OBJECTIVE: To optimize the preparation technology of Compound Citrus reticulata buccal tablets, and to establish a method for content determination of hesperidin. METHODS: Using the taste, appearance, disintegrating time and hardness score as evaluation indexes, L9(34)orthogonal test was used to screen the amount of Zingiber officinale, ratio of lactose-mannitol. The preparation technology of Compound C. reticulata buccal tablets was optimized. The content of hesperidin was determined by HPLC. The determination was performed on InfinityLab Poroshell 120 EC-C18 column with mobile phase consisted of methanol-acetic acid-water (35 ∶ 4 ∶ 61,V/V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 283 nm, and column temperature was 25 ℃. The sample size was 5 μL. RESULTS: The optimal preparation technology included Z. officinale 7 g, lactose-mannitol ratio of 2 ∶ 1, peppermint oil 1 mL, stevioside 0.15% (by total amount of medicinal powder and filler), magnesium stearate 0.5% (by the weight of dry granule). The linear range of hesperidin was 0.045 0-0.450 0 mg/mL (r=0.999 9). The quantitation limit was 3.50 ng, and detection limit was 1.05 ng. RSDs of precision, stability and repeatability tests were all lower than 1%; the recoveries was 7.99%-101.65%(RSD=1.53%, n=6). CONCLUSIONS: Compound C. reticulata buccal tablets prepared by this technology are good in taste, complete and smooth in appearance, uniform in color, suitable in disintegration time and high hardness. The preparation technology is stable and feasible.
关键词
陈皮复方止咳含片制备工艺优化正交试验设计橙皮苷含量测定质量控制
Keywords
Compound Citrus reticulata buccal tabletsPreparation technologyOptimizationOrthogonal testHesperidinContent determinationQuality control