{"title":"The Heroic and Noble Life of Morizo ISHIDATE Commemorating the 115 years since his birth and 20 years since his death.","authors":"Kazushige Morimoto","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Morizo Ishidate was born in the city of Aomori on January 24, 1901, the third son in his family. As the 16th Director General of the NIHS, he announced his decision to reform the organization and implemented this action in 1966. In September 1970, as the president of the Central Pharmaceutical Affairs Council, he decided to stop the use of all quinoform preparations. On May 21, 1973, he held a historic talk with Dr. Taro Takemi. After the meeting, the separation of dispensing and prescribing functions opened a new chapter in pharmaceutical history. Such a heroic and noble life may be due to his faith. In April 1922, he entered “Doushikai,” a dormitory belonging to Tokyo Imperial University. Yoshinosuke Konishi was his best friend in the dormitory. They joined a bible class directed by an American missionary, Miss Laura J. Maukʼ. In September 1947, at the age of 49, Yoshinosuke decided to devote the rest of his life to being an evangelist. After that time, Morizo supported him for 33 years. At the age of 70, Morizo confessed his belief of Jesus Christ’s resurrection from the dead based upon following words in the bible, “Therefore, if anyone is in Christ, he is a new creation. The old has passed away; behold, the new has come,” (2 CORINTHIANS 5 : 17). On July 18, 1996, he passed away at the age of 95.</p>","PeriodicalId":83554,"journal":{"name":"Yakushigaku zasshi","volume":"51 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36463719","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":"The Change of Reference to Post-Marketing Surveillance Based on the Sequence of Revising the Pharmaceutical Affairs Law.","authors":"Haruo Takahashi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The present Pharmaceutical Affairs Law (PAL) was promulgated in October 1960 and enforced in February 1961.Thereafter, PAL has been frequently revised, was renamed the Pharmaceuticals and Medical Devices Act (PMD Act) in November 2013, and the PMD Act was enforced in November 2014. It describes the change of reference to Post-Marketing Surveillance (PMS) based on the sequence of revisions of PAL for approximately 50 years. Although the purpose of PAL in 1960 was “to control and regulate drugs, quasi-drugs, cosmetics and medical devices (drugs, etc.), and to contrive proper use,” it did not include rules regarding PMS. Thereafter, “to assure the quality, efficacy and safety of drugs, etc.,” “to promote research and development of orphan drugs, etc.” and “to regulate designated substances” were added to the purpose of PAL over a period of time. At the time of establishing the PMD Act, “to assure the quality, efficacy and safety of regenerative products, to promote their research and development, and to prevent the onset and spread of hazards to public health and hygiene through the use of drugs, etc. ”was added to the purpose. Simultaneously, the matters of control and regulation using PAL were increased whenever PAL was revised.\u0000Additionally, the PMS systems, such as adverse drug reactions reporting, drug reevaluation and drug reexamination, and the Good Post-Marketing Surveillance Practice (GPMSP) regarding the enforcement standards of PMS, etc. were initiated by regulatory directions and legislated after their establishment. Moreover, an infection reporting system and early-phase pharmcovigilance, etc. were added to the PMS systems. Furthermore, GPMSP was divided into the Good Vigilance Practice (GVP) for marketing license conditions and the Good Post-Marketing Study Practice (GPSP) for enforcement standards regarding post-marketing investigations and clinical trials, and both are regulated.</p>","PeriodicalId":83554,"journal":{"name":"Yakushigaku zasshi","volume":"51 1","pages":"29-39"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36462967","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":"Pharmacology in a Cup of Coffee The Virtue of Coffee and Vitamins Learned from the History of Scurvy and Dropsy.","authors":"Kitaro Oka","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Scurvy, a vitamin C deficiency, was rampant during the age of discovery in Europe. In the mid-17th century, “Pasqua Rosée,” the first coffee house in London, put an ad in the newspaper “Publick Adviser” clearly stating, “It (coffee) is excellent to prevent and cure dropsy, gout, and scurvy.” A Netherlands trade merchant carried the information to Nagasaki, Japan, along with coffee beans harvested in the Netherlands’ new territory, Java Island. A Japanese physician in Nagasaki, Dr. Kai Hirokawa, translated the information into Japanese in his new book, “Dutch Medicines,” published in 1803. According to the ancient documents stored in Wakkanai City, Japan, the coffee beans were distributed to Tsugaru Clan soldiers who were guarding the northern coastline from 1855 to 1856. The purpose of the distribution was the prevention of scurvy and dropsy. As the result, none of the soldiers died from scurvy during the winter of 1855-1856. This paper discusses the pharmacological relationship between coffee micronutrients and vitamin deficiency syndrome.