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High-Performance Liquid Chromatographic Determination of Vinorelbine and its Application to Pharmacokinetic Study in Rat Plasma. 高效液相色谱法测定长春瑞滨在大鼠血浆中的药动学研究。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.601
Y. Nishida, K. Kikuchi, T. Ohishi, T. Masuike, K. Ohmori
In order to study the pharmacokinetics of vinorelbine and provide information necessary to determine the optimal therapy, a specific and reliable method to determine the levels of vinorelbine in biological fluids is required. We, therefore, established a highly sensitive and specific assay method for vinorelbine in biological fluids using reverse phase HPLC. The vinorelbine level was determined using HPLC with UV detection at 268 nm, combined with liquid-liquid extraction using diethyl ether for sample clean-up. The HPLC system used an ODS column and a mobile phase of 48 vol% methanol containing 0.05 vol% trifluoroacetic acid. The absence of endogenous interference and the excellent chromatographic behavior of vinorelbine provides accurate results even at low concentrations. The limit of determination is 2 ng/mL (100μL, sample), and the range of the assay is from 2 to 200 ng/mL. Consequently, this method is thus suggested to be highly sensitive and specific for determining the vinorelbine levels in biological fluids. Using this method, we measured the plasma concentrations of vinorelbine after a single intravenous administration of vinorelbine at 1.2 mg/kg in male rats. The plasma concentration ofvinorelbine disappeared triphasically after the intravenous administration of the drug.Based on these findings, this method is considered to be useful for drug monitoring of clinical specimens and also for basic studies, using small animals.
为了研究长春瑞滨的药代动力学并提供确定最佳治疗所需的信息,需要一种特定而可靠的方法来确定生物体液中长春瑞滨的水平。因此,我们建立了一种高灵敏度和特异性的反相高效液相色谱法测定生物体液中长春瑞滨的方法。采用高效液相色谱法测定长春瑞滨的含量,紫外检测波长268 nm,并用二乙醚液-液萃取法对样品进行清理。高效液相色谱系统采用ODS色谱柱,流动相为48 vol%甲醇,含0.05 vol%三氟乙酸。无内源性干扰和长春瑞滨良好的色谱行为提供了准确的结果,即使在低浓度。测定限为2 ng/mL (100μL,样品),测定范围为2 ~ 200 ng/mL。因此,该方法对测定生物体液中的长春瑞滨水平具有高度的敏感性和特异性。用这种方法,我们测量了雄性大鼠单次静脉注射长春瑞滨(1.2 mg/kg)后的血浆浓度。静脉给药后,长春瑞滨血药浓度呈三期消失。基于这些发现,该方法被认为可用于临床标本的药物监测以及使用小动物的基础研究。
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引用次数: 0
Variation of Constitution Ratio of Six Major Components in Teicoplanin Preparations. 替柯planin制剂中6种主要成分组成比的变化。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.345
Kana Matsumoto, K. Ueno, M. Takada, M. Shibakawa
Objectives: Teicoplanin is an antibiotic complex consisting of five closely related components of similar polarity designated A2-1, 2, 3, 4 and 5 and a more polar factor A 3. The variations in the constitution ratio of the six major components were measured to evaluate the validation of teicoplanin preparations.Methods: The concentrations of each component of teicoplanin were measured in 14 lots by high performance liquid chromatography.Results: No significant differences were observed regarding the variation in the constitution ratio between the A 2 and A 3 groups. However, significant differences were found in the A 2-1 component.Conclusions: Variations of the constitution ratio in Teicoplanin preparations may possibly affect the pharmacokinetics of teicoplanin. More care is thus called for during the manufacturing process.
目的:Teicoplanin是一种抗生素复合物,由五种相近极性的密切相关成分A2-1、2、3、4和5以及极性更高的因子a3组成。测定了六种主要成分组成比的变化,评价了替柯planin制剂的有效性。方法:采用高效液相色谱法测定14批替柯planin中各组分的浓度。结果:a2组和a3组的体质比变化无显著差异。然而,在A 2-1成分中发现了显著差异。结论:替柯planin制剂中组成比的变化可能影响替柯planin的药代动力学。因此,在制造过程中需要更加小心。
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引用次数: 1
Compliance for Oral Antidiabetic Agents and its Improvement by One dose Package. 口服降糖药的依从性及单剂量包装的改善。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.674
K. Ishida
The compliance of 60 year old or older diabetic patients taking oral antidiabetic agents was investigated. As a result, the compliance for oral antidiabetic agents with different dosing times declined according to the frequency that such medicine had to be taken.It is suggested that this case occurs when the complexity of medicines increases by using a heat seal and when patient's concern to oral antidiabetic agents declines since packaging forms of medicines are the same. A good compliance was obtained regardless of the dosing time if the total number of medications were 4 or less, if all the medicines could be included in one dose package and if the dosing time for all medicines was the same.
