降压物质检查法与组胺类物质检查法用于小牛血去蛋白提取物注射液质量控制的研究

Depressor Substances Test and Histamine Test for the Quality Control of Deproteinized Culf Blood Extractives Injection

目的:探讨降压物质检查法和组胺类物质检查法在小牛血去蛋白提取物注射液质量控制中的适用性。方法:对10批小牛血去蛋白提取物注射液进行降压物质检查和组胺类物质检查实验。结果:部分供试品在实验中表现出阳性反应。两种方法得出的结果呈正相关,但部分引起麻醉猫血压下降的供试品在组胺类物质检查实验中作用不显著或相对前者有所降低。结论:小牛血去蛋白提取物注射液有污染降压物质的风险,但部分活性杂质可能非组胺类物质,可考虑采用降压物质检查法控制产品质量。

Objective： To explore the applicability of depressor substances test and histamine test for the quality control of depro- teinized culf blood extractives injection. Methods： Depressor substances test and histamine test were carried out on 10 batches of deproteinized culf blood extractives injection samples. Results： Some samples showed positive reactions in the experiments. The correl- ative analysis showed positive correlation existed between the results of depressor substances test and histamine test. However, part of samples causing blood pressure decrease in anesthetized cats showed negative or relatively reduced results in histamine test. Conclu- sion： Deproteinized cull blood extractives injection may be contaminated by depressor substances. Part of these substances may not be histamine analogue, therefore, depressor substances test may be considered in the quality control of the product.