• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.2
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• pp.29-43
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• 2020

Objectives: The purpose of this study is to review and evaluate the effectiveness of oriental medicine per oral for recurrent vulvovaginal candidiasis (RVVC). Methods: We searched articles from Korean journal databases including Journal of Korean Obstetrics and Gynecology, Korean studies Information Service Studies, and Chinese National Knowledge Infrastructure, Cochrane Library, PubMed. Searched keywords were "재발성 칸디다성 외음질염", "recurrent vulvovaginal candidiasis", "㚆发性外阴阴道假丝酵母菌病", "中藥". Results: 10 randomized controlled trials with 700 patients were identified and reviewed. 8 studies compared combination of oriental medicine and anti-fungal agent with anti-fungal agent, and 6 of them reported that treatment group (TG) showed statistically higher total effective rate or cure rate and lower recurrence rate. One study compared oriental medicine and anti-fungal agent and TG showed statistically higher total effective rate and lower recurrence rate after 1 month. One study compared combination of oriental medicine and lacto bacillus capsule with lacto bacillus capsule, and TG showed statistically higher total effective rate and lower positive fungul test rate after 6 months. No severe adverse response was reported. Conclusions: Our review found that oriental medicine per oral is effective for alleviating symptoms, lowering recurrence rate and positive fungal test in RVVC patients. We recommend standardized randomized controlled trial guideline should be made to obtain stronger evidence and well designed trials with larger sample sizes are needed.

• Biomolecules & Therapeutics
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• v.6 no.3
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• pp.296-302
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• 1998

The bioequivalence of two cyclosporin A products was evaluated in 26 normal male volunteers (age 25 ~33 yr, body weight 56~84 kg) following single oral administration. Test product was a hard capsule containing the granule of cyclosporin A (Chong Kun Dang Corp., Korea) and reference product, Sandimmun", was a soft capsule containing surfactant, oil, alcohol and cyclosporin A (Sandoz, Swiss). Both products contain 100 mg of cyclosporin A. Four capsules of the test and the reference product were administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). Average drug concentrations at each sampling time and pharmacokinetic parameters were not significantly different between two products (p>0.05); the area under the concentration-time curve to last sampling time (24 hr) (AU $Co_{24}$) (5034.8$\pm$ 1760.6 vs 4635.4$\pm$ 1158.9 ng . h/ml), maximum plasma concentration ( $C_{max}$) (1002.7$\pm$353.1 vs 980. 4$\pm$ 171.7 ng/71), and mean residence time (MRT) (6.16$\pm$0.81 vs 5.64$\pm$0.50 h). The differences of mean AUC 7-,4,7~, T_ and MRT between the two products (7.93,2.22,16 and 8.39%, respectively) were less than 20% given as a guideline. The power (1-$\beta$) and treatment difference ($\Delta$) for AU $Co_{24}$, $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although $T_{max}$ of the two products was significantly different each other (p<0.05), $T_{max}$ might be an insignificant parameter because cyclosporin A generally requires long-term administration. From these results, the two products are bioequivalent.alent.t.

• Korean Journal of Clinical Pharmacy
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• v.15 no.1
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• pp.34-40
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• 2005

We examined the effects of food on pharmacokinetic and pharmacodynamic properties of fenofibrate released from sustained-release(SR) capsule as therapy for hypolipidemia. Twenty-four healthy volunteers were used in $3{\times}3$ crossover pharmacokinetic and pharmacodynamic study; Additional six volunteers were used as a control group (i.e., no fenofibrate administration). A single dose of fenofibrate (SR capsule, 250 mg) was administered on three occasions: after overnight fasting, after consumption of a standard breakfast, and after a high-fat breakfast. Serial blood samples were collected for the next 72 hours. Plasma fenofibric acid concentrations were measured by high performance liquid chromatography, and pharmacokinetic parameters were calculated using ADAPT II program. Plsama triglyceride concentrations were measured by blood chemistry analyzer (CH-100). The pharmacokinetic parameters were significantly affected by food intake. The high-fat breakfast affected the rate of absorption of fenofibrate more than did the standard breakfast and fasted conditions. Plasma concentrations of triglyceride at 24 hours decreased significantly after the administration of fenofibrate compared with the concentration at 0 hours(P<0.05). In healthy volunteers, the bioavailability of fenofibrate was greater when administered via sustained-release capsules immediately after the consumption of food than after fasting condition.

