• The Korea Journal of Herbology
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• v.30 no.5
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• pp.75-83
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• 2015

Objectives : The aim of this study was to find how Northeast Asia(Korea, China, Taiwan, Japan) supervise herbal formulas in their pharmacopoeia.Methods : We compared items, formula's effects, formulations, etc and analyzed common formulas among Northeast Asia`s herbal pharmacopoeia (Korea(2010), China(2010), Taiwan(2013), Japan(16th Edition), drugs in Japan OTC Drugs (2007-2008))Results : The Korean Pharmacopoeia, the Korean Herbal Pharmacopoeia, Taiwan herbal pharmacopoeia, the japanese pharmacopoeia, drugs in Japan OTC drugs and pharmacopoeia of the People's Republic of China have 5, 251, 200, 20, 294, 1059 formulas, respectively. In comparison of pharmacopoeia`s test item, Korea and Japan has many similarity, for example, not refer to the effect of formulas. Korea and China have many inspection test of formulations in pharmacopoeia. Each country has differences in ratio of efficacy categories. For example, China especially has a higher ratio of formulas that regulate the blood and Korea has higher ratio of formulas that calm the spirit and open the sensory orifices than those of other 3 countries. There are 17 common formulas among the 4 countries and 43 common formulas among Korea, Taiwan and Japan. Comparing dosage forms, Korea, Japan, Drugs In Japan OTC drugs, Taiwan, China uses 4, 2, 14, 3, 21 formulations, respectively.Conclusions : China has many formulations and new formulas. Taiwan and Japan supervised formulas only selected by the authorities. However, Korean pharmacopoeia has similar form with Japan and need to add more formulas on demand and new formulations.

• Korean Journal of Pharmacognosy
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• v.22 no.2
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• pp.124-127
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• 1991

In the preceding paper, it was reported that total 63 traditional Korean herbal medicines listed in the Korean Pharmacopoeia and Korean Natural Drug Standards were found to be different plants in terms of systematic botany when those were compared with other two countries' drug compendia, Chinese Pharmacopoeia, Japanese Pharmacopoeia and Japanese Natural Drug Standards. Among 63 traditional Korean herbal drugs, 28 items were subject to the chemical identification test by using official methods that are described in the Korean Pharmacopoeia and the Korean Natural Drug Standards. In addition, 5 items were also tested by using the official methods described in Chinese and Japanese drug compendia, since there are no official chemical tests available in the Korean drug compendia. It was found that most of chemical tests appeared to be suitable. It was noted that the chemical test for Atractylodis Rhizoma(蒼朮) was incorrect and unapplicable. Those chemical tests for Clematidis Radix(威靈仙), Rubi Fructus(覆盆子) and Viticis Fructus(蔓荊子) are desirable to be revised for more accurate identification.

• The Korea Journal of Herbology
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• v.28 no.5
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• pp.29-31
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• 2013

Objectives : 'Reconsideration about Nomenclature of Herbs Listed in the Korean Pharmacopoeia' was published by Doh and Lee with absolute misconception of nomenclature. A critical review of Doh and Lee's paper is given, to correct the confused the concept of nomenclature and to provide proper scientific name for taxa which are discussed. Methods : This paper discusses the proper usage, as mandated by the International Code of Nomenclature. Adherence to the rules described in this paper should reduce the present confusion in the nomenclature of scientific names listed in the Korean Pharmacopoeia. Results : Although Doh and Lee proposed four categories to correct the scientific names of the Korean Pharmacopoeia using available botanical databases, they failed to show how nomenclatural concepts are applicable due to misconception of legitimacy and the confusion about synonym. From a nomenclatural perspective, 'accepted name' or 'recommended name' is a subjective term which used to be employed for convenience in a certain databases or working group without nomenclatural meaning. Doh and Lee also pointed out the standardization of author citation. However, they missed the importance of author citation error such as basionym or validating authors. Conclusions : Doh and Lee were not able to solve nomenclatural problems of the Korea Pharmacopoeia due to lack of clarity on the nomenclature code. We strongly recommend that KFDA has to commence extensive nomenclatural review for the next revision of Korea Pharmacopoeia.

• The Korea Journal of Herbology
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• v.25 no.1
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• pp.45-54
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• 2010

Objectives : The purpose of this study is to determine the impurity tolerance of Zanthoxylum Peel. Methods : Compare with medicinal Herb Books and the Pharmacopoeia of 6 nations. Results : Current Pharmacopoeia show different Zanthoxylum Peel's Purity, such as 2.0% of seeds and fruit stalk, etc. in North Korea, 2% of seeds in Vietnam, totally 3% in China. On the other hand, Korea and Japan set the total number 26.0% including the specific numbers such as 20.0% of seeds, 5.0% of fruit stalk, 1.0% of the other foreign matter. This Zanthoxylum Peel's Purity, 26.0%, is too high compared to that of other medical matters specified by The Korean Pharmacopoeia Ninth Edition. When The Japanese Pharmacopoeia Sixth Edition firstly set the Zanthoxylum Peel's Purity, the herbal name was Fructus. However, since the part for medical usage in origin is well-ripen pericarp, not seed, the permissible level, 30.0%, is supposed to be simple error range, 3.0%. Conclusions : As a result, I think bills concerning the Zanthoxylum Peel's Purity should be revised to the total number 3.0% or specifically set the level 2.0% of seeds, 1.0% of fruit stalk, twig and so on.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.43-43
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• 2003

