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目的:评估加减活络效灵丹口服应用的安全性。方法:检索TCMlars(www.cintcm.com)、PubMed(MEDLINE)文献和《中华本草》1999年版、《世界卫生组织精选医用植物》(Ⅰ～Ⅲ卷)关于活络效是丹及其组成药物的毒性方面的内容。大鼠单次给予最大剂量活络效灵丹(9.2 g/kg)评价药物急性毒性;给予4.6g/kg活络效灵丹,连续给药9 d,采用运动功能实验和行为学观察等评价药物亚慢性毒性或不良反应;活络效灵丹2.30g/kg灌胃42d,评价药物慢性毒性或不良反应。结果:文献检索提示,活络效灵丹及其11味组成中药在中文中医药文献中没有副作用或不良反应记载。在临床习用剂量下,《中华本草》和《世界卫生组织精选医用植物》中没有发现该方组成药物有毒副作用或不良反应。大鼠实验提示:(1)应用单次口服最大剂量9.2 g/kg,在14 d观察期中没有发现活络效灵丹对大鼠体征、体质量有明显影响,无大鼠死亡;(2)运动实验提示,每日喂服4.6 g/kg,连续9 d,活络效灵丹未造成运动功能的损害;(3)活络效灵丹9 d连续给药,弗氏完全佐剂致炎大鼠没有出现明显的行为改变、不良反应和体征(最大观察剂量4.6 g/kg),正常大鼠连续9日每日喂服活络效灵丹4.6 g/kg,在用药期间以及停药后14 d内,未出现明显的不良反应;(4)每日应用活络效灵丹2.30g/kg连续42 d喂服正常大鼠,未观察到大鼠出现明显的行为改变、不良反应和体征,以及血清生化和组织病理改变。结论:动物实验提示加减活络效灵丹安全,无明显毒副作用,且文献报道中未发现加减活络效灵丹临床试验或动物实验中有副作用。
OBJECTIVE: To assess the safety of oral and concurrent oral administration of triamcinolone. Methods: The TCMlars (www.cintcm.com), PubMed (MEDLINE) and Chunghwa Materia Medica (1999 Edition) were searched. The WHO Effective Medical Devices (Volume I ~ III) Toxicity content. The rats were given a single dose of maximal active rhxylbine (9.2 g / kg) to evaluate the acute toxicity of the drug. 4.6g / kg active rhubarb was given for 9 days. The rats were evaluated on motor function and behavioral observation Chronic toxicity or adverse reactions; Active Lingding Dan 2.30g / kg orally 42d, evaluation of drug chronic toxicity or adverse reactions. Results: The literature search suggested that the Chinese herbal medicine of active ingredients Lingdan and its 11 flavors had no side effects or adverse reactions recorded in the Chinese medicine literature. At clinically useful doses, no toxic side effects or adverse reactions were identified in “Chinese Materia Medica” and “World Health Organization Selected Medical Plants”. The experimental results of rats showed that: (1) no significant effect on the signs and body weight of rats was found after application of the single maximal oral dose of 9.2 g / kg in the observation period of 14 days. (2) Exercise Experimental prompts, daily feeding of 4.6 g / kg for 9 days, active Ling Ling Dan did not cause impairment of motor function; (3) active dall after 9 d continuous administration of Freund’s complete adjuvant-induced inflammation in rats Significant changes in behavior, adverse reactions and signs (maximum observed dose of 4.6 g / kg), normal rats on the 9th daily feeding active Ling Ling Dan 4.6 g / kg during and within 14 d after drug withdrawal, No significant adverse reactions were observed. (4) No obvious behavioral changes, adverse reactions and signs, as well as serum biochemical and histological changes were observed in normal rats after daily application of active Lingdan 2.30g / kg for 42 days. Histopathological changes. Conclusion: The animal experiments suggest that the active and effective panax notoginseng is safe and safe, and no obvious toxic and side effects are found. There are no side effects in clinical trials or animal experiments of active and inactive drugs in the literature.