• Korean Journal of Clinical Pharmacy
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• v.12 no.1
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• pp.22-28
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• 2002

Aceclofenac, 2-[(2',6'-dichlorphenyl)amino]phenylacetoxiacetic acid, is a new nonsteroidal anti-inflammatory drug that belongs to the family of phenylacetic acids. It shows good tolerance and potent analgesic/antiinflammatory properties, and acts on cartilaginous chondriocytes, stimulating their repair mechanism. The purpose of the present study was to evaluate the bioequivalence of two aceclofenac products, $Airtal^{TM}$ tablet (Daewoong Pharmaceutical Co.) and $Acer^{TM}$ capsule (Kyungdong Pharmaceutical Co.), according to the guideliner of Korea Food and Drug Administration (KFDA). The aceclofenac release from the two aceclofenac products in vitro was tested using KP VII Apparatus II method at pH 7.8 dissolution media. Sixteen normal male volunteers, $23.13\pm2.03$ years in age and $66.33\pm7.08$ kg in body weight, were divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet or capsule containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentrations of aceclofenac in serum were determined using HPLC with UV detector. The dissolution profiles of the two aceclofenac products were very similar at pH 7.8 dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_max$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two products were $6.50\%,\;-1.06\%\;and\;11.96\%$ respectively, when calculated against the $Airtal^{TM}$ tablet. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;were\;89.82\%\;and\;82.84\%$, respectively. Minimum detectable differences $(\Delta)\;at\;\alpha=0.05\;and\;1-\beta=0.8$ were less than $20\%\;(e.g.,\;17.51\%\;and\;19.30\%\;for\;AUC_t,\;C_{max}$, ). The $90\%$ confidence intervals were within $\pm20\%\;(e.g.,\;-3.73\%\sim16.73\%\;and\;-12.34\%\sim10.22\%\;for\;AUC_t,\;C_{max},\;respectively)$. Two parameters met the criteria of KFDA for bioequivalence, indicating that $Acer^{TM}$ capsule is bioequivalent to $Airtal^{TM}$ tablet.

• Journal of Periodontal and Implant Science
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• v.31 no.2
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• pp.287-298
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• 2001

Recently, many natural medicines, which have advantage of less side effects and possibility of long-term use have been studied for their capacity of anti-bacterial, anti-inflammatory and regenerative potential of periodontal tissues. Olibanum has the effects to hemostasis, analgesic and anti-inflammatory, and it also has been traditionally used as a drug for the treatment of bone disease in oriental medicine. The purpose of the present study was to investigate the effects of Olibanum extracts on the activity and differentiation of MC3T3-E1 cells, alkaline phosphatase(ALP) synthesis, formation of bone nodules and expression of type I collagen of MC3T3-E1 cells. To examine the cellular activity, MC3T3-E1 cells were cultured with ${\alpha}-MEM(control)$ and each concentration of Olibanum for 2 days and 4 days. To compare the ALP synthesis, MC3T3-E1 cells were cultured with ${\alpha}-MEM(negative\; control)$, dexamethasone(positive control), and each concentration of Olibanum for 2 days and 4 days. To compare the bone nodule formation, MC3T3-E1 ells were cultured for 21 days, and to compare the type I collagen expression, MC3T3-E1 cells were cultured for 4 days. The cellular activity of MC3T3-E1 cells treated with $1{\mu}g/ml$ of Olibanum extracts was significantly increased at 4-day(p<0.05) to control. The activity of ALP in MC3T3-E1 cells treated with $1{\mu}g/ml$ Olibanum extracts was significantly increased at 4-day(p<0.05). All the experimental groups showed much more bone nodule formation than control groups. The group treated with $1{\mu}g/ml$ of Olibanum extracts was the highest bone nodule formation, and showed much more type I collagen expression than negative control. These results indicate that Olibanum extracts may be considered effective in the activity and differentiation of MC3T3-E1 cells.

