• 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 Korea Journal of Herbology
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• v.39 no.5
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• pp.19-30
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• 2024

Objective : Mu-yi (蕪荑, Ulmi Semen Pasta) is the fermented product of the seeds of Ulmus macrocarpa Hance (Ulmaceae) or other species of Ulmus genus mixed with adjuvant materials. The medicinal origin and preparing method of Ulmi Semen Pasta are different from those in the past literature. Therefore, medicinal origin of Ulmi Semen Pasta and its preparation method were investigated by literature study. Methods : The classic and contemporary literatures from Korea, China, and Japan regarding to Ulmi Semem Pasta were searched to find the time-based changes of Ulmi Semen Pasta preparation and its origin. Results : The fruit or seed of U. macrocarpa has been medicinally used as Mu-yi (蕪荑) or Mu-yi-in (蕪荑仁) respectively in Korea, China, and Japan until early in 20th century. However, from the middle of the 20th century, the fermentation was performed in medicinal preparation of the fruit or seed of U. macrocarpa mixed with various adjuvant materials such as clay, Chrysanthmi Flos, Ulmi Cortex, etc. The roles or evidences of those adjuvant materials have not been clearly explained, which could not guarantee the consistent quality of Ulmi Semen Pasta. Conclusion : Current preparation method of Ulmi Semen Pasta have challenges in terms of quality maintenance, standardization, and marketing. Therefore, it is suggested that apparent evidence of current preparation method should be established or intact botanical part (seed or fruit) could be used as medicinal part.

• Mycobiology
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• v.47 no.4
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• pp.483-493
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• 2019

Antrodia cinnamomea is a unique medicinal fungus in Taiwan. It has been found rich in some pharmacologically active compounds for anti-cancer, hangover, and immune regulation etc. With the in-depth study of these components, it would be interesting and important to establish a molecular system for basic studies of A. cinnamomea. Thus, we would like to set up a foundation for this purpose by studying the A. cinnamomea protoplast preparation and regeneration. Firstly, we studied the optimization method of protoplast preparation of A. cinnamomea, and found various factors that may affect the yield during protoplast preparation, such as mycelial ages, pH values, and osmotic stabilizers. Secondly, in the regeneration of protoplasts, we explored the effects of various conditions on the regeneration of protoplasts, including different media and osmotic pressure. In addition, we found that citrate buffer with pH value around 3 dramatically increased the regeneration of protoplasts of A. cinnamomea, and provided a set of regeneration methodology for A. cinnamomea.

• 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.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.

• Journal of the Korean Chemical Society
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• v.49 no.6
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• pp.546-553
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• 2005

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.57-68
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• 2010

Objectives: Standard is a unified criterion for some repeated things or concepts in a certain scope. It is fundamental to implement standardization in English translation of traditional Korean medicine (TKM) formulae to promote progress in the evaluation of TKM and also to serve in enhancing the efficiency in studies of medical formulae. Methods: We undertook literature research on current Korean and Chinese medicinal formulae in English translation, analyzing 485 Korean formulae and 464 Chinese. We also undertook a comparative study of 102 common English translation of both Korean and Chinese, proposing a constant and effective methods for English translation of medical formulae. Results: To have a precise English translation we classified medical formulae nomenclature in advance. We found that formulae naming can be fundamentally classified into 6 forms which are (a) Materia Medica + Preparation Form, (b) Materia Medica + Indication + Preparation Form, (c) Materia Medica Numbers + Preparation Form, (d) Indication + Preparation Form, (e) Concept + Preparation Form, and (f) Miscellaneous. Based on these findings we could determine that these 6 types ((a)-(f)) can all be translated into English by (1) Materia Medica + Preparation Form and (2) Indication + Preparation Form + of (with) + Materia Medica schemes. In regard to translation of Indication it can follow Noun+~ing participle form. Conclusion: This research provides a common method of TKM medicinal formulae English translation for better understanding, education, training, practice and research in TKM. Consequently, English translation using these methods can serve as the initial study for standardization of TKM medicinal formulae.

• 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.1
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• pp.18-24
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• 2009

GCSB-5 preparation is a purified extract from a mixture six herbal medicines (Acanthopanacis Cortex, Achyranthis Radix, Saposhnikoviae Radix, Cibotii Rhizoma, Glycine Semen Nigra, Eucommiae Cortex) that have been widely used in traditional medicine to treat various bone disorders. This study was carried out to obtain the HPLC analysis method that can be used to establish quantitative analysis of Glycine Semen Nigra and Eucommiae Cortex for standardization of GCSB-5 preparation. HPLC analysis methods for the simultaneous determination of genistin (Glycine Semen Nigra) and geniposide (Eucommiae Cortex) were established for the quality control of herbal medicinal 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. As the result of quantitative analysis, the contents of genistin and geniposide in the raw material of GCSB-5 preparation were 0.0426-0.0427 mg/g and 0.431-0.432 mg/g. And GCSB-5 preparation contained genistin of 0.0202-0.0203 mg/capsule and geniposide of 0.211-0.212 mg/capsule, respectively.

• Bulletin of the Korean Chemical Society
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• v.24 no.9
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• pp.1381-1384
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• 2003