摘要
本文对夜明砂法定药材标准、炮制规范及含夜明砂的已上市中成药的质控现状进行了回顾分析,就基原、炮制、安全用药等方面的问题进行了探讨。建议:①加强夜明砂药材的专属性鉴别研究,并明确采集时感染病毒等病原微生物的风险及个人防护注意事项。②参照古法对夜明砂进行水洗、炒制等处理,提高饮片用药的安全性。③对于夜明砂直接粉碎入药的已上市中成药应加强研究,采用合适的炮制方法,必要时增加病毒等病原微生物的灭活工艺。④对于处方中使用夜明砂的中药新药,应加强相关研究,充分说明夜明砂入药的科学性、必要性,保证新药安全有效。
This article reviewed and analyzed the current quality standards of Yemingsha's statutory medicinal materials,processing practice,and quality control status of marketed Chinese patent medicines containing Yemingsha,and discussed issues such as the origin,processing,and safe use of the medicines.Some suggestions were put forward.Firstly,it is necessary to strengthen the specific identification research of Yemingsha medicinal materials,and clarify the risk of pollution by pathogenic microorganisms such as viruses and personal precautions during collection.Secondly the ancient method should be followed to wash and fry Yemingsha to improve the safety of decoction pieces.Thirdly it is necessary to strengthen research on the marketed Chinese patent medicines for which Yemingsha is crushed directly into the medicine and adopt appropriate processing methods,and inactivation process of pathogenic microorganisms such as viruses should be added if necessary.Lastly for the novel traditional Chinese medicines that use Yemingsha in the prescriptions,relevant research should be carried out to fully explain the scientificity and necessity of adding Yemingsha to ensure that the new medicines are safe and effective.
作者
李灿
周跃华
LI Can;ZHOU Yue-hua(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第16期1851-1855,共5页
Chinese Journal of New Drugs
关键词
夜明砂
药材标准
炮制规范
Yemingsha(bat dung)
medicinal material standard
processing specification