Quality characterization of Angong Niuhuang Pills based on characteristic spectrum of natural musk/bezoar and four herbal medicines / 中草药

ABSTRACT

Objective: To establish an Angong Niuhuang Pills (ANP) characteristic spectrum analysis method, and to comprehensively characterize the quality properties and characteristics of ANP, and then to apply it to the quality detection and analysis of 10 batches of ANP, and to find out the specificity of the quality characterization of ANP. Methods: The UPLC-PDA multi-wavelength was used in the method, and a Waters Cortecs shields RP18 Column (100 mm × 2.1 mm, 1.6 μm) was used, the mobile phase was acetonitrile and 0.3% phosphoric acid solution, the detection wavelength was set at 240, 262, 330, 360, 274, and 440 nm, the column temperature was kept at 38 ℃, and the flow rate was 0.2 mL/min. Results: The results showed that the established analytical method can simultaneously determine 13 index components (including geniposide, genipin1-gentiobioside, crocin I, crocin II, berberine hydrochloride, coptis hydrochloride, palmatine chloride, epiberberine, baicalin, wogonoside, baicalein, wogonin and curcumin) in ANP, and a total of 35 characterstic peaks were identified in ANP. It included natural musk characteristic peak and natural bovis calculus characteristic peak which can identify the natural properties of raw materials. The mean values of the 13 index components in 10 batches of ANP were 2.87, 1.14, 0.40, 0.03, 3.17, 0.94, 0.74, 0.58, 10.01, 1.62, 0.34, 0.17, 0.05 mg/g, respectively. The RSD values ranged from 4.19% to 20.81%. All the 10 batches of ANP could be detected with 35 characteristic peaks, the average area values of natural musk and natural bovis calculus characteristic peaks were 0.031 and 0.003, and the RSD values ranged from 1.5% to 26.79%. Conclusion: According to the analysis of characteristic spectrum, the quality of finished products of 10 batches of ANP was relatively stable, and all showed the specific quality characterization of raw materials of natural musk, natural bovis calculus and Curcumae Radix; According to the analysis of the content of index components, the large fluctuation of the index components in 10 batches of samples mainly comes from Scutellaria baicalensis and Curcumae Radix, while the content of crocin I in Gardeniae Fructus and four alkaloids in Coptidis Rhizoma were relatively stable.