After the long isolation in the Edo era, the new Meiji government tried to import science and culture from western countries. In the field of medical science, Kanpo, Chinese medicine, was abolished and western medicine was introduced in Japan. A medical system was established in 1874, but the division of prescribing medicines and dispensing them had not been introduced yet, and this situation prevented the increase in newborn pharmacists and solid pharmaceutical education for a long time. However, when the division of prescribing and dispensing medicines started in the late 1980s, the demand for pharmacists increased and a six-year pharmaceutical education system was introduced in 2006. The core curriculum that was established about 10 years ago had many problems, but the system was revised in 2013. The goal of the efforts is to improve the situation regarding the quality, quantity and contents of clinical pharmaceutical education for the new generation of pharmacists to come over the next 10 years. It is important to look at the pharmaceutical education of Japan in light of that of France, where the division of prescribing and dispensing medicine, and the pharmacy itself had been established in medieval times, focusing on the history of the educational system and requirements for pharmacists.
Rakugo, traditional Japanese story-telling, has a history of over 300 years. The stories consist of jokes, anecdotes, and funny messages. The content often includes critical points of view from the perspective of normal people. Some of the targets of criticism are physicians and druggists. This study looked at the number of medical and medicinal items mentioned in kamigata rakugo (rakugo in Osaka). There were ten occasions in which medical/medicinal items were used for practical purposes in scenarios and 27 occasions in which they were simply mentioned. Some of the uses show us the medical and pharmaceutical situation in the 18-19th century in a humorous way. For example, mentions of kyu:moxibustion, biwayoutou:loquat herb tea, and ninjin:ginseng.
This publication, commemorating the sixty years since the founding of Japan Society for the History of Pharmacy (JSHP), provides an overview of the Japanese pharmaceutical industry over a thirty-year span from 1980 to 2010. In the first section, entitled Medical Evolution: The Growth Period for Pharmaceutical Products, and the second section, "Patient-Based Medicine: The Period of Information Prioritization, the following themes are examined. Changes in Drug Pricing Policies, Promotion of Bungyō (separation of prescription from dispensing), Measures to Improve the Safety of Pharmaceutical Products; Appropriate Use of Pharmaceutical Products, Drug Discovery: Changes in Pharmaceutical Product Development and Actual Conditions in the Domestic Launch of New Medicines; Marketing (Medical Representative) Reforms, Pharmaceutical Industry Mergers and Acquisitions, Internationalization of the Pharmaceutical Industry. The following papers are provided as further references to support the conclusions made in the sections above. Changes in Japanese Drug Discovery Technologies and Drug Development. Japan's Pharmaceutical Market and Shifts in Manufacturing and Sales. Changes in Clinical Trials in Japan and Appropriate Use of Pharmaceuticals. Internationalization of the Japanese Pharmaceutical Industry.
Ginseng is prepared from Panax ginseng C.A. Meyer root. The root of wild P. ginseng has long tortuous rhizome called traditionally "Rozu" in Japanese. In the present historical studies on ginseng, it has been proven that ginseng has sometimes been used after removing "Rozu" due to its emetic effects. However, ginseng with "Rozu" is prescribed in almost all the present Kampo formulations used clinically in China and Japan. Possible reasons for this are (1) some formulations including "Rozu" have been used for vomiting resulting from the retention of fluid in the intestine and stomach, "tan-in" in Japanese, and (2) the present cultivated ginseng has shorter "Rozu" than wild ginseng. Furthermore, it is proved that "Rozu", rich in ginsenoside Ro with oleanane-type aglycone, is distinguished from ginseng roots rich in ginsenosides Rb1 and Rg1 with dammarane-type aglycone. This is the first report to declare the distribution of ginsenosides in underground parts of wild P. ginseng. Ginsenoside Ro is a minor ginsenoside in ginseng whereas it is the major ginsenoside in P. japonicus rhizome (chikusetsu-ninjin in Japanese). Ginsenoside Ro is characterized by antiinflammatory effects which differ from ginsenosides Rb1 and Rg1 responsible for adaptogenic effects of ginseng. These results suggest that "Rozu" containing both oleanane- and dammarane-type ginsenosides might be a promising raw material distinct from ginseng root or P. japonicus rhizome.
