Bulletin of National Institute of Health Sciences最新文献

{"title":"[Quality assurance of the chemical analysis measurements of foods].","authors":"Rieko Matsuda","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This document outlined the quality assurance of measurements in the chemical analysis practiced in the food testing in Japan. The quality required for a measurement is the confidence, but necessary degree of confidence is dependent on the intended use of the measurement. The recognition of the purpose of measurement is important in quality assurance of measurements. Once the required quality is decided, the quality of the measurement is assured by various quality assurance means. The international documents about quality assurance of measurement are introduced in this document, as well as the domestic notifications enforced in Japan. Means such as the validation of analytical method and the internal quality control are explained. The concept of the measurement uncertainty is also introduced.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"21-30"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31127268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Improved methodology for quantitative determination of thiabendazole].","authors":"Noriko Furusho,&nbsp;Noriko Otsuki,&nbsp;Takashi Ohtsuki,&nbsp;Chiye Tatebe-Sasaki,&nbsp;Kyoko Sato,&nbsp;Hiroshi Akiyama,&nbsp;Yoko Kawamura","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The method prescribed in the 8th edition of Japan's Specifications and Standards for Food Additives (JSSFA) for the quantitative analysis of thiabendazole was improved by eliminating the use of toxic reagents such as mercuric acetate and chromium trioxide. For exclusion of mercuric acetate, a nonaqueous titration was performed using four types of solvent systems, including acetic acid:acetic anhydride (1:5), acetic acid:acetic anhydride (3:7), acetic acid alone, and formic acid:acetic acid (1:10), that did not contain mercuric compounds. Because precipitates were formed in titrations using acetic acid alone and formic acid:acetic acid (1:10), we considered that it was difficult to determine the purity using these solvent systems. However, it was confirmed that the purity of thiabendazole dissolved in the two acetic acid:acetic anhydride solvent systems can be determined using either a visual indicator or potentiometry. Specifically, the purity of thiabendazole was determined to be 99.9% (relative standard deviation (RSD) = 0.07%) for acetic acid:acetic anhydride (1:5) and 99.7% (RSD = 0.13%) for acetic acid:acetic anhydride (3:7) With respect to chromium trioxide, it was determined that chromium trioxide can be excluded using acetic acid, which conforms to the JIS K8001 standard for nonaqueous titrations. Therefore, in this study, an improved method for the quantitative determination of thiabendazole was developed without the use of toxic reagents.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"46-9"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31127737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Studies on the food allergenic proteins contained in pharmaceutical excipients].","authors":"Shinobu Sakai,&nbsp;Reiko Adachi,&nbsp;Tamaki Miyazaki,&nbsp;Yukio Aso,&nbsp;Haruhiro Okuda,&nbsp;Reiko Teshima","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Most drugs contain pharmaceutical excipients. These are pharmacologically inactive substances used as vehicles for the active ingredients of a medication. Some of these pharmaceutical excipients are produced from allergenic foods (e.g., milk, egg, peanut, soybean, and sesame) and removing proteins completely from such excipients is difficult. Therefore, if individuals with food allergy consume drugs containing allergenic food-derived excipients, eliminating the risk of developing specific allergic symptoms induced by them may not be possible. We determined the levels of proteins in pharmaceutical excipients and ethical drugs (inhalants and injections) by spectrophotometric analyses. The level of protein in the pharmaceutical excipient lactose in each sample was approximately 1 mg/g. In the case of oils from soybeans, peanuts, and sesame in pharmaceutical excipients, proteins were detected in the range 7-9 microg/g sample. We also determined levels of allergenic proteins in pharmaceutical excipients and ethical drugs using commercial enzyme-linked immunosorbent assay systems. The milk proteins in lactose were detected in the range 1.39-13.07 microg/g. The results of this study suggest that physicians, patients with food allergies, pharmacists, and healthcare providers must pay attention to presence of potential impurities those may cause allergic symptoms in pharmaceutical products.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"58-65"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31127739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Determination of the relative light scattering intensity of aggregates induced by stirring of humanized monoclonal antibody product using dynamic light scattering].","authors":"Motoko Endo,&nbsp;Shingo Niimi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>To evaluate the usefulness of dynamic light scattering for estimation of the relative level of aggregates in the manufacturing process of monoclonal antibody substance and its final product, the particle sizes and relative light scattering intensities of monomer and aggregates induced by stirring of humanized monoclonal antibody product were determined by dynamic light scattering. The particle sizes of monomer and aggregates were approximately 5 and 500 nm, respectively. When aggregates and monomer were mixed at the ratio of 1 to 6, the relative light scattering intensity of aggregates was approximately 50%. These findings indicate the relative light scattering intensity of aggregates is approximately 7 times higher than that of monomer. Furthermore, these findings suggest that dynamic light scattering may be useful for the estimation of relative content of aggregates in the case that the relationship between the particle sizes of monomer and aggregates, and their relative light scattering intensities has been already examined.