• Biomolecules & Therapeutics
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• v.10 no.3
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• pp.202-207
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• 2002

The hepato-protective activity of the GODEX (Hepadif-s capsule) has been studied in the rats against $CCl_4$-ethanol induced liver toxicity. The rats were oral1y treated with $CCl_4$ (corn oil/ $CCl_4$ 1:1, 1 mg/kg). And one week passes, $CCl_4$(0.4 mg/kg) administered two times a week for 7 weeks. The drugs have been administered every two days for 4 weeks after $CCl_4$ injection. The experimental groups have consisted of the GODEX (250 mg/kg), Hepadif (200 mg/kg), DDB complex (DDB 50 mg/kg and garlic oil powder 50 mg/kg), DDB (50 mg/kg), and vehicle control respectively. There was a significant decrement on the serum level of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin in all treated groups. Specially, ALT level of GODEX and Hepadif only treated groups was decreased c1early. Also, serum albumin level was significantly enhanced in GODEX treated group compared with control and DDB treated groups. In histological results, hepatocellular vacuolar degeneration, lobular restructure and necrosis of bile duct were severely showed in control. But other treated groups showed centerilobular degeneration and mild hyper-plasia. Hepadif or DDB has a effects of the recovery on serum parameters and structure ill liver injury. When it was compared GODEX to Hepadif alone or DDB complex or DDB, it suggested to have the best activity of the liver recovery.

• YAKHAK HOEJI
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• v.54 no.5
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• pp.362-369
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• 2010

Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.

• Journal of Pharmaceutical Investigation
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• v.23 no.1
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• pp.41-49
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• 1993

The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was $Rosec^{\circledR}$ capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study ($2\;{\times}\;2$ Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) $(AUC_{0-8hr})$ $(1946.5{\pm}675.3\;vs\;2018.3{\pm}761.6\;ng{\cdot}hr/ml)$, AUC from time zero to infinite $(AUC_{o-\infty})$ $(2288.6{\pm}1212.8\;vs\;2264.9{\pm}1001.3\;ng{\cdot}hr/ml)$, maximum plasma concentration $(C_{max})$ $(772.5{\pm}283.3\;vs\;925.8{\pm}187.7\;ng/ml)$, time to maximum plasma concentration $(T_{max})$ $(2.38{\pm}1.06\;vs\;2.34{\pm}1.09\;hr)$, apparent elimination rate constant $(k_{\ell})$ $(0.5339{\pm}0.2687\;vs\;0.5769 {\pm}0.2184\;hr^{-I})$, apparent absorption rate constant $(k_a)$ $(1.1536{\pm}0.5278\;vs\;0.9739{\pm}0.9507 hr^{-1})$ and mean residence time (MRT) $(3.13{\pm}0.73\;vs \;3.41{\pm}1.04\;hr)$. The differences of mean $(AUC_{0-8hr})$, $C_{max}$, $T_{max}$ and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power $(1-{\beta})$ and treatment difference $(\triangle)$ for $AUC_{o-8hr}$ $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of $Rosec^{\circledR}$ capsule. Therefore, two products are bioequivalent based on the current results.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.18 no.1
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• pp.115-119
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• 1996

Myoepithelioma is composed exclusively of myoepithelial cells. Myoepithelial cells are ectodermally derived contractile cells that can be routinely identified in many normal tissues having secretory function such as major and minor salivary glands, lacrimal gland and sweat gland. Tumors composed exclusively of myoepithelial cells, so-called myoepitheliomas, are rare-less than 1% of all salivary gland tumors. Grossly, these tumors are well demarcated. The external surface is smooth and may be bosselated. The cut surface is white and homogenous. Microscopically, these tumors are surrounded by a thin fibrous capsule. They are composed of benign-appearing spindle- shaped and/or polygonal cells. Mitoses are rare. Frequently these tumors contain myxomatous stroma which is susceptible to alcial blue stain. Clinically, myoepitheliomas present as slow-glowing, painless masses and can not distinguished from pleomorphic adenomas. Treatment is the same as for pleomorphic adenoma, and the surgical excision should include a margin of normal tissue. Although the majority of myoepitheliomas have behaved in a beingn manner, pleomorphism and mitotic activity have been associated with local aggressiveness.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.32 no.4
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• pp.384-390
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• 2006

