• Journal of Pharmacopuncture
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• v.18 no.2
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• pp.51-59
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• 2015

Objectives: This study was performed to analyze the toxicity and to find the lethal dose of the test substance Hominis placenta pharmacopuncture when used as a single-dose in 6 week old, male and female Sprague-Dawley (SD) rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institution authorized to perform non clinical studies, under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of Hominis placenta pharmacopuncture extracts, 0.125, 0.25 and 0.5 mL, were administered to the experimental group, and 0.5 mL doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the groups. Also, no significant changes in body weights were observed among the groups, and no significant differences in hematology/biochemistry, necropsy, and histopathology results were noted. Hematologically, some changes in the male rats in two experimental groups were observed, but those changes had no clinical or toxicological meaning because they were not dose dependent. Histopathological tests on the injected parts showed cell infiltration in the male rats in one of the experimental groups; however, that result was due to spontaneous generation and had no toxicological meaning. Therefore, this study showed that Hominis placenta pharmacopuncture had no effect on the injected parts in terms of clinical signs, body weight, hematology, clinical chemistry, and necropsy. Conclusion: As a result of single-dose tests of the test substance Hominis placenta pharmacopuncture in 4 groups of rats, the lethal dose for both males and females exceeded 0.5 mL/animal. Therefore, the above findings suggest that treatment with Hominis placenta pharmacopuncture is relatively safe. Further studies on this subject are needed.

• The Korean Journal of Applied Statistics
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• v.37 no.4
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• pp.411-444
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• 2024

The objective of Phase I clinical trials is to ascertain the maximum tolerated dose (MTD) that is safe for human administration. Accurately determining the MTD within an acceptable safety margin is imperative, necessitating evaluations up to sufficiently high doses. To estimate the MTD, a plethora of methods have been developed, encompassing algorithm-based, model-based, and model-assisted techniques. In this paper, a new dose exploration method based on continual reassessment method (CRM) is proposed to address for the shortcomings of existing dose exploration methods. Through a comprehensive simulation study, this method's efficacy was compared against that of existing methodologies across a variety of scenarios. The findings from this study underscore its enhanced precision and safety in estimating the MTD, alongside a reduction in the number of subjects required for testing.

• Toxicological Research
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• v.11 no.1
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• pp.133-136
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• 1995

HRccine(HFRS-virus vaccine) was administered subcutaneously or intragastrically to Spargue Dawley rats and subcutaneously to Japanese white rabbits to investigate the acute toxicity. $LD_50$ values were above 600 times the expected clinical dose in both animals. There were no differences in body weight changes, clinical signs and autopsy findings between all treated groups and control group in both animals. Therefore, it was concluded that HRccine is a very safe substance.

• Journal of Acupuncture Research
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• v.37 no.3
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• pp.167-172
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• 2020

Background: This study aimed to assess the toxicity of capsaicin (CP) pharmacopunture in an animal model. Methods: The toxicity of a single-muscular dose of CP (45.45 mg/mL) was evaluated in 6-week-old male and female Sprague-Dawley rats. A total of 20 rats were assigned to 2 groups which were sex and weight matched. All rats acclimatized for 1 week before receiving 1.0 mL of CP (45.45 mg/mL) or normal saline solution (control) intramuscularly. The general condition and mortality of the animals were observed. The rats were sacrificed 2 weeks after CP was administered and histopathology was performed. Results: No abnormal symptoms or deaths were observed, and there was no difference in body weights between the CP and control groups throughout the study. No significant differences in histopathology were observed between the groups. Conclusion: No toxicological changes related to the administration of CP were observed. This study indicated that the safe dose of CP in Sprague-Dawley rats was 1.0 mL of CP (45.45 mg/mL) or less. Further studies are needed to confirm the safety of CP in the human body.

• Journal of Environmental Health Sciences
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• v.29 no.1
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• pp.8-15
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• 2003

In this study, chlorine dose at water storage tank was predicted to meet the recommended guideline for free chlorine residual in drinking water distribution system, using EPANET which is a computer program that performs extended Period simulation of hydraulic and water quality behavior within pressurized pipe networks. The results may be summarized as follows. The decay of chlorine residual by season varied considerably in the following order; in summer ($25^{\circ}C$) > spring and fall (15$^{\circ}C$) > winter (5$^{\circ}C$). For re-chlorination at water storage tank by season, season-varying chlorine dose was required at its maximum of 1.00 mg/l in summer and minimum of 0.40 mg/l in winter as free chlorine residual. The decay of chlorine residual through out the networks increased with water age spent by a parcel of water in the network except for some points with low water demand. In conclusion, the season-varying chlorine dose as well as the monitoring of water quality parameters at the some points which showed high decay of chlorine residual may be necessary to deliver the safe drinking water.

