• Korean Journal of Clinical Pharmacy
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• v.7 no.1
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• pp.17-21
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• 1997

Cefaclor is a second generation cephalosporin antibiotic that shows a potent antibacterial activity against both Gram-positive and Gram-negative bacteria, when it is orally administered. Due to its patent expiration, a number of generic drugs have been marketed, but not yet elucidated to ensure therapeutic equivalence. In this study, cefaclor capsules manufactured by Chong Kun Dang were bioequivallently assessed by comparing with $Ceclor^{TM}$ introduced originally by Daewoong Lilly. A total of 16 healthy male volunteers were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of cefaclor in plasma were measured upto 6 hours following a single oral administration of two capsules (500 mg of cefaclor) by high-performance liquid chromatography with UV detection. Although the plasma concentration at 6 hours was not detected, the computed half-life of cefaclor was approximately 0.5 hours. The area under the concentration-vs-time curve from 0 to 4 hours $(AUC_{0-4h})$ was calculated by the trapezoidal summation method. The differences in mean values of $AUC_{0-4h}$, peak plasma concentration $(C_{max})$, and time to peak concentration $(T_{max})$ between the two products were $4.63\%,\;1.84\%,\;and\3.28\%$, respectively. The least significant differences at $\alpha4= 0.05 for $AUC_{0-4h},\;C_{max},\;and\;T_{max}\;were\;6,53\%,\;4.05\%,\;and\;6.47\%$, respectively. In conclusion, the test drug was bioequivalent with the reference drug.

• Biomolecules & Therapeutics
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• v.15 no.2
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• pp.118-122
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• 2007

This study was performed to evaluate the bioequivalency between the Osmetone$^{TM}$ Tablet (Myeongmoon Pharm. Co., Ltd.) as a test formulation and the Relafen$^{TM}$ Tablet (Handok Pharm. Co., Ltd.) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with Ultra-Violet (UV) detector. AUC$_t$, C$_{max}$ and T$_{max}$ were obtained from the time-plasma concentration curves, and log-transformed AUC$_t$ and C$_{max}$ and log-untransformed T$_{max}$ values for two formulations were compared by statistical tests and analysis of variation. AUC$_t$ was determined to be 897.8${\pm}$431.1 ug.hr/ml for the reference formulation and 902.3${\pm}$408.4 ug.hr/ml for the test formulation. The mean values of C$_{max}$ for the reference and test formulations were 24.2${\pm}$8.9 and 24.0${\pm}$9.5 ug/ml, respectively. The AUC$_t$ and C$_{max}$ ratios of the reference Relafen$^{TM}$ Tablet to the test Osmetone$^{TM}$ Tablet were +5.01% and -0.83%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for logtransformed AUC$_t$ and C$_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for AUC$_t$ and C$_{max}$ were located in ranges from log 0.80 to log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The Osmetone$^{TM}$ Tablet as the test formulation was considered to be bioequivalant to the Relafen$^{TM}$ Tablet used as its reference formulation, based on AUC$_t$ and C$_{max}$ values.

• Korean Journal of Pharmacognosy
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• v.40 no.4
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• pp.298-302
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• 2009

Samultang is one of traditional medicine composed of Paeonia lactiflora, Angelica gigas, Rehmannia glutinosa and Cnidium officinale. To develop simultaneous determination of paeoniflorin, decursin and 5-HMF in Samultang, a high performance liquid chromatography with diode array detector was used. To separate three marker components, Dionex $C_{18}$ column (5 ${\mu}m$, 120 ${\AA}$, 4.6 mm${\times}$150 mm) was used with a gradient elution system of water and methanol. UV wavelength of detector set at 230 nm and 280 nm. This method was validated by linearity, precision test and recovery test. Calibration curves of three standard components were showed good linear regression ($R^2$>0.9973). LOD and LOQ ranged from 0.08 ${\mu}g$/ml to 0.38 ${\mu}g$/ml and 0.25 ${\mu}g$/ml to 1.16 ${\mu}g$/ml, respectively. The relative standard deviations (RSDs) of data of the inter-day and intra-day experiments were less than 0.54% and 0.89%, respectively. The measured results of recovery test were varied from 93.36 to 107.79 with RSD values 0.01~1.45%. The established method was applied for separation of bio-conversion Samultang sample and compared with control sample.

