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目的:建立速效心痛喷雾剂的质量标准。方法:采用TLC法对处方中的川芎、牡丹皮、冰片进行定性鉴别;采用HPLC法测定丹皮酚的含量。色谱柱为迪马C18色谱柱(250 mm×4.6 mm,5μm);流动相为甲醇-水(60∶40);流速为1.0 mL.min-1;检测波长274 nm。结果:进样浓度在9.576~38.304μg.mL-1范围内线性关系良好(r=0.999 9);平均回收率100.3%,RSD为0.93%(n=5)。结论:该方法操作简单,准确可靠,重复性好,可作为速效心痛喷雾剂的质量控制方法。
Objective: To establish a quality standard for quick-acting heartache sprays. Methods: The qualitative identification of Chuanxiong, Mudanpi and Borneol in the prescription was carried out by TLC. The content of paeonol was determined by HPLC. The column was a Dima C18 column (250 mm×4.6 mm, 5 μm); the mobile phase was methanol-water (60:40); the flow rate was 1.0 mL.min-1; the detection wavelength was 274 nm. RESULTS: The calibration curve showed good linearity in the range of 9.576-38.304 μg.mL-1 (r=0.999 9). The average recovery was 100.3% and the RSD was 0.93% (n=5). Conclusion: This method is simple, accurate, reliable, and reproducible. It can be used as a quality control method for quick-acting heartache sprays.