的鲎试验法(LT法)已载入中国药典,由于首次收载,90版中国药典只允许2种放射药品,注射用水等4种大输液参照部颁标准用LT法检查热原,扩大应用亟待研究。本文考查了20％甘露醇等6种大输液对鲎试验的影响,建立了6种大输液热原检查的LT法。     

介绍一种检查大输液中重金属的操作取量简表

按照药典规定,大输液必须进行重金属的检查。在每次检查时,要根据药典规定的限度,计     

对大输液和实验用水有关重金属限度的商榷

检验结果的准确性至关重要,为确保检验结果的准确、可靠,必须严格按照药典的要求进行检验。在实际检验工作中由于所用化学试剂质量问题带来不少麻烦,影响检验工作的事例时有发生,然而实验用水对检验结果的影响尚未引起足够的重视。《中国药典》2000年版纯化水重金属检验方法较 1995年版蒸馏水检验方法作了改进,但大输液的方法没有     

Readmissions for treatment for alcoholism

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.     

Projections for insulin treatment for diabetics

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.     

Control of craving for methamphetamine: development of scales for dependence and search for medicines for treatment]

Methamphetamine dependence presents a serious problem not only for patients but also for society. Medical treatment has mainly targeted psychotic symptoms such as hallucination and delusion, and ignored the symptoms of craving, which are the major cause of dependence. Therefore, the risk of lapse into methamphetamine reuse remains very high. Although development of both medicines and programs for treatment of craving is needed, progress has been hampered by the lack of appropriate scales for assessing the severity of dependence and craving. On the other hand, recent breakthroughs in genomic sciences and molecular medicine have made it possible to investigate the molecular mechanisms underlying craving in animals. This paper reviews studies on the development of scales for assessing the severity of methamphetamine dependence and craving, together with recent data on candidate medicines for craving treatment in animals. The reliability and validity of the revised Addiction Severity Index -Japanese version (ASI-J) was confirmed after its administration to 100 drug abuse patients. The Craving Index was also newly developed, and its validity for prediction of relapse was confirmed. In animal experiments, fluoxetine, a selective serotonin reuptake inhibitor, was recognized as a candidate medicine for treatment of methamphetamine dependence.     

Prospects for MEK inhibitors for treating cancer

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.