Research and practice about risk control of shenfu injection / 中国中药杂志

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.

Risk control system construction of Shenfu injection / 中国中药杂志

<p><b>OBJECTIVE</b>To ensure the stable quality of Shenfu injection, control potential risk and reduce risk damage.</p><p><b>METHOD</b>To screen and evaluate the risk in the production, GAP, research and development, circulation, clinical application, intellectual property, emergency treatment,control and prevente the potential risks.</p><p><b>RESULT</b>The risk-control system of Shenfu injection has been constructed initially.</p><p><b>CONCLUSION</b>It has a great significance for the establishment of traditional Chinese medicive injections' risk-control system. The keys of the risk-control in future are to make strategy, perfect the organization structure and collaborating among various departments.</p>