• Journal of Physiology & Pathology in Korean Medicine
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• v.23 no.1
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• pp.135-143
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• 2009

There is currently increased interest in the identification of antioxidant compounds that are pharmacologically potent and have low or no side effects. Plants produce significant amounts of antioxidants to prevent the oxidative stress caused by photons and oxygen, therefore they represent a potential source of new compounds with antioxidant activity. Moutan Root Sark (MRS) has been frequently used as analgesic. antispasmodic, anti-inflammatory and remedies for female diseases. In this study. the antioxidant activity of extract from MRS was studied in vitro methods by measuring the antioxidant activity by TEAC, measuring the scavenging effects on reactive oxygen species (ROS) [superoxide anion, hydroxyl radical] and on reactive nitrogen species (RNS) [nitric oxide and peroxynitrite] as well as measuring the inhibitory effect on $Cu^{2+}$ induced human LDL oxidation and the inhibitory effect on collagen induced platelet aggregation. The MRS extracts were found to have a potent scavenging activity, as well as an inhibitory effect on LDL oxidation and on platelet aggregation. In conclusion, the MRS extracts have anti-oxidative and anti-atherosclerotic effects in vitro system, which can be used for developing pharmaceutical drug against oxidative stress and atherosclerosis.

• Journal of Life Science
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• v.31 no.12
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• pp.1128-1141
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• 2021

'Angelica' is one of the most traditionally consumed medicinal herbs around Northeast Asia including Korea for treatments of various diseases or health care purposes like hematopoiesis, blood circulation for women, sedative, analgesic, and a tonic medicine etc. Angelica gigas Nakai, a Korean native species of Angelica, is clearly different from the others in containing a high concentration of active ingredients like pyranocoumarines including decursin, decursinol, and decursinol angelate. These compounds have various kinds of positive effects such as anti-tumor activity including the precaution of neutropenia occurred during anticancer drug administration, improvements of metabolic disorders, menstrual irregularity, impairment of renal function, respiration improvement, cognition-enhancement, anti-inflammatory effect, anti-oxidative effect, enhancing fertility and so forth. Thus it implies incredible potentialities in future development for foods and drugs. However, certain purity-related qualities and/or overdose in food products can cause side effects like toxicities; therefore, their safety profiles should also be considered. This review focuses on the positive and negative effects of three pyranocoumarines in Angelica gigas Nakai and some possibilities and considerations for future food and drug products development.

• Journal of Pharmaceutical Investigation
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• v.41 no.2
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• pp.117-123
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• 2011

Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, 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 log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

• The Korean Journal of Pain
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• v.31 no.2
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• pp.102-108
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• 2018

Background: Nefopam is a non-opioid, non-steroidal analgesic drug with fewer adverse effects than narcotic analgesics and nonsteroidal anti-inflammatory drugs, and is widely used for postoperative pain control. Because nefopam sometimes causes side effects such as nausea, vomiting, somnolence, hyperhidrosis and injection-related pain, manufacturers are advised to infuse it slowly, over a duration of 15 minutes. Nevertheless, pain at the injection site is very common. Therefore, we investigated the effect of warmed carrier fluid on nefopam injection-induced pain. Methods: A total of 48 patients were randomly selected and allocated to either a control or a warming group. Warming was performed by diluting 40 mg of nefopam in 100 ml of normal saline heated to $31-32^{\circ}C$ using two fluid warmers. The control group was administered 40 mg of nefopam dissolved in 100 ml of normal saline stored at room temperature ($21-22^{\circ}C$) through the fluid warmers, but the fluid warmers were not activated. Results: The pain intensity was lower in the warming group than in the control group (P < 0.001). The pain severity and tolerance measurements also showed statistically significant differences between groups (P < 0.001). In the analysis of vital signs before and after the injection, the mean blood pressure after the injection differed significantly between the groups (P = 0.005), but the heart rate did not. The incidence of hypertension also showed a significant difference between groups (P = 0.017). Conclusions: Use of warmed carrier fluid for nefopam injection decreased injection-induced pain compared to mildly cool carrier fluid.

• Korean Chemical Engineering Research
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• v.47 no.1
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• pp.54-58
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• 2009

Ketoprofen and ibuprofen are non-steroid anti-inflammatory drug(NSAID) that have analgesic and antipyretic properties. (S)-ketoprofen and (S)-ibuprofen have pharmacological activity, while (R)-ketoprofen and (R)-ibuprofen are either inactive or have side effect. The chiral separation of racemic ketoprofen and ibuprofen enantiomers was carried out by using a Kromasil HPLC column. Some chromatographic parameters (selectivity, resolution, number of theoretical plates and ${\Delta}H$) are calculated under different mobile phase compositions of hexane/t-BME/acetic acid and temperatures. The selectivity, resolution and number of theoretical plates were observed high at $25^{\circ}C$ and the composition of hexane/t-BME/acetic acid (80/20/0.1).

