Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (3): 165-168.

Previous Articles     Next Articles

Literature Review and Risk Assessment of Hyoscymi Semen

JIANG YI-fan1, GAO Jian-chao2, TIAN Chun-hua2, ZHAO Yan1, PENG Dan-bing1, XIA Dong-sheng2   

  1. 1.Guizhou Province Center for Drug Reevaluation, Guizhou Guiyang 550001, China;
    2.Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2015-10-27 Revised:2016-04-12 Online:2016-03-20 Published:2016-04-12

Abstract: Objective To summarize the researches of Hyoscymi Semen, and explore its risks in clinical practices. Methods The literatures of Hyoscyamus niger L. seeds were collected and summarized in the aspects of herbalogy, chemical constituents, pharmacology, toxicity, processing, and so on. Results Hyoscymi Semen has a long history of medicinal usage, which has been recorded in many ancient medical books. Modern studies have shown that hyoscine and atropine are the main composition mediating the pharmacological and toxic effects of Hyoscymi Semen. A lot of poisoning cases caused by accidental ingestion of high doses of Hyoscymi Semen. seeds have been reported, which were expressed as dry mouth, skin reddening, restlessness, tachycardia, dilated pupils, urinary retention, constipation, and even coma. It has been reported in the literatures that Hyoscymi Semen were primarily used in the external treatment of the lumps, pain, infection, fester of skin etc. Conclusion Hyoscymi Semen is documented as a hypertoxic drug in Chinese pharmacopoeia. There were many risks of Hyoscymi Semen in literatures such as poisoning induced by misidentification or misuse of easily confused medicinal materials, irrational usage and dosage as well as long-time application of Hyoscymi Semen in the treatment of injured skin as recorded in folk prescriptions, and furthermore, there were no acknowledged processing and poison reducing Methods of Hyoscymi Semen so far. The risks mentioned above should be seriously considered in the clinical application of Hyoscymi Semen.

Key words: Hyoscymi Semen, safety, review

CLC Number: