• 무역학회지
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• 제47권5호
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• pp.95-113
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• 2022

Tariffs on pharmaceuticals are generally low, but the time-consuming and costly licensing procedures of importing countries may act as barriers to trade. Accordingly, in terms of improving export competitiveness through cost reduction of exporting countries and improving public health for importing countries, international regulatory collaboration is effective for both countries. However, little is known about the impact of cross-border cooperation in pharmaceutical regulation on international trade. This study empirically analyzed the effect of cross-border regulatory collaboration on pharmaceutical trade using the gravity model. It was confirmed that the regulatory collaboration measures had a trade promotion effect in all drugs(HS29+HS30), finished drugs (HS30), and vaccines (HS300220). This study is meaningful in that it empirically analyzed with the consideration of the reference pharmacopoeia, safety and effectiveness in addition to the GMP inspection used in the previous study.

• 한방안이비인후피부과학회지
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• 제13권2호
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• pp.182-187
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• 2000

Current status and quality administration of botanical products in America which has one of the biggest market need to be analyzed for the internationalization of oriental medicine. In this study, current status of botanical products as dietary supplements was analyzed and quality adminstration by United States Pharmacopoeia and National Formulary(USP-NF) was compared with The Korea Pharmacopoeia and botanical drug standard collection(KP), Even though the number of botanical products in USP-NF is small, it is rapidly increasing and more detailed compared with KP. Especially, reference standard compound should be determined for each botanical drugs, and more detailed standard for other items should be established in KP considering international trends. Though the history of botanical drugs in America is short, its annual market is about 3.2 billion dollar, so American administration system should be examined carefully for the internationalization of oriental medicine and related industry.

• 약학회지
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• 제59권3호
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• pp.98-106
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• 2015

Analytical method for related substances can be categorized into two methods depending on the necessity of reference standard (RS). The analytical method of related substances with RS is fast and accurate, but it's very expensive and technically difficult to synthesize RS due to their complicated structure. Another method is using relative retention time (RRT) and relative response factor (RRF) which are already validated with RS. Validation of this method is not easy and time consuming, but once it has been developed, it can save cost and time. In this study, we developed the analytical method for related substances of fenofibrate using RRT and RRF. We validated the method by evaluating specificity, linearity, accuracy and precision according to the "Manual for Guideline Application for Validation of Analytical Procedures" of MFDS. Also, we calculated RRT and RRF between fenofibrate and fenofibrate related substances. The results of this study showed high specificity for fenofibrate and fenofibrate related substances. Correlation coefficient(r) of all substances were more than 0.99, and the recovery of fenofibrate, fenofibrate related substance I, II and III were 99.44%, 100.84%, 99.14% and 101.58%, respectively. Precision of fenofibrate and its related substances were ranged between RSD 0.29% and 0.93%. Quantification limits of fenofibrate, fenofibrate related substance I, II and III were determined to be $0.03{\mu}g/ml$, $0.05{\mu}g/ml$, $0.04{\mu}g/ml$ and $0.02{\mu}g/ml$, respectively by confirming signal to noise ratio of each chromatogram. The RRT for fenofibrate related substance I, II and III were determined to be 0.35, 0.41 and 1.34, respectively. Also, the RRF for fenofibrate related substance I, II and III were determined to be 1.28, 0.98 and 0.79, respectively. The developed method was applied to determine contents for fenofibrate related substances in commercial fenofibrate (active pharmaceutical ingredient). As a result, developed analytical methods of related substances will be used for revising the monograph of fenofibrate in Korean Pharmacopoeia revision and contribute quality control of drugs by improving cost and time consuming problem of RS.

• 원예과학기술지
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• 제35권2호
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• pp.276-286
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• 2017

