维脑路通片压片工段工艺质量回顾分析

The Process quality review analysis in Pelleting section of troxeurtine tablets

目的:通过维脑路通片压片工段工艺质量回顾分析,保证药品质量的安全生产要求。维脑路通是芦丁经羟乙基化半合成的产物,对抗5-羟色胺、缓激肽引起的血管损伤,增加毛细血管抵抗力,能降低毛细血管的通透性和脆性,并有抑制血小板凝集、防止血栓形成的作用,降低毛细血管通透性,可防止血管通透性升高引起的水肿。对急性缺血性脑损伤有显著的保护作用。适用于脑血栓形成和脑栓塞所致的偏瘫、失语以及心肌梗死前综合征、动脉硬化等。维脑路通是临床上治疗闭塞性脑血管病的常用药物。根据2010年修订的《药品生产质量管理规范》第二百六十六条要求,企业至少应当对关键中间控制点及成品的检验结果进行回顾分析。方法:是通过联系跟踪95批次的产品,进行片重的分析。结果:是平均偏差SD=0.000467,平均数average=0.125679,相对平均偏差RSD=0.003716,RSD(%)=0.3716,RSD<3%,符合方法学要求。结论:是验证工厂使用的压片机的性能符合GMP的要求,达到了阶段性的压片工段的质量管理要求。

Objective：we can ensure production safety requirements of drug quality by venoruton tablets quality retrospective analysis section process.Troxeurtine tablets is semisynthetic product by hydroxyethyl rutin brain road,Which can against blood vessel damage caused and increase the capillary resistance, reduce capillary permeability and brittleness, and inhibit platelet coagulation, prevention of thrombosis, reduce capillary permeability, can prevent edema caused by increased vascular permeabilityby serotonin and slow stimulate peptide. A significant protection against acute ischemic brain injury. Suitable for hemiplegia due to cerebral thrombosis and cerebral embolism, aphasia syndrome before and myocardial infarction, atherosclerosis, etc. Troxeurtine tablets is clinically commonly used drugs for the treatment of occlusive cerebrovascular disease. According to the two hundred and sixty-sixth requirement of the 2010 revision of the＂drug production quality management standard＂, enterprise should review analysis at least among the key control points and finished product test results.Method： By contacting tracking 95 batches of the product.Result：SD =0.000467, the average =0.125679,RSD =0.003716, RSD（%）=0.3716,RSD3%, which conform to the requirements of the methodology. Conclusion：The Verificion shows Tablet press Performance meets the requirement of GMP and reach the stage of pelleting section of the quality management requirements,ensure the quality of production safety requirements.