Background: The aim of this pilot study was to assess the safety and dosing of scolopendrid pharmacopuncture (SPP). Methods: A total of 40 healthy Sprague-Dawley rats (males and 20 females 20) were selected following a 7-day inspection and acclimation period. SPP was administered via intramuscular injection, over a 2-week period using 3 doses including a high-dose [0.84 mg of scolopendrid per kg of body weight (BW)], a med-dose (0.42 mg/kg BW), and a low-dose (0.21 mg/kg BW). The control group was injected with sterile water into the muscles. Unusual changes caused by administration of the test substance were observed. Weight, feed intake, organ weight, and hematological examinations were compared among the groups. Using the SPSS statistical program, Levene's test was performed to evaluate the homogeneity of variances, and a one-way ANOVA test was subsequently performed to assess the significance between each test group. Results: During the experiment no animals died. Weight change, food consumption, organ weight, hematological test, and blood biochemical tests showed no significant differences in the treatment groups compared to controls. Conclusion: No toxicological changes related to the administration of test substances were observed. Therefore, the LD50 (lethal-dose that kills 50%) of scolopendrid pharmacoupuncture in rats was greater than 0.84 mg/kg.
Journal of Physiology & Pathology in Korean Medicine
/
v.23
no.5
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pp.993-1002
/
2009
The object of this study was to evaluate the single dose toxicity of Taeumjowui-tang(TUJWT), a polyherbal formula have been traditionally used as prevention or treatment agent for obesity, in male and female mice. Aqueous extracts of TUJWT (Yield = 10.5%) was administered to female and male ICR mice as an oral dose of 2000, 1000 and 500 mg/kg (body wt.) according to the recommendation of KFDA Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy, organ weight and histopathology of 12 principle organs were examined. As results, we could not find any mortality, clinical signs, and changes in the body and organ weight except for diarrhea restricted in TUJWT 2000 mg/kg treated one male mouse at 1 day after administration, and increases of popliteal lymph node weights in all TUJWT administered groups. In addition, no TUJWT-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for increases of the frequency of hypertrophy and hyperplasia of lymphoid cells in the popliteal lymph nodes in all TUJWT treatment groups with some sporadic accidental findings. These increases of popliteal lymph node weights with hypertrophy and hyperplasia of lymphoid cells were considered that related to the immune modulate effect of TUJWT not toxicological signs. The results obtained in this study suggest that the TUJWT does not cause any toxicological signs. The 50% lethal dose and approximate lethal dose of TUJWT aqueous extracts in both female and male mice were considered as over 2000 mg/kg.
Journal of Physiology & Pathology in Korean Medicine
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v.23
no.5
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pp.1145-1153
/
2009
The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.
This study was conducted to obtain the acute information of the oral dose toxicity of Polycan - originated from Aureobasidium pullulans SM-2001 (half of the dry material is -1,3/1,6-glucans), a UV induced mutant of A. pullulans, having various pharmacological effects, in male and female mice. In order to calculate $50\%$ lethal dose $(LD_{50})$, approximate LD and target organs, test article was administered twice by oral gavage to male and female ICR mice at total 1000, 500 and 250mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings. The results obtained in this study suggest that the Polycan is non-toxic in mice and is therefore likely to be safe for clinical use. The L050 and approximate $(LD_{50})$ in mice after single oral dose of Polycan were considered over 1000 mg/kg, respectively.
Kim, Kyung-Hu;Gam, Cheol-Ou;Choi, Seong-Hun;Ku, Sae-Kwang
Toxicological Research
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v.28
no.1
/
pp.11-18
/
2012
The aim of this study was to evaluate the single oral dose toxicity of Bupleuri Radix (BR) aqueous extracts, it has been traditionally used as anti-inflammatory agent, in male and female mice. BR extracts (yield = 16.52%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principal organs were examined. As the results, no BR extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs were detected up to 2,000 mg/kg in both female and male mice, except for soft feces and related body weight decrease detected in male mice treated with 2,000 mg/kg. Therefore, $LD_{50}$ (50% lethal dose) and approximate LD of BR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg, respectively. Although it was also observed that the possibilities of digestive disorders, like soft feces when administered over 2,000 mg/kg of BR extracts in the present study, these possibilities of digestive disorders can be disregard in clinical use because they are transient in the highest dosages male only.
