| Tiaowei Chengqi Decoction represent the theory of "ralax the bowels",the theory has been raised by Zhang zhongjing,the famous doctor who is living in the late Eastern Han Dynasty. Tiaowei Chengqi Decoction,with a history of thousands of years, clinical practice has significant curative effect after inspection,has been attracting different dynastie s doctors.in recent years, Tiaowei Chengqi Decoction has been successfully and widely modified as the basic prescription in clinical treatment on various diseases,such as Chronic pancreatitis, Acute appendicitis, Urticaria, Senile constipation, Intestinal obstruction and etc. In order to comply with the requirements of the times and the trend of development of traditional Chinese medicine, This experiment develop granule Granules of extraction of Chinese prescription for clinical application,which can fully used classical prescription and change the traditional mode of administration,which use traditional herb pieces as medicine and decoct before use.Objective:We choose the Tiaowei Chengqi Decoction as the research object, which has the definite clinical effect. Researching the relationship between the prescription and Chinese herbs, studying preparation technology,comparing particle prescription and traditional decoction by means of pharmacodynamics and chemical combination. Studying the standardization and evaluation System on the quality of particle prescription. To provide reference for the development and application of the particle prescription of Tiaowei Chengqi Decoction.Method:1. According to the "Chinese Pharmacopoeia"(2015)'s [2]requirements to research the quality of rhubarb, licorice, and mirabilite.2. Comparing the rhubarb and its processed products when used in decoction,with the experiment of purgation, gastric emptying and small intestine propulsion,the effects on the basal metabolism and the function of the stomach in mice.3. Assessing the decoction comprehensively by using the content of combined anthraquinone, free anthraquinone and glycyrrhizinic acid, the ratio of plaster. Decocting technology was reviewed by soaking time, decocting time, water amount, the decoct time after the mirabilite is added. Using Box-Behnken design-response surface method (4 factors and 3 levels) based on single factor experiment analysis decoction process.4. Evaluating the quality through the index of appearance, particle size and moisture, hygroscopicity, and solubility. Finding the best materials varieties, the ratio between the materials and the amounts by single factor test. To test the quality of molding particles, to investigate the critical relative humidity, angle of repose. The quality standard and preliminary stability study of TLC, routine examination (character, particle size, microbial limits), content determination and so on. And draft the quality standard draft of the prescription granule.5. Searching the differences in the mainly chemical composition between Tiaowei Chengqi Decoction dispensing granules and decoction by the use of HPLC. Establishing rate model of dryness-heat in Yangming Fushi syndrome. The content of serum ET and TNF-a is detected, and to find the differences between the pathological state animal and the normal state animal in Intestinal tissues.Results:1. The quality of the pieces conforms to the pharmacopoeia standard.2. The effect of Compound in which Rhubarb after washing with wine is obvious, the "stomach injury" role is greatly reduced.The medical effect reflected in:it not only ensures the purpose of purging heat, but also alleviates the effect of adverse reactions.3. Combined with the actual situation, determine the boiling process to add 11 times the amount of water, soak 66 min, decoction 2 times,28min/time, into the Glauber were fried 20min.The deviation of experimental and predicted values of the preferred process is small, indicating that the process is stable and feasible.4. Selecting the lactose and mannitol for the best molding materials,to make out mixed granules with the optimum ratio that is cream:lactose:mannitol=l:3:l.The granules are uniform size,the mold-ability,solubility,mobility are all well,and not easy to absorb moisture.The critical relative humidity is 69%,and the repose angle is less than 40 degrees.5. Preliminary stability results showed that the quality of granules is stable within 3 months. According to the results of identification, examination and content, the quality standard draft of the prescription granule was drafted.6. The main chemical components of The traditional decoction and the formula granules of Tiaowei chengqi is basically the same, the content of six kinds of characteristics composition in formula particles is higher than the traditional decoction; Pharmacological results show,under the same dose, the drug effect of the formula granules of Tiaowei chengqi group than traditional one is good.Conclusion:The wine-washed rhubarb used in Tiaowei Chengqi Decoction has its certain practical significance and scientific nature.The preferred process of the formula granules of Tiaowei chengqi decoction can improve its effectiveness and stability significantly,quality can be controllable and the process is quite reasonable,providing efficient experimental basis for clinical research and production. |
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