注射用血栓通和血栓通注射液降压物质及过敏反应方法学研究

目的: 建立注射用血栓通和血栓通注射液"降压物质"和"过敏反应"检查项,提高其临床用药安全。方法:通过对注射用血栓通和血栓通注射液与组胺对照品引起麻醉猫血压下降程度进行比较,以确定降压物质检查法的限值。测定注射用血栓通和血栓通注射液豚鼠腹腔和静脉给药的无毒反应剂量,采用豚鼠过敏试验的方法设定腹腔致敏和静脉过敏激发的剂量限值。结果:降压物质检查中,注射用血栓通和血栓通注射液限值分别为15,7 mg·kg^-1;过敏反应检查中,注射用血栓通和血栓通注射液限值试验浓度分别为5,4 mg·mL^-1,致敏每只用0.5 mL,激发每只用1 mL。结论:为减少本品临床使用的不良反应,建议在其质量标准的检查]项中增加"降压物质"和"过敏反应"项目。

Methodology Study on Depressor Substance and Anaphylaxis of Xueshuantong for Injection and Xueshuantong Injection

Objective: To establish "depressor substance" and "anaphylaxis" inspection items for Xueshuantong for Injection and Xueshuantong Injection. Methods: Determining the limiting value of depressor substance test by comparing the blood pressure descent degree on the anesthetic cats among Xueshuantong for Injection, Xueshuantong Injection and Histamine Diphosphate standard substance. By determining the non-toxic reaction doses ip and iv for guinea pigs to figure out the limits for sensitization ip and challenge iv of guinea pig hypersensitive test. Results: The depressor substance limits of Xeushuantong for Injection and Xueshuantong Injection were 15 mg·kg^-1 and 7 mg·kg^-1, respectively.The hypersensitive test limits were 5 mg·mL^-1 and 4 mg·mL^-1, 0.5 mL for sensitization dose, 1.0 mL for challenge dose. Conclusion: It''s necessary to add the inspection items of "depressor substance" and "anaphylaxis" into the current quality standards for both Xueshuantong for Injection and Xueshuantong Injection in order to reduce the occurring of adverse reactions.