</p>","PeriodicalId":83554,"journal":{"name":"Yakushigaku zasshi","volume":"51 1","pages":"5-10"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36463720","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":"\"Terumeru,\" A Patent Medicine of the Late Edo Era-The Packaging, Efficacy Statement, and Dosage Form.","authors":"Kayoko Nojiri","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>“Terumeru” was a patent medicine that an apothecary in Osaka sold as an expectorant and medicine for internal diseases towards the end of the Edo era. Due to its manufacturer, Gengendo, closing its expectorant business in the early Meiji era, further details are unknown. The author investigated Terumeru products dating back approximately 200 years. The objective of this study is to clarify what kind of patent medicine Terumeru was, and furthermore, compare it to other medicines with names spelled using katakana that were distributed around the same time as a topic of discussion.\u0000The characteristics of Terumeru were as follows : the dosage form was three times as much as that prescribed for similar drugs ; and although it was said to be of Dutch origin, the name of a Chinese clinician, Zhu Zhenheng, was cited on its efficacy statement and advertising. These findings revealed that there were problems with its formulation and inconsistency in its brand image. These reasons led to the conclusion that Terumeru was considered a katakana-named patent medicine during the pioneering days of pharmacology Japan.</p>","PeriodicalId":83554,"journal":{"name":"Yakushigaku zasshi","volume":"51 2","pages":"104-11"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36462927","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":"Transition of Psychotropic Drugs in Japanese Pharmacopoeia (JP) (Part 18) The Study for New Knowledge and Decisions regarding Cultivation Method for Japanese Valerian (Kisso).","authors":"Kiyohisa Yanagisawa","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In Japanese Pharmacopoeia (JPXVII 2016), there is a description about Kanokoso, “This item is the root and rootstock of Kanokoso Valeriana fauriei Briquet (Valerianaceae). Kanokoso Valeriana fauriei Briquet is referring to Ezokanokoso Valeriana fauriei forma yezoensis Hara, which is the same variety. The Hokkai-kisso currently cultivated in Japan is the Ezokanokoso variety. The author analyzed the history of the variety of Japanese Valerian previously cultivated, but it’s incomplete. To maintain the quality and efficacy of a medicine, it is important to disseminate information regarding the origin of the crude drug. To ensure the quality of Kanokoso and stable efficacy of the medicine, it’s indispensable to maintain the original plant variety when cultivated.The author obtained the following knowledge during research. The variety cultivated in Kanagawa early in the Showa era was Japanese Valerian, sometimes being two kinds, lobule and round leaf. It is presumed that the original variety cultivated in Kanagawa early in the Showa era was Hokkai-kisso.The ingredients of the variety of Japanese Valerian cultivated and that which grows wild vary. The basis of the chemical structure of sesqui terpene kinds of α-Kessyl alcohol (KA) and Kessyl glycol diacetate (KGD), etc. has Kessane skeleton. It’s this consistency and is gathered using the same type of system. The consistency is interesting. Pursuing the relation between the consistency and type of system is regarded as a problem. To obtain the same kind of ingredient and form from Hokkai-kisso in the current state seems difficult. To maintain today’s quality of Hokkai-kisso and medicinal efficacy, it’s important for continue to cultivating the plant by dividing the roots for replanting.</p>","PeriodicalId":83554,"journal":{"name":"Yakushigaku zasshi","volume":"51 2","pages":"96-103"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36462934","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}
Morimasa Yagisawa, Patrick J Foster, Tatsuo Kurokawa
{"title":"Historical and Hygienic Aspects on Roles of Quality Requirements for Antibiotic Products in Japan : Part 3-Introduction of Technology\u0000and Knowledge in the Production Process and Quality Control of Penicillin from the United States of America.","authors":"Morimasa Yagisawa, Patrick J Foster, Tatsuo Kurokawa","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In order to investigate the roles of quality requirements for antibiotic products in Japan, from historical and hygienic aspects, we examined and analyzed how technology and knowledge in the production and quality control of penicillin were introduced from the United States of America, applied, and further developed.\u0000Owing to the strong support of Colonel Crawford Sams, the chief of the Public Health and Welfare Section of the Supreme Commander for Allied Power/General Headquarters, via the Ministry of Welfare in Japan, the technology and knowledge were acquired from an experienced leader, Dr. Jackson W. Foster, and as a result, domestic production of penicillin was successfully achieved in amounts required to meet national demands sufficiently within three years in a devastated post-war-torn Japan.\u0000Based on the consensus that penicillin should be dealt with as “biological products” similar to vaccines and antisera, the quality standards for penicillin were enacted as the “Minimum Requirements for Penicillin (MRP)” on the 1st of May 1947. Due to the development of penicillin production technology, the quality standards of penicillin provided by the MRP were revised often to higher levels ; content of the active element from no less than 60 units/mg (purity 3.8%) to no less than 1,430 units/mg (purity 89.7%). Regarding the penicillin preparations, the content of the active ingredient per vial was changed from 30,000 units at the beginning, to 100,000 units in January 1948, to 3,000,000 units in December 1950, and two preparations containing 200,000 units and 1,000,000 units per vial are currently available, according to clinical convenience.</p>","PeriodicalId":83554,"journal":{"name":"Yakushigaku zasshi","volume":"51 1","pages":"18-28"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36462968","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}