• Korean Journal of Pharmacognosy
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• v.45 no.1
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• pp.84-87
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• 2014

A high performance liquid chromatography (HPLC) method for the quantitation of ellagic acid in Nymphaea tetragona was developed for the quality control of functional cosmetic ingredient, the extract of N. tetragona. Separation and quantitation were successfully achieved with a Kromasil C18 column ($5{\mu}m$, $250mm{\times}4.6mm$, i.d.) by isocratic elution of a mixture of acetonitrile containing 0.1% trifluoroacetic acid and water containing 0.03% phosphoric acid at a flow rate of 1.0 ml/min. The UV detector was used for the detection and the wavelength for quantitation was set at 254 nm. The presence of ellagic acid in the extract was determined by comparison of retention time and spiking with authentic standard. Analytical results showed good linearity ($R^2=0.99996$) in relatively wide concentration ranges. The R.S.D. for precision test was less than 3.0%. Recovery of the compound was 98.55~101.72% with R.S.D values less than 4.0%. In conclusion, this method has been successfully applied to the determination of ellagic acid in N. tetragona.

• Analytical Science and Technology
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• v.31 no.5
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• pp.179-184
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• 2018

Diphencyprone (DPCP) is frequently used as a compounded preparation in dermatology for the treatment of alopecia and recalcitrant warts based on the immune reaction of skin allergy. However, DPCP is a non-recognized agent in Pharmacopoeia, because there are no criteria or analytical method for quality control of its powder and formulation. DPCP is unstable under light irradiation because as it easily decomposes to diphenylacetylene (DPA). This study aims to develop a simultaneous HPLC analytical method for analyzing DPCP and DPA in the raw materials and compounded preparation. The method required a C18 column ($250{\times}4.6mm$, $5{\mu}m$) at $40^{\circ}C$ with a mobile phase of (A) 0.01 M phosphoric acid in water and (B) acetonitrile at UV 220 nm. DPA conversion to DPCP in the powder and compounded preparations was accelerated after light exposure for 60 min. In addition, this resulted in different patterns depending on the wavelength of light and the formulation. That is, DPCP in compounded preparation was more unstable than that in the powder. However, the DPCP formulation in amber bottles was observed to remain stable, although the measured concentrations of DPCP were somewhat different from the nominal concentration of the compounded preparations. The control of the exact concentration is required for effective disease treatment, depending on the state of the patient. In conclusion, these results will be useful for the recognition of DPCP in Pharmacopoeia and new DPCP formulation development to prevent photodecomposition.

• Archives of Pharmacal Research
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• v.29 no.12
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• pp.1164-1170
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• 2006

A triptolide-lysozyme (TP-LZM) conjugate was synthesized to achieve renal specific delivery and to reduce the side effects of triptolide. Triptolide was coupled to lysozyme through succinic via an ester bond with an average coupling degree of 1 mol triptolide per 1 mol lysozyme. The lysozyme can specifically accumulate in the proximal tubular cells of the kidney, making it a potential carrier for targeting drugs to the kidney. The structure of triptolide succinate (TPS) was confirmed by IR, $^{1}H-NMR$, MS and UV. The concentrations of triptolide in various samples were determined by reversed-phase high-performance liquid chromatography (HPLC). In this study, the physicochemical and stability profiles of TP-LZM under various conditions were investgated the stability and releasing profiles of triptolide-lysozyme (TP-LZM) under various conditions. In vitro release trails showed triptolide-lysozyme was relatively stable in plasma (less than 30% of free triptolide released) and could release triptolide quickly in lysosome (more than 80% of free triptolide released) at $37^{\circ}C$ for 24 h. In addition, the biological activities of the conjugate on normal rat kidney proximal tubular cells (NRK52E) were also tested. The conjugate can effectively reduce NO production in the medium of NRK52E induced by lipopolysaccharide (LPS) but with much lower toxicity. These studies suggest the possibility to promote curative effect and reduce its extra-renal toxicity of triptolide by TP-LZM conjugate.

