Homogenization of quality was important in order to use herbal medicines as pharmaceuticals. To solve this problem, it was important to establish quality standards. Atractylodis Rhizoma Alba has no quantitative method in the Korean Pharmacopoeia. Thus, we have researched to improve the quality evaluation method of Atractylodis Rhizoma Alba with an HPLC. Atractylenolide III and atracylodin were selected as potential marker compounds. This analytical procedure was subject to validation. According to validation guideline of South Korea's Ministry of Food and Drugs Safety, the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy were measured. Because the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy meet criteria of the guideline, the analytic method was validated. With this analysis, Atractylodis Rhizoma Alba and Atractylodis Rhizoma analyzed. As a result, both atractylenolide III and atracylodin appear to be suitable standard compounds. it confirmed that tractylodes Rhizome, similar to Atractylodes Rhizome Alba, could be distinguished.
Jo, Jun Hyeon;Kim, Sun Joo;Nam, Woong Shik;Seung, Eun Ji;Lee, Sangkyu
Environmental Analysis Health and Toxicology
/
v.31
/
pp.16.1-16.9
/
2016
Objectives Banha-sasim-tang (BST), which consists of seven different herbs, is one of the most popular herbal formulae for treating gastrointestinal disorders in Eastern Asia. The commonly used herbal medicine is often co-administered with other therapeutic drugs, which raises the possibility of herb-drug interactions and may modify the clinical safety profile of therapeutic drugs. Methods We investigated the potential herb-drug interactions between BST extract and midazolam (MDZ) in mice. The area under the plasma concentration-time curve (AUC) of MDZ and 1'-hydroxymidazolam (1'-OH-MDZ) was evaluated for both oral and intraperitoneal administration of MDZ, following oral administration of BST (0.5 and 1 g/kg). Results It was found that the AUC of MDZ and 1'-OH-MDZ was lower in case of oral administration of MDZ. Administration of BST extract was not associated with hepatic cytochrome P450 activity. BST extract induced a strong reduction in pH and it has been reported that oral mucosal absorption of MDZ is lower at low pH. The decreased absorption rate of MDZ might be caused by the ingredients of BST and may not be related to other factors such as increased excretion of MDZ by P-glycoprotein. Conclusions The altered pharmacokinetics of midazolam caused by co-administration with BST in vivo could be attributed to a decrease in pH and subsequent reduction of MDZ absorption rate.
Kwon, Da Hye;Kim, Min Young;Hwangbo, Hyun;Ji, Seon Yeong;Park, Cheol;Choi, Yung Hyun;Hong, Su Hyun
Herbal Formula Science
/
v.28
no.2
/
pp.169-177
/
2020
Objectives : This experiment was designed to assess the single oral toxicity of Ethanol Extract Inulae Flos (IF) ethanol extracts. IF is one of the important herbs to remove phlegmy which is the viscous turbid pathological product that can accumulate in the body, causing a variety of diseases. Nevertheless, there has been a lack of research on the pharmacology toxicity of IF. Methods : In this study, IF was orally administered to 5 weeks ICR mice as an oral dose of 2,000 or 3,000 or 5,000 mg/kg. The condition of the mice was observed for 14 days and their weights were measured every two days. Results : None of the mice died for 14 days. The abnormal clinical symptoms and anatomical signs of toxicity were not found in any treatment groups. The gain of net body weight was observed. There was also no significant difference in the organ weight. The serum biochemistry and hematological analysis showed a decrease in BUN, red blood cells, white blood cells and platelets although within the normal ranges. Conclusions : These results suggest that the 50% lethal dose of IF is more than 5,000 mg/kg. This could be thought that IF is a safe drug without acute toxicity and side effects. However, IF showed some weight loss and change in blood test, so it will need to be careful when using it for high doses.
Nahyun Jeong;Chae-Rim Yoon;Su-Hyun Choi;Dahee Jeong;Yoohyun Sim;Hae-in Jeong;Na-Yeon Ha;Jinsung Kim
The Journal of Internal Korean Medicine
/
v.45
no.3
/
pp.381-395
/
2024
Objectives: The main purpose of this study is to investigate the clinical characteristics of patients complaining of indigestion after COVID-19 infection (CI) or COVID-19 vaccination (CV) and to confirm the effectiveness and safety of Korean medical treatment. Methods: We retrospectively collected and investigated the medical records of 39 patients admitted to the Kyung Hee University Korean Medicine Hospital with a chief complaint of dyspepsia from January 1, 2020 to February 29, 2024 who reported the onset or significant exacerbation of dyspepsia after CV or CI. Patients were divided into vaccination and infection groups, and their demographic characteristics, Ryodoraku results, presenting symptoms, traditional Korean medicine treatments, and treatment outcomes were analyzed. Results: When comparing the groups with dyspepsia after CV and after CI, it was observed that the CI group had significantly lower average body weight, and the measurements of LH6, LF1, and LF6 in the Ryodoraku test were significantly lower. Additionally, compared to the CV group, the CI group showed significantly more abdominal distension, nausea, and abdominal pain. Significant relief of upper gastrointestinal symptoms was observed in both the CV and CI groups after treatment. No adverse reactions were observed during the course of treatment. Conclusion: The CI group tended to complain more severely of various dyspeptic symptoms and had a tendency to lower body weight than the CV group, as was also reflected in the results of the Ryodoraku test. Korean medical treatment can be effective and safe in treating these patients.