• Journal of Pharmacopuncture
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• v.22 no.3
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• pp.131-139
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• 2019

Introduction: Mastalgia is the most common benign breast disorder during the fertility period of women. So far a wide range of natural or complementary medicines is used to cure mastalgia. Sanitary organizations need complete and suitable details to help women, for making the proper decision for alternative treatment based on the evidence. The aim of the present study is to introduce medicinal plant-based treatments about mastalgia and summarizes clinical trials about this disorder. Method: The articles were provided using mixture of keywords including cyclic pain, breast, treatment, therapeutics, therapy, clinical trial, herbal, drug, mastalgia and all the probable terms, in national and international databases SID, Iran Medex, Magiran, PubMed, Scopus, Medline, Science direct and Cochrane library, in both Persian and English languages. All cross-sectional and review articles about herbal treatment of mastalgia until 2018 November were studied. Results: Nineteen articles from all of the available articles (45 cases) and a sample size about of (1987 cases) were included in our study. The articles were clinical trials. The results revealed that mastalgia could be healed by Nigella sativa, Vitex agnus-castus, curcumin, Hypericum perforatum, Citrus sinensis, wheat germ, and Ginkgo biloba. Conclusion: Most of the evaluated medicinal plants possessing antioxidant compounds with anti-inflammatory and analgesic properties, exhibited healing effects in the treatment of mastalgia. Thus, medicinal plants can be considered in the treatment of mastalgia; however, further investigations are needed to obtain more details about their probable side effects.

• The Korea Journal of Herbology
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• v.33 no.2
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• pp.29-43
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• 2018

Objectives : Araliae Continentalis Radix(AC) is a medicinal herb belonging to the drug efficacy group treating musculoskeletal disorders(MSD) with anti-inflammatory, analgesic and antipyretic action. However, due to morphologic and onomastic similarity, adulterants(Angelicae Pubescentis Radix: AP, Gypsophilae Oldhamianae Radix: GO, Levistici Officinalis Radix: LO) have been included or replaced the standard. Methods : Multilateral methods were carried out on the identification of AC and its adulterants. Macroscopic and microscopic characteristics were observed by using stereoscope and microscope. For the comparison of chromatogram pattern, standard compounds were analyzed simultaneously using high performance liquid chromatography. Results : 1. The macroscopic identification of original plants was determined by the phyllotaxis type, the inflorescence type, the leaf margin and the color of flowers. The macroscopic identification of herbal materials was examined by oil spots, the cambium, heteromorphic vascular bundles, and the pholem. 2. For the microscopic identification, the fact whether its xylem ray is proliferated or not was first determined. Then medicinal herbs were secondly divided by cellular inclusions, fiber bundles, the distribution of secretary canals and the shape of cambium. 3. AC and its adulterants showed different chromatographic fingerprints. AC was containing continentalic acid and kaurenoic acid. AP was containing osthole and columbianadin. LO was containing osthole and falcarindiol. None of the compounds were found in GO. Conclusions : This recent identification keys of might be helpful to discriminate the pharmacopoeia standard and its adulterants for the right usage in clinics.

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.67-73
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• 2006

Lornoxicam is a nonsteroidal anti-inflammatory drug that decreases prostaglandin synthesis by inhibiting cyclooxygenase. It has analgesic, antipyretic and antiinflammatory effects. The purpose of the present study was to evaluate the bioequivalence of two lornoxicam tablets, $Xefo^{\circledR}$ (Hyundai Pharmaceutical Ind. Co., Ltd.) and Lornocam (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of lornoxicam from the two lornoxicam formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $24.39{\pm}1.95$ years in age and $68.63{\pm}7.25$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After a single tablet containing 4 mg as lornoxicam was orally administered, blood samples were taken at predetermined time intervals and the concentrations of lornoxicam in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Xefo^{\circledR},$ were -1.56%, 2.16% and -17.12% for $AUC_t,\;C_{max}\;and\;T_{max},$ 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 1.25 (e.g., $log\;0.90{\sim}log\;1.05$ and $log\; 0.88{\sim}log\;1.17$ for $AUC_t\;and\;C_{max},$ respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Lornocam tablet was bioequivalent to $Xefo^{\circledR}$ tablet.