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.
Tetsuo Isogawa was born in Oita in 1852 and in 1879 began working in the Imperial Japanese Pharmaceutical Laboratory (shiyaku-jo) for medicine inspections. The same year, Dr. Tsunekichi Torigata, head of Oita Prefectural School of Medicine recruited him as its chief pharmaceutical officer. After the school's closing in 1889, he was hired as pharmaceutical lieutenant officer of the Oita prefectural government, where he strove to improve chemical and food safety for two decades. Through his work for the government, Isogawa created the modern pharmaceutical system in Oita in the late 19th century. Tetsuo Isogawa retired from public office in 1905 and died in 1908. Tetsuo Isogawa was not officially registered as a pharmacist under the 1890 Pharmacy Law; however, a special funeral address was written by the vice-president of the Oita Pharmaceutical Association on his behalf and published in the Association's journal.
About 75% of Japanese liver cancer is caused by hepatitis C. Widespread infection of the virus resulted from inadequate medical knowledge, as well as the political, economic and administrative conditions of the time. We investigated the association between the widespread infection of the hepatitis C virus and the historical events. We used a fishbone diagram to investigate the cause of widespread infection of the hepatitis C virus and considered the issue from a historical standpoint. We found causes including treatment (medical care), transfusion (medicine), economy (expense) and people (infection route). These causes are explained in further detail below. 1) Treatment (medical care). The initial large-scale infection occurred following attempts to eradicate Schistosoma japonicum involving mass vaccination in schools and public health centers. 2) Transfusion (medicine). The use of non-heated fibrinogen for massive postpartum hemorrhage spread the virus further. In 1987, it resulted in a mass outbreak of hepatitis in Aomori Prefecture. 3) Economy (expense). Recognition of the benefit of disposable syringes was delayed. As a result, disposable syringes were too expensive to be widely available, and did not become low-priced. 4) People (infection route). The second wave of dissemination of the hepatitis C virus was stimulant abuse after World War II. Prior to the discovery of the hepatitis C virus, transmission resulted from repeated use of contaminated syringes. Although we initially thought that these four causes occurred independently on a historical chronology, associations between the causes were found when we investigated the problem with a fishbone diagram.
Cinchona is known as a magic bullet for malaria and its cultivation was dominated by Java on a global scale in the 19th century. In 1875, in accordance with a suggestion by Takeaki Enomoto, the Meiji government made a request to the Dutch government that cinchona seedlings be distributed to Japan. In response to that request, in 1876, 42 cinchona seedlings arrived in Yokohama from Java. It was the first time cinchona seedlings were shipped to Japan. After that, cinchona seeds and seedlings were shipped to Japan a total of three times between 1876 and 1883. The seeds shipped in 1878 were raised at the Nishigahara Agricultural Experiment Station and then planted at nine places in both Okinawa and Kagoshima Prefectures in 1882. The planter was Yasusada Tashiro. However, all of the planted seedlings had died by 1884. The first national farming plan of cinchona in Japan ended in failure. These matters were found in documents included in Nomutenmatsu compiled by the Ministry of Agriculture and Commerce of the Meiji government in 1888.
This paper reviews the status of clinical trials and appropriate use of drugs from historical perspectives in the last 30 years in Japan. Industry-sponsored clinical trials in Japan began being regulated under the revised Pharmaceutical Affairs Law in 1980. Japanese modifications were made to the ICH-GCP, which reached step 4 in May 1996, and a notification called the "New GCP" was issued in March 1997. This was fully implemented as of April 1998. The number of clinical trials, however, dropped sharply after 1998. Patients worldwide who have no drugs for their diseases are waiting for new medicines. Clinical trials must be held as part of a scientific and valid process. Physicians have a duty to use new medicines considering a balance of effectiveness and safety. In Japan, several "yakugai" cases were observed in the past. They were not only caused by the toxicological effects of drugs but were also due to social factors in drug use. Responding to these scandals, new regulations were developed and contributed to the appropriate use of drugs in Japan.
