鸦胆子油自微乳化颗粒质量控制方法研究

Study on the Quality Control for Self-microemulsifying Granule of Brucea Javanica Oil

摘要:

目的：建立鸦胆子油自微乳化颗粒的质量控制方法。方法：以处方中的鸦胆子油为研究对象，依据《中国药典》有关规定，进行制剂质量评价，并采用HPLC对油酸、亚油酸进行含量测定。采用Agilent ZORBAX Eclipse XDB-C₁₈（4.6 mm×250 mm，5 μm）色谱柱，以甲醇-水（95：5）为流动相，流速1 mL·min^-1，检测波长242 nm。结果：制剂检查符合药典规定；油酸、亚油酸分别在进样质量浓度为0.004 362~0.043 62（r=0.999 5）0.000 912~0.009 14 g·L^-1（r=0.999 6）呈良好的线性关系（n=6）；平均回收率为98.04%，101.60%，方法精密度高，重复性好。结论：该方法灵敏、简便、准确，可作为鸦胆子油自微乳化颗粒质量控制的方法。

Abstract:

Objective: To establish the methods of quality control for self-microemulsifying granule of Brucea Javanica Oil. Method: According to Chinese Pharmacopoeia, the quality of preparation was estimated. The HPLC method was used to determine the content of oleic acid and linoleic acid. The product was analyzed by HPLC, using Venusil XBP-NH₂column (4.6 mm×250 mm, 5 μm), with methanol-water (95:5) as the mobile phase, the flow rate of 1.0 mL·min^-1 and the detection wavelength of 242 nm. Result: The quality of preparation accorded with Chinese Pharmacopoeia regulation. The calibration curve showed good linearity over the range of 0.004 362-0.043 62 g·L^-1 for oleic acid;the average recovery was 98.04%. The calibration curve showed good linearity over the range of 0.000 912-0.009 14 g·L^-1 for linoleic acid;the average recovery was 101.60%. The content method is convenient, accurate and reduplicative. Conclusion: TLC and HPLC methods are simple, accurate and fast, which could be used effectively for the quality control of self-microemulsifying granule of Brucea Javanica Oil.