| Chronic fatigue syndrome(CFS) is a cryptogenetic disease which has influenced different population of every classes and every age grades all the world. Recently, CFS has been become one of focal points in scientific and clinical research, and it has become key issue of healthy in 21th century. Compound Jing Huo decoction comes from empirical formula, and its medicinal substances consist of rhodiola, epimedium, dodder, medlar and polygonatum. CFS could be treated by this empirical formula. But the decoction is spoilage, so not easy to conserve. To take and carry it were not convenient. Thus, modern preparation must be made to substitute traditional preparation. Dispersible tablet is a new dosage form. Its merits include quickly absorption, highly bioavailability and so on. So CFS could treat efficaciously by compound jing huo dispersible tablet.In the extraction process of compound jing huo dispersible tablet, according to the different property of medicinal substances, rhodiola, epimedium and dodder were extracted by alcohol. Using single-factor experiment and orthogonal experiment, the optimum conditions of alcohol extraction were determined by the content of salidroside and the yield of flavonoids. The optimal extraction conditions were as follows: ratio of material to solvent 1:8, 70% alcohol, extracted twice, and each time been 1.5h. Medlar and polygonatum were extracted by water with cellulase. Using single-factor experiment and central composite design, the optimum conditions of water extraction were determined by the yield of polysaccharides. The optimal extraction conditions were as follows: reaction temperature 50℃, pH 4.6, ratio of material to solvent 1:7.6, and the cellulase dosage 0.5%, reacting 2h, then the reaction temperature been rose to 80℃, the cellulase was inactivated and the decoction was extracted 90 min. The decoction of polysaccharides was purified by chitosan flocculant. Using single-factor experiment and orthogonal experiment, the optimum conditions of purification were determined by the rate of polysaccharides remains and the rate of purification. The optimal purification conditions were as follows: 0.4 mg ? ml-1 of liquid concentration, the dosage of flocculant 15%, flocculation pH 4, and flocculated 3h, then centrifugalized 10min with 3000r·min-1. The decoction was concentrated and desiccated with decompressor. The extracta was obtained. In the preparation process of compound jing huo dispersible tablet, Using single-factor experiment and central composite design, the optimal preparation prescription and preparation process were determined by disintegration time. The optimal conditions were as follows: 50% relative humidity, and compared to the dosage of extracta, the dosage of MCC been 1.1 times, the dosage of CMS-Na been 0.35 times, the dosage of L-HPC been 0.19 times, water as moistening agent, and the disintegrant was added 50% both internally and externally. The dosage of magnesium stearate was 0.3% weight of tablet, pressed in 4KN. The results showed that compound jing huo dispersible tablet was prepared by the optimal process, which completely collapsed in 3 min, and was up to the standard of the Chinese Pharmacopoeia.To study quality standard of compound jing huo dispersible tablet, the characteristics, qualitative identification, and the content and dissolution test were examined. The qualitative identification of rhodiola, epimedium and medlar were set up without negative interference. The content of salidroside was determined by high performance liquid chromatography, and methodological tests were studied. The linearity range of salidroside was 4.0 20.0μg·ml-1. The average content of three batches were 0.0715 mg, RSD=1.39%. So the content of salidroside in this quality standard was not less than 0.0572mg. The result of dissolution test showed that the dissolution trended to balance in 30 min, and accumulated dissolution was more than 88%, and the uniformity of dissolution was good. |
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