Studies On The Method For Evaluating The Quality Of SHENMAI Injection

It is well known that quality control (QC) of traditional Chinese medicine (TCM) is one of the important and difficult tasks of the modernization for TCM. In this study, focusing on the methodology of TCM quality analysis, researches on quality control and its application to SHENMAI injection were carried out.SHENMAI injection is made from red ginseng and ophiopogon. According to The Principle of TCM injection fingerprinting and Chinese pharmacopoeia published in 2005, some further researches were carried out on the chemical constitutes of SHENMAI injection. Based on the existent quality standard of SHENMAI injection promulgated by Ministry of Public Health, the chemical fingerprint and chromatographic determination was newly applied and some more items were added to the existent inspection items. The major work is listed as follows:1) On the basis of the existent standard, we added to some new inspection items such as particulate matter, visible matter, protein, resin, oxalate, potassium ion, total solid, residue of burn, arsenic salt and heavy metal.2) The method to quantify ginsenoside Rg1, Re and Rb1 of SHENMAI injection was developed and the method was used for test the remarkable compounds in SHENMAI injection.3) The fingerprinting analytical method of SHENMAI injection was developed. The HPLC fingerprints of samples from five manufacturers were obtained and the results were dealt the software recommended by Chinese Pharmacopoeia Commission. Finally, we developed the standard fingerprints of crude material, semi-product and final product of SHENMAI injection and it would help a lot for quality control.4) The content determination and fingerprinting analysis were combined to evaluate the quality of SHENMAI injection produced with different manufactures and satisfactory results were obtained.5) Chromatographic fingerprinting was applied to evaluate the stability of extraction process of Red Ginseng.