Abstract:
OBJECTIVE To construct and validate a systematic, efficient and scalable “five-in-one” integrated identification system using Carthami Flos as a model, and enhance the detection capability and regulatory technical proficiency regarding adulteration and weight gain practices.
METHODS A hierarchical strategy comprising “preliminary screening by macroscopic characteristics-microscopic identification-physicochemical verification-instrumental confirmation-standard response” was established. This approach integrated traditional identification experience with modern analytical technologies to systematically identify common weight-gaining adulterants such as oils, inorganic salts, starches, and sugars. The system was applied to analyze 296 batches of nationally sampled Carthami Flos, with method validation and data analysis supported by 52 batches of self-collected Carthami Flos from producing areas.
RESULTS The system effectively identified adulterants in Carthami Flos, including soybean oil, calcium carbonate, starch, and high-fructose corn syrup. Among the 296 batches of sampled products, the detection rate of non-compliant samples increased significantly from 9.8% using current standard testing methods to 28.7%, revealing substantial quality issues obscured by existing standards. Based on the analytical data, revisions to the limits for total ash and acid-insoluble ash in Carthami Flos were recommended. Furthermore, preliminary specialized supplementary testing methods for detecting adulteration with oils, starch, and sugars were established.
CONCLUSION The system significantly improves the accuracy of identifying adulteration and weight gain issues in Chinese medicines and decoction pieces, as well as the efficiency of regulatory oversight. This system provides a feasible technical reference and decision-making basis for quality control and standard improvement of Carthami Flos and other medicinal materials.
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