• 생약학회지
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• 제42권3호
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• pp.265-270
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• 2011

Acute toxicity of a combined preparation of the standardized extracts Scutellaria baicalensis GEORGI and Salvia miltiorrhiza BUNGE in a ratio of 3:1 was examined in male and female ICR mice. Mice were treated with the test substance intragastrically at a dose of 0 mg/kg, 5 mg/kg, 50 mg/kg, 500 mg/kg or 2,000 mg/kg and observed for two weeks. No death or abnormal clinical sign was shown during the observation period. Also there were no difference in net body weight gain, organ weight, and gross pathological findings at the terminal sacrifice. The results suggested that acute oral toxicity of a combined preparation of the standardized extracts is very low at the conditions employed in this study.

• 종양간호연구
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• 제11권1호
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• pp.33-40
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• 2011

Purpose: This study compared the effect of two oral care agents on preventing stomatitis and discomfort for acute leukemic patients. Methods: A total of forty patients was enrolled and randomly assigned to sodium bicarbonate or chlorhexidine group. WHO oral toxicity scale was used for measuring stomatitis and Beck's subjective oral discomfort scale for evaluating oral comfort. Data was collected from August 2009 to February 2010. The data was analyzed using Chi-square test, Fisher's exact test, and Mann-Whitney test. Results: Data analyzed was thirty five one. The incidence of stomatitis was 47.4%, 68.8% in sodium bicarbonate and chlohexidine group respectively. The onset of stomatitis was about the 10th and 9th day after chemotherapy initiation, and the duration was 8.0 and 8.67 day respectively. The severity of stomatitis was highest on the 21st day after chemotherapy initiation. There were no statistical differences in the status of stomatitis and the levels of oral comfort during treatment periods. Conclusion: Nurses should routinely assess oral cavity and encourage patients to do oral care actively from second to third week after chemotherapy initiation. Also sodium bicarbonate agent can be recommended to for preventing stomatitis.

• 대한본초학회지
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• 제28권2호
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• pp.61-65
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• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• Journal of Periodontal and Implant Science
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• 제25권3호
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• pp.470-477
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• 1995

Flavonoids from Scutellariae Radix possessed a dual function both as an anti-inflammatory agent and an enhancer of cellular activity in gingival fibroblast. The purpose of this study was to evaluate on the toxicity of ethanolic extract from the root of Scutellariae Radix Georgi and its flavonoids, Wogonin, Baicalein, and Baicalin were isolated and purified by the following method. The crude drug was extracted with ethyl acetate and the residue was dissolved in ethyl alcohol. The ethyl alcohol soluble fraction was separated, concentrated, and then chromatographed on a silica gel column. The acute oral LD 50 in rats was determined for EtOH ex. of Scutellariae Radix and three compounds were evaluated with a single oral gavage at three graded dosage levels. The acute intravenous LD 50 was determined with a single intravenous injection via the jugular vein at three graded dosage levels. Groups of 5 male and 5 female rats, 6 week of age at the start of the study, were fed diets containing 3 graded dosage levels for 14 days. Groups of 5 male and 5 female hamster received O.5ml of the test article at once in a day for 5 days to the buccal cheek pouch for two minutes each. The acute oral LD50 for EtOH ex. of Scutellariae Radix is 1430mg/kg, and for Wogonin 1320mg/kg, for Baicalein 1250mg/kg, for Baicalin 1330mg/kg. The acute intravenous toxicity of EtOH ex. of Scutellariae Radix and its extracts was found to be 27mg/kg body weight No toxic effects were observed in rats fed up to 200mg/kg of EtOH ex. of Scutellariae Radix, Wogonin, Baicalein and Baicalin in the diet for 14 days. The acute Mucouse Membrane LD 50 in hamsters was found to be greater than 100mg/kg. These results suggested that EtOH ex. of Scutellariae Radix and its flavonoids are safe for oral care products using limited amount of extract.

