The Preparation Process Of The Liver Granules And Quality Standards

Gankang pellet, which is made from Radix Paeoniae, Radix Salviae Miltiorrhizae, Radix Astragali, Radix Curcuma and Poria, is Pure Chinese native medicine preparation, for treating Hepatic fibrosis and Chronic hepatitis B stasis hot symptoms by invigorating the blood to stop pain, cooling blood, reinforcing Qi, nourshing Xu. The author has made an experimental study on its preparation, quality standards and primary pharmacodynamics.1. Study of the preparationIn the point of preparation technology, we used the content of Salvia miltiorrhiza alkoneⅡA, Ginger flavine, Paeoniflorin, Polysaccharide and extracting indexes and investigated the optimum preparing and refining conditions by the orthogonal test method and selecting optimum extraction orthogonal test. The optimum extracting condition was: Salviae Miltiorrhizae and Curcuma absorb liquid two times, five times the amount of 80% ethanol increase immersion 1.5h. Heating extract two times, each time Decocting 1h: Paeoniae, Astragalus, Poria and Salviae Miltiorrhizae and Curcuma alcohol extract six times the volume of water increases the residue after extraction three times, each time Decocting 1h.Then we concentrate the extracting liquid and using high speed centrifuging method in order to purify it. Hot conditions for the separation and purification of ethanol extracts with 350 head, Filter filtration, extract water to 16,000 rpm speed centrifugation, filtration supernatant, spare.On the basis of these studies, we selected the mixture of silicon Gel and microcrystalline cellulose as the excipients to reduce the hygroscopy and increase the fluidity of extracting powder. The optimizing spray pelletization technology was confirmed, the frequency of main fan was 35±5Hz, atomization pressure was 0.1Mpa, the rate of spray was 1.4 Hz, the density of liquid medicine was 1.10-1.12g/mL. The best effect of particle hygroscopicity critical relative humidity of 56%.In the film-coating process, we use HPMC coating material, the quality of the coated particles before and after the inspection. After the particles are coated with melted performance results Pharmacopoeia, HPMC coated particles melt and good; In comparison with water, coating the panicles dissolved in acid significantly improved. In prove of the rationality and feasibility of the techniques, the techniques was enlarged 10 times for 3 groups.2. Study of quality standardRadix Paeoniae, Radix Salviae Miltiorrhizae, Radix Astragali, Radix Curcuma and Poria were identified by TLC. And it was verified that, Provide to try an article color to compose to win, in checking against the position that the medicine material color table corresponds, the spot of all same color, and the feminine gender check against be corresponding position to then have no interference.Paeoniflorin preparation for the HPLC determination of the study, silica gel as a filler column: Methanol-36%acid-isopropanol -water (27:2:2:69) as the mobile phase, temperature was 30℃, UV detection at 230 nm. After a standard curve of its linear range, reproducibility, and recovery test results proved the method is accurate and reliable, Determination can be used in the formulations. The content of Paeoniflorin is all of 15.0mg in one gramme.3. Research on the stability of pharmaceuticalIn accordance with Stability of relevant provisions of the Chinese Pharmacopoeia., We conducted a preliminary stability of the product. Overpass seeing about the fringe stabilization of characters, identifications, test, and content determination unchanged in six months. It showed that the quality is stabilized.4. Summary of literatureThe article elaborated the research of briefing of pathology on TCM treating chronic hepatitis. With refer to the correlate summary of literature in system, summing up entirely and simply on the production of treating chronic hepatitis with TCM and making expectation on the foreground of exploitation.