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[法玛希姆公司甲硝唑的临床前研究]

[Preclinical research on Pharmachim's ronidazole].

作者信息

Dilov P, Antonov S, Dzhurov A, Chaleva E, G'osheva B

出版信息

Vet Med Nauki. 1985;22(7):90-7.

PMID:4082486
Abstract

Ronidazol-Pharmachim (RPh) in the form of 10 per cent water-soluble powder was studied in terms of resistance to various values of pH of the surrounding medium, acute toxicity, the species-specific tolerance of various mammals of it, its subchronic toxicity and residual amounts with pigs. The preparation was found to be stable in water solutions (pH 5.0 to 9.0) in the course of at least 96 hours, and in n HCl--for more than a month. At oral administration LD50 of RPh was 34000 mg (2982 divided by 3876) per kg for albino rats weighing 150-200 g. At intraperitoneal injection in the form of pure substance LD50 was 1500 mg (1320 divided by 1690) per kg. With pigs at single oral application at the rates of 20, 60, and 180 mg/kg (= 20-30 times the ED50) RPh was tolerated with no changes in the behaviour and appetite. When used with the drinking water at rates of 60, 180, and 300 ppm in the course of 30 days there was no unfavourable effect on the gain and the blood picture and no injury of the structure of viscera of pigs. In concentrations of 180 ppm it was shown to stimulate the growth of pigs. The withdrawal time with pigs given RPh with the drinking water was at least 72 hours after the preparation was offered last.

摘要

对10%水溶性粉剂形式的罗硝唑-法玛西姆(RPh)进行了研究,内容包括其对周围介质不同pH值的耐受性、急性毒性、各种哺乳动物对它的种属特异性耐受性、亚慢性毒性以及在猪体内的残留量。结果发现,该制剂在水溶液(pH 5.0至9.0)中至少96小时内稳定,在盐酸中稳定超过一个月。对于体重150 - 200克的白化大鼠,口服RPh的半数致死量(LD50)为每千克34000毫克(2982至3876)。以纯物质形式腹腔注射时,LD50为每千克1500毫克(1320至1690)。对于猪,单次口服剂量为20、60和180毫克/千克(= ED50的20 - 30倍)时,RPh耐受性良好,行为和食欲无变化。当以60、180和300 ppm的剂量与饮用水一起使用30天时,对猪的增重和血液图像没有不利影响,也没有对猪内脏结构造成损伤。在180 ppm的浓度下,它能刺激猪的生长。给猪饮用含RPh的水后,停药时间至少在最后一次投喂制剂后72小时。

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