Study On The Preparation Process And Quality Tiaogan Huoxue Wenya Granules

Objective:To design and test the preparation process route by analyzing the composition of the formula for regulating liver,promoting blood circulation,and stabilizing blood pressure,as well as the effective ingredients of traditional Chinese medicine.The formula will be made into safe,stable,and effective granules,and modern analytical methods will be used to establish the quality standards for regulating liver,promoting blood circulation,and stabilizing blood pressure granules.Method:Using the comprehensive scores of extract yield and salvianolic acid B transfer rate as indicators,the extraction process was determined using a single factor examination method combined with Box Behnken design response surface methodology.The concentration,drying,and molding processes were studied to determine the preparation process of Tiaogan Huoxue Wenya granules.Thin layer chromatography was used to identify traditional Chinese medicine in the formula,and high-performance liquid chromatography was used to determine the content of four components including salvianolic acid B in the formula.Quality standards were established and pilot scale experiments were conducted.Conduct stability checks on scaled up samples in the pilot scale.Result:By examining the extraction process,concentration process,drying process,and molding process,the preparation process of Tiaogan Huoxue Wenya granules was determined,and a pilot scale experiment was conducted.The pilot samples were tested according to the proposed quality standards.The characteristic spots of four drugs,including Gastrodia elata,Danshen,Gouteng,and Gardenia,were detected by thin-layer chromatography.The content of Panax notoginseng in the formula was determined by high-performance liquid chromatography.The total amount of Panax notoginseng saponin R₁,Panax ginseng saponin Rg₁,and Panax ginseng saponin Rb₁was calculated as not less than 23mg/bag;Danshen is calculated based on the content of salvianolic acid B,and should not be less than 25mg/bag.All routine testing items comply with regulations.Through influencing factor tests,accelerated tests,and long-term stability tests,it was found that the quality of Tiaogan Huoxue Wenya granules was stable within 6 months.Conclusion:The preparation process of this study is simple and has strong operability;The proposed detection method is stable and feasible;The prepared particles have good stability.Provided relevant experience for the research and development of formulations in medical institutions in this province.