The mission of pharmacopoeia is to promote the public health by establishing and disseminating the officially recognized standards of the quality of medicines and authoritative information about the use of them and other health care technologies by health professionals, patients, and consumers. Korean Pharmacopoeia was first established on October 10, 1958 and revised per 5 years. 8th edition was published December 30, 2002 and we are preparing English edition. (omitted)

• Journal of Pharmaceutical Investigation
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• v.34 no.5
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• pp.427-433
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• 2004

With the Sunshine policy, exchange of materials and cultures inter Koreas has been broadened and expectancy of reunification is getting higher. Especially, medical supplies and medicines are one of the biggest parts in the exchange goods. So, preparing an unified official drug standard preparing new medical administration system is required. We compared the Korean pharmacopoeia with North Korean Pharmacopoeia. Two pharmacopoeias have been developed in different direction and have many differences in the nomenclature and format. In this study, we compared general notices, general rules for preparations and crude drugs, monographs, general tests, processes and apparatus.

• The Korea Journal of Herbology
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• v.28 no.5
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• pp.103-111
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• 2013

Objectives : Herbal medicines were used a lot in the Northeast Asia, traditionally. However, the pharmacopoeia standards in South Korea, China, Japan, Taiwan, and North Korea including many other Asia are different and cause confusion. If the origins are not belonging to same genus, it should be careful to distinguish. In this study, herbal medicines in the pharmacopoeia were analyzed for different genus of origins in order to identify the disruptive items for each country. Methods : The scientific names of herbal medicines (plant based) was analyzed origins from Pharmacopoeias of Republic of Korea, People's Republic of China, Japan, Taiwan, and Democratic People's Republic of Korea. The origins specified differently were examined. Especially, the items which have different genus were analyzed in detail and confirmed for correct scientific name. Results : The analyzed herbal medicines in Pharmacopoeia were all 753 items. 320 items were in only one country's Pharmacopoeia. 237 items were in more than two countries' Pharmacopoeia, but their origins were same on each other. The items which have different genus were 35 items. Conclusions : In general, species belonging to the same genus have similar ecological, morphological, and pharmacological activity. However, species with different genus may have different medicinal ingredients and pharmacological activity. Thus, the items which have same name but different genus are required to analyze for comparison of pharmacological activity. Also, other species belonging to the different genus should be used for different items.

• Analytical Science and Technology
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• v.30 no.3
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• pp.154-158
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• 2017

The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9999$), while the RSDs for intra- and inter-day precision were 0.25-0.37 % and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

• Korean Journal of Pharmacognosy
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• v.47 no.4
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• pp.389-398
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• 2016

Korea, China and Japan have developed individually their own official compendia for crude drugs to tune with the times. Recent globalization has enlarged trade volume among these countries, and so the necessity for new quality standards has increased. This study was accomplished to offer basic data and appropriate suggestions to rebuilding standard principles for quality control of crude drugs in Korean official compendia. For this, seven standard items related to quality control in official compendia of these countries were compared. The items were identification, loss on drying, total ash, acid-insoluble ash, extract content, essential oil content and assay. The official compendia of three countries were the Korean Pharmacopoeia Eleventh Edition, the Korean Herbal Pharmacopoeia 2015, Chinese Pharmacopoeia 2015 and Japanese Pharmacopoeia Seventeenth Edition. Based on this basic research, new principles for each standard of crude drugs were suggested.

• The Korea Journal of Herbology
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• v.23 no.3
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• pp.135-140
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• 2008

Objectives : The purpose of this study is to clarify the medicinal using part of Linderae Radix. Methods : Find out the using part of Linderae Radix in the Pharmacopoeia, main Herbal book and present day scientific research result. Results : 1. In the Phamacopoeia of 6 Nation, The herbal name of Lindera strychnifolia is Linderae Radix, the origin is root, shapes of Linderae Radix are recorded spindle-shaped, slightly curved, some constricted in the middle to be moniliform on every Pharmacopoeia. But only in the Pharmacopoeoa of the people's republic of china, root is recorded as root tuber. 2. The Straight root of Linderae Radix can not be used as medicine on the Pharmacopoeia of the China, Vietnamese, Chinese Taipei. 3. In Gaebo Boncho(開寶本草) and Bonchodogyeong(本草圖經), Dongeuibogam(東醫寶鑑), Bonchogangmok(本草綱目), ickmulmyeongsildogo(植物名實圖考), only the spindle-shaped root of Linderae Radix can be used as medicine. 5. The picture of the root is also spindle-shaped. Conclusions : The herbal name of Lindera strychnifolia is Linderae Radix, medicinal using part is root tuber, spindle-shaped, some constricted in the middle to be moniliform, straight and not spindle-shaped tap roots can not be used medicinally, and allowing guide line of straight root will upgrade the quality of Linderae Radix.