The 2-year rodent carcinogenicity test involves long-term, repetitive dosing of animals that is both time consuming and expensive. Alternative approaches have been attempted using specific transgenic or knockout mice or toxicogenomics to predict carcinogenicity without conducting a 2-year rodent test. In addition, toxicogenomic analysis of carcinogen-treated animals could also enhance our understanding of molecular mechanisms and aid in the diagnosis of acute toxicity induced by carcinogens. Therefore, we investigated transcription profiles after administering the carcinogens 4,4-dimethylformamide (DMF) and 4-biphenylamine (ABP). BALB/c male mice were treated once with DMF (650 mg/kg i.p.) or ABP (120 mg/kg p.o.). Standard blood biochemistry and histological changes were observed. Gene expression profiles in the livers of mice treated with either vehicle or the carcinogens were analyzed using the Affymetrix $GeneChip^{(R)}$ assay. In all, 1,474 differentially expressed genes in DMF- or ABP-treated mice were identified as being either up- or down-regulated over 1.5-fold (P< 0.01), and these genes were analyzed using hierarchical clustering and Ingenuity Pathways Analysis. Of these, 107 genes were consistently regulated in both carcinogen-treated groups. Genes associated with cancer were upregulated (Por, S100a10, Tes, Ctcf, Ddx21, Eapp, Nel, and Pa2g4) or downregulated (Cbs and Gch1). Toxicological function analysis also identified genes involved in organ toxicity, including hepatotoxicity. These data may help to identify molecular markers for acute hepatotoxicity induced by carcinogens.
Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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v.18
no.2
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pp.108-112
/
2007
Otolaryngological manifestations of acid reflux include a wide range of pharyngeal and laryngeal symptoms ; and the constellation of symptoms has been called laryngopharyngeal reflux (LPR). In the absence of definite diagnostic criteria, LPR disease remains a subjective entity. A diagnosis of LPR is usually based on response of symptoms to empirical treatment. Investigative modalities such as pH monitoring and, more recently, impedance studies are generally reserved for treatment failures. LPR usually requires more aggressive and prolonged treatment to achieve regression of both symptoms and laryngeal findings. The suppression of gastric acid and secretion with anti-secretary agents has been the mainstay of medical treatment for patients with acid-related disorders. The suppression of gastric acid secretion achieved with Hz-receptor antagonist $(H_2RA)$ has proved suboptimal for relief of reflux symptoms. The rapid development of tolerance and rebound acid hypersecretion after the with-drawal of $H_2RA$ limit their clinical use. Proton pump inhibitors (PPI) have been proved to be very effective for suppressing intragastric acidity, but the optimal dose and duration is unknown. Current evidence indicates that pharmacologic intervention should include, at a minimum, a 3 month trial of twice daily PPI. Symptoms of LPR improve over 2 months of therapy. The physical findings of LPR resolve more slowly than the symptoms and this continues through out at least 6 months of treatment. For most patients with LPR, twice daily dosing with a PPI is usually recommended for an initial treatment for a period of no less than 6 months treatment, and lifetime treatment may be required.
Kim Hui-Tae;Lee Joong-Youp;Han Sang-Yeop;Kim Young-Mog;Oh Seung-Hyub
Journal of the Korean Society of Propulsion Engineers
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v.9
no.4
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pp.96-103
/
2005
The main purpose of launch vehicle is to insert satellite into a target orbit safely and correctly. To accomplish the main purpose of launch vehicle, the inserting velocity, inserting angle, and final mass of launch vehicle should be within the allowable range. In general, such requirements are satisfied with applying TCS(Thrust Control System) and TDS(Tank Depletion System), which manage thrust and mixture ratio by controlling propellant flow rate with thrust and mixture ratio control valves. In this study, the control characteristics of thrust and mixture ratio control valve were examined by PID control logic for stable operation of liquid-Propellant rocket engine at on-dosing point. The analysis on the control characteristics of control valves was done with AMESim code and the results from control valve test facility at KARI.