Licorice, a traditional Korean medicinal plant, is recognized for its main active ingredient, glycyrrhizin. The level of glycyrrhizin in Chinese licorice (Glycyrrhiza uralensis) is lower than the reference level (2.5%) set by the Korean Pharmacopoeia, reducing its value as a medicinal herb. In this study, we aimed to overcome this problem by generating an interspecific licorice hybrid by crossing European licorice (G. glabra) with Chinese licorice, resulting in the production of 32 $F_1$ lines. A comparison of genetic traits revealed variations in glycyrrhizin content among lines, ranging from 1.5 to 5.6%, with a mean value of 3.2%; these values are higher than that of the parental plants. Additionally, 25 lines (78.1%) had a glycyrrhizin content greater than 2.5%, which is higher than the reference level set by the Korean Pharmacopoeia. Four of these lines had glycyrrhizin levels higher than the WHO recommended level of 4.0%. A comparison of phenotypic characteristics showed that the leaves of the hybrids possessed all of the characteristics of European and Chinese licorice; however, the stems of most hybrids had characteristics of European licorice. Finally, we determined the genetic distances of 34 samples of Glycyrrhiza plants (parents, 32 $F_1$ lines) by random amplified polymorphic DNA (RAPD); the $F_1$ lines showed a close genetic distance. We plan to develop to a cultivar using five of these lines (glycyrrhizin content < 4.0%).

• 생약학회지
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• 제40권2호
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• pp.155-160
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• 2009

The reference herbal extracts and their identification methods by Korean Pharmacopoeia IX were established based on the organic solvent extracts to detect their marker compounds. However, most of herbal medicine decoctions in the market are prepared with water as extracting solvent. As the reference herbal extracts and their identification methods are not appropriate for the practical test, new preparation of alternative reference herbal extracts and their identification test methods are essential for the correction of test methods and identification of herbal drugs. Three novel identification test methods were developed for Evodiae Fructus, Cimicifugae Rhizoma and Aurantii Fructus Immaturus. Total 10 reference herbal extracts and their identification methods were optimized for Ephedrae Herba, Schisandrae Fructus, Curcuma longae Rhizoma, Citri Unshius Pericarpium, Puerariae Radix, Corni Fructus, and Cinnamomi Cortex.

• 생약학회지
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• 제41권1호
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• pp.67-72
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• 2010

In the recent version of the Korea Pharmacopoeia(KP) and the Korean Herbal Pharmacopoeia(KHP), there are 563 items(181 in KP, 381 in KHP) of herbal medicines including finished drugs. Also, approximately 507 items including herbal extracts and herbal medicinal products was published in the 3th edition of Korea Pharmaceutical Codex (KPC). These items help the persons working in the pharmaceutical manufacturing field to register the drug and in research fields to develop the new drug considering as a standard specifications. This study was carried out to establish standard analytical methods for 'Compound Hawthorn Berry 60% Ethanol Extract, Ginkgo Biloba Leaf Extract and Garlic Oil Capsules' in the 3th edition of Korea Pharmaceutical Codex. Ginkgo flavonoid and terpene lactone were employed as reference compounds for analytical method. Analytical methods established in this study could be applied to a reasonable and unified quality control of G. biloba leaf extract and hawthorn berry extract.

• Journal of Ginseng Research
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• 제37권1호
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• pp.124-134
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• 2013

The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.

• 생약학회지
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• 제39권3호
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• pp.218-222
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• 2008

This study was carried out to establish standard analytical methods for Ginkgo biloba leaf extract. Ginkgo flavonoids, terpene lactones, ginkgolic acids were employed as reference compounds for analytical method. Analytical method of US Pharmacopoeia was adopted for flavonoids and terpene lactones, and a new method was developed for ginkgolic acids. Analytical methods established in this study could be applied to a reasonable and unified quality control of G. biloba leaf extract.

• 생약학회지
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• 제53권4호
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• pp.226-233
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• 2022

Ephedra herbs are defined as stem of Ephedra sinica , Ephedra intermedia and Ephedra equisetina in the Korean Pharmacopoeia. It is important to use pure herbs to derive the safety and efficacy of herbal medicine. However, the identification of these herbs by conventional taxonomic methods is difficult. Recently, many studies have applied these DNA barcoding for the identification of herbal medicinal species using standard DNA markers. In this study, we report a case study in which the identification of Ephedra species was done by DNA barcoding. For identification of Ephedra species, 17 samples were collected, and a reference DNA barcode library was developed using 6 markers (rbcL, matK, ITS2, ycf1, ycf3, and rpoC2). To develop KASP-SNP markers, we selected 4 markers (ycf1, ycf3, rpl2, and rbcL), which were able to distinguish three Ephedra species. In the result, the specific markers for each of the three Ephedra were clustered into FAM-positive section, whereas non-targeted plants were clustered either HEX-positive or negative section. Therefore, we have developed KASP assay that allow rapid and easy Ephedra species identification using three KASP markers.