• 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.

• Journal of Society of Preventive Korean Medicine
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• v.18 no.1
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.61-74
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• 2015

Objectives: The main purpose of this study is to find a solution for modernized classification of herbal medicinal preparations in dual medical systems. Through this study, we expect to provide a reasonable foundation of herbal medicine for public health. Methods: We studied legal or technical terms of herbal medicinal preparations from the past regulations, and through this procedure, we could suggest clear definitions of terms for herbal medicinal preparations. We also investigated documents for approval of herbal medicinal preparation from US, EU(European union), The People's Republic of China, Japan, so that we can refer to them to revise regulation for appropriate use of herbal preparations. Results: In Korea pharmaceutical affairs act, any basis of 'Crude drugs' does not exist. But in some subordinary notifications, the way that they use the 'Natural product medicine' is used as a means of limiting basic rights of doctor or pharmacist of Korean medicine compared to doctor or pharmacist. At the same time, in subordinary notifications, provisions are vague and not enough for scientific evidence of Korean medicine. Thus, we re-categorized herbal medicinal preparations into new drugs, drugs made from herbal medicinal preparations and suggested requirements for drug approval. Conclusions: Instead of using the term 'Crude drug preparations', and we should use term 'Herbal medicinal preparations' in related act and notification. And also we suggest to amend subordinary regulations and documents for approval of herbal medicinal preparations. Through this, we can make herbal medicinal preparations be more industrialized.

• Korean Journal of Pharmacognosy
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• v.40 no.2
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• pp.103-108
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• 2009

GCSB-5 preparation is a purified extract from a mixture of 6 medicinal plants(Acanthopanacis Cortex, Achyranthis Radix, Saposhnikoviae Radix, Cibotii Rhizoma, Glycine Semen Nigra, Eucommiae Cortex) that have been widely used for the treatment of various bone disorders. The aim of this study was to investigate HPLC analysis method and screening of standard compound on Saposhnikoviae Radix for quality standardization of a medicinal crude drug GCSB-5. Standard compound of Saposhnikoviae Radix was decided with cimifugin by isolation and instrumental analysis such as NMR. HPLC analysis method for the simultaneous determination of cimifugin was established for the quality control of the medicinal plants of Saposhnikoviae Radix species, GCSB-5 raw material and preparation. And validation of HPLC analysis methods were conformed for verification of HPLC methods by check to specificity, linearity, intra-day precision, inter-day precision and accuracy following ICH guideline.

• Korean Journal of Pharmacognosy
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• v.39 no.4
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• pp.316-323
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• 2008

In this study, we have investigated the HPLC analysis methods and quantitative analysis of standard compounds for quality standardization of a medicinal crude drug GCSB-5, a herbal formulation consisting of 6 medicinal plants (Acanthopanacis Cortex, Achyranthis Radix, Ledebouriellae Radix, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex) which are used in traditional medicine to treat various bone disorders. HPLC analysis methods of acanthoside D(Acanthopanacis Cortex), 20-hydroxyecdysone(Achyranthis Radix) which were known standard compounds among 6 medicinal plants were developed on crude material and product. And validation of HPLC analysis methods were conformed for verification of HPLC methods by check to specificity, linearity, intra-day precision, inter-day precision and accuracy following ICH guideline. Content of acanthoside D and 20-hydroxyecdysone on raw material of GCSB-5 were decided at 0.577-0.578 mg/g and 0.311-0.312 mg/g. And we confirmed that content of acanthoside D and 20-hydroxyecdysone on GCSB-5 preparation were 0.302-0.303 mg/capsule and 0.113-0.115 mg/capsule.

• Korean Journal of Pharmacognosy
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• v.36 no.1 s.140
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• pp.21-25
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• 2005

The Chinese crude drug, 'Man Sam(蔓蔘)', which is derived from the root of Codonopsis plants of the family Campanulaceae, has been used as a tonic. In China, the same crude drug derived from Codonopsis plants, called 'Dang Same(?蔘)', has been used as remedies for anorexia, fatigue, cough, etc. Although Codonopsis roots have been widely used for medicinal purposes in Korea, the botanical origin of the crude drug has never been studied pharmcognostically. To clarify the botanical origin of 'Man Sam', the root morphology and anatomy were examined for the Korean species of Codonopsis species, such as C. lanceolata (Sieb. et Zucc.) Trautv., C. pilosula (Franch.) Nannf. and C. ussuriensis (Rupr. et Maxim.) Hemsl. The study shows that 'Man Sam' is the root of Codonopsis pilosula.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2010.05a
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• pp.7-7
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• 2010

Korea is one of the Northeast Asian countries in the Northern climatic zone. It is wide spread from north to south so that can be affected by various kinds of plants flora of the continent of Asia. Korea has complicated topography, mountains and hills included by an alpine belt. According to the distribution of plants, it can be classified to 5 areas; Northern part, Central part, Southern part, JeJuDo(濟州道) and UlLungDo(鬱陵島). Nakai of Japan, reported Plants in Korean peninsula as 3176 species, 841 varietal species and 174 varieties in "A Synoptical sketch of Korean flora". Lee of Korea, reported 3409 species, 6 sub-species, 756 varietal species and 287 varieties in "Korean Plants Resources". Isidoja(石戶谷) of Japan, simply described crude drug names, scientific names, effects, etc. of 45 species of Korean Medicinal Plants in the book "Journal of Jo-Seon Pharmacy(朝鮮藥學會會報)" third edition (published in 1925) and also explained 250 species of crude drug collected in Manchuria, Mongolia and Korean peninsula in the book "Medicinal plants in Northern Asia(北支那의 藥草)"(1931). Im and Jung organized 227 species of Medicinal Plants in "Wild Medicinal Plants from Jo-Seon(北支那의 藥草)" and it is said that 1000 species of plants can be used for medicinal purposes in Korea.

• Toxicological Research
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• v.7 no.2
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• pp.151-155
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• 1991

Thirty six crude drug samples have been prepared from different parts of twenty five plants belonging to different families, and antimutangenic activities were studied by using SOS chromotest (E. coli PQ 37). The following crude extracts of PNG medicinal plants which had a appreciable antimutagenic activity against mitomycin C were: Artocarpus communis (stem bark), Cycas circinalis (leaves), Merremia peltata (leaves), Intsia palembanica (leaves), Annona muricata (stem bark), and Artocarpus altilis (root bark).

• Korean Journal of Pharmacognosy
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• v.41 no.1
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• pp.48-53
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• 2010

GCSB-5 preparation is a purified extract from a mixture of 6 medicinal plants(Acanthopanacis Cortex, Achyranthis Radix, Saposhnikoviae Radix, Cibotii Rhizoma, Glycine Semen Nigra, Eucommiae Cortex) that have been widely used for the treatment of various bone disorders. The aim of this study was to investigate HPLC analysis method and screening of standard compound on Cibotii Rhizoma for quality standardization of a medicinal crude drug GCSB-5. Onitin-4-O-$\beta$-D-glucopyranoside was isolated from Cibotii Rhizoma as the standard compound and identified on the basis of spectroscopic data such as NMR. HPLC analysis method for the determination of onitin-4-O-$\beta$-D-glucopyranoside was established for the quality control of the medicinal plants of Cibotii Rhizoma species, GCSB-5 raw material and GCSB-5 preparation. And validation of HPLC analysis methods were conformed for verification of HPLC methods by check to specificity, linearity, intra-day precision, inter-day precision and accuracy following ICH guideline.