Quality Control Of Shengmai Injection

Shengmai Injection was made from the sterilized aqueous solution which was obtained via extracting from Radix Ginseng(Panax gensing C.A.Mey.), Radix Ophiopogonis(Ophiopogon japonicas(L.F) Ker-Gawl.) and Fructus Schisandrae(Schisandra Chinensis(Turcz.) Baill).It was ranked in the national protected species of Chinese Medicine. Shengmai Injection have been mostly used for the treatment of different type of cardiopathy,such as myocardial infarction、cardiac shock and infectious shock..According to the decree of《Notice on improving the safety re-evaluation of Chinese herbal medicine injection》enacted by State Drug Adminisrtation, in order to control the quality and ensure the sacurity and efficiency of the injection,Various analytical methods was used to carry out the research on the quality control of Shengmai injection,its raw materials and intermediates.The total contents of sugar in shengmai injection and its intermidate was determined with phenol-sulfuric acid by different pretreatment methods,the method validation was very well, The results showed that more than 50% were sugar,and the contents were quite different between different batches; A HPLC-ELSD method was used for determining the contents of four kinds of sugar with Prevail carbohydrate ES column,the result was similar with UV method,and it showed the UV result was accuracy.The general contents of total saponins in shangmai injection and Ginseng Radix et Rhizoma Rubra intermediate were determined with vanilin glac ial acetic acid with macroporous resins,The method to quantify s ingle saponins in Shengmai Injection and intermediates were developed and the method was used for remarkable compounds; The Amino Acid Analyzer was used to determine the contents of amino acids; Extraction with petroleum ether to get the total lignans and determine the contents by UV;The Waters Xbridge Amide column was used to determination of organic acids in Schisandrae chinens is fructus intermediate,while acetonitrile phosphate buffer as mobile phase.Establish the fingerprint of Ginseng Radix et Rhizoma Rubra and its intermediates for its quality control. Sharpsil-T C18 column(4.6 mm×250 mm,5 μm)was used with acetonitrile-water in gradient elution mode. The flow rate was 1.0 ml/min, the column temperature was maintained at 30 ℃, and the detective wavelength was 203 nm. 24 co-possessing peaks were selected as fingerprint peaks and the similarities between each of the ten areas and the standard chromatographic fingerprints of Panax ginseng Rubra were calculated while Rb1 peak selected as the reference peak. The similarity was more than 0.940. Eleven chemical compounds were identified by comparing the reference substance,18 co-possessing peaks were selected as fingerprint peaks and the similarities between each of the ten areas and the standard chromatographic fingerprints of Panax ginseng Rubra were calculated while Rh4 peak selected as the reference peak. The similarity was more than 0.935.