CAJ | 학술논문

为确保悦安欣苦碟子注射液（简称苦碟子注射液）临床应用安全有效，本研究根据《中药注射剂安全性再评价生产工艺评价等7个技术指导原则》，对苦碟子注射液的上市后研究开展系统梳理，包括生产工艺、质量控制、药理毒理、上市后临床研究、前瞻性的临床安全性医院集中监测、基于国家药品不良反应（ADR）监测中心提供的自发呈报系统（SRS）数据分析、文献研究等多方面。结果显示：苦碟子注射液从 GAP 到生产过程药品质量严格控制。急性毒性试验、长期毒性试验、特殊毒理学未见不良反应；上市前治疗冠心病和脑血栓的Ⅲ期临床研究未见明显不良反应；上市后治疗冠心病心绞痛（心血瘀阻证）和中风（脑梗死）恢复期的有效性和安全性的随机、仿盲、阳性药平行对照、多中心临床试验表明安全有效；近3年 SRS691例 ADR 报告， PRR 法和 BCPNN 法显示，头痛、头晕是 ADR 预警信号；通过这一系列的研究荟萃，形成苦碟子注射液安全性的证据系列，为临床、科研、生产企业提供可靠的安全用药依据。
위학보열안흔고설자주사액（간칭고설자주사액）림상응용안전유효，본연구근거《중약주사제안전성재평개생산공예평개등7개기술지도원칙》，대고설자주사액적상시후연구개전계통소리，포괄생산공예、질량공제、약리독리、상시후림상연구、전첨성적림상안전성의원집중감측、기우국가약품불량반응（ADR）감측중심제공적자발정보계통（SRS）수거분석、문헌연구등다방면。결과현시：고설자주사액종 GAP 도생산과정약품질량엄격공제。급성독성시험、장기독성시험、특수독이학미견불량반응；상시전치료관심병화뇌혈전적Ⅲ기림상연구미견명현불량반응；상시후치료관심병심교통（심혈어조증）화중풍（뇌경사）회복기적유효성화안전성적수궤、방맹、양성약평행대조、다중심림상시험표명안전유효；근3년 SRS691례 ADR 보고， PRR 법화 BCPNN 법현시，두통、두훈시 ADR 예경신호；통과저일계렬적연구회췌，형성고설자주사액안전성적증거계렬，위림상、과연、생산기업제공가고적안전용약의거。
In order to ensure safety and efficacy of Yueanxin Kudiezi Injection (referred to as KDI)we launched a comprehensive re-search ranging from production,quality control,pharmacology,to post-market safety evaluation etc.The results showed KDI was strictly QC’ed from GAP to the production process.No adverse reaction was shown in acute toxicity test,long-term toxicity test,and phase III clinical study for treatment of coronary heart disease and cerebral thrombosis;KDI was approved to be effective and safe in a random-ized,double-blind,positive controlled,multi center clinical trials for treatment of coronary disease angina pectoris (blood stasis syn-drome)and stroke (cerebral infarction);691 cases reported in SRS,PRR method and BCPNN method displayed,headache is warning signal of ADR;Our research results provided safety information of KDI for clinical use,scientific research and production.