Study Of Preparation Process And Quality Standard Of Wenyun Granules And Its Effect On Spleen-deficiency Diarrhea

Wenpihuashizhuyun Decoction is the clinical experience prescriptions that used by the national famous Chinese medicine master Wang Shouchuan in treatment of children Spleen-Deficiency Diarrhea.Under the guidance of traditional Chinese medicine theory and the latest development of modern research,this recipe will be developed into granules preparation and be named as Wenyun granules.In this paper,we adopted multiple indexes to study the extraction and preparation process of each herb,and then optimized the optimal technological parameters.The content of 6-gingerol was used as the index to select the optimal ethanol extraction process of Zingiberis Rhizoma.The best technology is adding 10 times amount of 60%ethanol,45min for one reflux,3 times for extraction.The content of atractyodin and essential oils were used as the index to select the optimal extraction process of Atractylodis Rhizoma.The best technology is adding 8 times amount of water without soaking and distilling for 4 hours.The content of total polysaccharide were used as the index to select the optimal extraction process of Poria.The best technology is adding 10 times amount of water,30min for one decoction,3 times for extraction.The inclusion percentage of essential oil and yield of the inclusion complexes were used as the index to select the optimal inclusion process of essential oils.The best technology is adding 8 times amount of 8%(3-cyclodextrin solution and including 60min by ultrasonic method in the condition of 30 ?.According to the situation of pellet formation,we optimizd the best molding process as follows:First,adding 0.6 times amount of soluble starch and 0.4 times amount of powdered sugar into dry paste powder.Then,adding the inclusion compound of essential oils in proportion.At last,5‰aspartame and l‰ orange flavor were added as taste masking agent,90%ethanol as the moistening agent in the process of wet extrusion granulating.Three batches of small sample were prepared according to the best process to study the quality standard.The test confirmed that all three samples met the inspection requirements in the general provisions of the Chinese pharmacopoeia(part 4)formulations in 2015.According to the characteristics of the compatibility,the TLC method was used to identify the four herbs:Atractylodis Rhizoma,Alpiniae Oxyphyllae Fructus,Zingiberis Rhizoma and Amomi Fructus.In this paper,the content of atractyodin and 6-gingerol,which respectively belongs to the main herb and side herb,were determined.The draft of quality standard was established according to the result.On the basis of the foregoing research,the model of mice Spleen-Deficiency Diarrhea was used to evaluate the preliminary pharmacodynamics of Wenyun granules and verify its curative effect.Metabonomics study was carried out to explore the effects of Spleen-Deficiency Diarrhea and Wenyun Granules on body metabolism.The experimental results show that Wenyun granules could significantly improve the Spleen-Deficiency Diarrhea in mice induced by the senna,and can improve the metabolic disorder caused by Spleen-Deficiency Diarrhea.The result proved once againe that the preparation process of Wenyun granules is feasible.