Quality standard of Bufei Granules / 中草药

ABSTRACT

Objective: To establish a scientific and reasonable quality control method of Bufei Granules through the qualitative and quantitative research of thin layer identification and content determination of Bufei Granules. Methods: Based on the main chemical constituents of each drug in Bufei Granules, TLC method was used to analyze Corni Fructus, Ephedrae Herba, Paeoniae Radix Rubra, Scutellariae Radix, Citri Reticulatae Pericarpium, and Glycyrrhizae Radix et Rhizoma; HPLC was used to determine the content of loganin and baicalin. The content of loganin was analyzed by Agilent Eclipse XDB-C18 column (250 mm × 4.6 mm, 5 μm) with the mobile phase of acetonitrile-methanol-water-formic acid (101890.1). The detection wavelength was set at 236 nm; The content of baicalin was analyzed by Dikma Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) with the mobile phase of methanol-water-formic acid (49510.1). The detection wavelength was set at 280 nm. Results: The TLC identification method can distinguish Ephedrae Herba, Paeoniae Radix Rubra, Scutellariae Radix, Citri Reticulatae Pericarpium, and Glycyrrhizae Radix et Rhizoma with clear spots, no negative interference, good separation and strong specificity. Loganin and baicalin were used as index components in methodological study. The average recovery of loganin was 98.49% and the RSD was 0.80%; The repeatability test RSD was 0.83% which met the requirement. The linear range was from 4.76 μg/mL to 50.70 μg/mL and the linear relationship was good (r = 0.999 9). The average recovery of baicalinrate was 101.20% and the RSD was 0.77%. The repeatability test RSD was 0.90%, which met the requirements. The linear range was from 6.00 μg/mL to 96.00 μg/mL and the linear relationship was good (r = 0.999 9). The loganin content of three bantches of samples was 12.04, 9.78 and 11.81 mg/bag; And the content determination result of baicalin was 121.13, 101.31 and 103.14 mg/bag. Conclusion: The method is easy to operate, strong in specificity, accurate and sensitive, with good repeatability. It can be applied for the quality control of Bufei Granules.