肠胃宁胶囊安全性评价研究
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(1. 山东仙河药业有限公司,山东东营 2572311; 2. 山东省药学科学院新药评价中心, 济南 250100)

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R-33

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Safety evaluation of the Chang Wei Ning Capsule
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(1. Shandong Xianhe Pharmaceutical Co. Ltd., Dongying 257231, China.2. New Drug Evaluation Center of Shandong Academy of Pharmaceutical Sciences, Jinan 250100)

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    摘要:

    目的 研究肠胃宁胶囊单次和重复给药的临床前安全性,为临床用药提供参考?方法 40 只小鼠分为肠胃宁胶囊组和空白对照组,每组20 只小鼠,肠胃宁胶囊给药剂量为32 g/ kg,空白对照组给予同体积纯水,详细观察动物体征至药后14 d,剖检肉眼大体观察各脏器形态?120 只大鼠分为肠胃宁胶囊9?3?1 g/ kg 剂量组和空白对照组,每组30 只大鼠,连续灌胃给药13 周,分别于给药13 周和停药后4 周时取部分大鼠进行血液学指标?血液生化学指标?病理组织学检查?结果 肠胃宁胶囊以32 g/ kg 剂量单日灌胃给药,药后观察至第14 天小鼠未见明显毒性反应?肠胃宁胶囊9?3?1 g/ kg 剂量连续灌胃给药13 周,大鼠体重?血液学?血液生化学指标及组织病理学未见明显毒性反应?结论 肠胃宁胶囊小鼠单次给药最大给药量为32 g/ kg;大鼠重复给药13 周最大无毒反应剂量大于9 g/ kg?

    Abstract:

    Objective To study the safety of the Chang Wei Ning Capsule and to provide a reference for clinicalapplication. Methods Forty mice (males and females) were randomly divided into a Chang Wei Ning Capsule group and anormal control group, each containing twenty mice. Mice of the test group received 32 g/ kg body weight Chang Wei NingCapsule, while those of the control group received the same volume of pure water. A detailed observation of the mice,including examination of viscera morphology by naked eye, was conducted until day 14 post-drug administration. Onehundred and twenty rats (males and females) were randomly divided into a normal control group and three different ChangWei Ning Capsule dosage groups (9, 3, 1 g/ kg bodyweight). The rats received consecutive intragastric administrations ofChang Wei Ning Capsule over a 13-week period. In addition to observing the general condition of the animals, body weight,blood, hepatic function and renal function measurements, and a histopathology analysis, were performed after the 13 weektreatment duration and at four weeks-post drug withdrawal. Results No toxic reaction was observed in mice that receivedintragastric administrations of Chang Wei Ning Capsule (32 g/ kg). No abnormal reaction was also observed in the rats of alldosage groups that received intragastric Chang Wei Ning Capsule over a 13-week period. Conclusions The maximumadministered dose of Chang Wei Ning capsule in mice was 32 g/ kg body weight in a single-dose toxicity test. No observed adverse effects were observed in rats receiving up to 9 g/ kg drug per day in repeated-dose toxicity tests.

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刘丽,戴晓莉,孙超,马玉奎.肠胃宁胶囊安全性评价研究[J].中国比较医学杂志,2019,29(4):93~97.

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  • 收稿日期:2018-11-20
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  • 在线发布日期: 2019-05-10
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