| Objective: To approach the basic mode and the meaning of the compound prescriptions of the traditional Chinese medicine (TCM) extracted by "the semi-bionic extraction method (SBE method)" with Maxing Shigan Tang as the illustration.Method: With hydrochloric ephedrine> glycyrrhetinic acid^ hydrocyanic acid> calcium-ion and dried extract as the indexes, the uniform-design was used to optimize the prescription's extract conditions for the SBE method. The optimal combination for the four medical herbs and the optimal clarify conditions for the prescription were selected. According to the former conditions, the 4 kinds of extract methods, including SBE (semi-bionic extraction) method, SBAE (semi-bionic extraction and alcohol precipitate) method, WE (water extraction) method and WAE (water extraction and alcohol precipitate) method, were compared in the contents of the index ingredients, in the pharmacologic activity and in the fingerprinting of the rabbit's blood serum. Based on the former study, the Maxing Shigan aerosol was prepared and the quality control standards, the HPLC fingerprinting, and the stability of the preparation were studied.Results: The conditions of the SBE method are that the pH values of the water for the 1st, 2nd and 3rd decoctions are 2.00, 6.50 and 9.00; and the times of the 3 decoctions are 2.0h, l.Oh and 0.5h. The optimal combination of the prescription is Ephedra and Gypsum, Liquorice and Bitter Apricot Seed decocted respectively and the decoctions combined finally. The optimal clarify condition is 60% alcohol sediment. The order of the total index Y value of the five ingredients is YSBE>YWE >YSBAE>YWAE.The 4 kinds extractions can prolong the cough incubation period of the mousestimulated by aqua ammonia, decrease the cough times and improve the mononuclear-macrophage's phagocytic function of the mouse obviously. The 4 kinds of extractions can also enhance the weight, prolong the cough incubation period, restore the leukocytes' count and classification, reduce the ET-1 content in the blood and the lung tissue, and improve the bronchi's and the lung's pathological structure of the asthma cat, but have no effect on the weight of the mouse's immune organs. With statistics procession there have no significant difference among the 4 kinds of extractions. The HPLC fingerprinting and the HPCE fingerprinting of the rabbit blood serum show that the SBE decoction's metabolic rate is more rapid than the WE decoction in vivo.Maxing Shigan aerosol was prepared. The quality control standards were formulated and the content range of the index ingredients are: hydrochloric ephedrine above 1.2 mg ?ml/1, hydrocyanic acid form 0.7mg ?ml/1 to l.lmg ?ml/1, calcium-ion above 34 mg ?ml/1, Glycyrrhetinic acid above 0.66mg ?ml/1 and dried extract above 0.24%. 13 peaks are established as the characteristic absorption peaks of the preparation's HPLC fingerprinting, the relative retention time (the relative peak area) of the characteristic peaks in order are 0.31(0.50), 0.35(0.21), 0.44(0.42), 0.53(0.91), 0.58(0.95), 0.86(0.21), 0.90(0.42), 0.96(0.36), 1.07(0.21), 1.22(0.56), 1.50(0.38), 1.58(0.10). The study of the preparation's stability shows that the expiration date of the aerosol is 1 year.Conclusion: SBE method can persist the holism theory of TCM and embody the multi-target, multi-link and multi-channel features of the traditional Chinese medicine's action. It is a new extract method superior to the conventional WE method. SBE method provides new thinking and new method for the study of the prescriptions of the TCM and has high scientific meaning and high practicability.
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