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A Simple Assay for Amiodarone and Desethylamiodarone and its Clinical Application. 胺碘酮和去乙基胺碘酮的简易测定方法及其临床应用。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.28
K. Masaki, K. Ueno, M. Tsuji, K. Hiraki, M. Takada, S. Kamakura, M. Shibakawa
A simple reverse-phase high-performance liquid chromatographic (HPLC) assay for the measurement of amiodarone and its metabolite, desethylamiodarone in the serum was established. The ODS-2 column was used and the absorbance of the effluent from the column at 254 nm was measured. The standard curves for amiodarone and desethylamiodarone were linear up to 5μg/ml. The coefficent of variation (CV) was within 10% at a concentration of 100 ng/ml, and the CV of the intra-and interday variation was within 10% at concentrations of 0.25, 0.5 and 1μg/ml, respectively. These results suggest that the limit of detection is 100 ng/ml for amiodarone and desethylamiodarone, and this assay is thus considered to be a reliable method in clinical practice. On the other hand, the serum amiodarone and desethylamiodarone concentrations were measured in 10 inpatients who received amiodarone for at least 1 month. No significant correlation was observed between the doses and serum drug concentrations. There findings therefore suggest that TDM (Therapeutic Drug Monitoring) should be performed on anyone taking amiodarone.
建立了反相高效液相色谱法测定血清中胺碘酮及其代谢物去乙基胺碘酮含量的简便方法。采用ODS-2色谱柱,测定出液在254 nm处的吸光度。胺碘酮和去乙基胺碘酮的标准曲线在5μg/ml以内呈线性。当浓度为100 ng/ml时,变异系数(CV)在10%以内;当浓度为0.25、0.5和1μg/ml时,日内和日间变异系数(CV)在10%以内。结果表明,胺碘酮和去乙基胺碘酮的检出限为100 ng/ml,是一种临床可靠的检测方法。另一方面,对10例接受胺碘酮治疗至少1个月的住院患者进行血清胺碘酮和去乙基胺碘酮浓度测定。剂量与血清药物浓度无显著相关性。因此,研究结果表明,应该对任何服用胺碘酮的人进行TDM(治疗性药物监测)。
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引用次数: 4
Investigation of Pharmaceutical Equivalency in Pioneer and Generic Enteric-Coated Tablets. 先锋型和仿制型肠溶片药物等效性的研究。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.450
F. Ojima, T. Toyoguchi, T. Syoji, Y. Nakagawa
In order to investigate the pharmaceutical equivalency of four propentofylline enteric-coated tablets (a pioneer preparation and 3 generic preparations), a quantitative analysis, disintegration testing and dissolution testing were all performed to evaluate them.The mean contents of propentofylline in each preparation ranged from 96 to 102%. All of the tested materials conformed to the findings for the disintegration test for enteric-coated articles in the thirteeth revised edition of Japanese Pharmacopoeia (JP). However, at the end of the disintegration test with the 1st test medium (pH 1.2), swelling was observed in one or more of the 6 tested tablets for two of the generic preparations. Although no release of propentofylline was recognized, the core of the swollen tablets had completely disintegrated inside the enteric coating film in one of the two swollen generic preparations. When doing the same test aften placing the disks in gastric fluid, the propentofylline finally dissolved in the medium after 120 min. The dissolution test was performed with a paddle (100 rpm) according to JP using a 0.05 M phosphate buffer at pHs of 6.5 and 7.2. The dissolutions were complete in less than 60 min at both pHs, and they were faster at pH 7.2 for all preparations. However, the dissolution was significantly delayed, and the 75% dissolution time was also significantly prolonged for one of the three generic preparations at both pHs when compared to the other preparations.All of the propentofylline enteric-coated preparations were acceptable based on the JP criteria, however, the pharmaceutical equivalency of the generic preparations to the pioneer preparation heve not yet been obtained. As a result, the changes between generic preparations and pioneer preparations are therefore considered to be considerable, especially ragarding enteric coated preparations
