• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.26 no.3
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• pp.1-19
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• 2013

Objective : The primary purpose of present study is to evaluate the effect of herbal cosmetics containing Cortex Betulae Platyphyllae extract complex on acne. The second is to comparatively evaluate safety of this cosmetics. Methods : We opened collecting of applicant that men and women(the 18~35-year-old) with acne on face. We selected subjects who came up to entire inclusion criteria and were not included in the exclusion criteria. We checked changes of Acne Global score, skin sebum, moisture, pores counts, Skindex-29 for 8 weeks. Results : 1. Comparison of changes in Global score, it declined in both experimental group and control group. But Experimental group showed a statistically significant decline than control group. 2. Comparison of changes in sebum and moisture, it declined in both experimental group and control group. But there was no statistically significant difference between those two groups. 3. Comparison of changes in erythema normal area, it declined in both experimental group and control group. But there was no statistically significant difference between those two groups. 4. Comparison of changes in pore counts, it increased statistically significantly in both experimental group and control group. 5. Comparison of changes in Skindex-29, it declined in both experimental group and control group. But there was no statistically significant difference between those two groups. Conclusion : Considering the above experiments, it is suggested that herbal cosmetics containing Cortex Betulae Platyphyllae extract complex have a positive effect on acne.

• The Journal of Korean Medicine
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• v.35 no.3
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• pp.135-154
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• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.25 no.1
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• pp.104-111
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• 2012

Objective : The aim of this study is to report the effect and safety of Traditional Korean Medicine on the treatment of erythrodermic psoriasis which appeared after stopping high potency topical steroids. Methods : A patient with psoriasis stopped topical steroids after the first outpatient care and was treated with herbal medicine, acupuncture, moxibustion for eight months. The severity of psoriasis was assessed with Psoriasis Area and Severity Index. Liver and renal functions were tested to observe the hepatic and renal toxicity of the treatment. Results : PASI score were 6.2 on the first visit and three months after it increased to 30 and the patient showed symptoms of erythrodermic psoriasis. And seven months after the first visit, it decreased to 0.6. There was no hepatic and renal toxicity of the treatment. Conclusion : These findings suggest that Traditional Korean Medicine might be effective and safe for the treatment of erythrodermic psoriasis.

• Journal of Korean Medicine Rehabilitation
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• v.34 no.3
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• pp.89-96
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• 2024

Objectives This study is designed to evaluated the safety of peony root extract tablet in healthy male volunteers. Methods 12 healthy male volunteers were recruited, and this study was conducted by a single center. The safety was evaluated by collecting laboratory test and vital signs of volunteers. As the registration process, 12 subjects were assigned by serial number. To evaluate safety, vital signs were checked and blood samples were collected 4 times during the screening period, pre & post-administration (after 8 hours) and post-administration (after 7 days). The difference in variables was summarized by the mean±standard deviation. The normality test was carried out using the Shapiro-Wilk test and Kolmogorov-Smirnov test. When normality is fulfilled, a paired t-test is applied and the significance level was p<0.05. And the incidence of all adverse effects and serious adverse effects are shown in percentage. Results In the case of vital sign, body temperature (BT) (℃) was 0.06±0.05 ℃ (p=0.008), and there was a statistically significant difference in before and after administration. However, clinical symptoms were not occurred and BT (℃) of all subjects before and after administration showed values within the normal reference value. There was no significant difference from the control group in all other vital signs and laboratory test data. And no side-effects associated to clinical trial drugs were followed. Conclusions The peony root extract tablet was considered to be safe for healthy male volunteers.

• Journal of Physiology & Pathology in Korean Medicine
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• v.33 no.2
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• pp.123-130
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• 2019

In this study, we investigated the effects of MOK pharmacopuncture at high-doses which are increased 10 to 100-fold in clinics, on propylthiouracil (PTU)-induced hypothyroidism in rats and the safety. We measured the changes of body weight, food and water intake, body temperature, the serum levels of thyroid hormones (TSH, T3, and T4), AST and ALT, glucose, lipid metabolites (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) and observed histopathological changes of thyroid tissues by H&E staining. We also analyzed the peaks of constituents of MOK using HPLC. In the results, the treatment of MOK pharmacopuncture at high-dose (30 mg/kg) in hypothyroidism-induced rats for 2 weeks was shown the improvement effects on the decrease of body weight, food intake, and body temperature, The MOK pharmacopunture at high dose regulated the imbalance of thyroid hormones, glucose, and lipid metabolites and also inhibited the structural damages of thyroid tissues. In liver damage, the MOK pharmacopuncture at high dose reduced the increase of AST and ALT levels in hypothyroid rats. We identified the MOK constituents in HPLC analysis. In conclusion, the treatment of MOK pharmacopuncture at high dose has a therapeutic effect on hypothyroidism without liver toxicity, suggesting that the MOK pharmacopuncture be usefully applicable to treat with hypothyroidism in clinics.

