Ginseng Saponin Injection Quality Standards And Their Fingerprint Study

The General Ginsenosides Injection (GGSI) of Ginseng Folium and Stem is made from the general Ginsenoside extracts of Ginseng Folium and Stem (Panax ginseng C.A.Mey ). It has the efficacy of tonification and invigoration, tranquilizing the mind and benefitting wisdom. Therefore it is not only used to reinforce immunity function, accommodate disturbance of endocrine and vegetative nerve function, but also used to enhance cardiac muscle contraction, improve the heart action and nourish the liver. In order to control the quality and insure the security and efficiency of the Injection, we studied the quality standard and fingerprints of the GGSI and raw materials (Folium and Stem of Ginseng) and intermediates (the general Ginsenoside extracts) with modern analytical and testing technics.Qualitative identification of them was made with TLC and the spots of Ginsenoside Rgi and Re were detected distinctly. The general contents of Ginsenoside were determined accurately, sensitively and conveniently with Perchloricacid-Vanilin Chromometry. The contents of Ginsenoside Rg1 and Re were determined by HPLC and the technique was sensitive, accurate ,repeatable and credible. The intermediates and GGSI were tested by different methods mainly from Chinese Pharmacopoeia, the established testing standards were testified as the effective quality control methods of GGSI.According to the decree of 《Technic Requirements of Injection Fingerprints of Chinese Materia Medica》 enacted by State Drug Adminisrtation, fingerprints of GGSI, raw materials (Folium and Stem of Ginseng) and intermediates (the general Ginsenoside extracts of Folium and Stem of Ginseng) were studied with TLC (including scanning method and images analysis).Then a complete detecting technic of fingerprints and the method of it's similarity evaluating were established. All technics and methods were low-cost, straight, speedy, accurate and generalizable.Our study results will contribute great importance to the establishment of the evaluating methods of GGSI and its raw materials, prompt the use of TLC on fingerprint study of Chinese Herbs, serve as guidance of manufacture and quality control of raw materials, it also can be the guarantee of the stability and security of the finished product.