Objective:To optimize the preparation process of Shenqi Tongmai Oral Liquid.Methods:Basis on of single factor tests,the orthogonal test was employed to optimize the ethanol extraction conditions of Ginseng Radix et Rhizoma Rubra and water extraction conditions of the prescription with total saponins,total flavonoids,and extract yield as the evaluation indexes.With total saponins,total flavonoids,precipitation status,and clarity as the evaluation indexes,the weighted scoring method was used to optimize the ethanol precipitation process of the prescription.With total saponins,total flavonoids,and clarity as the evaluation indexes,the effects of different pH values were investigated.The main technical parameters and the type and dosage of pharmaceutical excipients were determined,and the preparation process of Shenqi Tongmai Oral Liquid was then established.Results:The optimal ethanol extraction process of Ginseng Radix et Rhizoma Rubra was extraction with 20 volumes of 60%ethanol for 3 times(2.5 h each time).The optimal water extraction process of the prescription was extraction with 10 volumes of water twice(1.5 h each time).The optimum ethanol precipitation process was precipitation of water extract(relative density of 1.25 at 80℃)with 80%ethanol at 35℃.The flavoring agent was xylitol,and the preservatives were benzoic acid(0.1%)and hydroxyphenyl ethyl ester(0.03%).The system was adjusted to reach pH 4.0-5.0.Under the conditions above,the concentrations of total saponins and total flavonoids were increased to 131.050 and 9.765 mg·mL-1,respectively.Conclusion:The optimization significantly increases total saponins and total flavonoids in Shenqi tongmai Oral Liquid.The method is stable,feasible,and operable and it is thus suitable for mass production.
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