调查60岁及以上糖尿病患者口服降糖药的依从性。因此,口服降糖药不同给药时间的依从性随服药频率的增加而下降。有人建议,当使用热封增加药物的复杂性时,当患者对口服降糖药的关注下降时,因为药物的包装形式是相同的,这种情况就会发生。如果药物总数为4种或更少,如果所有药物都可以包含在一个剂量包中,并且所有药物的给药时间相同,则无论给药时间如何,依从性都很好。
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引用次数: 1
Development of the Documentation System for the Pharmaceutical Management and Counseling Services Implementation of Pharmaceutical Standardized-Languages: PAC, POC and PIC. 药品管理与咨询服务文件系统的开发。药品标准化语言:PAC、POC和PIC的实施。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.369
T. Murayama
If Pharmaceutical Management and Counseling Services are required for active participants in the health care industry, then innovative strategies must be adopted to accurately document pharmacist's contributions for the area. We therefore attempted to develop a new documentation method to enable pharmacy departments to achieve certain patient outcomes. The Pharmaceutical Assessments Classification (PAC) is standardized language system for pharmaceutical assessments. The Pharmaceutical Outcomes Classification (POC) to evaluate the pharmaceutical outcome and the Pharmaceutical Interventions Classification (PIC) to determine pharmaceutical intervention were therefore developed. A database program was designed and included the patient's database, medication history, care plan, flow sheet and Focus Charting®, using the Microsoft Access® software package. With the addition of these standardized languages, the above program allowed pharmacists to document each intervention and its associated outcome through a process that is readily accessible, quick, reproducible, and clearly interpretable. The widespread use of this new system is thus expected to accelerate the normal evolutionary changes in both pharmaceutical standards and practice.
如果医药管理和咨询服务需要积极参与医疗保健行业,那么必须采用创新的策略来准确地记录药剂师对该领域的贡献。因此,我们试图开发一种新的记录方法,使药房部门能够实现某些患者的结果。药品评价分类(PAC)是用于药品评价的标准化语言系统。因此,制定了评价药物疗效的药物结局分类(POC)和确定药物干预措施的药物干预分类(PIC)。使用Microsoft Access®软件包设计数据库程序,包括患者数据库、用药史、护理计划、流程图和Focus chart®。随着这些标准化语言的加入,上述项目允许药剂师通过一个易于获取、快速、可重复和可清晰解释的过程记录每次干预及其相关结果。因此,这种新系统的广泛使用预计将加速药物标准和实践的正常演变变化。
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引用次数: 0
Effects of the Medicative Consultations and Counseling on Colestyramine for Familial Hypercholesterolemia Outpatientst. 家族性高胆固醇血症门诊患者抗胆胺药物咨询的效果。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.287
T. Ichikawa, M. Hirata, Hiromi Sasaki, I. Johno, S. Ishida, Y. Okano
The effects of the medicative consultations and counseling to eight outpatients with familial hypercholestrolemia on colestyramine medications mainly by pharmacists were investigated. Eight outpatients had showed a frequent noncompliance for colestylamine but also other therapeutic drugs would be considered. In this study, a questionnaire survey on the patient's view regarding colestyramine resulted in the conclusion that large doses in suspension were difficult to swallow. In addition, some of the patients did not have sufficient knowledge of their own diseases. These above reasons were considered to be the main causes for noncompliance.Trial of the medicative consultations and counseling were thus performed with both patients and pharmacists regarding colestyramine dosing and dieteric problems. These trials were thus found to improve medication compliance and the patient's understanding of their own diseases. Furthermore, the mean values of total cholesterol (T-Chol) and low density lipoprotein-cholesterol (LDL-Chol) concentrations in the eight patients all significantly decreased after the medicative consultations and counseling compared to the period before starting the therapy (p<0.01) and these trials (p<0.05), respectively. In addition, decreases in the percentages of T-Chol and LDL-Chol per month after medicative consultations and counseling increased to about 2.5 times based on the values before medicative consultations and counseling and the difference was significant (p<0.01 in T-Chol, p<0.05 in LDL-Chol).These results suggested that the medicative consultations and counseling with pharmacists and patients were found to improve pharmaceutical compliance in patients with familial hypercholesterolemia.
