• 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 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.

• Journal of Ginseng Research
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• v.15 no.3
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• pp.192-196
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• 1991

As a part of studios on the Quality control of index components in crude drug preparations, extraction yields of ginseng saponins from crude drug extracts were identified by TLC and quantified by HPLC. So-Shi-Ho-Tang(小柴胡湯), Sa-Kun-Ja-Tang(四君子湯), Yook-Kun-Ja-Tang(六君子湯) and In-sam-Tang(人蔘湯) were extracted with water, 30%-ethanol, 50%-ethanol, 80%-ethanol and absolute ethanol to analyze ginseng saponins in the crude drug extracts prepared with various concentrations of ethanol. Ginseng saponins were extracted considerably more from the extracts with higher concentrations of ethanol than those with water or lower concentrations of ethanol. Extraction yields of ginseng-side-Rb$_1$, -Rb$_2$ and -R$_c$ from four crude drug preparations were the lowest as 4.9~45.9%, 5.0~40.1, and 6.3~43.7% in water extract and the highest as 29.5~62.6%, 26.7~61.4% and 31.4~62.0% in absolute ethanol extract, compared with those of 80%-methanol extracts.

• Korean Journal of Pharmacognosy
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• v.21 no.2
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• pp.126-129
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• 1990

Platelet anti-aggregating activities were evaluated with three combined crude drug preparations which have been used for 'eahyul'-one of the pathological concept in oriental medicine presumably concerning blood stasis or stagnant syndrome. The water extract of each combined preparation and each component plant was tested for their effects against ADP, arachidonic acid (AA) or collagen induced rat platelet aggregations. Mild inhibitory activities were observed with all the three tested preparations, Kaechibokryung-Hwan, Dangkqijakyak-San and Ohnkyung-Tang, and the component plants which are included in at least two of the above preparations.

• Journal of Ginseng Research
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• v.15 no.1
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• pp.1-5
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• 1991

For the quality control of crude drug drink preparations, methods for identification of cinnamon components and quantitative determination of cinnamic acid were established. Cinnamon components were identified by TLC with benzene/ethyl acetate (1:1, v/v) on silica gel plate by spraying p-anisaldehyde-sulfuric acid. Cinnamic acid contents were determined at UV 280 nm by HPLC on $\mu$-Bondapak Cls column with acetonitrile/water/acetic acid (40:60:2, v/v). Recoveries of cinnamic acid in three crude drug drink preparations were between 84.1-90.2% compared to the content of the cinnamon extract.

• Korean Journal of Pharmacognosy
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• v.12 no.3
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• pp.119-124
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• 1981

In our country, in order to cure diseases, a large number of crude drug preparations has been available. Nevertheless, the development of crude drug preparations have been inhibited, because the quality control is not completed so far. Therefore, we have eontinued on studing the quality control method by Zig-zag TLC. profile analysis. The water extract of 'Samyo-Tang' and componental crude drug (Glycyrrhizae Radix, Ephedrae Herba, Armenicae Semen) were developed on Silica gel $60F_{254}\;plate\;(E.\;Merck)$ useing elution solvent. The developed plate were examined useing Dual Wavelength Zig-zag Scanner (Shimadzu). According to the results of the experiment, it could be summarized as follow: 1) Original patterns of TLC profiles of 'Samyo-Tang' componental crude drug and mixing two crude drugs of 'Samyo-Tang' were observed. 2) Original patterns TLC profile of each extract after spraying with 2% ninhydrine were observed. 3) In the extract of addition and subtraction of Ephedrae Herba, peak area of Rf 0.48 and Rf 0.60 were varied quantitatively.

• Herbal Formula Science
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• v.21 no.2
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• pp.29-43
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• 2013

Objectives : The aim of this study is reviewing the past legal definition and regulations, to provide basis for the future desirable direction of Korean herbal pharmaceutical industry and national herbal drug policies. Methods : We reviewed how concept of herbal medicinal preparation has been utilized and changed along with various national laws and regulations. And this study also reviewed problems related herbal medicinal preparation policies. Results : Since 1990s, especially inauguration of Korea Food & Drug Administration (KFDA) at 1998, the concept of crude drug preparation has constantly expanded and distorted the scope of herbal medicinal preparations. This resulted in decline of herbal medicinal preparation industry. Conclusions : It means policies related herbal medicinal preparation which was driven steadily during this decade have lost their consistency. Also, it restricted the various medical options which can guarantee people's health rights.

• The Journal of Korean Medicine
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• v.35 no.3
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• pp.135-154
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• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

• 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.

• Natural Product Sciences
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• v.11 no.4
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• pp.189-192
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• 2005

Anti-amnestic activities of Korean red ginseng (Ginseng Radix Rubra) and Crude drug-combined preparations (RGCDP-1, RGCDP-2, and RGCDP-3) were evaluated by the animal experiment. RGCDP-1 and RGCDP-2 were prepared based on Korean folk prescriptions, 'Chongmyongtang' and 'Guibitang', respectively, while RGCDP-3, by a combination of both. Among the three preparations, RGCDP-3 was found to show the most potent anti-amnestic activity as evaluated by the passive avoidance test with mice, indicating synergistic action by combined effect of RGCDP-1 and RGCDP-2.