• Proceedings of the PSK Conference
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• 2002.10a
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• pp.405.2-405.2
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• 2002

A near infrared (NIR) method was developed to analyze specious diversity for morphologically similar umbelliferous herbal medicine. Cnidium officinale Makino. This herbal medicine has been widely used as 'chungung' without any discrimination of its quality and original plants. though it has the ambiguous origins of plants between various countries especially Korea. China and Japan. It is named by Cnidium officinale Makino in Korea and Japan. in comparison with Ligusticum chuanxiong Hort. in China. (omitted)

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.288.1-288.1
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• 2003

The determination method of decursin and decursin angelate from Angelicae gigantis Radix, an important crude drug in oriental medicine, was developed and validated by a reverse-phase liquid chromatography. The decursin and decursin angelate, the structural isomer aspyranocoumarin each other, are the main organic constituents in Angelicae gigantis Radix. (omitted)

• The Journal of Korean Medicine
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• v.31 no.3
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• pp.128-132
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• 2010

Objectives: This study aimed to review the general features of drug induced liver injury (DILI) and the important factors in consideration of herbal drugs and DILI. Methods: We reviewed general aspects of DILI such as classification, inducible factors, diagnosis methods, prevention, and the status of herbal drug-associated DILI via literature. Results: Besides the drug itself, genetic and environmental factors affect hepatic toxicity. There is a lack of definitive diagnoses of DILI by drugs, including herbal remedies. The possibility of herbal drug-associated DILI is exaggerated, and majority of herbal drug-derived hepatic injury could be easily prevented if Oriental doctors pay attention to this issue. Conclusion: This study can provide Oriental doctors an overview and be helpful in minimizing the episodes of hepatotoxicity in use of herbal drugs.

• Proceedings of the PSK Conference
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• 2002.04a
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• pp.192.1-192.1
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• 2002

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.201-205
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• 2005

The aim of publishing the Korean Pharmaceutical Codex is to update and set specification of essential drugs for humane health. In accordance with speedy development of new drugs and improvement of science and technology, the need of revision of drug specification through the ICH guidelines and discussions between regulatory agency and pharmaceutical industry for the quality assurance of safer and efficient drugs is getting higher. The first edition of Korean Pharmaceutical Codex was published in 1983. Now, the third revision of the Codex is prepared because of the revision of domestic and foreign Pharmacopeias, changes of drug control environment, improvement of science and technology and so on. The aim of 3th edition is to improve the quality of essential drugs through the setting of the required specifications and discussions between the regulatory agency and pharmaceutical industry.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2019.10a
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• pp.97-97
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• 2019

사삼(沙蔘, Adenophorae Radix)은 "대한민국약전외한약(생약)규격집(KHP)"에 잔대 Adenophora triphylla var. japonica Hara 또는 사삼(당잔대, A. stricta Miq.)의 뿌리로 수재되어 있으나, 형태학적으로 유사한 제니(모시대, A. remotiflorus Miquel), 층층잔대(윤엽사삼, A. tetraphylla (Thunb.) Fisch), 더덕 Codonopsis lanceolata (Sieb. et Zucc.)과 오 혼용 우려가 있어 이들을 구별하기 위한 종 감별법이 필요하다. 본 연구에서는 '사삼'과 오 혼용 우려가 있는 종들을 구별할 수 있는 유전자 마커 개발을 위하여 DNA 바코드로 활용되고 있는 유전자 부위를 분석하여 ITS (25%), atpB-rbcL (15%), atpF-atpH (14%), rpl16 (13%), trnL-F (10%), matK (9%), rpoC1 (7%)에서 변이율(percent of variable sites)을 확인하였다. 또한, 분석한 유전자 부위 중 종간 차이를 확인하기 용이한 matK 구간을 활용해 기원종인 잔대, 당잔대와 형태적으로 유사하여 오 혼용될 우려가 있는 층층잔대, 모시대 및 더덕을 감별 할 수 있는 유전자 마커를 개발하였다. 본 연구를 통해 얻어진 염기서열과 분자 마커는 '사삼'의 품질관리에 유용하게 활용 가능할 것으로 사료된다.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2019.10a
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• pp.98-98
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• 2019

제니(薺苨, Adenophorae Remotiflori Radix)는 "대한민국약전외한약(생약)규격집(KHP)"에 모시대(Adenophora remotiflorus Miquel)의 뿌리로 수재되어있으나, 형태학적으로 유사한 잔대(A. triphylla), 당잔대(A. stricta) 및 더덕(Codonopsis lanceolata)과 오 혼용 우려가 있어 이들을 구별하기 위한 정확하고 객관적인 종 감별법이 필요하다. 본 연구에서는 '제니'의 기원인 모시대와 오 혼용 우려가 있는 종들을 구별 할 수 있는 유전자 마커를 개발하기 위하여 Genbank에 등록된 ycf2 구간을 활요하여 모시대와 잔대, 당잔대를 구분 할 수 있는 INDEL (insertion/deletion) 마커를 개발하였다. 또한, 보다 정확한 종감별을 위해 DNA 바코드로 활용되고 있는 유전자 부위의 염기서열을 분석하여 ITS (25%), atpB-rbcL (15%), atpF-atpH (14%), rpl16 (13%), trnL-F (10%), matK (9%), rpoC1 (7%)에서 변이율(percent of variable sites)을 확인하였다. 향후, 본 연구에서 개발된 INDEL 마커와 더불어 추가적으로 개발을 진행 중인 분자 마커는 한약재 '제니'의 품질관리에 활용 가능할 것으로 사료된다.

• Journal of Korean Medical classics
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• v.27 no.4
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• The Journal of Korean Medical History
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• v.27 no.2
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.192.1-192.1
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• 2003

Acanthopanax cortex (Acanthopanax sessiliflorum, Araliaceae, KP VIII), an important herbal drug, has been used as tonic, antistress and immuno-enhancing drugs in Korea. And Peiplocae cortex(Periploca sepium, Asclepiadaceae, CP 2000) has been used as cardiotonic, anti-inflammatory, and sedative effect in china. These are called “Namogapi” of Acanthopanax cortex and “Bukogapi” of Periplocae cortex in Chinese herbal market. These herbal medicines are sometimes circulated as same herbal medicine “Ogapi”. (omitted)