摘要
目的建立腑血平胶囊的质量标准,以便更有效地控制产品质量。方法鉴别项采用薄层色谱(TLC)法;含量项采用高效液相色谱(HPLC)法测定制剂中的大黄素、大黄酚,色谱柱为Shimadzu VP-ODS柱(150mm×4.6mm,5 μm),流动相为甲醇-0.1%磷酸溶液(85∶15),流速为1.0mL/min,检测波长为254nm,柱温为30℃。结果在TLC中均能检出三七、大黄,大黄素和大黄酚进样量在0.2114～20.6400 μg/mL和0.4588～40.8000 μg/mL范围内均与峰面积线性关系良好,r均为0.9999,平均回收率分别为99.4%和99.5%,RSD分别为0.77%和0.82%。结论鉴别方法专属性强,定量方法简便、准确、重现性好,可用于腑血平胶囊的质量控制。
Objective To establish the quality standard for Fuxieping Capsule. Methods The identification was carried out by TLC. Emodin and ehrysophanol in preparation were determined by HPLC. The Shimadzu VP-ODS （150 mm ×4. 6 mm, 5 tLm） column was chosen with a mixture of methanol-0. 1% H4PO4 acid （85：15） as the mobile phase. The flow rate was 1.0 mL/min,the detection wavelength was 254 nm. The column temperature was 30℃. Results The linear range of emodin was 0. 211 4- 20. 640 0 μg/mL and chrysophanol was 0.458 8 - 40. 800 0 μg/mL The correlation coefficient of emodin and chrysophanol was 0. 999 9 and 0. 999 9, respectively. The average recovery rate was 99.4% and 99.5%, RSD was 0. 77% and 0. 82%, respectively. Conclusion The method is simple,accurate and reproducibie. It can be used for the quality control for Fuxieping Capsule.
出处
《中国药业》
CAS
2007年第19期20-21,共2页
China Pharmaceuticals