BACKGROUND: Prochloraz has been widely used as an imidazole fungicide on fruits and vegetables in Korea. Analytical approaches to evaluate prochloraz residues in herbal medicine are required for their safety management. In this study, we developed a GC-ECD method for quantitative determination of prochloraz in Platycodi Radix. The metabolite 2,4,6-trichlorophenol (2,4,6-T) was used as a target compound to evaluate total prochloraz residues as it is categorized to a representative residue definition of prochloraz. All residues containing 2,4,6-T were converted to 2,4,6-T and subjected to GC-ECD. METHODS AND RESULTS: In order to verify the applicability, the method was optimized for determining prochloraz and it metabolite 2,4,6-T in Platycodi Radix. Prochloraz and its metabolite 2,4,6-T residuals were extracted using acetone. The extract was diluted with and partitioned directly into dichloromethane to remove polar co-extractives in the aqueous phase. The extract was decomposed to 2,4,6-T, and then the partitioned ion-associate was finally purified by optimized aminopropyl solid-phase extraction (SPE). The limits of quantitation of the method (MLOQs) were 0.04 mg/kg and 0.02 mg/kg, respectively for prochloraz and 2,4,6-T, considering the maximum residue level (MRL) of prochloraz as 0.05 mg/kg in Platycodi Radix. Recovery tests were carried out at two levels of concentration (MLOQ, 10 MLOQ) and resulted in good recoveries (82.1-89.7%). Good reproducibilities were obtained (coefficient of variation < 2.8%), and the linearities of calibration curves were reasonable (r2 > 0.9986) in the range of 0.005-0.5 ㎍/mL. CONCLUSION(S): The method developed in this study was successfully validated to meet the guidelines required for quantitative determination of pesticides in herbal medicine. Thus, the method could be useful to monitor prochloraz institutionally in herbal medicine.
Objectives: The aims of this study were to evaluate the fidelity of stroke stage reporting, the timeliness of the outcome measures, and the use of the core outcome set. Methods: We searched the literature using 6 domestic databases. We selected studies that used Korean medicine interventions and targeted stroke patients with motor sequelae. We examined whether the included studies reported the stroke stage and whether they used the outcome measures in the appropriate period based on the recommendations of the "Stroke Evidence Database to Guide Effectiveness". We also confirmed the use of the essential assessment tools suggested by the core outcome set. Results: Overall, 77 studies were finally selected, with 16 (21%), 55 (71%), and 6 (8%) published on the acute, subacute, and chronic phases, respectively. Only 11 of the studies directly mentioned the stroke stage. The most commonly used assessments were the National Institutes of Health Stroke Scale, Modified Barthel Index, and Manual Muscle Testing. Only 5 studies failed to apply the stage-related outcome measures at the recommended period. The outcome variables used inadequately were the National Institutes of Health Stroke Scale, Functional Ambulation Categories, 36-Item Short Form Health Survey, and Mini-Mental State Examination. Among the core outcome set items, some studies used liver and renal function tests, but no herbal medicine safety reporting was conducted. Conclusions: In future studies, we propose to ensure accurate reporting of the stroke stage with reliable outcome measures to deliver better clinical and research outcomes. Furthermore, in future clinical studies on stroke, a standard protocol that reflects the core outcome set should be developed.
