Study On Preparation Process And Quality Standard Of Hu Gankang Dispersible Tablet

Silybum marianum L. Gaertn is Compositae silymafin genus, Originating in southern Europe, North Africa, it is a civil herbs for the treatment of liver and gallbladder diseases, have a anti-virus hepatolithiasis and protection of liver cell membrane effect. Silymarin, a polyphenolic flavonoid isolated from the seeds of milk thistle Silybum marianum, is composed mainly of silibinin with small amounts of other silibinin. Silibinin is the principal component and main active substance of silymarin. Silymarin or silibinin is used clinically for the treatment of liver diseases, which has the advantage of good therapy and little side-effect. This study dosage form was chosen considering the herbs's nature and clinical needs, designed on the basis of dispersible tablets' making process. the Hu gankang dispersible tablets was designed and developed.On the premise of the best abstraction solvent, Orthogonal test was used for studying the effect of silymarin extraction and purifiction as total flavonoids and silybin contentcontent index. The best extracting technical conditions of silymarin were as follows: 5times Petroleum ether impregate the comminute silymarin used to excluding oil, 10 times of amount of 90% alcohol extracted for 3 times each time for 1 hours. The best purifying technical conditions were as follows: 3 times amount of ethyl acetate extracted 8% concentrated solution for 2 times each time for 10 minutes. Purified silymarin total flavonoids extract of the content is as high as the 70 percent, silybin content to 27%.Comparing experimental study and more indicators orthogonal test was optimized by multi-level single-factor experiment.The prescription of Hu gangkang desperside tablet as fellow: the extraction product of silymarin 117g, Microcrystalline cellulose 75g, Dextrin 30g, Sodium carboxymethyl starch 10g, Low replace hydroxypropyl cellulose 16.5g. Magnesium stearate 1.5g. The specifications of prcparations is 1.5 g per tablet, which contain 30mg silybin. All targets are in line with the standard requirements of dispersible tablet formulations. HPLC conditions is: The Kromasil C18 column was used, The mobile phase consisted of methanol-acetonitrile-0.5% glacial acetic acid Solution (40:5:55). The detection wavelength was 287nm., Column tempcrature is 30℃, flow ratc is 1ml/min. injection size is 5μl. The soluble point experiment is follow China Pharmacopoeia (2005) Dissolution of the first methods. 0.5%tween80 solution 900 ml for dissolution media, the temperature is 37±0.5℃, the rotation speed is 100 r/min, put out samples when it have past 45 minutes. Dissolution point of Silymarin must not be lower than 70%.Research shows that, The optimum extraction and purifition technology of total flavonoids from Silybum marianum is stable and feasible. Preparation Process of Hu gankang dispersible tablets is scientific, stable, specific. UV spectrophotometry and HPLC spectrophotometry which was used to determinate the silymarin is accurate and reliable.