• Korean Journal of Pharmacognosy
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• v.16 no.4
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• pp.227-232
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• 1985

Gardenia jasminodes has been medically used for anti-inflammation, sedation and anti-diarrhea; The extract of this plant has been traditionally used as food colorant and referred as crocin dyes. In the present study, the possible hepatic toxicity of this dye has been evaluated on the basis of its alteration on the marker enzymes, namely, glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, alkaline phosphatase, lactate dehydrogenase and gamma-glutamyltransferase. Crocin dyes did not affect hepatic function when they were orally administered to rats in a daily dose of 50 mg/kg for 8 days, but could induce acute hepatic discoloration. A high dose of 100 mg/kg for 2 weeks could induce both hepatic damage and black pigmentation, but a lower dose of 10 mg/kg for 40 days did not The induced black pigmentation and the acute hepatic damage were completely reversible. In conclusion, the crocin dyes have a very low hepatic toxicity in rats, even in high experimental dosages which could hardly happen in human practice. It is therefore suggested that the crocin dyes are safe for coloring foods.

• Clinical and Experimental Pediatrics
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• v.57 no.9
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• pp.379-383
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• 2014

Recombinant growth hormone (GH) is an effective treatment for short children who are born small for gestational age (SGA). Short children born SGA who fail to demonstrate catch-up growth by 2-4 years of age are candidates for GH treatment initiated to achieve catch-up growth to a normal height in early childhood, maintain a normal height gain throughout childhood, and achieve an adult height within the normal target range. GH treatment at a dose of $35-70{\mu}g/kg/day$ should be considered for those with very marked growth retardation, as these patients require rapid catch-up growth. Factors associated with response to GH treatment during the initial 2-3 years of therapy include age and height standard deviation scores at the start of therapy, midparental height, and GH dose. Adverse events due to GH treatment are no more common in the SGA population than in other conditions treated with GH. Early surveillance in growth clinics is strongly recommended for children born SGA who have not caught up. Although high dose of up to 0.067 mg/kg/day are relatively safe for short children with growth failure, clinicians need to remain aware of long-term mortality and morbidity after GH treatment.

• The Journal of Korean Society for Radiation Therapy
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• v.7 no.1
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• pp.15-31
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• 1995

The radiosurgery treatment is one time, non surgical approach to the treatment of patients with intracranial disorders whose conditions would be difficult or dangerous to treat with conventional sugical procedures. The LINAC based radiosurgery is based on the combination of multiple isocentric arc irradiation with small fields centered in the stereotactic target. The absorption of the beam in a tissue equivalent medium, such as water, as well as the uniformity, or profile, of the beam must be precisely documented. The beam characteristics and dosimetric measurememts of the 6MV X-ray beam from a ML-6M linear accelerator are examined. The percent depth dose (PDD) and beam profile (including flatness, symmetry and penumbra) is calibrated with the radiosurgery cone in water phantom. The cone is made of lead which size is from $10{\times}10mm{\phi}$ to $30{\times}30mm{\phi}$ All of these dosimetric measurements sufficiently characterized the beam to permit safe clinical use.

• Journal of Acupuncture Research
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• v.31 no.1
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• pp.105-110
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• 2014

Objectives : The objective of this study is to analyze the single-dose toxicity of horse placenta hydrolysate extracts. Methods : Sprague-Dawley rats were chosen for the study. Doses of horse placenta hydrolysate extracts, 2,000 mg/kg, 1,000 mg/kg and 500 mg/kg, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : In all 4 groups, no deaths occurred, and the horse placenta hydrolysate extracts administered by oral was over 2,000 mg/kg. No significant changes in the weight between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ, the results showed no significant differences in any organs or tissues. Conclusions : The above findings suggest that treatment with horse placenta hydrolysate extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.45 no.3
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• pp.152-157
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• 2019

Objectives: The number of elderly patients with systemic basal disease requiring invasive dental treatment has increased. Appropriate prediction of surgical invasiveness and combined use of psychosedation are thought to contribute to safe whole-body management. Dexmedetomidine (DEX) exhibits analgesic and anti-anxiolytic properties and causes mild respiratory depression. Studies regarding DEX use in elderly non-intubated patients are scarce. We aimed to use retrospective data to determine an effective dose of DEX to induce adequate sedation in elderly patients undergoing invasive dental surgery under local anesthesia. Materials and Methods: One hundred two patients aged 70 to 96 years were presumably appropriately controlled with sedation. DEX was administered at an initial loading dose of 2.0 to $3.1{\mu}g/kg/hr$ for 10 minutes. We divided the patients into five groups by age and compared their blood pressures and heart rates. Results: In all five groups, blood pressure decreased suddenly at approximately 15 and 20 minutes after DEX administration. A marked decrease in blood pressure was noted in patients aged 75 to 79 years. Conclusion: For elderly patients aged 75 years and above, the initial loading dose of DEX needs to be reduced to lower than half that required for young and middle-age adults.