• Food Science and Biotechnology
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• v.16 no.6
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• pp.868-872
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• 2007

The microbiological and chemical identification of antibiotic residues was attempted for livestock and seafood products including pork (n=34), beef (n=34), chicken (n=32), flatfish (n=37), armorclad rockfish (n=36), and sea bream (n=27). The meat (n=100) and seafood (n=100) samples were collected from 9 markets in 5 major Korean cities. Antibiotic substances were identified from the classes of tetracyclines, macrolides, penicillins, aminoglycosides, polyethers, peptides, sulfonamides, quinolones, chlorampenicols, and novobiocins using a microbiological assay, the Charm II test and high performance liquid chromatography (HPLC) with ultra violet (UV) and fluorescence detectors. The results showed that 2 tetracyclines (oxytetracycline and tetracycline) and 3 quinolones (ciprofloxacin, norfloxacin, and enrofloxacin) were detected in 4 samples of flatfish among all 100 seafood samples tested. No antibiotic residues were detected in the 100 livestock product samples tested. The amounts (min-max, mg/kg) of the residual antibiotics were as follows; tetracycline 0.78-0.85, oxytetracycline 0.49-0.74, ciprofloxacin 0.09-0.83, norfloxacin 0.01-0.21, enrofloxacin 0.12-2.98. These data indicate that the total detection rate of antibiotics in livestock and seafood products was approximately 2%.

• Korean Journal of Food Science and Technology
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• v.37 no.6
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• pp.1024-1027
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• 2005

Rapid and simple method was developed for simultaneous determination of vitamins $D_3\;and\;K_1$ contents in infant formula. Contents of vitamins $D_3\;and\;K_1$, extracted by column-switching HPLC with reversed phase column using enzymatic hydrolysis and organic solvent, in CRM determined by developed method were within certified ranges of standard values.

• KSBB Journal
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• v.21 no.2
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• pp.129-132
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• 2006

The importance of natural preservative has increased in recent years. The natural preservatives have been used in the field of foods, cosmetics and pharmacology. In the present work Artemisia sp., well recognized for their effect of antimicrobial activity, were extracted by methanol and water sequentially for selecting only water-soluble compounds that can be used as additives in food and cosmetics. Antimicrobial activities of water extracts from stem and leaf of Artemisia princeps var. orientalis were investigated by the disc diffusion method. Two gram positive bacteria(Staphylococcus aureus and Bacillus subtilis) and three gram negative bacteria(Escherichia coil, Agrobacterium tumefaciens and Pseudomonas putida) were used for antimicrobial activity studies. The water-soluble compounds from methanol extract showed higher antimicrobial activity than only water extract to these bacteria. Comparative evaluation of water-soluble metabolite profiles with caffeic acid that is known as an antimicrobial compound from Artemisia sp. was performed by high performance liquid chromatography with photo-diode array detection.

• Korean Journal of Pharmacognosy
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• v.43 no.1
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• pp.10-15
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• 2012

An accurate and sensitive analysis method was established for simultaneous determination of three bioactive compounds (glycyrrhizin, 6-gingerol and ginsenoside Rg3) in the Ejung Tang with high-performance liquid chromatography (HPLC)-photodiode array detection (DAD)-electrospray ionization (ESI)-Mass spectrometry (MS). The optimizing chromatographic separations a were acquired by an $C_{18}$ column ($5{\mu}m$, $4.6I.D{\times}250mm$, SHISHEDO) using gradient elution with water comprising 0.1% TFA(trifluoroacetic acid) and acetonitrile at a performing temperature of $35^{\circ}C$. Flow rate was 1.0 ml/min. A detection UV wavelength set at 205 nm and 250 nm. The three compounds were identified by electrospray ionization mass spectrometry. All calibration curves indicated great linear regression within test ranges ($R^2>0.9997$). The established method provided acceptable precision and accuracy. The relative standard deviations (RSDs) of intra-day and inter-day were less than 2.00% and 3.00%, respectively. The recoveries were found to range from 94.49 to 101.10% for the three compounds analyzed. These results showed that this method was effective and reliable for quality control of Eiung-Tang.