Pleomorphic adenoma is the most common salivary benign tumor, constituting over 60% of parotid gland tumor, 25% of sublingual gland tumor and 50% of minor salivary gland tumor. It is somewhat more frequent in the fourth to sixth decades. The recurrent rate which enforces only a simple enucleation is very high $(20{\sim}45%)$. Histologically, it contains the epithelial cell, the myo-epithelial cell and mesenchymal ingredient, which is various aspect. We analyzed clinicopathologically and immunohistochemically the patients(34 cases) who are diagnosed with pleomorphic adenoma in Dept. of Oral & Maxillofacial Surgery, College of Dentisty, Dankook university since 1998. The results are as follow: 1. The incidence of the tumor was most frequent in age 30 to 50. The ratio of male to female was 1:1.43. 2. The most chief complain was a painless mass(94.1%) and the duration time was more than decade in 18 cases(52.9%). 3. Palate(soft & hard palate) was the most occurred site(64.7%). In major salivary glands, the parotid gland was the most frequent site(17.6%). 4. The tumor size was 2 to 3cm on the average. Most of tumors were with capsule(91.2%). 5. Surgical excision was a main treatment method(20 cases, 58.8%) and 14 cases were excised with a glandectomy, 1 case was treated with a partial maxillectomy. Only 1 case of all cases was recurred. 6. Histopathologically, 9 cases(26.5%) were cellular type, 11 cases(32.4%) were intermediate(classic) type and 14 cases(41.1%) were myxoid type. 7. Immunohistochemically, the specimen of all tumors reacted positively to cytokeratin and vimentin marker.

• Journal of Pharmaceutical Investigation
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• v.34 no.1
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• pp.49-55
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• 2004

To develop a aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected as a formula of aceclofenac soft capsule (Clanza $S^{TM}$), since it showed the fastεst dissolution rate. Bioequivalence of aceclofenac tablet, $Airtal^{TM}$ (Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza $S^{TM}$ (Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KA Fourteen normal male volunteers (age 20 - 25 years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After oral administration of one tablet or capsule containing 100 mg of aceclofenac, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method under UV detector The pharmacokinetic parameters ($C_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmetically transformed $AUC_t$, $C_{max}$ and $T_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between Aral tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(15) (e.g. log(0.81) -log(1.23) ad log(0.89) -log(1.4)) fo $AUC_t$ and $C_{max}$, respectively. Thus, the criteria of the KFDA guidelines for the equivalence was satisfied, indicating that Clanza $S^{TM}$ soft capsule is bioequivalent to$Airtal^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.18 no.2
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• pp.61-67
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• 1988

The influence of different suppository bases on the dissolution, and the bioavailability of aspirin suppositories in rabbits and humans was investigated using Witepsol H15 (WIT), WIT-Tween 80 (TWE), WIT-sodium lauryl sulfate (SLS), polyethylene glycol (PEG), hollow WIT (WIT-HOLL) and capsule incorporated into WIT (WIT-CAP). The results obtained were as follows: 1) Dissolution rates of aspirin suppositories with different bases in distilled water were faster in the order of WIT-TWE >WIT-SLS >PEG >WIT-HOLL >WIT >WIT-CAP. 2) The maximum blood levels $(C_{max})$ of aspirin in rabbits and humans were highest in WIT-TWE and WIT-SLS bases, but $C_{max}$ from WIT base was lower than that in oral administration of aspirin suspension. 3) The times reaching the maximum blood levels $(T_{max})$ in rabbits were 1 hr for oral administration, 1.5-2.5 hr for WIT-TWE, WIT-SLS, PEG, and WIT bases, and 2.5-4.0 hr for WIT-HOLL and WIT-CAP bases, but $T_{max}$ in humans were 1 hr for oral administration and WIT-TWE base, and 2-4 hr for WIT and WIT-HOLL bases. 4) Relative bioavailability (RBA) of aspirin suppositories in rabbits was higher in WIT-SLS, WIT-TWE and PEG bases than that in oral administration, and RBA of aspirin suppositories in humans was higher in the order of WIT-TWE >PEG >WIT-HOLL >oral >WIT bases tested. 5) Good correlation between dissolution rates and $C_{max}$ was obtained: y = 0.60x+32.23 (r = 0.96) for rabbits, and y = 0.60x+35.74 (r = 0.97) for humans.