注射用甲磺酸加贝酯异常毒性及降压物质方法学研究

Methodology Study on Abnormal Toxicity and Depressor Substance Tests of Gabexate Mesilate for Injection

目的建立注射用甲磺酸加贝酯异常毒性及降压物质检查项,提高其临床用药安全。方法通过求得LD50及其可信限,确定其异常毒性检查法的限值。通过对注射用甲磺酸加贝酯与组胺对照品引起麻醉猫血压下降程度比较研究,确定降压物质检查法的限值。结果异常毒性检查项的限值定为65 mg/kg,降压物质检查项的限值定为1.0 mg/kg,按此限值检查结果符合规定。结论为减少本品临床使用的不良反应,应在质量标准中检查项中增加异常毒性和降压物质项目。

Objective To establish the method for abnormal toxicity and depressor substance test of Gabexate Mesilate for Injection. Methods Through test of LDS0 and its confidence limits, the limit of abnormal toxicity test was determined. The limit of depressor substance was determined by comparison of the degree of blood pressure drop induced by Gabexate Mesilate for Injection and histamine diphosphate standard substance. Results The limit of abnormal toxicity test of Gabexate Mesilate for Injection was defined as 65 mg/kg, the limit of depressor substance test was defined as 1.0 mg/kg. Conclusion Tests for abnormal toxicity and depressor substance of Gabexate Mesilate for Injection should be included in inspection terms of quality standard.