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가설 설정
- 1. There were no mortalities related with CMT extracts treatment.
제안 방법
- All numerical data are presented as mean±SD of five mice, and multiple comparison tests for the different dose groups were conducted.
- Body weight were measured at the day of administration, oral gavage (Day 0) immediately before treatment, 1, 2, 7, 13 and 14 days after dosing. In addition, to reduce the differences from individual body weight of animals at initial of this experiment, the body weight gains during Day 0~Day 7, Day 7~Day 13 and Day 0~Day 13 was also calculated based on measured body weight at each points.
- Each of twenty female and male SPF/VAF outbred CrljOri:CD1 (ICR) mice (6-wk old upon receipt, OrientBio, Sungnam, Korea) were used after acclimatization for 10 days.
- In addition, each female and male vehicle control groups were added according to the KFDA Guidelines7. Test material was orally administered using distilled water as vehicle in this study.
- In order to observe the 50% lethal dose (LD50) and approximate lethal dosage (ALD), test articles were once orally administered to female and male mice at dose levels of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of KFDA Guidelines9. The mortality, changes in body weight, clinical signs and gross observation were monitored during 14 days after oral administration of CMT lyophilized aqueous extracts with organ weight and histopathological changes of principle organs.
- The objective of the present study, therefore, was to obtain the primary safety information about CMT, a famous traditional Korean polyherbal formula has been used for neuroprotective agents, aqueous extracts (yield=9.7%), and further clarify its safety for clinical use. In order to observe the 50% lethal dose (LD50) and approximate lethal dosage (ALD), test articles were once orally administered to female and male mice at dose levels of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of KFDA Guidelines9.
- Brown colored CMT extracts were stored in a refrigerator at 4 ℃ to protect from light and degeneration, and it is well soluble upto 100 mg/mL concentration levels in distilled water, used as vehicle as clear light brown solution in this experiment. The test article was single orally administered at a dosage volume of 20 mL/kg using distilled water as vehicle at 2,000, 1,000 and 500 mg/kg dose levels (Table 1).
- There were no gross findings related with CMT extracts treatment in this study as compared with equal gender of vehicle control, except for some sporadic accidental findings such as slight (1+) congestion spots of lung, atrophy of thymus, spleen atrophy or hypertrophy, submandibular lymph node hypertrophy and edematous changes of uterus sporadically detected throughout all experimental groups tested in this study including both gender of vehicle control, respectively (Table 5).
대상 데이터
- Representative sections of each specified organs were stained with hematoxylin & eosin for light microscopical examination according to previous established methods12-15. Specific organs sampled were lung, heart, thymus, kidney (left), spleen, adrenal gland (left), testis (left), liver, pancreas (splenic lobes), epididymis (left), submandibular lymph node (left), ovary (left), brain, and uterus.
데이터처리
- Homogeneity of variance was examined using the Levene test16. If the Levene test indicated no significant deviations from variance homogeneity, the obtain data were analyzed using a one way ANOVA test followed by least-significant differences multi-comparison (LSD) test to determine which pairs of group comparisons were significantly different. In the case where significant deviations from variance homogeneity were observed in the Levene test, a non-parametric comparison test, Kruskal-Wallis H test, were used.
이론/모형
- If the Levene test indicated no significant deviations from variance homogeneity, the obtain data were analyzed using a one way ANOVA test followed by least-significant differences multi-comparison (LSD) test to determine which pairs of group comparisons were significantly different. In the case where significant deviations from variance homogeneity were observed in the Levene test, a non-parametric comparison test, Kruskal-Wallis H test, were used. When a significant difference is observed in the Kruskal-Wallis H test, the MannWhitney U (MW) test, was used to determine the specific pairs of group comparison that were significantly different17.
성능/효과
- 2. There were no clinical signs, changes in the body and organ weight, or gross necropsy findings except for several accidental sporadic findings which did not show any obvious dose-relations.
- As results of this experiment, we could not find any CMT extracts treatment related mortalities, clinical signs, changes in the body and organ weight, gross and histopathological observations against 14 principle organs up to 2,000 mg/kg in both female and male mice, except for some accidental sporadic findings which did not show any obvious dose-relations and most of them also demonstrated in the both female and male vehicle control mice in this experiments.
- There were no unscheduled or CMT extract-treat related mortalities detected in all dose groups tested in this study, and accordingly all of animals (5/5; 100%) including both female, male and vehicle control mice were subjected to the terminal necropsy at 14 days after end of treatment in this study.
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