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"43-5"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31127736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Renewal of NIHS computer network system].","authors":"Katsunori Segawa,&nbsp;Tatsuya Nakano,&nbsp;Yoshiro Saito","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Updated version of National Institute of Health Sciences Computer Network System (NIHS-NET) is described. In order to reduce its electric power consumption, the main server system was newly built using the virtual machine technology. The service that each machine provided in the previous network system should be maintained as much as possible. Thus, the individual server was constructed for each service, because a virtual server often show decrement in its performance as compared with a physical server. As a result, though the number of virtual servers was increased and the network communication became complicated among the servers, the conventional service was able to be maintained, and security level was able to be rather improved, along with saving electrical powers. The updated NIHS-NET bears multiple security countermeasures. To maximal use of these measures, awareness for the network security by all users is expected.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"75-7"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31126015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Analysis of drug safety information using large-scale adverse drug reactions database].","authors":"Kaoru Morikawa","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The worldwide situations of drug safety have changed dramatically. Drugs are used based on the evaluation of safety data collected in clinical practice worldwide. US Food Drug Administration collects spontaneous reports and requires manufacturers to report adverse drug reactions (ADRs) of US marketed drugs occurring worldwide. These worldwide data are available through the Adverse Event Reporting System (AERS) (about 4.1 million reports on about 3,073,340 patients, for 13 years: 1997.4th qr-2010.4th qr.). The current issues are how to analyze and utilize such large-scale safety data. Potential biases should always be kept in mind, because AERS is based on spontaneous reports. However, its huge volumes and exhaustiveness allow for sufficient scientific evaluation with the aid of current IT technology. Therefore, analysis of large-scale ADR database becomes a new research area not only from the medical science but also from the statistical viewpoint. In this report, I introduce some case studies in which we analyzed the AERS data on psychotropics including antipsychotics, antiepileptics, and antidepressants. Antipsychotics caused ADRs specific to each drug, and, in combination therapy, increased the incidences of diabetes mellitus, pancreatitis, and neuroleptic malignant syndrome; antiepileptics caused AEs (adverse events) including serious skin reactions such as Stevens-Johnson syndrome (SJS), congenital anomaly, and closed-angle glaucoma; and antidepressants caused AEs including serotonin syndrome, suicidal events, and congenital anomaly, and AEs occurring at a higher incidence for other indications, drugs often used in the elderly and AEs in combination therapy. We have analyzed ADRs associated with concomitant drug therapies using Bayesian approach. In the analysis we faced difficulties of overdispersion and we have to estimate a number of parameters, given a large number of target drugs as well as ADRs. In addition, ADR reports are not collected from uniform populations, we also have to consider the variations in the target populations. So, we use Bayesian statistics. Bayesian analysis has become feasible with advances in computer technologies and the Markov chain Monte Carlo (MCMC) methods. It allows us to analyze ADRs associated with concomitant drug therapies and estimate the ADR signals for each drug. Therefore, the analysis and evaluation of large-scale ADR database can provide important safety information in clinical practice and the studies on ADR database are the most important issues in ensuring the postmark safety of pharmaceutical products.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 129","pages":"1-26"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30398853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Current topics on inactivation of norovirus].","authors":"Mamoru Noda,&nbsp;Masashi Uema","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Human norovirus is the most important foodborne virus in Japan. According to the statistics of food poisoning by the Ministry of Health, Labour, and Welfare (MHLW), the number of patients infected with norovirus has accounted for half of all the patients with food poisoning in recent years. One of the most important measures for the control of infectious diseases is establishing of techniques for inactivating pathogens. For the prevention of food poisoning caused by norovirus, MHLW recommends that foods be subjected to heat treatment at 85 degrees C for 1 min or more; moreover, it recommends the use of sodium hypochlorite to inactivate (disinfect) this virus. However, application of these treatments is not always feasible because heat results in denaturation and sodium hypochlorite can be toxic to the human body and can cause discoloration. Therefore, it is necessary to develop and improve the efficacy of disinfectants and physiochemical treatments against the virus. Human norovirus cannot be propagated in cell culture or in a small animal. This matter is the greatest hindrance for testing the stability of this virus in environments or for evaluating the efficacy of disinfectants, heat treatment, pH treatment, ultraviolet or gamma irradiation, high hydrostatic pressure treatment, and other methods for the inactivation of the virus. Hence, some viruses such as human enterovirus, feline calicivirus, or mouse norovirus have been used as surrogates of human norovirus. The data on inactivation and stability of surrogate viruses are exclusively used as the data of human noroviruses. In recent years, some attempts to distinguish between infectious and noninfectious virus particles by genetic methods such as polymerase chain reaction have been made. These methods include