对8例门诊家族性高胆固醇血症患者进行以药师为主的药物咨询和咨询,了解其对胆碱类药物的影响。8例门诊患者经常出现不遵医嘱,但也会考虑使用其他治疗药物。本研究通过问卷调查患者对大肠杆菌胺的看法,得出大剂量混悬剂难以吞咽的结论。此外,一些患者对自己的疾病没有足够的了解。上述原因被认为是不合规的主要原因。因此,对患者和药剂师进行了关于肠胱胺剂量和饮食问题的药物咨询和咨询试验。因此,这些试验被发现提高了服药依从性和患者对自己疾病的了解。8例患者的总胆固醇(T-Chol)均值、低密度脂蛋白胆固醇(LDL-Chol)浓度均较治疗前显著降低(p<0.01),较治疗前显著降低(p<0.05)。此外,药物咨询和咨询后每月T-Chol和LDL-Chol的下降百分比比药物咨询和咨询前增加了约2.5倍,差异有统计学意义(T-Chol <0.01, LDL-Chol <0.05)。这些结果表明,与药师和患者进行药物咨询可以提高家族性高胆固醇血症患者的药物依从性。
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引用次数: 1
Effect of Hepatic and Renal Failure on the Pharmacokinetics of ACE Inhibitors in Rats. 肝肾衰竭对ACE抑制剂在大鼠体内药动学的影响。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.309
K. Omoda, T. Konishi, Y. Maeda, Hiroyuki Yamato, S. Fukuhara, Mamoru Nakamura, M. Fukuzawa, S. Tsukiai
Inhibitors of angiotensin convering enzyme (ACE) are widely used for the treatment of hypertension and cardiac insufficiency. However, such patients demonstrate a wide range diseases and conditions, and hence appropriate ACE inhibitors must be selected depending upon the condition of each individual patient. In the present study, we prepared model rats for various circulatory disorders and investigated which medicine should be used for various disorders based on pharmacokinetic investigations of the ACE inhibitor drug excreted in the bile and from the kidney (temocapril hydrochloride, Acecol®) and another ACE inhibitor excreted from the kidney (lisinopril, Longes®) using the models. In the temocapril dosed groups, the elimination rate constant (Ke, 1/hr) was 1.03 for the hepatic disorder model group and 0.15 for the cholestatic model group, and both were significantly smaller than the 1.58 rate constant for the control group. Although no significant difference was noted, the renal disorder model group showed a slightly decreased Ke value of 1.27 compared with the control group. In the lisinopril dosed groups, the half-life was long, and no intergroup difference was observed in the pharmacokinetic parameters until 6 hr after administration. The results of the present study suggest that the use of temocapril is safer when renal disorders occur while the use of lisinopril is safer for hepatic disordes. In order to minimize the development of adverse reactions and to obtain the desired clinical efficacy, it is necessary to select drugs only after sufficiently analyzing the condition of each illness and taking into account the characteristic properties of the individual drugs.
血管紧张素转换酶(ACE)抑制剂广泛用于高血压和心功能不全的治疗。然而,这些患者表现出广泛的疾病和状况,因此必须根据每个患者的情况选择适当的ACE抑制剂。在本研究中,我们制备了各种循环疾病模型大鼠,并利用模型对胆汁和肾脏排泄的ACE抑制剂(盐酸替莫普利,Acecol®)和另一种肾脏排泄的ACE抑制剂(赖诺普利,Longes®)的药代动力学研究,探讨了各种疾病应该使用哪种药物。替莫april给药组肝脏疾病模型组和胆汁淤积模型组的消除速率常数(Ke, 1/hr)分别为1.03和0.15,均显著小于对照组的1.58。肾脏疾病模型组Ke值较对照组略有降低,为1.27,差异无统计学意义。赖诺普利给药组半衰期较长,直至给药后6小时药代动力学参数均无组间差异。本研究的结果表明,在发生肾脏疾病时使用替莫普利更安全,而在发生肝脏疾病时使用赖诺普利更安全。为了最大限度地减少不良反应的发生,获得理想的临床疗效,在选择药物时必须充分分析每种疾病的病情,并考虑到每种药物的特性。
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引用次数: 0
Study on Factors that Contribute to Poor Patient Compliance with Medication in Japan 日本患者服药依从性差的影响因素研究
Pub Date : 1999-12-10 DOI: 10.5649/JJPHCS1975.25.634
H. Hashimoto, Masayo Tanaka, Tadashi Oyake, T. Gomi, T. Ikeda, Masanori Yoshida, T. Fujimoto, M. Umezu, K. Nagashima, T. Fujita, M. Fujii, Y. Matsumoto, M. Fukuoka, M. Matsumoto, M. Ishi
Patient compliance is an important part of drug therapy, but not all patients take their medication exactly as directed. Although it is very important to investigate and identify factors that contribute to poor compliance, there have so far been very few studies of this kind in Japan. We therefore performed a cross-sectional study to analyze the factors associated with poor patient compliance (various patient background factors and a dozen matters dealing with medical care: the relationship between physicians and hospital staff, the time required to visit hospital, the drug therapy regimen, etc.) using the data obtained from patients who had been subjects of a QOL study on Carvedilol.The results showed that patient compliance was “good” is 83.3% of the patients, and that compliance was poorer among the following three groups of patients: employed patients (odds ratio: 5.15, 95% confidence level: 1.53-17.30, p=0.01), female patients (odds ratio: 3.39, 95% confidence level: 1.07-10.74, p=0.038), and patients who felt that their attending physicians did not provide enough information about the administered drug (odds ratio: 2.58, 95% confidence level: 0.88-7.58, p=0.084).