Kim, Jung-Keun;Kim, Se-Won;Lee, Byung-Eui;Hwang, Hyeon-Hwan;Kwon, Jong-Seok;Ko, Seon-Yle
Journal of Oral Medicine and Pain
/
v.32
no.1
/
pp.35-43
/
2007
This study was conducted to investigate the preventing effects of OPB (water extracts of Rehmannia glutinosa Libosch and Eleutherococcus senticosus Max) on bone loss in ovariectomized rats. Twenty Sprague Dawley rats of 13 week-old were divided into two groups: control group (ovariectomized, OVX)) and experimental group (OVX + OPB). The preventing effects of OPB on bone loss, OPB were fed with 100 mg OPB/kg body weight from 3 days after ovariectomization. The duration of the treatment period was 8 weeks. All bone mineral density, bone mineral content indices and bone strength indices measured by peripheral quantitative computerized tomography (pQCT) and serum bone marker assessment were carried out at end of experiment. pQCT scanning showed that OVX induced a significant decrease in cancellous bone mineral density in the proximal tibia ($-29.8{\pm}3.0%$). These decreases were significantly prevented by the administration of OPB 100 mg/kg ($-21.4{\pm}2.3%$. p<0.05). Bone strength indices showed significant difference between OVX and OPB treated rats (anti-fracture, anti-twisting, p<0.05). These data suggested that administration of OPB inhibited the loss of bone in OVX rats. CTx level were lower than in the OPB-treated animals compared with OVX. However there was no significant difference between OVX and OPB treated OVX rat. Our results suggest that OPB is effective in preventing the development of bone loss induced by ovariectomy in rats.
Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.
Kim, Hyung Joong;Lee, Eun Ju;Lee, Sun Haeng;Chang, Gyu Tae
The Journal of Pediatrics of Korean Medicine
/
v.28
no.4
/
pp.96-107
/
2014
Objectives The purpose of this study is to understand what caregivers think advantageous and disadvantageous regarding Acupoint sticking Dog-days. Also, to know whether Acupoint sticking in Dog-days affect vital signs, and to investigate if occurrence of side effects are related to application duration, sweat, or compliance to precautionary measures. Methods Survey has been handed out to parents of the children who took Acupoint sticking in Dog-days. 10 days after the first dose was administered, survey was performed to examine any side effect occurrences, characteristics of sweat, duration of application, parents' thought about this therapy. Also, vital signs were checked before the first dose, and 10 days after to see any differences in vital signs in regards to this therapy. Results Preferable opinions about Acupoint sticking in Dog-days are 'convenient than herbal medications' (76.5%), 'less reluctance of child' (47.1%), 'reasonable price' (20.6%), 'good effectiveness' (17.6%), 'less side effect' (14.7%), 'no worry about agrochemicals or heavy metals uptake' (11.8%). Downsides were 'difficult to admit to hospital right on the Dog-days' (73.5%), 'no conspicuous effectiveness' (11.8%), 'expensive' (5.9%), 'reluctance of child' (2.9%). Vital sign differences were minimal when examined before and after Acupoint sticking in Dog-days. Side effects occurred 5 times in 34 cases, and they were erythema, itchiness, and hot sensation. There were no scars or blisters reported. All 5 cases were resolved without any interventions within 3 days. Conclusions Acupoint sticking in Dog-days doesn't affect vital signs. Severe side effect is rare, reported side effects were relatively mild, suggesting that it may be safe and well-tolerated. 'Convenience' (76.5%) is biggest advantage of Acupoint sticking in Dog-days and 'less reluctance of child' is also big advantage of Acupoint sticking in Dog-days. 'Difficulty to admit to hospital right on the Dog-days' (73.5%) is biggest disadvantage of Acupoint sticking in Dog-days.
Objectives: The purpose of the study is to assess both the approximate lethal dose and the single dose intramuscular injection toxicity of Danggui (Angelica gigantis radix) pharmacopuncture (DGP) in Sprague-Dawley (SD) rats. Methods: The experiments were conducted at the good laboratory practice (GLP) laboratory, Biotoxtech Co., which is a laboratory approved by the ministry of food and drug safety (MFDS). The study was performed according to the GLP regulation and the toxicity test guidelines of the MFDS (2009) after approval of the institutional animal care and use committee of Biotoxtech. Single doses of DGP were injected intramuscularly into the rats in three test groups of 6 week old SD rats (5 male and 5 female rats per groups) in the amounts of 0.1, 0.5, and 1.0 mL/animal for groups 2, 3, and 4, respectively, and normal saline solution in the amount of 1.0 mL/animal was injected intramuscularly into the rats (5 male and 5 female rats) in the control group. Observations of the general symptoms and weight measurements were performed during the 14 day observation period after the injection. Hematologic and serum biochemical examination, necropsy, and a local tolerance test at the injection site were done after the observation period. Results: No death was observed in three test groups (0.1, 0.5 and 1.0 mL/animal group). In addition, the injection of DGP had no effect on general symptoms, weights, hematologic and serum biochemical examination, and necropsy. The results from the local tolerance tests at injection site showed no treatment related effects in the SD rats. Conclusion: The results of single dose intramuscular injection of DGP suggest that the approximate lethal dose is above 1.0 mL/animal for both male and female SD rats and that intramuscular injection of DGP may be safe.
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