pretreatments by RNase for digesting viral RNAs from non-intact or destroyed virus particles, or addition of a reagent such as ethidium monoazide for inhibiting PCR amplification of viral RNAs from them, before RNA extraction. Non-intact virus particles, which may represent virus particles with some damage (s) in the structural protein(s), are not necessarily synonymous with non-infectious virus particles. However, the results of methods using these treatments, compared to the results of traditional methods without these treatments, seem to be more correlated to the amount of the infectious virus particles. Although many disinfectants or physiochemical treatments have been reported, traditional techniques such as removal of virus particles by washing in running water, heat treatment, or disinfection by sodium hypochlorite are still important control measures. Establishment of control measures for human norovirus and successful propagation of the virus in cell culture are strongly desired.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 129","pages":"37-54"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30399028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Study of radiation dose rate in air at Setagaya in Tokyo].","authors":"Akiko Hachisuka,&nbsp;Yoshie Kimura,&nbsp;Ryosuke Nakamura,&nbsp;Reiko Teshima","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The great earthquake occurred at East Japan on March 11, 2011 and the following tsunami induced the accident which environmentally leaked radioactive materials from the nuclear power plant of the Fukushima Daiichi. We measured radiation dose rate in air by the NaI (Tl) scintillation and GM survey meters from March 15 to May 30 at Setagaya in Tokyo. Three measured points were at the 1m height from the ground on asphalt surfaced road, at the 5cm height from ground with weeds, and at the room of a reinforced concrete building. As a result, a transient increase was observed on March 15, a sustained rise was observed on both days of March 21 and 22. The latter was thought to be due to the radioactive rainfall. These measured values were compared with the radiation dose rate in air of the cities in Kanto area, and it was confirmed that the measured values at Setagaya are not so different from that of those cities.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 129","pages":"129-33"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30399913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Current movements of four serious adverse events induced by medicinal drugs based on spontaneous reports in Japan].","authors":"Chie Sudo,&nbsp;Yu-ichiro Azuma,&nbsp;Keiko Maekawa,&nbsp;Nahoko Kaniwa,&nbsp;Kimie Sai,&nbsp;Yoshiro Saito","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Spontaneous reports on suspected serious adverse events caused by medicines from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated by the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety features. Although causal relationship between the medicine and the adverse event is not evaluated, and one incidence may be redundantly reported, this information would be useful to roughly grasp the current movements of drug-related serious adverse events, We searched open-source data of the spontaneous reports publicized by Pharmaceutical and Medical Devices Agency for 4 serious adverse events (interstitial lung disease, rhabdomyolysis, anaphylaxis, and Stevens-Johnson syndrome/toxic epidermal necrolysis) from 2004 to 2010 fiscal year (for 2010, from April 1 st to January 31th). Major drug-classes suspected to the adverse events were antineoplastics for interstitial lung disease, hyperlipidemia agents and psychotropics for rhabdomyolysis, antibiotics/chemotherapeutics, antineoplastics and intracorporeal diagnostic agents for anaphylaxis (anaphylactic shock, anaphylactic reactions, anaphylactoid shock and anaphylactoid reactions), and antibiotics/chemotherapeutics, antipyretics and analgesics, anti-inflammatory agents/common cold drugs, and antiepileptics for Stevens-Johnson syndrome/toxic epidermal necrolysis. These results would help understanding of current situations of the 4 drug-related serious adverse events in Japan.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 129","pages":"111-7"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30399911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Volatile organic compounds (VOCs) emitted from wood furniture--estimation of emission rate by passive flux sampler].","authors":"Hideto Jinno,&nbsp;Toshiko Tanaka-Kagawa,&nbsp;Mitsuko Furuta,&nbsp;Masayoshi Shibatsuji,&nbsp;Tetsuji Nishimura","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of this study was to evaluate aldehydes and other volatile organic compounds (VOCs) emission from furniture, which may cause hazardous influence on human being such as sick building/sick house syndrome. In this study, VOCs emitted from six kinds of wood furniture, including three set of dining tables and three beds, were analyzed by large chamber test method (JIS A 1911). Based on the emission rates of total VOCs (TVOC), the impacts on the indoor TVOC was estimated by the simulation model with volume of 20 m3 and ventilation frequency of 0.5 times/h. The estimated increment of formaldehyde were exceeded the guideline value (100 microg/m3) in one set of dining table and one bed. The estimated TVOC increment values were exceeded the provisional target value for indoor air (400 microg/m3) in two sets of dining tables and two beds. These results revealed that VOC emissions from wood furniture may influence significantly indoor air quality. Also, in this study, to establish the alternative method for large chamber test methods, emission rates from representative five areas of furniture unit were evaluated by passive sampling method using flux sampler and emission rate from full-sized furniture was predicted. Emission rates predicted by flux passive sampler were 10-106% (formaldehyde) and 8-141% (TVOC) of the data measured using large chamber test, respectively.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 129","pages":"86-92"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30399033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}