患者依从性是药物治疗的重要组成部分,但并非所有患者都完全按照指示服药。虽然调查和确定导致依从性差的因素非常重要,但迄今为止在日本进行的此类研究很少。因此,我们进行了一项横断面研究,分析与患者依从性差相关的因素(各种患者背景因素以及与医疗保健有关的十几个问题:医生与医院工作人员的关系、就诊时间、药物治疗方案等),使用的数据来自于卡维地洛生活质量研究的受试者。结果显示,83.3%的患者依从性为“良好”,其中在职患者(优势比5.15,95%置信水平:1.53 ~ 17.30,p=0.01)、女性患者(优势比3.39,95%置信水平:1.07 ~ 10.74,p=0.038)和认为主治医生对给药信息提供不足的患者(优势比2.58,95%置信水平:0.88 ~ 7.58,p=0.084)依从性较差。
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引用次数: 3
Effect of Acarbose Taken Just before and after a Meal on Plasma Glucose Level in Japanese Healthy Subjects 日本健康人餐前餐后服用阿卡波糖对血糖水平的影响
Pub Date : 1999-12-10 DOI: 10.5649/JJPHCS1975.25.715
T. Asakura, H. Seino, S. Nozaki, Yuko Suzuki, R. Abe
We studied the effect of a patient forgetting to take acarbose and also investigated whether there is any benefit in taking it within certain time periods after a meal. The subjects consisted of 10 volunteers and the tests were conducted during lunch periods. Over 6 test days the subjects ingested breakfast (100 kcal; carbohydrate 78%) and lunch (624 kcal; carbohydrate 56%) each day. On the first test day, as a control, no acarbose was given. Blood was drawn 7 times to determine the levels of plasma glucose and immunoreactive insulin (IRI) (just before and after a meal, and after 30 minutes, 45 minutes and 60 minutes, 90 minutes, and 120 minutes after a meal). The same 10 subjects then took 100 mg of acarbose just before a meal, and 30 minutes, 45 minutes and 60 minutes after starting a meal respectively on different days. The levels of plasma glucose and IRI were measured for the 7 blood drawing times. The levels of plasma glucose of the subjects who took acarbose just before a meal were significantly lower at the 5 times, from just after meal to 90 minutes after starting time of a meal, compared to the controls. The levels of IRI in the subjects who took acarbose just before meals were lower at all times compared to the controls and other intakes. There was no significant difference in the area under the blood concentration-time curve (AUC0-120) 1of plasma glucose during the 120 minute period after starting a meal between the subjects who took acarbose just before a meal, just after starting a meal, and 30 minutes after starting a meal. It was found that taking acarbose was therefore the most effecctive just before a meal but, if this is forgotten, it can still be effective if taken 15-30 minutes after starting a meal.
