CAJ | 학술논문

目的：本试验选择阿奇霉素（原料药）及注射用阿奇霉素的辅料-枸橼酸（助溶剂）进行降压物质检查试验，了解原料药及辅料对麻醉猫不引起血压下降的剂量，以确定注射用阿奇霉素产生降压反应的物质基础，为临床用药安全及合理使用抗生素及助溶剂的选择问题提供借鉴。方法选用猫作为实验动物，分别对三批阿奇霉素和枸橼酸进行降压物质检查试验，确定该品种对麻醉猫不引起血压下降（或血压下降未超过组胺对照品引起血压下降）的剂量,找出引起降压反应的主要物质。结果阿奇霉素以浓度为1万IU/ml,0.2ml/kg剂量静脉注射后，三批样品的降压幅度均低于磷酸组胺对照品所致血压下降幅度。枸橼酸以浓度为0.5mg/ml,1.0ml/kg剂量静脉注射后，三批样品的降压幅度均低于磷酸组胺对照品所致血压下降幅度。结论最终确定了该品种对麻醉猫不引起血压下降的剂量为阿奇霉素：2000IU/kg，枸橼酸：0.5mg/kg，其比例与制剂中两者的比例一致。提示注射用阿奇霉素的降压反应可能主要是由于枸橼酸（辅料）引起的。
목적：본시험선택아기매소（원료약）급주사용아기매소적보료-구연산（조용제）진행강압물질검사시험，료해원료약급보료대마취묘불인기혈압하강적제량，이학정주사용아기매소산생강압반응적물질기출，위림상용약안전급합리사용항생소급조용제적선택문제제공차감。방법선용묘작위실험동물，분별대삼비아기매소화구연산진행강압물질검사시험，학정해품충대마취묘불인기혈압하강（혹혈압하강미초과조알대조품인기혈압하강）적제량,조출인기강압반응적주요물질。결과아기매소이농도위1만IU/ml,0.2ml/kg제량정맥주사후，삼비양품적강압폭도균저우린산조알대조품소치혈압하강폭도。구연산이농도위0.5mg/ml,1.0ml/kg제량정맥주사후，삼비양품적강압폭도균저우린산조알대조품소치혈압하강폭도。결론최종학정료해품충대마취묘불인기혈압하강적제량위아기매소：2000IU/kg，구연산：0.5mg/kg，기비례여제제중량자적비례일치。제시주사용아기매소적강압반응가능주요시유우구연산（보료）인기적。
Objective To know the dosis of raw medicine and adjuvant that couldn’t cause an depressurization effect of anesthetized cats,we choose Azithromycin(the raw medicine) and its’auxiliary material-citric acid(adjuvant) to test the hypotensive substance.Then we can determine the substrate which cause the depressurization effect.It will provide referenc to clinical drug safety and rational use of antibiotics and the selection of solvent.Methods In order to determine the dosis of the species that couldn’t cause an depressurization effect of anesthetized cats(or the drop of blood pressure did not exceed the drop caused by histamine reference standard),and search for the major substance which cause the depressurization effect,we choose cats as the laboratory animal,and do hypotensive substance inspection on three batches of samples.Reasult The lowering range caused by Azithromycin(10000IU/ml,0.2ml/kg) and citric acid (0.5mg/ml,1.0ml/kg) with intravenenous injection,is lower than the control substance: histamine phosphate. Conclusion It can be concluded that the dose of variety which couldn’t cause depressurization effect in anesthetized cats is 2000IU/kg(Azithromycin); 0.5mg/60kg(citric acid). The proportion is the same as the praeparatum.It can indicate that citric acid(adjuvant) may be the substance which cause the depressurization effect.