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作 者:匡荣[1] 陈男[2] 朱社敏[1] 康桦[1] 邓祖跃[1] 王丹[1] 张劲松[1]
机构地区:[1]浙江省食品药品检验所,杭州310004 [2]浙江工业大学药学院,杭州310014
出 处:《中国药品标准》2012年第5期343-347,共5页Drug Standards of China
摘 要:目的:研究豚鼠离体心脏灌流法在冠心宁注射液生物活性检测中的应用,为完善其质量标准提供参考。方法:采用离体豚鼠心脏灌流技术,对6个厂家27批冠心宁注射液样品进行生物活性检测。结果:冠心宁注射液能显著增加离体豚鼠心脏的冠脉流量。在一定剂量范围内,冠心宁注射液表现出一定的量效关系;在一定剂量下,其对同一只离体心脏的灌流增加量重复性较好,但在不同心脏上重复性较差。结论:此法有望成为冠心宁注射液的有效性质量控制方法。Objective:To investigate the application of isolated heart pcrfusion technique to evaluate the bioactivity of Guanxinning injection, and provide the reference for improving the standards of quality control further. Methods:The isolated guinea pig heart perfusion technique was used to measure the bioactivity of 27 samples of Guanxinning Injection from six manufacturers by studying doseeffect relationship, repeatability. Results: Guanxinning Injection could increase the coronary flow significantly in this model. In a certain dose range, Guanxinning Injection showed some doseffect lationship and in certain dose, the repeatability of the result was better in the same isolated heart but it was poor in the different herts. Conclusion:The isolated guinea pig heart perfnsion technique will become a good method for measuring the bioactivity of Guanxinuing Injection.
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