三参胶囊的质量标准研究

The Study on the Quality Standard for Sanshen Capsule

目的 建立三参胶囊的质量标准。方法 采用薄层色谱法对丹参、人参、制首乌进行了定性鉴别,采用反相高效液相色谱（RP-HPLC）法测定了胶囊中丹参素钠的含量,采用Shim-pack VP-ODS C18柱（5μm,150 mm×4.6 mm）;检测波长280 nm;流动相：0.5%冰醋酸-甲醇（94∶6）;流速：1.0 ml.min^-1;柱温：30℃。结果 此法线性范围0.110 9-1.663 5μg,r=0.999 9;丹参素钠的平均回收率为98.82%（RSD=1.45%,n=5）。结论 该方法稳定、可靠,可作为该制剂的质量控制方法。

Objective To develop a quality standard for Sanshen capsule. Methods TLC was used to identify the ingredients such as Danshen Root Ginseng Root and Tuber Fleeceflower Root respectively . Meanwhile, the content of Danshensu in Sanshen capsule was determined by RP-HPLC with Shim -pack VP- ODS C18 （5 μm, 150 mm× 4.6mm） . The detection wavelength was 280 nm;0.5% Acetic acid -Methanol（94： 6） was used as mobile phase, the rate of 1.0 ml · min^-l and the column temperature was at 30℃. Results The method was linear within the range of 0.110 9 - 1. 663 μg, （r = 0.999 9 ）. The average recovery of Danshensu was 98.82% , （RSD = 1.45% ,n = 5）. Conclusion The method is accurate,reliable,and can be used for quality control of the production.