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通过建立血栓通胶囊(XST)体外抑制血小板聚集的生物活性测定法用于补充其质量控制方法。以体外抑制大鼠血小板聚集作用来考察血栓通胶囊的生物活性。以三七总皂苷、注射用血塞通冻干粉作为标准对照物质进行效价测定。研究结果发现血栓通胶囊对凝血酶诱导的血小板聚集具有显著抑制作用,并且呈现出剂量依赖关系。注射用血塞通冻干粉比三七总皂苷对照品体外抗血小板活性更稳定,适宜作为标准对照物质。采用“量反应平行线”法作为血栓通胶囊体外抗凝血酶诱导血小板聚集的生物效价检测方法,重复性较好(RSD 2.9%),样品检测结果均能通过可靠检验(偏离直线P>0.05,偏离平行P>0.05)。该研究建立的生物效价检测方法可以作为血栓通胶囊生物评价的质控方法之一。
Bioactivity assays that inhibit platelet aggregation in vitro by establishing XST (Capsule) are used to supplement their quality control methods. In vitro inhibition of platelet aggregation in rats to study the biological activity of Xueshuantong capsule. To Panax notoginseng, injection of Xuesaitong freeze-dried powder as a standard control substance for potency determination. The study found that Xueshuantong capsule on thrombin-induced platelet aggregation was significantly inhibited, and showed a dose-dependent relationship. Injection of Xuesaitong freeze-dried powder than Panax notoginseng saponins in vitro anti-platelet activity more stable, suitable as a standard control substance. The method of “parallel reaction of volume reaction” was adopted as the biological potency detection method of Xueshuantong Capsule induced platelet aggregation induced by antithrombin in vitro. The reproducibility was good (RSD 2.9%). The test results of the sample could all pass the reliable test P> 0.05, deviation from parallel P> 0.05). The biological potency detection method established in this study can be used as one of the quality control methods for the bioassay of Xueshuantong capsule.