Establishment of quality control methods and standards for Sipunculus nudus
Objective:The present study sought to establish quality control standards for dried checkered Sipunculus nudus products,providing a value reference for quality assessment and scientific development and utilization.Methods:The characteristics,microscopic identification,and thin-layer chromatography(TLC)identification of 30 batches of dry Sipunculus nudus from three different sources were studied following the guidelines of the Chinese Pharmacopoeia(2020 edition).Additionally,the content of active substances,including amino acids and total sugars,was measured.The impurities,moisture content,total ash content,acid-insoluble ash content,heavy metals,and water-soluble extract content were determined using supplementary tests.The content of aflatoxin in dry Sipunculus nudus was determined using high-performance liquid chromatography(HPLC).Results:The body wall of dry Sipunculus nudus is reminiscent of an earthworm,with a lattice-like structure that crisscrosses.Microscopic examination reveals light brown,blunt,and rounded bristles at the apex.Furthermore,thin-layer chromatography(TLC)analysis exhibits characteristic chromatographic patterns for arginine,alanine,and glycine.The analysis of amino acid content revealed that glutamic acid,arginine,and aspartic acid were the most abundant.The total sugar content was 2%,while the impurities,moisture content,total ash content,and acid-insoluble ash content of dry Sipunculus nudus were 3%,11%,10%,and 2%,respectively.Moreover,the water-soluble extract content was 38%,while the aflatoxin content in dry Sipunculus nudus was not more than 10 μg/kg.Conclusion:The established quality testing methods for dry Sipunculus nudus possess great stability,providing a reference for the quality control of this medicinal material.
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