Study On The Quality And Chemical Composition Of Shuxuening Injection

Ginkgo biloba, which belongs to Ginkgopsida, is a kind of plant referred as living fossil. Shuxuening is a kind of traditional Chinese medicine injection which is made from Ginkgo biloba leaves or extract of Ginkgo biloba leaves. The efficacy of Shuxuening include dilate vessels and improve microcirculation. It’ s an effective treatment for ischemic cardio-cerebrovascular diseases.State Food and Drug Administration has issued a Traditional Chinese medicine and natural medicine injections basic technical requirements. The document set forth in that the injection manufacturers have responsibility to conduct the quality researches of injections include the studies of processes, quality standards and stabilities. So the chemical researches and content determinations can be advantages to improve the quality of the injections. This subject consists of three parts. The details are as follows:1 Separation and identification of the compounds from Shuxuening injectionSeparate the compounds from intermediate of Shuxuening injection by using macro porous resins (D101), Sephadex LH-20 and semi-preparative liquid chromatography. By spectrum analysis methods, such as NMR, and physicochemical properties the structures of 10 compounds were identified.They are rutin, narcissin, quercetin-3-O-(2,6-α-L-dirhamnopyranosyl-β-D-glucoside), quercetin-3-O-(2-β-D-glucopyranosyl-α-L-rhamnoside),kaempferol-3-O-(2-β-D-glucopyra-nosyl-α-L-rhamnoside), quercetin-3-O-[2-(6-p-coumaroyl-β-D-glucosyl)-α-L-rhamnoside], ka empferol-3-O-(2,6-α-L-dirhamnopyranosyl-β-D-glucoside), isorhamnetin-3-O-(2,6-α-L-dirha mnopyranosyl-β-D-glucoside), kaempferol-3-O-rutinoside, kaempferol-3-O-[2-(6-p-co-umaroyl-β-D-glucosyl)-α-L-rhamnoside].2 Determination of fructoses and glucoses in Shuxuening injection by HPLCA HPLC method for determination the content of fructose and glucose in Shuxuening injection were created. Using the method the content of fructose and glucose in 12 batches of Shuxuening injection was determinated. The linear ranges of fructose and glucose were 4.0060～48.4073μg and 5.0230-60.2760μg, respectively. The regression equation of fructose was y=1.3003x+1.3698 (r=0.9991) and glucose y=1.2480x+1.0686 (r=0.9996). The results show that the method is simple, accurate, reliable, and provides references for further study of Shuxuening injection quality control.3 Content determinations of total favonol glycosides and terpene lactones in leaves of Ginkgo biloba L. from different areasTo determine the content of total favonol glycosides and terpene lactones in leaves of Ginkgo biloba L. from different areas.The content of total favonol glycosides and terpene lactones were determined according to the methods of Chinese Pharmacopoeia (2010). The content of total favonol glycosides was 0.311%～0.682%. The maximum content of total favonol glycosides was 0.629% in leaves of Ginkgo biloba L. from Jiangsu; The content of terpene lactones was 0.232%-0.538%.The maximum content of terpene lactones was 0.441% in leaves of Ginkgo biloba L. from Shandong. The content of total favonol glycosides and terpene lactones were significantly different in leaves of Ginkgo biloba L. from different areas.