Research On Improvement Dosage Form Of Chinese Medicine Complex Prescription Under The Guidance Of Biological Pharmacy

Objective:Mahuang Tang(one of the famous recipe of traditional Chinese medicine) is as a research prescriotion,it contains Ephedra herb,ramulus cinnamomi,almond and liquiritia.Oil extracted from the herbs mix is as a oil phase,other extracted ingredients from the herbs mix are the drugs and excipient and these become self-emulsifying system by adding surfactant according to the definition of self-emulsifying drug delivery system(SEDDS).Adding water is to dissolve all the components and recover the status of decoction.Then compared the absorption of the Mahuang Tang and its self-emulsifying system in small intestine in situ,to study the similarities and differences of the absorbing between the two preparations.This study is a preliminary research,and the purpose is to improve the dosage form of Chinese medicinal formulations with new research methods and ideas.Method:To extract fat-soluble components and water-soluble components of the ingredients,we applied extraction of the two-step approach,to prepare Mahuang Tang self-emulsifying system.Mark ingredients and particle size are for the analytical indicatrix.Combination of microscope and particle Size Analyzer we determined the particle size of Mahuang Tang,Mahuang Tang self-emulsifying system,Mahuang Tang-self-emulsifying system eliminated emulsifier and commercial formula after dissolved them in water.The absorption rate was investigated with perfusing small intestine of rats in situ.Fingerprints and the concentration of ephedrine and pseudoephedrine was determined using HPLC-electrochemical detection and the concentration of cinnamaldehyde was determined by RP-HPLC.Results:The use of emulsifier is about 40 percent and combine use of lecithin and poloxamer(a ratio of 3:1)in the self-emusifying system.In this condition, emulsifying outcome is the best,the size of milk drops is smaller and similar to the size in Mahuang tang.They were(3.51±2.46)μm and(3.86±2.73)μm under microscope respectively. The sensitivity and accuracy of detecting ephedrine and pseudoephedrine are good using reversed phase high-performance liquid chromatography(RP-HPLC) electrochemical detection,and also in quantitative determination of cinnamaldehyde using UV detection of the RP-HPLC.Samples are stable at room temperature.The results of the preparation particle size and its absorption in the small intestine showed that the particle size of drug will affect its absorption,when the particle size is bigger than the size of a limited size,the absorption of ephedrine, pseudoephedrine and cinnamaldehyde will be affected.The absorbed amount of Ephedriae were decreased in the order of Mahuang tang,home-made self-emulsifying system and home-made self-emulsifying system eliminated emulsifier.These are consistent with their particle size.The absorbed amounts of Cinnamaldehyde is related to its concentration in the prparations and not related to the particle size,the higher the concentration the more absorptive the component.The results of fingerprints show that peak height of licorice glycosides, ephedrine and pseudoephedrine after one hour administration were lower than their peak before administration,but the peak height after 1 hour and after 3 hour were similar.Excluding the volume change,the absorbed amount of Amygdalin was rare. The change was similar in the decoction and self-made self-emulsifying system.The results also showed that the phenol red was not absorbed,to use its concentration as reference to calibrate the change of solution volume is reasonable and feasible.Conclusions:The particle size of preparations is the key point of affecting drug absorption in the limited size.The smaller the particle size,the faster the drug absorption;smaller than certain size,the absorption of some drugs may be no relation with particle size.If the preparations could be similar to its original decoction after the dosage form reforming,the work could be seem more successful.The results indicated that self-emulsifying drug delivery system is useful in the reforming of preparation decoction of traditional Chinese medicine.The method for improving dosage form of materials broth has a certain significance.