• 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.

• 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.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.

• 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.

• 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).

• The Korea Journal of Herbology
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• v.28 no.3
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• pp.61-68
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• 2013

Objectives : A precise and simple system of nomenclature was required to avoid error, ambiguity or confusion. Although medicinal plants must be produced or distributed based on a pharmacopoeia described origin including scientific name, the Korean Pharmacopoeia tenth edition (KP 10) had many names against the nomenclature. Therefore, this study aimed at searching correct scientific names for 241 plants in KP 10. Methods : Authoritative databases - The Plant List, International Plant Name Index, YList, Tropicos, eFloras, World Checklist of Selected Plant Families, The Global Compositae Checklist, The International Legume Database and Information Service, et al. - and previously performed researches, floras were cross-checked. Results : The arrangement of this list was designed for four cases, errors including illegitimate, nomenclatural synonyms, recommended names and decision reserved names. Consideration about the scientific names produced nine correct names for ten misspellings and illegitimate, and thirty-six correct names for forty-one nomenclatural synonyms. These results should be reflected in the next of KP 10. Separately, ten recommended names were also suggested for taxonomic synonyms which had been used indiscriminately due to diverse taxonomic opinions. In addition to those, decision reserved names were suggested for thirteen species which had been corridor of uncertainty. Then again, there was need to study about authorship, because KP 10 did not keep recommendations for author citations. Conclusions : Correction of scientific names for some medicinal plants which violated the International Code of Nomenclature would be useful to improve the accuracy of a Pharmacopoeia as the criterional materials.

• Analytical Science and Technology
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• v.31 no.4
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• pp.143-148
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• 2018

Currently, the Korean Pharmacopoeia (KP XI) recommends HPLC and potentiometric titration (which is less specific than HPLC) for the determination of triflusal content in capsules and raw materials, respectively. Additionally, the British Pharmacopoeia (BP 2017) and European Pharmacopoeia (EP 8.0), which include a monograph for triflusal in raw materials only, describe a titration method for the assay. The latest version of the United States Pharmacopoeia (USP 39) and Japanese Pharmacopoeia (JP 17) still have not published monographs for triflusal and its preparations. To improve the specificity and efficacy of the assay, we present an HPLC method to determine triflusal content in both raw materials and capsules. The proposed method was validated in accordance with the requirements of the International Conference on Harmonization. A good linear relationship was achieved for triflusal in the range of $200-1250{\mu}g/mL$ with a coefficient of determination of approximately 0.9996. The relative standard deviations (RSDs) of inter- and intraday precision were 0.73-1.12 % and 0.34-0.51 %, respectively. The recovery percentage of triflusal was in the range of 98.80-101.31 %. Because its system suitability, intermediate precision, and robustness were satisfactory, this method could be suitable for determining triflusal content in raw materials and capsules.