The Studies On The Separation And Dosage Form Of The Sanyuemahuang Decoction Utility Portion

Objective:①To screen the extracting program of standard Sanyuemahuang Decoction; ② To separate and confirm the utility portion of Sanyuemahuang Decoction;③To study the physical and chemical propertyes of the utility potion and build up the quality control standard of the utility portion.④ To screen the producing program of the utility portion preparation , study the principal pharmacodynamics effect and pharmacokinetics procedure.Methods:① According to the mono factor design and uniform design, we used the relative contents of hesperidin, glycyrrhizin and the weight of chloroform extracting matter as index to select the extracting program I of Sanyuemahuang Decoction(the extracting solvent is ethanol solution). Then we used the relative contents of efedrina and the weight of 8 5% ethanol solution extracting matter as index to select the extracting program II of Sanyuemahuang Decoction(the extracting solvent is water). ② The polarity portions of Sanyuemahuang Decoction were separated by the syste-solvent methods. The separating solvents were ethyl acetate, chloroform and n-butanol. Then two principal pharmacodynamics effects, which are the effect on the abdominal cavity capillary permeability of mouse and the effect of reducing the amount of trachea sputum, were selected as idexes of screening the utility portion.③ After studied the physical and chemical propertyes of the utility portion (such as the moisture absorption, solubility, angle of repose, bulk density), we selected the granules as the dosage form of the utility portion. Then the quality control standard of the utility portion was built up after the methodology test. ④First we set up three systems of colligation scoring which are synthesizingmark, overall desirability and rank sum ratio. Then separately using colligation score as screening index, we selected the formula composition of Sanyuemahuang granules through mono factor experiment. Then the principal pharmacodynamics effects of Sanyuemahuang granules were studied according to reference methods. At last, the effect on the abdominal cavity capillary permeability of Mouse was selected as test index, the pharmacokinetics procedure of Sanyuemahuang granules was studied by the Smolen method.Results: ① The extracting program I of Sanyuemahuang Decoction is as following: the extracting solvent is 80% ethanol solution, extracting 3 times, every time add 8 times extracting solvent to the Chinese medicine drug and the extracting lasts 1.5 hours. The extracting program II is as following: the extracting solvent is water, extracting 2 times, every time add 16 times water to the Chinese medicine drug and the extracting lasts 2.5 hours.②The n-butanol portion was confirmed as utility portion. ③The critical relative humidity (CRH) of the utility portion is 51% and the solubility of utility portion is bigger in n-butanol than in other solvents. The angle of repose and the bulk density of the utility portion separately are 50.2° and 0.41g/ml. The quality of the utility portion is controlled by the thin layer chromatograph and the high performance chromatograph. The selected formula is as following: add four shares lactose to one share extra to granule. The selected formula by the systems of colligation scoring is similar to the selected formula by the systems of overall desirability. The study of principle pharmacodynamics shows that the Sanyuemahuang granules have following active effects: first, the granules can significantly decrease the rabbit's temperature which has been raised by injecting the typhoidpolysaccharide bacterial vaccine. Second, the granules can reduce the rat metatarsus swelling, which was caused by injecting carrageenan. The granules can also reduce the abdominal cavity capillary permeability of mouse. Third, the granules can decrease the number of times of mouse twisting body caused by injecting acetic acid. Fourth, the granules can increase the amount of phenolsulfonphthalein excretion in mouse trachea and decrease the number of times of coughing caused by the ammonia water. Fift...