• 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.

• YAKHAK HOEJI
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• v.37 no.1
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• pp.54-65
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• 1993

A method for the determination of 16 residual pesticides in crude deugs was examined. Crude drug was extracted with acetonitrile/water solution and the extract was partitioned between hexane/CH$_{2}$Cl$_{2}$ and NaCl saturated water. The organic layer was passed through cleanup column and subjected to the GC/ECD or GC/NPD analysis. Essential oil components in crude drug interfere with the analysis, and sulfuric acid treatment was adapted to overcome this interference.

• 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.

• 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 Korean Medical classics
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• v.27 no.2
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• pp.77-95
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• 2014

Objectives : This study was to analyze the definitions of herbs, herbal drugs, crude drugs and 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 herbs, herbal drugs, crude drugs and 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 : Herbs are defined as "refined things that are cut and dried in their most original state". The definition of crude drugs includes herbs and the "cell contents, secretion, extracts, minerals and other parts of animals and plants that are used medicinally". The concept of natural products is expanded to adding tissue cultures to the definition of crude drugs. Conclusions : The definition of herbs should at least include all products that are "processed, extracted and prepared" as well as contents that consist of various forms of hospital-prepared herbs. The term "herbal drug" corresponds to a traditional term of "drug", and this should be established as a concept to explain "drugs in raw materials that are used to prepare herbs and/or manufacture herbal medicine". The legal definition of herbs should include the concept of crude drugs. Herbal drug preparations and crude drugs should be included in the definition of herbal drugs.

• 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.

• Journal of Ginseng Research
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• v.14 no.2
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• pp.112-116
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• 1990

As a part of studies on the quality control of crude drug preparation drinks, ginseng saponins were identified by HPLC. Ginsenoside-Rb1 was determined quantitatively by HPLC. Ginsenoside MeOH/H2O(65:35:10, v/v) on Si-gel plate. Ginsenoside-Rb1 content determined by HPLC on Lichrosorbtract drinks was 57.5-70.4% compared to the content in the red ginseng extract.

• YAKHAK HOEJI
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• v.46 no.6
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• pp.392-397
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• 2002

A simple and sensitive high performance liquid chromatographic method to quantitate ursodeoxycholic acid in crude drug pharmaceuticals was investigated. Ursodeoxycholic acid react with 2-bromoacetyl-6-methoxynaphthalene (Br-AMN) in the presence of triethylamine to form highly fluorescent derivative. The derivatization procedure was performed at 7$0^{\circ}C$ and completed within 30 min. The optimal wavelength of the fluorescence detector are λ$_{ex}$=300 nm and λ$_{em}$ = 460 nm. The LOD of the ursodeoxycholic acid was 25 ng/mι based on the S/N =3, and the LOQ was 80 ng/mι based on S/N = 10. Crude drug pharmaceuticals pretreated by solid phase extraction (Sep-pak $C_{18}$ cartridge) which were shown very good separation and recovery values for the compound.d.

• 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.25 no.4 s.99
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• pp.399-401
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• 1994

$Yongkaksan^{\circledR}$ is a powdered crude drug which is used to treat cough and recommended it as an expectorant. It is composed of Platycodi Radix (11.7 mg), Senegae Radix(0.5 mg), Armeniacae Semen(0.83 mg) and Glycyrrhizae Radix(8.3 mg). For the identification of individual ingredients in such powdery mixtures, microscopic method may be considered to be efficacious due to requirement of a small amount of specimens. In this paper, effectiveness of this method will be exemplified by the identification of the ingredients in $Yongkaksan^{\circledR}$ which contains 4 powdered crude drug ingredients.