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该研究以药物消化和吸收体外模型取代耗时耗力的动物实验研究,用于连花清瘟胶囊微量金属分析前处理,即模拟人体消化环境,加入消化液所含有机物和无机物,模拟胶囊在胃肠中的消化和吸收机制。鉴于消化管和血管间生物膜为类脂质膜,以单层脂质体为生物膜模型,以单层脂质体亲和态、水溶态界定微量金属配合物的形态。以单层脂质体亲和态含量评价微量金属生物可给性,比较胃肠中单层脂质体亲和态金属浓度,确定微量金属的主要吸收部位。据微量金属营养日需求量、微量金属日允许摄入最大值和国家《药用植物及制剂进出口绿色行业标准》中重金属总量,评价该胶囊的服用安全性。结果表明,胶囊中微量金属含量丰富,主要在肠被吸收,对病人体内缺乏的微量元素起补充和调节作用。重金属砷(As),镉(Cd),铅(Pb)总量分别为0.38,0.07,1.60 mg·kg-1,远低于《药用植物及制剂进出口绿色行业标准》中规定含量。
In this study, drug-digestion and absorption in vitro model to replace the time-consuming animal experimental study for Lianhua Qingwen capsule micro-metal analysis pretreatment, that is, to simulate the human digestive environment, adding digestive juice containing organic and inorganic, simulated capsules Digestion and absorption mechanisms in the gastrointestinal tract. In view of the biomembrane between the digestive tract and the blood vessel is a kind of lipid membrane, the monolayer liposome is used as a biomembrane model to define the morphology of the trace metal complex in the single-layer liposome affinity state and the water-soluble state. The bioavailability of trace metals was evaluated by the monolayer affinity state of liposomes, and the affinity state of monolayer liposomes in gastrointestinal tract was compared to determine the main absorption sites of trace metals. According to the demand of trace metals nutrition, the maximum daily allowable intake of trace metals and the national “green import and export of medicinal plants and preparations,” the total amount of heavy metals, evaluation of the capsule safety. The results show that the content of trace metals in the capsule is rich, mainly absorbed in the intestine, which can supplement and regulate the trace elements lacking in the patient’s body. The contents of heavy metal arsenic, cadmium and lead were 0.38,0.07,1.60 mg · kg-1, respectively, much lower than those specified in the Green Industry Standard for Import and Export of Medicinal Plants and Preparations.