Studies On The Fingerprint Of Sang Jiang Gan Mao Injection And Revises The Standard Of Quality Control

The topic "Studies on the Fingerprint of Sang Jiang Gan Mao Injection and Revises the Standard of Quality Control" was allotted by the Committee of Pharmacopoeia and it was the vital item of the Department of Education of Shaanxi Province.(No. 02JS08).It utilized modern technology of phytochemistry and apparatus analyze .Firstly we studied on the fingerprint of the injection, semi-manufactured goods of the injection and crude drugs ,then investigated the correlation between them. Addition to it ,the data of HPLC were computed by the software of "Computer Aided Similarity Evaluation ".At the same time, the quality standard of the injection was revised with establish an HPLC method for the determination of forsythoside in the injection. The paper includes 3 parts.The first part: Summarized the evolution of fingerprint about traditional Chinese medicine and their injection.The second part: According to the technical demand of the study about injection of traditional Chinese medicine and the technical demand of fingerprint about injection of traditional Chinese medicine, We formulated the fingerprint's examination standard of the injection , the semi-manufactured goods and crude drugs .There are 11 characteristic peak in the injection's fingerprint .It was 100 minutes that HPLC collected the chromotogram signal. Similarity of each batch of injection was from 0.8893 to 0.9760. There are 10 characteristic peak in the fingerprint of semi-manufactured goods of the injection .It was 90 minutes that HPLC collected the chromotogram signal. Similarity of each batch of injection was from 0.9179 to 0.9859.As the result the method of fingerprint was accurate, repeatable and steady. The fingerprint's examination standard was verified by the Institutions for Drug Control of Shaanxi Province.The third part: According to pharmacopoeia (1st section ,the 2000 edition)wedrafted out the quality standard of the injection of Sang Jiang Gan Mao ,and established an HPLC method for the determination of forsythoside in the injection .Beckman column C18ODS (4.6mm X 250mm ,5um) was used, mobile phasewas aceonitrile-water (28: 72)detection, wavelength was at 277nm;temperature was at :20C; flow velocity was 1mL/min . the calibration curve showed a good linearity within the range of 5.1~56.2ug/ml .The average recovery was 99.7% and RSD was 0.74%(n=6). We have accomplished the mission that allotted by the Committee of Pharmacopoeia.