• 대한한의학회지
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• 제30권6호
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• pp.103-111
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• 2009

Objectives: To investigate the possibility of GamiSamgieum (SGMX) as a combination therapy with statins on hyperlipidemia using an animal model. Methods: Forty eight ICR mice (male) were divided into six groups of eight mice each: naive, induced, Lipitor 5 mg/kg, Lipitor 5 mg/kg plus SGMX 100 mg/kg, Lipitor 10 mg/kg, and Lipitor 10 mg/kg plus SGMX mg/kg treatment group. Hyperlipidemia was induced by feeding a purified high fat diet for all groups (except naive) along with treatment of drugs for 6 weeks, and then biological parameters were examined on the last experiential day. Results: Lipitor treatment lowered total cholesterol and increased HDL-cholesterol compared to the induced group with no statistical significance. However, co-treatment of SGMX with Lipitor revealed synergic effects on total cholesterol and HDL-cholesterol significantly (P < 0.05) in both. SGMX co-treatment also significantly protected liver tissues from the oxidative stress in liver tissues (P < 0.05) and augmented inhibitory effect of Lipitor against fat accumulation in the body. Conclusion: These results indicate the possibility of that SGMX can be used for patients having hyperlipidemia as a combination therapy with statin drugs.

• Journal of Pharmaceutical Investigation
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• 제38권2호
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• pp.135-142
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• 2008

The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

• 대한한방내과학회지
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• 제41권2호
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• pp.224-232
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• 2020

Objectives: This case report presents the effects of traditional Korean medicine on a patient with idiopathic bilateral facial nerve palsy. Methods: Two evaluation scales, the House-Brackmann (H-B) scale and the Yanagihara scale, were used to evaluate the symptoms of bilateral facial palsy. Herbal medicine and acupuncture treatment were administered to improve the patient's symptoms in parallel with Western oral medication (Valvirus Tab 500 mg, Solondo 5 mg, Lipitor 20 mg, Almagel 15 ml, Lanston 15 mg). Results: Before treatment, the patient had severe facial paralysis with an H-B scale of 5/5 and a Yanagihara scale of 3/2 on both sides. However, after treatment, the symptoms improved significantly with an H-B scale of 2/3 and a Yanagihara scale of 31/26. Conclusions: This case report shows that traditional Korean medicine in parallel with Western oral medication can be effective in the treatment of idiopathic bilateral facial nerve palsy.

• Journal of Pharmaceutical Investigation
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• 제37권6호
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• pp.339-347
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• 2007

SMEDDS is mixture of oils, surfactants, and cosurfactants, which are emulsified in aqueous media under conditions of gentle agitation and digestive motility that would be encountered in the gastro-intestinal(GI) tract. The main purpose of this work is to prepare self-microemulsifying drug delivery system(SMEDDS) for oral bioavailability enhancement of a poorly water soluble drug, atorvastatin calcium. Solubility of atorvastatin calcium was determined in various vehicles. Pseudo-ternary phase diagrams were constructed to identity the efficient self-emulsification region and particle size distributions of the resultant micro emulsions were determined using a laser diffraction sizer. Optimized formulations for in vitro dissolution and bioavailability assessment were $Capryol^{(R)}$ 90(50%), Tetraglycol(16%), and $Cremophor^{(R)}$ EL(32%). The release rate of atorvastatin from SMEDDS was significantly higher than the conventional tablet ($Lipitor^{(R)}$), 2-fold. Our studies illustrated the potential use of SMEDDS for the delivery of hydrophobic compounds, such as atorvastatin calcium by the oral route.

• Journal of Pharmaceutical Investigation
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• 제38권2호
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• pp.111-117
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• 2008

To overcome the solubility of poorly water-soluble drug, the formation of solid dispersion using a spray-dryer with polymeric material, that can potentially enhance the dissolution rate extend of drug absorption was considered in this study. $Eudragit^{(R)}$ E100 as carrier for solid dispersion is acrylate copolymer that soluble in acidic buffer solutions (below pH 5.0). It was used to increase dissolution of atorvastatin calcium as a water-insoluble drug in acidic environments. In this study, a spray-dryer was used to prepare solid dispersion of atorvastatin calcium and $Eudragit^{(R)}$ E100 for purpose of improving the solubility of drug. Atorvastatin calcium and $Eudragit^{(R)}$ E100 were dissolved in ethanol and spray-dryed. DSC and XRD were used to analyze the crystallinity of the sample. It was found that atorvastatin calcium is amorphous in the $Eudragit^{(R)}$ E100 solid dispersion. FT-IR was used to analyze the salt formation by interaction between atorvastatin calcium and $Eudragit^{(R)}$ E100. Comparative dissolution study exhibited better dissolution characteristics than the commercial drug ($Lipitor^{(R)}$) as control. The dissolution rate of atorvastatin calcium was markedly increased in solid dispersion system in simulated gastric juice (pH 1.2). This study proposed that this solid dispersion system improved the bioavailability of poorly water-soluble atorvastatin calcium.