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目的测定金茵利胆口服液中柚皮苷、新橙皮苷的含量,并对其初步稳定性进行研究。方法采用高效液相色谱(HPLC)法对金茵利胆口服液中柚皮苷、新橙皮苷的含量进行测定。色谱柱为Phenomenex C18柱(4.6 mm×250 mm,5μm),流动相为甲醇-0.1%磷酸水溶液,梯度洗脱,流速为1.0 m L/min,柱温为2 5℃,检测波长为254 nm。通过影响因素试验和加速试验考察其初步稳定性。结果柚皮苷和新橙皮苷的线性回归方程分别为Y=163 492X+4 625.2,r=0.999 9;Y=117 867X+8 035.9,r=0.999 8。结果表明,柚皮苷和新橙皮苷分别在0.56~5.60μg,0.38~3.80μg范围内呈良好的线性关系。柚皮苷、新橙皮苷的平均加样回收率分别为99.86%(RSD=2.04%,n=9),98.95%(RSD=2.45%,n=9)。初步稳定性试验表明,该制剂在性状、p H、相对密度、装量差异、含量测定方面均符合规定。结论该方法操作简便、可信度高,制剂质量可控,稳定性良好。
Objective To determine the content of naringin and neohesperidin in Jin Yin Liguan Oral Liquid and study its preliminary stability. Methods The contents of naringin and neohesperidin in Jin Yin Lili oral liquid were determined by high performance liquid chromatography (HPLC). The chromatographic column was a Phenomenex C18 column (4.6 mm × 250 mm, 5 μm) with a mobile phase of methanol-0.1% phosphoric acid and a gradient elution at a flow rate of 1.0 mL / min with a column temperature of 25 ° C and a detection wavelength of 254 nm . Through the influence factor test and accelerated test to investigate the initial stability. Results The linear regression equations of naringin and neohesperidin were Y = 163 492X + 4625.2, r = 0.999 9, Y = 117 867X + 8 035.9, r = 0.999 8, respectively. The results showed that there was a good linear relationship between naringin and neohesperidin in the range of 0.56 ~ 5.60μg and 0.38 ~ 3.80μg respectively. The average recoveries of naringin and neohesperidin were 99.86% (RSD = 2.04%, n = 9) and 98.95% (RSD = 2.45%, n = 9), respectively. Preliminary stability tests showed that the formulation in terms of traits, p H, relative density, loading differences, content determination are in line. Conclusion The method is simple, reliable, preparation quality controllable and stable.