[Objectives] To establish the preparation process and quality standard of Rougan Huaxian ointment.[Methods] The L 9(3 4) orthogonal test was employed to optimize the preparation process by considering the multiplicati...[Objectives] To establish the preparation process and quality standard of Rougan Huaxian ointment.[Methods] The L 9(3 4) orthogonal test was employed to optimize the preparation process by considering the multiplication of water addition, extraction time, and extraction frequency as influencing factors. The dry paste yield was utilized as the evaluation criterion, in conjunction with the actual production conditions. Thin layer chromatography was employed to identify Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati. Ethanol served as the solvent for the determination of ethanol-soluble extractives using the cold immersion method.[Results] The preparation process was conducted as follows: the specified quantity of medicinal materials was combined with water for extraction purposes, performed in two separate stages. In each stage, eight times the amount of water was added. The first extraction lasted for 1.5 h, while the second extraction was completed in 1.0 h. The resulting liquid was then concentrated into a thick paste with a relative density ranging from 1.25 to 1.30 at a temperature of 60 ℃. The thin-layer chromatography analysis of Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati demonstrated distinct spots, effective separation, and the absence of interference from negative samples. Additionally, the ethanol-soluble extractives yielded a minimum of 8.0% in terms of dry weight.[Conclusions] The preparation process for Rougan Huaxian ointment is both stable and feasible. Furthermore, the quality standards established for this preparation are unique and reproducible, thereby facilitating effective quality control.展开更多
基金Supported by Guangxi Key R&D Programme Project(GK AB21196057)National Old Pharmacist Inheritance Studio Construction Project.
文摘[Objectives] To establish the preparation process and quality standard of Rougan Huaxian ointment.[Methods] The L 9(3 4) orthogonal test was employed to optimize the preparation process by considering the multiplication of water addition, extraction time, and extraction frequency as influencing factors. The dry paste yield was utilized as the evaluation criterion, in conjunction with the actual production conditions. Thin layer chromatography was employed to identify Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati. Ethanol served as the solvent for the determination of ethanol-soluble extractives using the cold immersion method.[Results] The preparation process was conducted as follows: the specified quantity of medicinal materials was combined with water for extraction purposes, performed in two separate stages. In each stage, eight times the amount of water was added. The first extraction lasted for 1.5 h, while the second extraction was completed in 1.0 h. The resulting liquid was then concentrated into a thick paste with a relative density ranging from 1.25 to 1.30 at a temperature of 60 ℃. The thin-layer chromatography analysis of Radix Astragali, Lycii Fructus, Herba Dendrobii, and Rhizoma Polygoni Cuspidati demonstrated distinct spots, effective separation, and the absence of interference from negative samples. Additionally, the ethanol-soluble extractives yielded a minimum of 8.0% in terms of dry weight.[Conclusions] The preparation process for Rougan Huaxian ointment is both stable and feasible. Furthermore, the quality standards established for this preparation are unique and reproducible, thereby facilitating effective quality control.
