牛大力药材质量标准提升研究OA

Objective To establish the specification for Niudali(Radix Millettiae Speciosae).Methods Microscopy and thin-layer chromatography(TLC)were used for qualitative identification of Niudali(Radix Millettiae Speciosae).According to the relevant methods in Volume IV of the Chinese Pharmacopoeia(2025 Edition),water content,total ash,acid-insoluble ash,and extractives of Niudali(Radix Millettiae Speciosae)were determined.Gas chromatography was used to determine pesticide residues in Niudali(Radix Millettiae Speciosae).Inductively coupled plasma mass spectrometry was used to determine the contents of five heavy metals,including lead,cadmium,arsenic,mercury,and copper,in Niudali(Radix Millettiae Speciosae).High-performance liquid chromatography(HPLC)was used to determine the content of erythraline in Niudali(Radix Millettiae Speciosae)and to establish a characteristic chromatogram.Results The microscopic characteristics of Niudali(Radix Millettiae Speciosae)were distinct.TLC identification showed clear spots with good resolution.Water content,total ash,acid-insoluble ash,pesticide residues,and heavy metals met the requirements specified in the General Principle for Inspection of Crude Drugs and Decoction Pieces of the Chinese Pharmacopoeia(2025 Edition,Volume IV).Water-soluble extractives were all greater than 15%.For erythraline determination using HPLC,the regression equation was y=5,141x+24,958,with a coefficient of determination(R2)=0.999 5.The results indicated good linearity of the erythraline reference standard over the range of 10.71 ng to 2,142 ng,with an average recovery of 100.08%.The characteristic chromatogram showed good reproducibility and can be used to evaluate batch-to-batch quality consistency and stability,with good representativeness.Conclusion The developed method is highly specific,accurate,and reproducible,making it suitable for quality control of Niudali(Radix Millettiae Speciosae).