• 농약과학회지
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• 제13권1호
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• pp.39-44
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• 2009

벼농사용 살충제인 fipronil의 비의도적 노출에 의한 꿀벌(Apis mellifera L.)의 피해를 확인하기 위해 급성독성시험, 엽상잔류독성시험, cage를 이용한 소규모야외시험을 실시하였다. 급성접촉독성시험에서 24시간과 48시간의 $LD_{50}$은 각각 0.008, $0.005{\mu}g$ a.i./bee 로 꿀벌에 매우 강한 급성독성을 보였으며 급성위해지수(QHc)는 12,500으로 매우 높은 수준이었다. 엽상잔류독성시험에서는 피프로닐 액상수화제 살포 후 28일까지 90%이상 치사율을 보여 장기간 꿀벌에 독성이 있음을 알 수 있었다. 이때 fipronil의 표면부착잔류량(dislodgeable foliar residue)을 분석한 결과 $DT_{50}$은 9일, $DT_{90}$은 31일이었다. 야외시험의 결과에서도 28일의 치사율이 40%로 조사되어 실내 엽상잔류독성시험과 유사한 잔류독성을 보였다. 이상의 결과를 종합하면 fipronil은 꿀벌에 대한 급성독성이 매우 강하면서 장기간의 잔류독성이 있어 잎 표면의 매우 낮은 잔류량으로 꿀벌에 피해를 줄 가능성이 매우 높은 살충제이다. 따라서 재배작물뿐만 아니라 살포지역 인근의 밀원식물에 약제살포시 바람에 날려 오염될 경우 화분매개용 꿀벌과 자연생태계 유용곤충에 위해가능성이 매우 높기 때문에 꿀벌이 왕성한 활동을 하는 시기에는 야외살포를 금지하여야 하며, 궁극적으로 야외생태계 유용곤충을 보호하기 위해서는 실내사용 목적으로만 사용되도록 제한해야 할 것으로 판단된다.

• 대한예방한의학회지
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• 제15권1호
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• pp.37-47
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• 2011

Objectives : Previous studies have shown that Fructus mume (FM) has anti-platelet effects. The present study was performed to determine the acute oral toxicity and quality control of a crude extract of FM in ICR mice. Methods : We investigated the in vivo single dose acute toxicity of FM 95% ethanol extract. This test was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000mg/kg body weight, respectively. Mortalities, clinical findings, autopsy findings and body weight changes were monitored daily for the 14 days following the administration. HPLC analysis was performed for the simultaneous determination of ursolic acid and p-hydroxycinnamic acid in FM. Reverse-phase chromatography using a C18 column and photodiode array detection at 211 nm was used for quantification of the two maker components. The mobile phase for gradient elution consists of water and acetonitrile. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. The mice did not die after single oral administration of maximum dose of FM. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of FM for ICR mice was more than 5000mg/kg on oral route. The HPLC analysis showed that ursolic acid and p-hydroxycinnamic acid amounts to 9.75- and 0.12% in the extract with the retention times of 47.99- and 15.38 minutes, respectively. Conclusions : These results suggest that no toxic dose level of FM in mice is considered to be more than 5000mg/kg. Consequently, it was concluded that FM have no effect on acute toxicity and side effect in ICR mice. For the quality control of FM extract, simultaneous determination of ursolic acid and p-hydroxycinnamic acid was established.

• Toxicological Research
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• 제6권1호
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• pp.41-49
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• 1990

Aconiti Tuber is the root of Aconitum sp (Ranunclaceae) which has been considered as one of the most important medicinal plant having cordiotonic, diuretic and analgesic effect. On the other hand, it has been known that Aconiti Tuber contained toxic agent, aconitine alkaloids so that only processed Aconiti Tubers have been used as herbal drug traditionally. For the safety evaluation of processed Aconiti Tuber, quantitative determination of aconitine and acute, subacute toxicity test were performed on 5 commercial processed Aconiti Tubers. Arapid and precise method using HPLC has been developed for the separation and determination of aconitine. Samples were extracted with hydrochloric acid (pH3) and hot water decoction. In case of d-HCL extracts, the contents of aconitine were from 0.08 mg/g to trace. But in case of hot water decoction extracts, the contents of aconitine were not detected. For the investigation of Aconiti Tuber toxicity in rats, hot water decoction samples and methanol extracts were tested. 1) Acute toxicity test Hot water decoction sample and methanol extracts from Aconiti Tuber did not show any toxic effects in rats by an oral administration. $LD_50values of 2 extracts were above 10.0 g/kg. 2) Subacute toxicity study In the repeated administration study, hot water decoction samples were given orally to Sprague-Dawlay rats for 2 week at daily doses of 5.0 g/kg. The results are as follows; No toxic manifestation, body weight changes and lethality were observed during wxperimental period. There were no significant changes in serum enzyme activities such as GOT, GPT, LDH, ALP between treated and control groups. However CPK values were decreased in the Subuja-treated group. (P<0.01). In addition, no gross and microscopic changes were noted in Aconiti Tuber-treated groups.

