不同来源灯盏花素注射液“生物活性”质量的比较研究

Comparison in Bioactivity of Breviscapine Injections with Different Origins

目的:比较不同厂家生产的含量测定合格的灯盏花素注射液在不同生物活性试验中的反应情况,以探讨"生物活性测定"在中药注射剂质量控制中应用的可行性。方法:选择小鼠脑血栓形成试验和小鼠脑循环障碍试验作为"生物活性测定"方法,确定生物活性检测限值;并比较两种规格4个样品"生物活性"测定结果。结果:以临床人用剂量的20倍(6.7mg/kg),给予实验动物可以得到样品"生物活性"的阳性结果,以此剂量作为生物活性试验的检测限值。在同样的检测限值下,灯盏花素注射液号样品对小鼠脑血栓形成有显著性对抗作用,而、、号样品则未见对抗作用。、号样品对小鼠急性脑循环障碍改善有明显作用,而、号样品则差异不显著。另外,号样品无细胞毒性反应的浓度与其他3个样品有明显差异。结论:在相同检测限度值下,由不同药厂或同一药厂生产的不同规格和批号的灯盏花素注射液虽然"含量测定"均符合规定,但"生物活性"却存在着明显的差异,表明"生物活性测定"与理化分析控制质量的不同。因此,结合理化分析手段,"生物活性测定"能够通过综合和分析的结合达到控制中药注射剂质量的目的。

Objective：To compare bioactivity of Breviscapine Injections produced by different factories which contents of those compounds measure up,and investigate the application of controling qualities of traditional herb injections through measuring bioactivity. Methods：To select two experiments as measuring methods which are brain thrombosis and brain circle obstruction in mice,and confirm measuring limited value, and compare bioactivity of four samples with two kinds of Specs. Results ：When mice were given drug at the dose of 6. 7mg/kg, being 20 times of Clinical dose,they appeared a positive bioactivity. So the dose was comfined as measuring limited value of bioactivity, According to this measuring limited value, sample Ⅰ of breviscapine can significantly inhibit brain thombosis, but sample Ⅱ , sample Ⅲ and sample Ⅳ did not show above effect. Sample Ⅲ and sample Ⅳ of breviscapine could significantly alleviate symptoms of acute brain Circle obstruction in mice, and sample Ⅰ and sample Ⅱ did not show this effect. Otherwise,the concentration of sample Ⅰ which did not show toxicity of cells was significantly different from concentrations of other drugs. Conclusion：According the same measuring limited value, though Contents of those breviscapines that they were produced by different factories or different specifications and batch numbers according with standard,their bioactivities show a difference significantly. It indicats that measuring bioactivity exist difference with controlling quality by analyzing properties of physics and chemistry of drug. So we should combine measuring bioactivity and analyzing properties of physics and chemistry of drug so that qualities of traditional herb injections were controlled well.