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超键对Sprague-Dawley大鼠的单剂量口服毒性研究。

A Study on the Single-dose Oral Toxicity of Super Key in Sprague-Dawley Rats.

作者信息

Kim Jinhee, Lee Jongcheol, Kim Sungchul

机构信息

Department of Korean Rehabilitation Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.

Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea ; Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea.

出版信息

J Pharmacopuncture. 2015 Sep;18(3):63-7. doi: 10.3831/KPI.2015.18.026.

Abstract

OBJECTIVES

This study was performed to analyze the single-dose oral toxicity of the super key (processed sulfur).

METHODS

All experiments were conducted at Medvill, an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate the oral toxicity of super key We administered it orally to Sprague-Dawley (SD) rats. The SD rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of super key 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg were administered to the experimental groups, and a dose of normal saline solution, 10 mL/kg, was administered to the control group. We examined the survival rates, weights, clinical signs, gross findings and necropsy findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. (Approval number: A01-14018).

RESULTS

No deaths or abnormalities occurred in any of the four groups. Although slight decreases in the weights of some female rats were noted, no significant changes in weights or differences in the gross findings between the control group and the experimental groups were observed. To check for abnormalities in organs, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs.

CONCLUSION

The results of this research showed that administration of 500 ─ 2,000 mg/kg of super key did not cause any changes in the weights or in the results of necropsy examinations. Neither did it result in any mortalities. The above findings suggest that treatment with super key is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

摘要

目的

本研究旨在分析超级密钥(炮制硫磺)的单剂量口服毒性。

方法

所有实验均在Medvill进行,这是一家经授权开展非临床研究的机构,实验遵循《良好实验室规范》(GLP)规定。为研究超级密钥的口服毒性,我们对斯普拉格-道利(SD)大鼠进行口服给药。SD大鼠被分为四组,每组五只雄性和五只雌性动物:第1组为对照组,第2、3、4组为实验组。实验组分别给予500毫克/千克、1000毫克/千克和2000毫克/千克的超级密钥,对照组给予10毫升/千克的生理盐水。我们检查了存活率、体重、临床体征、大体检查结果和尸检结果。本研究经机构动物伦理委员会批准进行。(批准号:A01-14018)

结果

四组中均未出现死亡或异常情况。虽然注意到部分雌性大鼠体重略有下降,但对照组和实验组之间的体重没有显著变化,大体检查结果也没有差异。为检查器官是否存在异常,我们使用显微镜检查了每个指定器官的代表性组织切片;结果显示任何器官均无显著差异。

结论

本研究结果表明,给予500至2000毫克/千克的超级密钥不会导致体重或尸检结果出现任何变化,也未导致任何死亡。上述发现表明,使用超级密钥治疗相对安全。需要对此主题进行进一步研究以获得更确凿的证据。

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本文引用的文献

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Sulfur for scabies outbreaks in orphanages.
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