| In this study, using the technique of modern traditional Chinese granulepreparation system, traditional prescription for improving dosage form of Pulsatillagranule. Pulsatilla decoction derived from Zhang Zhongjing’s Treatise on FebrileDiseases", with detoxification, cooling blood to stop diarrhea effect. Limited becauseof its form, has been severely affected in clinical application. In order to investigate theeffect of Pulsatilla decoction in dosage form changes appearing in the processof Pulsatilla granule, preparation process, quality control method,stability, safetyand pharmacodynamics were studied.And compare with the Pulsatilla decoction, fromthe pharmacy and pharmacodynamic evaluation of Pulsatillae granular aspect.By using the method of reflux extraction and wet granulation of the Pulsatillaegranular preparation reearch. In the Pulsatilla decoction as the study object, the rate ofextract, Pulsatilla Saponin B4and the content of Berberine hydrochloride as index,to the solvent concentration (A), the ratio of material to liquid (B), the number ofextraction (C) and extraction time (D) and amount of excipient (A), wetting agentconcentration (B) and drying temperature(C)as the influence factors, Through theorthogonal experiment, the optimal extraction technology and forming process. Theresults show that, the best extraction combination was A2B1C3D1, which is extractedby75%ethanol, ratio of material to liquid1:8,extracting for3times, each time1h;thebest molding conditions for using75%ethanol as wetting agent, extract: glucose5:5;drying temperature is60℃Using thin layer chromatography and high performance liquid chromatographyfor the qualitative and quantitative analysis of Pulsatillae granular quality, andestablishes the content of Pulsatilla Saponin B4and determination of Berberinehydrochloride method formulated the quality standard of Pulsatillae granular (Draft).Accelerated test and long-term test on particle stability was investigated by.The maximum dose of mice acute toxicity test administration method, granulartoxicity study. The results show that, Chinese Pulsatilla granule equality is stable, safeand notoxit,the method is simple, specific, in0.1~2.0mg/mL (r=0.9995) and2.5mg/mL(r=0.9995) range, the linear relationship was good, the average recovery ratewas99.28%(RDS=2.09%) and99.33%(RSD=0.82), and the provisions of each1g particles containing Pulsatillachinensis in by the PulsatillaSaponin B4and Coptis,phellodendron bark (by Berberine hydrochloride) shall not be less than10mg and5mg.Anti-inflammatory effect by xylene induced mouse earedema and carrageenaninduced rat paw swelling induced inflammation model study of particles. Studyon diarrhea caused by particles of animal model withsenna, castor oil anti diarrheaeffect, and the influence of inkmethod to study the Pulsatilla granules on the intestinalpropulsion; The antibacterial effect of Radix Pulsatillae granular investigation bypunch method and broth dilution method.Results show that the particle hasanti-inflammatory, antibacterial, Pulsatilla, antidiarrheal good effect, can inhibitthe intestinal movement, and the effect was significantly greater than thoseof Pulsatilla decoction. At the same time, Pulsatillae granular effect on experimentalColibacillosis in chickens. test results show, Pulsatilla granule has a good effect onthe induced colibacillosis of chickens, the effect of the prevention and treatment werehigher than those of the traditional prescription of Pulsatilla decoction,can effectivelyinhibit the typical pathological symptoms caused by the lower body,viscera index,promote weight gain.In summary, Pulsatillae granular preparation process is stable, controllable quality,scientific and reasonable; feasible; the effect is obviously, safe and non-toxic, and haswide prospects of clinical application... |
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