参附注射液药品风险控制研究思路及实践

Research and practice about risk control of Shenfu injection

风险控制对于保障中药注射剂的使用安全具有十分重要的意义,而如何制定符合中药注射剂特点的风险控制方案,并保证其完善可行,是一个需要研究和探索的问题。参附注射液由古方"参附汤"经剂型改进研制而成,上市前后有针对性地开展了大量的研究,涵盖了种质、药材、生产、质量控制、流通、贮藏、使用等各个环节,并系统开展了上市前的成分、药理、毒理等研究和上市后的临床定位以及安全性研究,形成较为完善的系统风险控制思路,大大地提高了产品的安全性。文献资料表明,参附注射液应用十分广泛,不良反应也较低。该文基于文献,梳理参附注射液的相关研究,从质量控制、非临床安全性、非临床药理、上市后临床安全性研究及风险管理计划等方面的实践来讨论参附注射液的风险控制思路,希望为同类研究提供参考。

Shenfu injection is developed by improving dosage form of ancient prescription ＂Shenfu Tang＂ and is mainly derived from extracts of both traditional Chinese medicine red ginseng and prepared lateral root of monkshood with polysorbate 80 as auxiliary material.Shenfu injection may be administered through intramuscular injection,intravenous drip or intravenous injection.It produces good effects in restoring Yang and rescuing patients from collapse,tonifying Qi and preventing exhaustion.It is mainly used to treat not only syncope and prostration resulting from sudden Yang collapse（infectious,hemorrhagic and water depletion shock etc）,but also pavor,palpitation,dyspnea with cough,stomachache,diarrhea and arthralgia etc caused by deficiency of Yang（deficiency of vital energy）.Research group has audited the monitored hospitals and has carried out postmarketing study of Shenfu solution from many aspects including literature review,spontaneous reporting system（SRS） and hospital information system（HIS） data analysis etc.A summary is shown below.