为了考察4种丙烯茶碱肠溶片(1种先锋制剂和3种仿制制剂)的药物等效性,对其进行了定量分析、崩解试验和溶出度试验。各制剂中丙烯茶碱的平均含量为96% ~ 102%。试验材料均符合日本药典(JP)第13版肠溶包衣崩解试验结果。然而,在用第一种试验介质(pH 1.2)进行崩解试验结束时,两种仿制制剂的6个被试片中有一个或多个出现肿胀。虽然没有发现丙烯茶碱的释放,但在两种肿胀仿制药中,有一种肿胀片的核心在肠包衣膜内完全崩解。将膜片置于胃液中进行同样的测试,120分钟后丙烯茶碱最终溶解于培养基中。根据JP使用0.05 M磷酸盐缓冲液,在ph为6.5和7.2时,用桨(100 rpm)进行溶解试验。在两种pH下,溶解均在60分钟内完成,在pH为7.2时,溶解速度更快。然而,与其他制剂相比,三种仿制制剂中有一种在两种ph值下的溶出时间明显延迟,75%的溶出时间也明显延长。根据JP标准,所有丙烯酚肠溶制剂均可接受,然而,尚未获得仿制制剂与先驱制剂的药物等效性。因此,仿制制剂和先锋制剂之间的变化被认为是相当大的,特别是肠溶包衣制剂
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引用次数: 0
Clinical Use of Drug Delivery Systems: Prescription Survey on Clinical Use of PGE1 in Lipid Emulsions with Aqueous Infusions. 给药系统的临床应用:PGE1在脂质乳状液水溶液输注中的临床应用处方调查。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.393
B. Hino, Y. Kurosaki, K. Yamauchi, K. Kamiya, H. Araki, Y. Gomita, N. Goto, M. Masada, H. Kawasaki
As DDS drugs with various drug delivery functions are often prescribed under in conbination with a widerange of concurrent drug therapies, drug information closely related to its clinical usage is required to guarantee the appropriate multiple pharmaceutical functions of DDS drugs: We surveyed the actual concurrent therapy of lipo-PGE1 (Palux® inj. and Liple®), a targeting-type DDS, with various aqueous infusions at both Okayama University Hospital and Fukui Medical School Hospital. The term of the survey, which was done by evaluating the prescription records, and the total number of prescriptions were 14 months and 1, 005 prescriptions, respectively. Lipo-PGE1 was scarcely administered without any concurrently prescribed infusions. Although lipo-PGE1 was mostly diluted with Glucose Injection or Isotonic Sodium Chloride Solution, some electrolyte infusions were also concurrently prescribed with Lipo-PGE1 in some cases. The magnification of the dilution and the administration route seemed to be related each other. The data revealed in this report ave considered to be useful for a clinical usage-based assessment system to obtain further information guaranteeing the drug delivery function of Lipo-PGE1 from both a pharmaceutical and pharmacodynamic viewpoint one word.
由于具有多种药物传递功能的DDS药物经常与多种并发药物治疗联合使用,因此需要与其临床使用密切相关的药物信息,以保证DDS药物的多种药物功能合适:我们调查了lipop - pge1 (Palux®inj)的实际并发治疗情况。和Liple®),一种靶向型DDS,在冈山大学医院和福井医学院医院进行各种水输注。调查周期为14个月,总处方数为1005张。lipop - pge1几乎没有同时规定的输注。虽然脂质pge1主要用葡萄糖注射液或等渗氯化钠溶液稀释,但在某些情况下,一些电解质输注也同时使用脂质pge1。稀释的放大程度与给药途径似乎是相互关联的。本报告中揭示的数据被认为对基于临床使用的评估系统有用,从药理学和药效学的角度获得进一步的信息,保证lipop - pge1的给药功能。
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引用次数: 0
Effect of Diabetes on Theophylline Disposition in the Rat. 糖尿病对大鼠茶碱代谢的影响。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.603
A. Takahashi, K. Saito, Y. Takizawa, R. Murata
We examined the pharmacokinetics of theophylline in two types of experimental diabetic rats, streptozotocin-induced diabetic (STZ) rats with insulin dependent diabetes mellitus, and a genetic model of non-obese Goto-Kakizaki (GK) rats with non insulin dependent diabetes mellitus. After the rats were administered theophylline either intravenously or orally plasma was taken for a pharmacokinetic study. There were no significant differences in the pharmacokinetics of theophylline in the STZ rats compared with those of the controls. On the other hand, a delayed elimination process and absorption rate of theophylline were observed in GK rats in comparison to those of the controls. There findings suggest that two different phamacokinetics of theophylline exist depending on the two types of diabetic rats.
