蟾酥制剂中蟾酥质量控制的研究进展

Research progress in quality control of Bufonis Venenum in preparations

蟾酥作为临床常用的动物药材,广泛用于心血管疾病、风湿和恶性肿瘤疼痛的治疗。因其具有高活性和高毒性的特点,关注蟾酥制剂中蟾酥药味的质量控制,对于保障临床用药的安全有效至关重要。通过梳理我国药品标准收载的蟾酥制剂情况,明确已批准上市的蟾酥制剂有102种474个批号,其中《中国药典》2020年版收载14种,《中华人民共和国卫生部药品标准》收载68种。这些制剂中,蟾酥多以原粉入丸、散剂,功能主治主要集中在清热解毒、消肿止痛、益气活血、开窍醒脑等方面。除了2020年版《中国药典》收载的蟾酥制剂中蟾酥药味的质量控制水平相对较高以外,其他蟾酥制剂中蟾酥药味的质控标准均较低,甚至缺失,亟需进行蟾酥制剂的质量标准提升研究。进一步检索中国知网(CNKI)、PubMed、Web of Science,对国内外报道的蟾酥制剂的质量评价研究和质量控制现状进行归纳总结,有64种蟾酥制剂报道了定性定量分析方法,主要有薄层鉴别、HPLC指纹图谱和多成分含量测定,指标成分涉及日蟾毒它灵、沙蟾毒精、蟾毒它灵、蟾毒灵、华蟾酥毒基和脂蟾毒配基等主要的蟾蜍甾类成分。综合文献信息,提示在完善蟾酥制剂质量标准过程中,需要关注蟾酥药材、饮片和制剂分析方法和检测指标的关联性,加强吲哚生物碱类成分的监控,以及重视含量均匀度检查等项目,以提升蟾酥制剂的整体质量控制水平。

Bufonis Venenum,an animal medicinal material,is widely used for treating cardiovascular diseases and pain induced by rheumatics or malignant tumors.In view of the high activity and high toxicity,it is of great significance to pay attention to the quality control of Bufonis Venenum to ensure the safety and effectiveness of its preparations.China′s drug standards involve 102 preparations(474 batch numbers)containing Bufonis Venenum approved for sale,including 14 preparations in the Chinese Pharmacopoeia(2020 edition)and 68 preparations in the standards issued by the Ministry of Health Drug Standard of the People′s Republic of China.Bufonis Venenum is mostly used in pill and powder preparations in the form of raw powder,with the main functions of clearing heat,removing toxin,relieving swelling and pain,replenishing qi,activating blood,opening orifice,and awakening brain.Except the high level of quality control for Bufonis Venenum in the preparations in the Chinese Pharmacopoeia(2020 edition),the quality control standards of Bufonis Venenum in other preparations are low or even absent.Therefore,it is urgent to conduct research on the improvement of quality standards for the preparations containing Bufonis Venenum.This study retrieved the reports focusing on the quality evaluation and quality control of the preparations containing Bufonis Venenum from CNKI,PubMed,and Web of Science.Qualitative and quantitative analysis methods for 64 preparations containing Bufonis Venenum have been reported,mainly including thin-layer chromatography,HPLC fingerprint,and multi-component content determination.The index components mainly involved bufadienolides,such as gamabufalin,arenobufagin,bufotalin,bufalin,cinobufagin,and resibufogenin.According to the literature information,this paper suggests that attention should be paid to the correlations between the analysis methods and detection indexes of medicinal materials,decoction pieces and preparations,the monitoring of indole alkaloids,and the content uniformity inspection for further improving the quality standards for the preparations containing Bufonis Venenum.