Studies On Intravenous Ginsenoside Rh₂ Submicro-Emulsion

In this article, The properties of ginsenoside Rh2 and the quality control methodes and the stabilities about intravenous ginsenoside Rh2 submicro-emulsion are studied.Ginsenoside Rh2 is assayed by HPLC.The HPLC system consisted of a pump and a UV detector.A C18 reverse-phase column(5μm,4.6×250mm) is used at 40℃.The mobile phase consisted of methyl cyanide(55%), water(45%) and phosphoric acid(0.125%).The flowrate is 1.0ml·min-1.The injection volume is 20μl, and the signal is monitored at 203nm.As a result, a good linearity is obtained over the range of 0.0542～1.084 mg·ml-1 with r=0.9999 for ginsenoside Rh2, the average recovery is 99.70%, RSD is 0.92%.With this method three batches crude drug of ginsenoside Rh2 are detected.The content of ginsenoside Rh2 in the crude drug are all much more than 80%.Its stabilty in the oil, its solubilities in soybean oil and water, the influence of egg lecithine on its solubility in the soybean oil, the influence of glycerol on its solubility in the soybean oil, and the compatibilities of ginsenoside Rh2 and the adjuvants are investigated.Results suggest that it is stable in the soybean oil, it is insoluble in water and slightly soluble in soybean oil, egg lecithine can add its solubility to 0.03 mg-g-1 in soybean oil, glycerol can hardly influent its solubility in water, and the compatibilities of ginsenoside Rh2 and the adjuvants are fine.These investigation are helpful to the development of intravenous ginsenoside Rh2 submicro-emulsionIntravenous ginsenoside Rh2 submicro-emulsion is assayed for drug concentration by HPLC.Its pH is detected by precise pH meter.Its globule size distribution is evaluated by Nicomp 380 ZLC Zeta/particle detector.Indirect iodimetry is used to detect its peroxide value.Its free fatty acids are detected by acid-base titration.Its sterility and bacterial endotoxins are detected according to Chinese Pharmacopoeia 2005.The fingerprints of the crude drug and the preparation are investigated by HPLC, the results are analyzed by computer Similarity Evaluation System of Chinese Herbal Medicine on Chromatographic Fingerprint and similarities were more than 0.90.These studies are useful for quality control of the crude drug and intravenous ginsenoside Rh2 submicro-emulsionIn stability test, its physico-chemical properties for example appearance, pH, globule size distribution, peroxide value, free fatty acids, sterility, bacterial endotoxins, fingerprints, and drug content in intravenous ginsenoside Rh2 submicro-emulsion,et al are analyzed. Isothermal test-weibull distribution method, class isothermal method and long-term storage test are used to estimate the chemical stability of intravenous ginsenoside Rh2 submicro-emulsion, respectively. Compared with class isothermal method, weibull distribution method is more suitable for the chemical stability prediction of intravenous ginsenoside Rh2 submicro-emulsion. Intravenous ginsenoside Rh2 submicro-emulsion has steady physico-chemical properties after storing at 25℃for 18 months. Intravenous ginsenoside Rh2 submicro-emulsion will have a good development future.