我们研究了病人忘记服用阿卡波糖的影响,也调查了在饭后的特定时间内服用是否有任何好处。研究对象由10名志愿者组成,测试在午餐时间进行。在6天的测试中,受试者摄入早餐(100千卡;碳水化合物78%)和午餐(624千卡;碳水化合物(56%)。在第一个试验日,作为对照,没有给予阿卡波糖。取血7次(餐前、餐后、餐后30分钟、45分钟、60分钟、90分钟、120分钟)测定血糖和免疫反应性胰岛素(IRI)水平。然后,同样的10名受试者在不同的日子里分别在饭前、饭后30分钟、45分钟和60分钟服用100毫克阿卡波糖。测定7次抽血时的血糖和IRI水平。与对照组相比,餐前服用阿卡波糖的受试者的血糖水平在餐后至用餐开始后90分钟的5次中显著降低。饭前服用阿卡波糖的受试者的IRI水平始终低于对照组和其他摄入量。餐前、餐后、餐后30分钟服用阿卡波糖的受试者在餐后120分钟内血糖血药浓度-时间曲线下面积(AUC0-120) 1无显著差异。研究发现,在饭前服用阿卡波糖是最有效的,但如果忘记了这一点,在饭前15-30分钟服用阿卡波糖仍然有效。
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引用次数: 4
結腸癌患者の術後感染管理に及ぼす経口腸管洗浄剤 (ニフレック®) の影響 口服肠管清洗剂(niflex®)对结肠癌患者术后感染管理的影响
Pub Date : 1999-12-10 DOI: 10.5649/jjphcs1975.25.663
徳昭 北田, 聡子 関戸, 睦展 吉岡, 隆之 辻, 雅克 渡, 和夫 黒田
We examined that the influences of pre-treatment with the peroral intestinal irrigator (Niflec®) for the 69 post-operative patients of colon cancer from June 1995 to June 1997.Number of irrigation methods have been increasing administrated at the Takarazuka City Hos-pital since 1995. The Niflec® irrigator was used for the 39 patients.In the patient group, in which such these irrigator were used, the administrative periods of theantibiotics significantly decreased. On the other hand, the hospital-stay of the these patients alsoshorted.In our investigation, the 1st and 2nd generation cephems were considered to be the first choicein post-operative infection control. Those drugs were thus used as the antibiotics of choice forthe infection control according to the species of the bacterium and their amounts. MRSAs wasnot detected.The results obtained from this survey suggest that pre-treatment of patients with a peroral in-testinal irrigator is therefore an effective treatment for post-operative infection control.
我们对1995年6月至1997年6月69例结肠癌术后患者经口灌肠器(Niflec®)预处理的影响进行了研究。自1995年以来,宝冢市医院管理的灌溉方法越来越多。39例患者使用Niflec®冲洗器。在使用这些冲洗器的患者组中,抗生素的给药时间明显缩短。另一方面,这些病人的住院时间也缩短了。在我们的研究中,第1代和第2代头孢醚被认为是术后感染控制的首选。因此,根据细菌的种类和数量,这些药物被用作控制感染的首选抗生素。未检测到mrsa。本调查结果提示术前经口肠内冲洗器是术后感染控制的有效方法。
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引用次数: 0
Determination of Tosufloxacin in Plasma by High-Performance Liquid Chromatography with Column Switching 柱切换高效液相色谱法测定血浆中托舒沙星的含量
Pub Date : 1999-12-10 DOI: 10.5649/JJPHCS1975.25.595
M. Kudo, T. Ohkubo, K. Sugawara
A high-performance liquid chromatography (HPLC) assay was developed for the determination of tosufloxacin in plasma. The plasma samples were directly introduced onto a HPLC precolumn, or after filtering through a Molcut (R) membrane filter, which prolonged the life time of the precolumn resulting from the removal high molecular proteins. The tosufloxacin and sparfloxacin as an internal standard in plasma or filtrate were separated from any interfering substances and then were concentrated on a pre-column using as ODS stationary phase and then were introduced to an analytical column with an ODS stationary phase by column switching. To-. sufloxacin and sparfloxacin were detected by ultraviolet absorption at 269 nm. The determination of tosufloxacin was possible over the concentration range of 50-1500 ng/mL ; and the limit of detection was 20 ng/mL. The recovery of tosufloxacin added to plasma was 96.2-99.5% with a coefficient of variation of less than 1.9%. This method is applicable to drug level monitoring in the plasma of patients being treated with tosufloxacin and in healthy volunteers participating in a scientific investigation to analyze the pharmacokinetics of drug-drug interaction of tosufloxacin.
建立了高效液相色谱法测定血浆中托沙星含量的方法。血浆样品直接导入HPLC预柱,或经过Molcut (R)膜过滤器过滤后,由于去除了高分子蛋白,延长了预柱的使用寿命。将血浆或滤液中的托舒沙星和司帕沙星作为内标,与干扰物分离后,作为ODS固定相在前柱上浓缩,然后通过柱切换进入ODS固定相的分析柱。- - - - - -。采用269 nm紫外吸收法检测苏氟沙星和斯氟沙星。在50 ~ 1500 ng/mL的浓度范围内可测定tosu氟沙星;检出限为20 ng/mL。血浆中添加tosu氟沙星回收率为96.2 ~ 99.5%,变异系数小于1.9%。本方法适用于接受托氧氟沙星治疗的患者血浆药物水平监测,以及参与科学调查分析托氧氟沙星药物相互作用药代动力学的健康志愿者。
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引用次数: 2
期刊
Japanese Journal of Hospital Pharmacy
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