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目的:研究甲诺参洗剂的制备及质量控制方法,制定制剂的制备工艺及质量控制方法。方法:利用中西药结合复方制剂中主药成分配伍后产生协调作用的原理,合理组方。采用高效液相色谱法同时测定甲诺参洗剂中甲硝唑和诺氟沙星的含量,采用KromasilC18色谱柱,以0.7%三乙胺(以磷酸调pH至3.0)-甲醇(200∶300)为流动相,流速为1.0ml·min-1,检测波长为290nm。结果:甲硝唑在20.0～150.0μg·ml-1的范围内,峰面积与其浓度线性关系良好(r=0.9999),平均回收率为98.6%,重复性实验RSD为0.5%(n=5),检测限为2.0×10-3μg。结论:该制剂处方设计合理,制备工艺简便,稳定性好,质量易于控制。
Objective: To study the preparation and quality control methods of Forsythia Ginseng lotion, and to establish preparation methods and quality control methods. Methods: The principle of coordination between the main medicines in the combination of traditional Chinese medicine and western medicines was established and a reasonable formula was adopted. Simultaneous determination of metronidazole and norfloxacin in gentesin lotion by high performance liquid chromatography using a Kromasil C18 column with 0.7% triethylamine (pH adjusted to 3.0 with phosphoric acid) - methanol (200:300) In the mobile phase, the flow rate was 1.0 ml·min-1 and the detection wavelength was 290 nm. Results: Metronidazole was in the range of 20.0～150.0μg·ml-1. The linear relationship between peak area and concentration was good (r=0.9999). The average recovery was 98.6%. RSD was 0.5% for reproducibility experiment (n=5). The detection limit was 2.0×10-3 μg. Conclusion: The formula of the preparation is reasonable, the preparation process is simple, the stability is good, and the quality is easy to control.