我们研究了茶碱在两种糖尿病大鼠体内的药代动力学,一种是链脲佐菌素诱导的胰岛素依赖型糖尿病大鼠(STZ),另一种是非胰岛素依赖型糖尿病的非肥胖后藤- kakizaki大鼠(GK)。给大鼠静脉或口服茶碱后,取血浆进行药代动力学研究。与对照组相比,茶碱在STZ大鼠体内的药代动力学无显著差异。另一方面,与对照组相比,GK大鼠的茶碱消除过程和吸收率延迟。结果表明,两种类型的糖尿病大鼠存在两种不同的茶碱药代动力学。
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引用次数: 1
Compatibility of Sodium Ferrous Citrate Improved-Granules in Combination with Other Preparations. 柠檬酸亚铁钠改良颗粒与其它制剂的配伍性。
Pub Date : 1999-01-01 DOI: 10.5649/jjphcs1975.25.176
Y. Arai, T. Nakane, A. Kubota, N. Mizushima, T. Shibata
Sodium Ferrous Citrate formulatio, Ferromia®granule was originally supplied as film-coated granules. However, some problems have been pointed out with this formulation regarding awkwardness in handling and unpleasantness during consumption.Therefore, corrigent was added while the film conting was removed in order to improve it.We investigated influence of changing the formilative method, and carry out the incompatibility test and hygroscopic test on 29 powders which can be admixed together. Furthermore, we also carried out a ferrous ion dissolution test on 11 powders which are likely to have an ionic interaction with iron. As a result, the modified granuls were incompatible when combined with ascorbic acid powder, Cinal ®granule, sodium bicarbonate and fblic acid powder (10%).The modified granules demonstrated no water-vapor sorption at 25°C, 75% RH at 30 days. Hygroscopicity was not considered to be related to incompatibility, and no noticeable difference was found due to the modification of the formulation.In the compounding the sample, dissolution property demonstrated only a slight difference in the ferrous ion elution.
柠檬酸亚铁钠配方,铁®颗粒最初作为薄膜包覆颗粒供应。然而,这一配方也存在一些问题,如操作笨拙和消费过程中不愉快。因此,在去除含膜物的同时加入correct,以改善其性能。考察了不同制备方法对其的影响,并对可混合的29种粉末进行了不相容试验和吸湿试验。此外,我们还对11种可能与铁离子相互作用的粉末进行了亚铁离子溶解试验。结果表明,改性颗粒与抗坏血酸粉、Cinal®颗粒、碳酸氢钠和10%的硫酸粉配伍时不相容。改性颗粒在25°C, 75% RH条件下,30天无水蒸气吸附。吸湿性不被认为与不相容有关,并且由于配方的修改而没有发现明显的差异。在复合样品中,亚铁离子洗脱的溶解性能仅表现出轻微的差异。
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引用次数: 0
Stability of Vitamins in the TPN Mixture at a Clinical Site. TPN混合物中维生素在临床的稳定性。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.40
Y. Wakiya, A. Saiki, N. Kondou, M. Masada
We investigated the stability of Vitamins in a total parenteral nutrition (TPN) solution. We compared examinations at the same clinical site at two different dosage periods for the administration of Vitamins (daytime and nighttime) with the finding of a basic examination. We thus found the stability in most instances to be the same as for the basic examination of stability in numerous Vitamins reports (effect of light and temperature, trace elements, sodium sulfite). At on clinical site during the different dosage periods, the dosage at nighttime was found to be better than that observed in the daytime. We consider this influence on stability of the Vitamins to be related to the alteration of the quantity of light during the daytime. These findings suggested that the addition of Vitamins to TPN solutions should therefore be avoided whenever possible during daytime administration.
我们研究了维生素在全肠外营养(TPN)溶液中的稳定性。我们比较了在同一临床部位在两个不同剂量时期(白天和夜间)给药的检查结果与基本检查的发现。因此,我们发现在大多数情况下,稳定性与许多维生素稳定性的基本检查报告(光和温度的影响,微量元素,亚硫酸钠)相同。在不同给药期的临床现场,夜间给药量优于白天给药量。我们认为这种对维生素稳定性的影响与白天光照量的变化有关。这些发现表明,在TPN溶液中添加维生素应尽可能避免在白天给药。
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引用次数: 0
Development and Utilization of the Database of Problem List from Pharmaceutical Care Records Concerned with Problems and Assessments on Pharmacotherapy in Wards. Proposal to Use and Develop Jointly the Database of Problem List from Pharmaceutical Care Records. 药学服务记录问题清单数据库的开发与利用、病区药物治疗问题及评价。建议共同利用和开发药学服务记录问题清单数据库。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.53
Mariko Asahi, Noriaki Kakimoto, J. Nishigami, R. Matsushita, F. Ichimura
The compilation of a Problem List for certain problems regarding drug therapy obtained through a clinical pharmacy service is useful for detecting and preventing any adverse drug reactions or potential problems in clinical practice. Such useful information is not available many other pharmacists in Japan. We tried to develop a database and a software program for such a Problem List based on the pharmaceutical care records at our hospital according to our proposed format. This database consists of 771 data which can be cross-referenced to diseases, drug names and clinical divisions, respectively. Moreover, we can statistically evaluate the Drug Information contents by pharmacists using this database. We here in propose that all pharmacists in Japan carefully preserve their pharmaceutical care records based on our format and so that all may use the database jointly.