Valerian has been used as a name for Japanese Valerian and European Valerian root. Valerian in the German market today was originally called Baldrian. Transitions in the standards and the test methods of Valerian root listed in the DAB were studied this time. Moreover, we compared these standards and test methods with those in the USP, BP, EP and JP. We also considered the pharmacology evaluation in Germany. At the time, the standards and test methods had content in accordance with the EP from DAB9 (1986) of the West Germany publication. It also agreed with the EP and BP of the same period. To date in the DAB, botanical features have been mainly derived from the discriminating characteristics of the Valerian root. In DAB9 (1986), standards and test methods were added to the content, enhancing it and making it more stringent. This is thought to have happened as a result of a new, academic finding showing an improvement in the pharmacology level. Valerian root has been listed continuously in the DAB. These listings suggest that Valerian root has continally been evaluated as a sedative. We think that the listing was connected with a relisting in the BP as a result of scientific communications between Britain and Germany, EC member nations, such as through EP publications. On the other hand, the oil made with Japanese Valerian was listed in a radical field in DAB6 (1926) in the past. This is a valuable result, proving that it was used and evaluated as an important herbal medicine from Japan and foreign countries at that time. The Japanese Valerian referred to is not grown in Japan today. Moreover, it is not possible that cultivation will be restarted through good quality revaluation. However, this fact introduces a valuable piece of history supporting the survival of Japanese Valerian and European Valerian root as a sedative in the future.
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Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943. This is also regarded as the origin of the current PAL (LawNo.145 in 1960). Through this analysis, we tried to clarify the relationship between the social change and the role of PAL in society. During the War, the bill was discussed, aiming at the improvement of both human resources who treated drugs, and the quality of drug materials. Diet members discussed three main points, namely, "the duty of pharmacists", "the mission of the Japan Pharmaceutical Association" and "the quality control of pharmaceutical products". Notably, the bill pharmacists are required not only to dispense drugs, a role they had previously, but also to manage drug and food hygiene through the quality control of pharmaceutical products and the inspection of food and drink, in order to improve the public health in Japan. Originally, the law was passed to deal with the extraordinary circumstances during the War, but through our analysis, we found that they proactively improved the role of the law to comply with various drug issues raised during the War, the rapid change of the pharmaceutical hygiene concept and the social transformation.
Wood creosote is a medicine that has been listed in the Japanese Pharmacopoeia (JP) since the first edition published in 1886. Medicines containing wood creosote and other natural ingredients have been very popular in Japan and Southeast Asian countries. In Japan, one such medicine, named Seirogan, has been used for more than 100 years. In this paper, we report the results of our examination on the historical aspects of wood creosote. One finding was that creosote, called "kereosote" at that time, was imported to Japan for the first time to Nagasaki by Johann Erdewin Niemann, who was the Director of the Dutch Mercantile House, and prescribed by Johannes Lijdius Catharinus Pompe van Meerdervoort and Anthonius Franciscus Bauduin. From our findings, we concluded that wood creosote was one of the essential medicines for the successful introduction and progression of Western medicine in Japan. Furthermore, we found that Dutch physicians introduced wood creosote to Japanese physicians, including Taizen Sato, Dokai Hayashi, and Jun Matsumoto, and that wood creosote was subsequently popularized by Rintaro (Ogai) Mori during the Russo-Japanese war. In addition, we examined the original plant for wood creosote, and consequently confirmed that the 15th edition of the JP, Supplement Two, clarifying the original plant for wood creosote, matches the pharmaceutical and historical facts. We also provide drug information relating to distinguishing between wood creosote and the creosote bush.