Acute renal failure refers to a rapid reduction in renal function that usually occurs in an individual with no known previous renal disease. Development of a complication of acue renal failure in critically ill surgical patients is not unusual, and it causes high morbidity and mortality. Acute renal failure can be divided as Pre-renal (functional), Renal (organic), and Post-renal (obstructive) azotemia according to their etiologies. Early recognition and proper correction of pre-renal conditions are utter most important to prevent an organic damage of kidney. These measures include correction of dehydration, treatment of sepsis, and institution of shock therapy. Prolonged exposure to ischemia or nephrotoxin may lead a kidney to permanent parenchymal damage. A differential diagnosis between functional and organic acute renal failure may not be simple in many clinical settings. Renal functional parameters, such as $FENa^+$ or renal failure index, are may be of help in these situations for the differential diagnosis. Provocative test utilyzing mannitol, loop diuretics and renovascular dilators after restoration of renal circulation will give further benefits for diagnosis or for prevention of functional failure from leading to organic renal failure. Converting enzyme blocker, dopamine, calcium channel blocker, and propranolol are also reported to have some degree of renal protection from bioenergetic renal insults. Once diagnosis of acute tubular necrosis has been made, all measures should be utilized to maintain the patient until renal tubular regeneration occurs. Careful regulation of fluid, electrolyte, and acid-base balance is primary goal. Hyperkalemia over 6.5 mEq/l is a medical emergency and it should be corrected immediately. Various dosing schedules for medicines excreting through kidney have been suggested but none was proved safe and accurate. Therefore blood level of specific medicines better be checked before each dose, especially digoxin and Aminoglycosides. Indication for application of ultrafiltration hemofilter or dialysis may be made by individual base.
In order to investigate experimental effects of Yangkyuksanwha-Tang, which is the typical prescription for diseased SOYANGIN, on diabetes rats, the observation and measurement was made on the content of volume of blood glucose, total cholesterol, triglyceride, phospholipid, total protein, electrolyte($K^+$, $Na^+$) in serum, by dosing the cooked Y.S.T. to diabetic rats, induced by streptozotocin and following result was obtained. 1. The volume of blood glucose, in the diabetes rats, was decreased significantly, and remarkable decrease of blood glucose was shown in the Y.S.T. (12.5ml/kg) dosed group, after 4weeks of experiment. 2. The volume of total cholesterol of blood serum was decreased notably, especially remarkable reduce of total cholesterol was shown in the Y.S.T. (12.5ml/kg) dosed group after a week. 3. The volume of triglyceride in the blood serum of diabetic rats, induced by the streptozotocin was decreased after 4 weeks, and remarkable decrease was shown in the Y.S.T. (12.5ml/kg) dosed group after 2 weeks of experiment. 4. The volume of the phospholipid in the diabetes rats, was decreased significantly in the Y.S.T. (12.5ml/kg) dosed group after 2 weeks of experiment. 5. The volume of total protein of diabetes rats, was increased in all group, and the remarkable increase was shown in the Y.S.T. (12.5ml/kg) dosed group after 4 weeks. 6. The volume of the sodium in the Y.S.T. (12.5ml/kg) dosed group, was notable in each Y.S.T. dosed group (1.25ml/kg, 12.5ml/kg) after a week experiment. According to above results, It is expected that Y.S.T. applied to SOYANGIN, can be used for medical treatment of diabetes with effect. But because the effect can be somewhat different depending upon dosage, appropriate operation on clinic is needed, for the best curing effect.
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