通过临床药学服务收集药物治疗的某些问题,编制问题清单,有助于发现和预防临床实践中的药物不良反应或潜在问题。这些有用的信息是日本许多其他药剂师无法获得的。我们尝试根据我们提出的格式,基于我们医院的药物护理记录,为这样一个问题清单开发一个数据库和一个软件程序。该数据库由771个数据组成,可分别交叉引用疾病、药物名称和临床部门。此外,我们还可以利用该数据库对药师的药品信息内容进行统计评价。我们在此建议日本的所有药剂师根据我们的格式仔细保存他们的药物护理记录,以便所有人都可以共同使用该数据库。
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引用次数: 0
Questionnaire Survey about the Side Effects of Drugs in the Multiple Medical Institutions. 多家医疗机构药品不良反应问卷调查。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.440
Y. Koike, K. Uno, Manabu Abe, M. Tsugita, M. Tobita, K. Kajiwara, K. Toyama, H. Kawase, N. Yohkoh, Mayumi Sasahara, Miho Takahashi, K. Ono, Youko Sutoh, S. Maruyama, Kazuhiko Nagai
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引用次数: 1
Survey of Drug Information Leaflet in Ranitidine Use for Outpatients. Switch OTC. 门诊患者使用雷尼替丁药品信息单张调查。开关场外。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.690
N. Takami, Ayumi Sakiya, K. Moriwaki, Masahiro Tamasiro
Switch OTC preparations of H2-receptor antagonists have been marketed since September 1997, which causes concern about the possible concomitant use with H2-receptor antagonists while the patient does not know that they are from the same drug class.We conducted a telephone-interview survey of patients awareness of drug information leaflets on switch OTC preparations of H2-receptor antagonists including precautions for use and adverse drug reactions in 203 patients who were taking ranitidine.Of the 203 patients, 16 (7.9%) purchased OTC preparations including cold remedy and gastric drugs. Of the 203 patients, 164 (80.8%) replied that they did not know about the selling of switch OTC preparations, because, for example, they were aware of their commercial message but did not know that they were from the same class of drug as ranitidine.Twenty-three (11.3%) of the 203 patients also received medication from other hospital (s), although type of drugs were not known.
自1997年9月以来,h2受体拮抗剂的转换OTC制剂已上市,这引起了人们对可能与h2受体拮抗剂同时使用的担忧,而患者不知道它们属于同一药物类别。我们对203例正在服用雷尼替丁的患者进行了电话访谈调查,了解患者对h2受体拮抗剂OTC药品说明书的了解情况,包括使用注意事项和不良反应。203例患者中,16例(7.9%)购买了包括感冒药和胃药在内的OTC制剂。203名患者中,有164名(80.8%)表示他们不知道销售非处方药的情况,例如,他们知道其商业信息,但不知道它们与雷尼替丁属于同一类药物。203名患者中有23名(11.3%)也接受了其他医院的药物治疗,但药物类型尚不清楚。
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引用次数: 0
Study of a Scale for Discriminating the Self-Regulation of Medication to Select the Correct Menu of Individualized Medication Consultation. 辨别性用药自律量表在个体化用药咨询中选择正确菜单的研究。
Pub Date : 1999-01-01 DOI: 10.5649/JJPHCS1975.25.138
N. Iihara, T. Tsukamoto, S. Morita
The purpose of this study is to establish the methodology of individualized medication consultation. We studied a Scale for Discriminating the Self-Regulation of Medication, which was an instrument of discriminating whether a patient was more likely to do a self-regulation of medication. Items of this scale are composed of principal factors related to self-regulation ofmedication age, degree of understanding common information for medication, and the patient's concept of what is important in taking medicines without anxiety. These items were extracted by multivariate analysis. For this analysis, we interviewed 73 patients. About 85 percent of subjects were discriminated correctly with this scale.This scale enables us: 1) to classify patients according to the discriminant values, where we can select the menu of consultation based on the classification, 2) to understand the reasons why a patient does self-regulation of medication. Consequently, it becomes easier to make an individualized medication consultation plan. To establish and validate this scale, further assessment is needed more in patients with various diseases.
本研究的目的是建立个体化用药咨询的方法学。我们研究了一个区分药物自我调节的量表,这是一个区分病人是否更有可能进行药物自我调节的工具。该量表的项目由用药年龄自我调节、对常用用药信息的了解程度、患者对无焦虑服药中重要事项的概念等主要因素组成。这些项目通过多变量分析提取。为了进行分析,我们采访了73名患者。大约85%的受试者被正确地用这个量表区分出来。该量表使我们能够:1)根据判别值对患者进行分类,并根据分类选择会诊菜单;2)了解患者自我调节用药的原因。因此,它变得更容易制定个性化的药物咨询计划。为了建立和验证这一量表,需要对不同疾病的患者进行进一步的评估。
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引用次数: 0
期刊
Japanese Journal of Hospital Pharmacy
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