Yagen (see text) is an oriental grinder for crude plant medicines. It consists of a disk and navicular mortar. A Chinese yagen with the inscription, "Product of the Ming-Zhengde Period (See text), (1506-1521 A.D.)" has been housed for 40 years in the Naito Memorial Museum of Pharmaceutical Science and Industry (Kakamigahara, Gifu Prefecture, Japan). To identify the district that produced this yagen, the authors analyzed the elements using an X-ray fluorescence spectrometer. The results showed that the blue design and blue Chinese characters on the yagen were enameled with elements of cobalt, manganese, and iron. Therefore, it is believed that the yagen was made in an old porcelain kiln near Zhangzhou in Fujian Province, China. However, as the period of production could not determined in the present study, further research is needed in the future.
In this paper, the writers reviewed in detail the pharmaceutical market and the shifts in manufacturing and sales including the trade balance in Japan over a thirty-year period from 1980 to 2010. From the 1980s to the 1990s, many innovative pharmaceutical products were developed and launched in the Japanese market. During the same period, some Japanese companies managed to develop their first internationally marketable drugs, which were antibiotics and effective remedies for the digestive and circulatory organs. During this period, Japanese pharmaceutical companies were also able to launch some of blockbuster drugs. For two decades, the pharmaceutical market grew rapidly. For this reason, it can be called "The Growth Period for Pharmaceutical Products" in Japan. After that period, drug development and sales slowed down due to a lack of expertise in genetic engineering and biotechnologies. This situation caused a large deficit in the trade balance for Japanese pharmaceutical products. However, with regard to the trade balance (including technical royalties) for pharmaceutical product technologies, Japan remains in the black even today.
In Japan, biologics have been described as special sorts of medicines in the Pharmaceutical Affairs Law and are regulated by the Ministry of Health, Labour and Welfare (MHLW). In contrast, in the United States, some of the regulatory laws for biologics are different from other medicines and the relevant regulatory agencies have been changed historically. We reviewed the histories of the laws and changes in regulatory agencies for biologics, especially focusing plasma fractionation products in the United States, which may give suggestions and advice for the regulation of biologics in Japan. In the earliest stage, biologics were regulated by the Biologics Control Act (BC Act) of 1902 and as parts of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938. The effectiveness of these regulations was not equivalent to that of other drugs; therefore, Congress passed some amendments to the FD&C Act, in which biologics were treated in the same way as other drugs. In 1972, the authority for biologics control was transferred from the National Institutes of Health (NIH) to the Food and Drug Administration (FDA). Thereafter, in order to achieve the most efficient regulation under the rapidly evolution of biologics, the biologics regulating sections in the FDA have changed several times. At present, some biologics that are used in ways similar to other drugs (e.g., cytokines, monoclonal antibodies and immunomodulators) are regulated by the Center for Drug Evaluation and Research (CDER), and other biologics (e.g., vaccines, blood products and cellular products) are regulated by the Center for Biologics Evaluation and Research (CBER) of the FDA.
In Japan, there are about 250 Yakushi Buddha (i.e., Buddha of Healing) statues in Buddhist temples. They are listed as Important Cultural Properties and 14 of them are National Treasures. Belief in Yakushi Buddha was especially prevalent from the 7th to the 13th centuries in Japan. The oldest wooden Yakushi Buddha statue is in Horin-ji Temple in Nara. Among the approximately 250 Yakushi Buddha statues, about 200 have medicinal containers-or rarely, a bowl-in the palm of the left hand. However, these medicinal containers are wooden blocks. Very recently, it was found that the Yakushi Buddha statue in the Suho-Kokubun-ji Temple in Yamaguchi Prefecture, Japan has a medicinal container in the palm of his left hand, in which an offering (i.e., 220 g of materials) was found. The date on the reverse side of the lid places the offering at October 12, 1699. The offering is composed of five cereals (rice, barley, wheat, soybean and azuki bean), five medicinal plants (Acori graminei, Acori calami, Ginseng, Flos caryophylli and Lignum santali albi) and six minerals (rock crystals, purple and blue lead glass, CaCO3 particles, and silver and golden foils). Recently, the pharmacy educational program was extended from four to six years in order to meet clinical pharmacy requirements for patients. From studying the Buddha of Healing and its medicinal container described above, the author suggests that, in addition to pharmaceutical bioscience, philosophical concept be studied as part of the history of pharmacy in the future.
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.
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