Research Report On Classic Formula Shegan Mahuang Granules

The classic formulas are Chinese traditional medicine preparations recorded in the classic medical records before or during the Qing Dynasty and used effectively for hundreds to thousands of years.In order to inherit the classic culture,the State advocates transforming classic famous recipes into products,making the wisdom of Chinese medicine for thousands of years in China more direct and convenient to serve the public health.The research of the classic formula includes the substance benchmarks and preparation process research.The substance benchmark is the intermediate from decoction to preparation and exists in the form of extract or dry extract.On the one hand,the research on the quality standards of the substance benchmarks is to control the quality of classic formula in the production process;on the other hand,the quality standards of the substance benchmarks can be directly used to recheck the quality of the preparations after the formulations are formed.The prototype of Shegan Mahuang Granules is Shegan Mahuang Decoction,which is derived from classic "Synopsis of the Golden-Chamber"of the Han Dynasty.It has the effects of relieving cough and asthma,dissipating phlegm and resolving stagnation.In this paper,by examining the records of Shegan Mahuang Decoction in classical medical books and modern usage and dosage,the prescription composition and dosage of Shegan Mahuang Decoction were picked and determined,namely:Shegan 9g,Mahuang 12g,Shengjiang 12g,Xixin 9g,Ziwan 9g,Kuandonghua 9g,Dazao 17.5g,Banxia 9g and Wuweizi 9g.According to the decoction methods recorded in ancient books,repeated experiments were performed to determine the relevant process parameters for the substance benchmarks,and the preparation molding process of Shegan Mahuang Granules was established.The preparation process of Shegan Mahuang Granules is as follows:the medicinal materials in the prescription are mixed according to the process prescription amount,25 times the amount of water in the medicinal material was added for decoction,the lid was covered,and the water was boiled for 1.5 hours,and then the decoction was filtered by 300 mesh filter cloth and concentrated under reduced pressure at 60℃ to an extract with a relative density of 1.20～1.30,and dried under reduced pressure at 70℃ for 48 hours.Then the dried substance was pulverized into a fine powder named substance benchmarks.In the formulation molding process,dextrin was the best excipient,and the optimal ratio of raw and auxiliary materials was 1:0.5.Aspartame was added in a total amount of 1.5%,and then wet granulated with 90%ethanol.Establish the quality standard for Shegan Mahuang Decoction which is also called substance benchmarks.In this paper,thin layer chromatography identification of Mahuang,Wuweizi,Xixin,and Shengjiang was established.The identified components had clear spots,good separation effect,and no negative display.A method for the simultaneous content determination of irisflorentin,schizandrin and(-)-asarinin was established.The Chromatographic conditions were as follows:The column was SHIMADZU VP-ODS(250mm × 4.6mm × 5μm),and the detection wavelength was 287nm,Flow rate 1mL/min,column temperature 40℃.The mobile phase A was acetonitrile,water was mobile phase B,gradient elution conditions:0-20 min,35%A-45%A,20-30 min,45%A-50%A,30-30.5 min,50%A-70%A,30.5-45min,70%A-100%A.Two sets of specific chromatogram were established to characterize the main characteristics of Shegan Mahuang Decoction and the transmission of medicinal materials and substance benchmark.The chromatographic conditions at 265nm were as follows:Agilent ZorBax SB-C18(250mm × 4.6mm × 5μm),the detection wavelength was 265nm,the column temperature was 40℃,the flow rate is 1.2mL/min,and the injection volume was 5μL.Mobile phase:acetonitrile(A)-0.1%formic acid 0.1%isopropanol solution(B),gradient elution conditions:0-15 min,10%A-18%A,15-40 min,18%A-20%A,40-100 min,20%A-100%A;15 common peaks were shown in this specific chromatogram,2 chromatographic peaks were identified.The specific chromatogram conditions at 210nm were as follows:the column was Agilent ZorBax SB-C18(250mm × 4.6mm × 5μm),detection wavelength was 210nm,column temperature was 30℃,flow rate 1mL/min,injection volume was 3μL,mobile phase:acetonitrile(A)-0.1%phosphoric acid solution(B),0-2min,2%A-4%A;2-10min,4%A-5%A;10-20min,5%A-8%A;20-35min,8%A-18%A;35-50min,18%A-19%A;50-60min,19%A-30%A;60-70min,30%A-40%A;70-100min,40%A-85%A;100-110min,85%A-100%A.36 common peaks were shown in this specific chromatogram,9 chromatographic peaks were identified.