The Pharmaceutical Study on the Extractum Folium Ginkgo Siccus Sustained Release Capsules
|School||Hubei College of Traditional Chinese Medicine|
|Keywords||Ginkgo biloba extract Sustained Release Capsules Crafts Macroporous resin High Performance Liquid Chromatography|
Since the 20th century, scholars of Ginkgo biloba pharmacological lot of research and found that its main medicinal ingredient flavonoids and terpene lactones. Pharmacological tests show that the role of the coronary vessels and blood vessels to dilate ginkgo flavonoids ginkgo total flavonoids with anti-free radical inhibit lipid peroxidation ginkgolide with to antagonize platelet activating factor (PAF). In the impact of the global chemical entity research and development of new drugs to further increase the difficulty, people turned to the study of the effective parts of the plant extracts and single constituents. Ginkgo series formulation is effective substances from the Ginkgo biloba extract, ginkgo biloba advent of successful clinical application, developed into a milestone in the history of botanical drug development. The promotion of modern drug delivery technology and a variety of formulations, ginkgo biloba will also become one of the most popular varieties of the plant on the market. In this study, Ginkgo biloba extract sustained-release capsules to do a preliminary study. The research mainly includes three parts: the extraction, separation and purification process, the preparation process of the research, formulation Determination. The first part of the extraction, separation and purification process in the extract preparation process research, ethanol extracted using orthogonal experimental design method, the ethanol concentration, the amount of ethanol extracted four factors of time and number of extraction L9 (3) 4 sup> orthogonal array experiments, preferably the best alcohol extraction process of the effective parts of Ginkgo biloba total flavonol glycosides and ginkgo terpene esters composition: 80% Ethanol 80 ° C reflow extracted three times, each time adding 8 times volume of dilute ethanol, and extraction of two hours. By static adsorption, the static desorption and adsorption kinetics studies, comparative analysis HPD100 HPD417, DM130, AB8, D101 five macroporous adsorption resin separation and purification effect of Ginkgo biloba extract total flavonoids and terpene lactones, and examine and optimize the process conditions of the separation and purification of total flavonoids and terpene lactones in Ginkgo biloba HPD417. The results show that: hydrogen bonding resin HPD417 adsorption rate of 87.72%, the desorption rate of 97.52%, hydrogen bonding resin HPD417 good performance ginkgo flavonoids and ginkgo terpene lactones adsorbent; optimum adsorption conditions: adsorption solution pH = 5.0 , the amount of resin: adsorption solution = 1:8, eluent 75% ethanol; dynamic the desorption study shows: 6 times the volume of eluent HPD417 resin adsorption ginkgo flavonoids and terpene lactones basic elution. Under optimum conditions, HPD417 macroporous resin purification of total flavonoid content in the extract can be up to 28.54%, the the ginkgo terpene lactone 8.83%. Study of the second part of the preparation process of hydroxypropyl methyl cellulose (HPMC), 10% polyethylene adjacent pyrrolidone (PVP) ethanol solution for materials, preparation of Ginkgo biloba extract (Ginkgo Biloba Extract, GBE) Sustained Release Capsules , the establishment of the slow release capsule phosphate buffer high performance liquid chromatography (HPLC) method for measuring; investigated affect GBE sustained release capsules release a variety of factors. The results show that: the prescription HPMC, 10% PVP block the release of the drug in the GBE sustained-release capsules, controlling the ratio of the two prescription drug release rate can be adjusted. GBE sustained-release capsules a Ginkgo total flavonol glycosides and ginkgo terpene lactones release HPLC determination method based on formulation optimization, research and methodology evaluation. The results show: Ginkgo biloba extract sustained-release capsules release of 50% at 6h, 12h release more than 90%; vitro release behavior of the Higuchi equation fitting better. The third part of preparations Determination Determination of Ginkgo biloba extract sustained-release capsules in total flavonol glycosides and terpene lactones ginkgolide content. HPLC, column: Aglient C 8 (250mm × 4.6mm, 5μm); mobile phase were methanol -0.4% phosphoric acid (52:48), methanol - water (35:65) ; flow rate of 1.0m1 min -1 sup>. Quercetin, kaempferol, isorhamnetin and bilobalide, ginkgolide A, B and C 4 the lactone could get better separation effect, a good linear relationship. The method is accurate, stable, sensitive and reproducible, and be able to control the quality of the preparation.