Decoction With Four Noble Ingredients Flavored Granule Preparation And Pharmacodynamic Evaluation

Diarrhea often occurred clinically. The main symptoms are defecated frequent. Traditional Chinese medicine believes, stagnation of dampness due to asthenia of the spleen is the cause of diarrhea. To treat diarrhea, at first is to activate the spleen function, the second is eliminating sampnes.Decoction of four noble ingredients flavored were composed of Radix Codonopsis Pilosulae, Rhizoma Atractylodis Macrocephalae, Poria, Radix Glycyrrhizae, which is the representative prescription to treatment asthenia of the apleen and stomach. The experiment carried out on the basis of diarrhea on dialectical theory. Treatments of diarrhea need to invigorate the spleen and to regulate the stomach energen, dampness diarrhea, eliminating sampnes and diarrhea, stagnation of qi pain. In addition and subtraction basis on decoction with four noble ingredients, through in vitro and in vivo animal models to screen out the prescription components of Radix Codonopsis Pilosulae, Rhizoma Atractylodis Macrocephalae, Dark plum, Curcuma and so on. This prescription is prepared in granules to treat chronic diarrhea. In this study, the extraction process and granules molding process was optimized, and quality standard of granules was studied. The pharmacodynamics of granules was evaluated by animal model. This research also lays the foundation for the prescription used.Depending on the character of herbs, medical material were extracted by water decocting. At the same time, the influence of different extraction methods to glycyrrhizic content was investigated. Finally, separate extracted Radix Codonopsis Pilosulae, Rhizoma Atractylodis Macrocephalae, Poria, Radix Glycyrrhizae and Chinese mgnoliavine fruit, Dark plum. Orthogonal experimental design was used to the extraction process. Optimum extraction processes of decoction with four noble ingredients were:soaking 10mins with 14 times of water. extract three times each time lasts for 60mins. In that condition, glycyrrhizic acid yield was 0.16% and extraction rate was 40%. Optimum extraction process of Chinese magnoliavine fruit and Dark plum were:soaking 14 times of water, extract three times each time lasts for 60mins. In that condition, tannin yield was 9.94%. According to the single-factor experiment, with the target of volatile oil content, the optimum extraction processes of Curcuma were:soaking 2h with 10 times of water, steam distilling for 6h, and in that condition, volatile oil yield was 6.0%, curcumol content was 0.33g/mL.In the four noble ingredients flavored granule molding process, consider the volatility of the volatile oil of curcuma, volatile oil HP-P-CD inclusion was prepared by saturated solution. By uniform design, the best inclusion conditions were:oil HP-β-CD ratio was 1:10,30℃ of inclusion temperature, continuous stirring 30mins, in that condition, curcumol drug loading was 2.93%. Combined single-factor experiments and central composite design, the preparation process was raw materials dextrin ratio as 1:2,54.74% ethanol as wetting agent, then using wet granulation technique, dry and divided dose.Based on volume I of Chinese pharmacopoeia (edition 2010), this experiment established quality standard of decoction with four noble ingredients flavored granule, and this quality standard is scientific and feasible. Accelerated test showed that the appearance, character and content of decoction with four noble ingredients flavored granule were meet the requirements, demonstrated this formulation was stable. Finally, the animal experiment showed that the effective amount of decoction with four noble ingredients flavored granule is 5g/kg, which efficacy significantly. After this treatment, the loose stools rate, diarrhea index, percentage of pushing carbo medicinalis and daily gain were no difference with normal mice.According to the guidance of the Chinese Medicine,dialectical treats, and based on the classical decoction with four noble ingredients flavored granule, reasonable, feasible, stable quality and controllable method of decoct four noble ingredients flavored granule was achieved, which is easy to use and exact effect. This study has laid a new choice for the development of new types Chinese medicine that used for prevention and treatment chronic diarrhoea also enriched the study for new content of non-polluting and non-residue veterinary drug.