• 대한본초학회지
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• 제33권1호
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• pp.71-76
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• 2018

Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.

• 한국식품영양과학회지
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• 제42권6호
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• pp.892-897
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• 2013

본 연구는 김치로부터 항진균 활성을 보이는 유산균인 Lactobacillus(Lb.) plantarum AF1이 생산하는 조항진균 물질의 부분 정제물이 천연 식품보존제 및 사료보존제로서 사용 가능성을 알아보기 위하여 안전성을 평가하고자 단회 급성독성시험을 실시하였다. 급성독성시험을 위하여 경구로 1회 시험물질을 최고 용량(2,000 mg/kg)으로 하여 ICR계통 암수 마우스에게 용량별 각 군당 10 마리씩 투여한 후 14일간의 일반증상, 사망률, 체중, 임상증상 및 육안적 소견을 관찰하였다. 단회 경구투여한 후 모든 시험군에서 사망례가 관찰되지 않았으며, 시험동물은 시험 종료 시까지 계속 생존하여 평균치사량을 산출할 수 없었다. 경구투여한 후 마우스의 체중변화에 있어서도 암수 모두 대조군과 시료물질 투여군 사이에 유의성 있는 차이는 보이지 않았으며, 용량 의존적인 차이도 볼 수 없었다. 경구투여한 후 시험 종료한 다음 생존동물 모두를 부검하여 주요 장기의 육안적 소견을 관찰한 결과 대조군과 시료투여군 모두에서 외관상이나 내부 장기에 어떠한 이상소견이나 병변이 관찰되지 않았다. 이상의 결과로부터 시험물질인 Lb. plantarum AF1이 생산한 조항진균 물질을 경구투여 시 ICR계통 암수 마우스에서 독성학적인 변화가 관찰되지 않았으며, $LD_{50}$은 경구투여 시 2,000 mg/kg 이상인 저독성의 안전한 물질로 사료된다.

• 대한화장품학회:학술대회논문집
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• 대한화장품학회 1999년도 IFSCC . ASCS 학술대회 발표 논문
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• pp.145-154
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• 1999

A novel retinol derivative, polyethoxylated retinamide (Medimin A) was synthesized, as an anti-aging agent. Collagen synthesis, skin permeation, stability, and toxicity of Medimin A were evaluated and compared with those of retinol and retinyl palmitate. In vitro collagen synthesis was evaluated by quantitative assay of [$^3H$]-proline incorporation into collagenase sensitive protein in fibroblast cultures. For in vitro skin permeation experiments, Franz diffusion cells (effective diffusion area: $1, 766{\;}\textrm{cm}^2$) and the excised skin of female hairless mouse aged 8 weeks were used The stabilities of retlnoids were evaluated at two different temperature ($25{\;}^{\circ}C$ and $40{\;}^{\circ}C$) and under UV in solubilized state and in OW emulsion. To estimate the safety, acute oral toxicity, acute dermal toxicity, primary skin irritation, acute eye irritation and human patch test were performed The effect of Medimin A on collagen synthesis was similar to that of retinol. The skin permeability of Medimin A was higher than those of retinol and retinyl palmitate. The Medimin A was more stable than retinol and retinyl palmitate. Medimin A was nontoxic in various toxicological tests. These results suggest that Medimin A would be a good anti-aging agent for enhancing bioavailability and stability.