[Application of fingerprint chromatogram in quality control of Shen-Mai injection].
The theory and practice of traditional Chinese medicine require some comprehensive methods to assess quality of the Chinese herbal medication. Fingerprint chromatogram is one of the feasible approaches to evaluate the quality of Chinese herbal medication. So the fingerprint chromatogram of Shen-Mai injection was established by using reversed-phase high performance liquid chromatography. The chromatographic conditions were as follows: a Hypersil C18 column was used; the mobile phase was composed of water (A) and acetontrile (B) with linear gradient elution (0-50 min, 5%-95% B, volume fraction); the flow rate was 1.0 mL/min and the UV absorbance detection was set at 202 nm. The peak-area ratios of twenty-three fingerprint peaks and internal standard (diphenyl) were taken as the criteria for quality control. The quality differences in various batches and various manufacturers of Shen-Mai injections were investigated by projection discriminance based on principal component analysis. The results show the method developed is convenient, reliable and applicable for the quality control analysis of Shen-Mai injection.
Shi
Xian-zhe
XZ
National Chromatographic R. & A. Center, Dalian Institute of Chemical Physics, Chinese Academy of Sciences, Dalian 116011, China.
Yang
Jun
J
Zhao
Chun-xia
CX
Xiong
Jian-hui
JH
Xu
Guo-wang
GW
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D005894:Panax / Q000737:chemistry; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D029633:Schisandraceae / Q000737:chemistry
D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; C009252:fructus schizandrae, radix ginseng, radix ophiopogonis drug combination