• Journal of Pharmacopuncture
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• v.25 no.4
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• pp.301-316
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• 2022

Objectives: This study aimed to evaluate the efficacy and safety of heat stimuli (e.g., fire needling, warm needling) in acupuncture for acute gout. Methods: Four international online databases (PubMed, Cochrane, Embase, and Chinese National Knowledge Infrastructure) were searched to identify randomized, controlled trials (RCTs) that used fire needling and warm needling for acute gout. The methodological quality of the RCTs was evaluated using the Cochrane risk-of-bias (RoB) tool. Thirteen RCTs (840 patients) were included and analyzed. Three evaluation tools (total effective rate, uric acid level, and pain score) were mainly used. Comparisons were made between Western medicine (WM) and i) fire needling or warm needling treatment alone, ii) fire needling and bloodletting combination treatment, iii) combination of fire needling, bloodletting, and herbal medicine, iv) warm needling (concurrently). Heat stimuli in acupuncture alone or in combination treatment were more effective in terms of the total efficacy rates, uric acid levels, and pain scores than WM alone. Results: In all the evaluation tools, the treatment effects in the fire needling alone or warm needling alone treatment group and the fire needling and bloodletting combination intervention group were significantly better than those in the WM control group. The warm needling and WM combination intervention groups also experienced significantly better treatment effects in terms of total efficacy rates and uric acid levels. Only the pain scores in the fire needling, bloodletting, and herbal medicine combination groups demonstrated significant improvement. Only four studies mentioned adverse reactions: one reported loss of appetite; three studies reported none. According to the Cochrane RoB tool, most studies showed either high or uncertain RoB. Conclusion: Heat stimuli during acupuncture could be effective for acute gout. However, as the included studies were regionally biased, more high-quality studies are needed to confirm the level of evidence.

• The Korean Journal of Pesticide Science
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• v.15 no.3
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• pp.254-268
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• 2011

Fenoxycarb, pyriproxyfen and methoprene are juvenile hormone mimic insecticide. These insecticides have been widely used for mosquito, fly, scale insects, and Lepidoptera. The purpose of this study was to develop a simultaneous determination procedure of fenoxycarb, pyriproxyfen and methoprene residues in crops using HPLC-UVD/MS. These insecticide residues were extracted with acetone from representative samples of four raw products which comprised brown rice, apple, green pepper, and Chinese cabbage. The extract was diluted with saline water, and then n-hexane/dichloromethane partition was followed to recover these insecticides from the aqueous phase. Florisil column chromatography was additionally employed for final clean up of the extract. The analytes were quantitated by HPLC-UVD/MS, using a $C_{18}$ column. The crops were fortified with each insecticide at 3 levels per crop. Mean recovery ratios were ranged from 80.0 to 104.3% in four representative agricultural commodities. The coefficients of variation were less than 4.8%. Quantitative limit of fenoxycarb, pyriproxyfen, and methoprene was 0.04 mg/kg in crop samples. A HPLC-UVD/MS with selected-ion monitoring was also provided to confirm the suspected residues. The proposed simultaneous analysis method was reproducible and sensitive enough to determine the residues of fenoxycarb, pyriproxyfen and methoprene in the agricultural commodities.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.2
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• pp.153-164
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• 2020

Objectives This study is designed to evaluate the safety of Soshihotang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times-screening, pre administration, post administration and follow up-during the whole trial. The incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Soshihotang soft extract were considered to be safe for healthy male volunteers.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.1
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• pp.77-85
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• 2023

Objectives This study is designed to evaluate the safety of palmul-tang soft extract in healthy male volunteers. Methods Twelve healthy male volunteers were recruited. And this study was conducted in a single center. As a result of the laboratory test, the safety was evaluated by collecting vital signs of volunteers. Twelve subjects were assigned by serial number according to the registration order. For safety evaluation, blood samples were collected and vital signs were checked four times throughout the test period, including screening, pre-administration, post-administration (after 48 hours) and post-administration (after 7 days). The difference in variables was summarized as the mean±standard deviation. The normality was performed using Kolmogorov-Smirnov and Shapiro-Wilk test. If normality is satisfied, a paired t-test is applied. Otherwise, the Wilcoxon sign rank test, which is a nonparametric method, is applied. The significance was p<0.05. The incidence of all side effects is expressed as a percentage. Results In the case of red blood cell, hemoglobin, and hematocrit values, the result of normality test of variables for the difference value before and after administration is significant level p<0.05. However, all laboratory test values before and after administration did not deviate from the normal range. Also the deviations in the normal range could not be seen as significance related to this clinical trial. And no side effects related to clinical trial drugs were observed. Conclusions The soft extract of palmul-tang was considered safe for healthy male volunteers.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.1
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• pp.79-90
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• 2014

Objectives : This study was carried out to evaluate the repeated dose oral toxicity of Alismatis Rhizoma in Sprague-Dawley(SD) rats. Methods : Male and female rats were administered orally with Alismatis Rhizoma water extract of 500 mg/kg(low dosage group), 1,000 mg/kg(middle dosage group) and 2,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 14 days(twice a day). After 14 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. In addition no significant changes of gross body and individual organs weight. Conclusions : These results suggest that water soluble extract of Alismatis Rhizoma has not repeated dose oral toxicity and oral LD50 value was over 2,000 mg/kg in SD rats. As a result, we can determine Alismatis Rhizoma is a relatively safe substance.