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目的:对复方丹参片不同生产厂家质量分析与评价。方法:采用实验室高效液相色谱进行复方丹参片质量评价,主要采用采用日本生产的LG-5A高效液相色谱进行丹参片质量评价,主要包括LC-10AT泵、SPD-10A检测仪和DGC-12A脱气仪器,同时采用分析天平、医用超声清洗设备和离心机。主要试剂采用原儿茶醛和丹参素,主要试剂采用原儿茶醛和丹参素标准试剂,辅助试剂主要为甲醇、乙腈等,均为分析级纯度。搜集10批复方丹参片药物进行研究,建立原儿茶醛和丹参素标准曲线和绘制回归方程进行分析。结果:对10批复方丹参片中丹参素和原儿茶醛含量进行分析研究显示,其中丹参素最大含量为0.412mg/片,最小含量为0.139mg/片;原儿茶醛最大含量为0.844mg/片,最小含量为0.246mg/片,丹参素及原儿茶醛含量均分布差异性较大。结论:采用高效液相色谱进行复方丹参片质量评价准确可靠且可重复性好,但复方丹参片中丹参素和原儿茶醛含量差异性较大。
Objective: To analyze and evaluate the quality of compound Danshen tablets from different manufacturers. Methods: The quality of Radix Salviae Miltiorrhizae was evaluated by HPLC. The quality of Radix Salviae Miltiorrhizae was evaluated by LG-5A high performance liquid chromatography (RP-HPLC) in Japan, including LC-10AT pump, SPD-10A detector and DGC- 12A degassing equipment, while the use of analytical balances, medical ultrasonic cleaning equipment and centrifuges. The main reagents used protocatechuic aldehyde and danshensu, the main reagents using protocatechuic aldehyde and danshensu standard reagents, auxiliary reagents mainly methanol, acetonitrile, etc., are of analytical grade purity. Collect 10 batches of compound Danshen tablets for research, establish the standard curve of protocatechuic aldehyde and danshensu and draw the regression equation for analysis. Results: The analysis of the contents of Danshensu and protocatechuic aldehyde in 10 batches of Danshen tablets showed that the maximum content of Danshensu was 0.412 mg / tablet, the minimum content was 0.139 mg / tablet, the maximum content of protocatechuic aldehyde was 0.844 mg / Tablet, the minimum content of 0.246mg / tablet, Danshensu and protocatechuic aldehyde content were significantly different. Conclusion: The quality evaluation of compound Danshen Tablets is accurate and reproducible with high performance liquid chromatography. However, the content of Danshensu and protocatechuic aldehyde in Danshen Tablets is quite different.