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目的:采用反相高效液相色谱法对骨筋丸胶囊中马钱子所含士的宁进行定量检测,以证明骨筋丸胶囊中士的宁含量测定分析方法能适合制剂检测的要求,确保检验结果的有效性。方法:采用十八烷基硅烷键合硅胶为填充剂(Kromasil250mm×4.6mm,5μm)的色谱柱;流动相为乙腈0.01mol.L-1庚烷磺酸钠与0.02mol.L-1磷酸二氢钾等量混合(用10%磷酸调节pH至2.8)(21:79);检测波长:254nm;流速:1.0mL.min-1。结果:RP-HPLC士的宁在0.2128~1.064μg范围内线性关系良好(r=0.9995),平均回收率为98.74%。结论:该方法准确可靠地对骨筋丸胶囊进行定性、定量检测,能有效地控制制剂的质量,使其更有利于指导生产,保证产品质量。
OBJECTIVE: To determine the content of strychnine contained in Fructus Scutellariae in GuZiMao capsule by RP-HPLC and to verify that the determination of strychnine in GuZi pills can be suitable for the requirements of the preparation test, to ensure Test the validity of the result. Methods: A column with octadecylsilane bonded silica as a filler (Kromasil 250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile 0.01 mol·L -1 sodium heptanesulfonate and 0.02 mol·L -1 phosphoric acid di Hydrogen and potassium equal mixture (adjusted to pH 2.8 with 10% phosphoric acid) (21:79); detection wavelength: 254nm; flow rate: 1.0mL.min-1. Results: The calibration curve of RP-HPLC was linear in the range of 0.2128 ~ 1.064μg (r = 0.9995) with the average recovery of 98.74%. Conclusion: This method is accurate and reliable qualitative and quantitative detection of Gusubaowu capsules, which can effectively control the quality of preparations, making it more conducive to guide the production and ensure product quality.