ABSTRACT
OBJECTIVE: To establish the quality standard of Wuziyanzong pills so as to improve the quality control capacity. METHODS: Thin-layer chromatography (TLC) was used for the qualitative analysis of Lycii Fructus in the formula. The fingerprint of Wuziyanzong pills based on combined control herbs, the screening method of Schisandrae Sphenantherae Fructus and the determination of hyperoside and schisandrin in the formula were established by HPLC. The contents of Pb, Cd, As, Hg, Cu and Cr were determined by ICP-MS method. RESULTS: The TLC identification method showed good separation effect and specificity. The fingerprint, using the combined control herbs, could simultaneously identify Rubi Fructus, Cuscutae Semen, Plantaginis Semen, and Schisandrae Chinensis Fructus with good method validation results. According to the peak area ratio of schisantherin A and schisandrin, it could screen out Schisandrae Sphenantherae Fructus in the formula when the ratio was proposed to be 0.20. In the assay, the content limits of hyperoside and schisandrin in Wuziyanzong pills were proposed. Three harmful elements, ie As, Hg and Pb exceeded the permitted limits in 19 batches of samples. This may be caused by using the same production line for different products and the samples may be contaminated by the residue of previous products. CONCLUSION: The established quality standard is simple and accurate and shows good specificity and reproducibility. It could be used for the comprehensive and overall quality evaluation of Wuziyanzong pills.