Study On Compound Huwei Granules

Gastric mucosal injury is a common clinical disease that can be triggered by a variety of internal and external factors,often causing stomach pain,vomiting and other symptoms,the disease has a long duration and is prone to recurrence,which seriously affects the quality of life of patients.Traditional Chinese medicine can protect the gastric mucosa and promote the healing of damaged mucosa through various ways,and it is safe and suitable for long-term use,which has unique advantages for the prevention and treatment of gastric mucosal injury.Based on this,this study was conducted to develop a health food with the efficacy of adjuvant protection of gastric mucosa by using three safe and effective herbal formulas of Astragalus membranaceus,Salvia miltiorrhiza and Aucklandia lappa.After the prescription was determined,the main components of the prescription that exerted gastric mucosa protection effects were extracted.Firstly,the volatile oil of Aucklandia lappa was extracted,and the volatile oil extraction rate was used as the index,the single-factor test combined with orthogonal design was applied to optimize the volatile oil extraction process as follows: Aucklandia lappa was crushed into the coarsest powder,10 times the amount of water was added,soaked for 0.5h,and heated to reflux extraction for 6h.The volatile oil was poorly stable and difficult to be incorporated uniformly into the solid formulation,so it was encapsulated withβ-cyclodextrin.The inclusion yield and volatile oil inclusion rate were used as indicators,and after assigning weights to the indicators by entropy weighting method,the inclusion process was optimized by applying orthogonal design as the dosage ratio of β-CD to volatile oil was 10:1(g:m L),and the inclusion was carried out at40℃ for 2h.The inclusion complexes were characterized by microscopic observation,thin layer identification and UV full scan to verify the successful inclusion.Finally,the Astragalus membranaceus and Salvia miltiorrhiza combined with the residue of Aucklandia lappa were studied in the aqueous extraction process,the G1-entropy weighting method was used to determine the comprehensive scoring formula with the content of astragaloside IV,salvianolic acid B and dry paste yield as indicators,and the best aqueous extraction process was optimized by combining with Box-Behnken design: adding 10 times the amount of water,extracting for 2h,extracting twice in total.Due to the high extraction rate of the three herbs in the aqueous extraction process and the need to take them together with the inclusions,the product is made into granules that are easy to take.The commonly used wet granulation method was selected,and the Qb D concept was used as a guide during the formulation process.Using moisture absorption rate,molding rate,solubility,flowability(angle of repose),and soft material production as evaluation indexes,the process was optimized by applying single-factor test combined with central composite design as follows:dextrin and dry paste powder were mixed in the ratio of 0.8:1,and soft material was produced by 90% ethanol solution with 20% dosage.To improve the taste,appropriate amount of mogroside V was added to the prescription.After the final formulation process was determined,the physical fingerprint profile of the product was established with the stacking,homogeneity,flowability and stability as the primary indicators.And the stability of the formulation process was evaluated by calculating the pearson correlation coefficient of the granules between batches.The results showed that the physical properties of the granules were similar among the batches,indicating that the formulation process was stable and feasible.In order to control the quality of this product,the quality standard of Compound Huwei Granules was established.It includes the routine examination method and the thin layer identification method of the three herbs in the prescription,and the application of HPLC-ELSD to determine the content of astragaloside IV,the simultaneous determination of calycosin-7-O-β-D-glucoside and salvianolic acid B by HPLC,and the determination of the total amount of costunolide and dehydrocostus lactone by HPLC.The content standards of the active ingredients are:astragaloside IV ≥30mg/100 g,salvianolic acid B ≥0.45g/100 g,calycosin-7-O-β-Dglucoside ≥10mg/100 g,the total amount of costunolide and dehydrocostus lactone≥15mg/100 g.The preliminary stability study of the product was conducted.The results of accelerated and long-term stability tests showed that the product was stable,and the results of all checks were in accordance with the quality standard during the inspection time,no significant abnormal changes were observed,which also provided a preliminary basis for the formulation of shelf life.According to the requirements of health food declaration,the preliminary safety evaluation and animal efficacy tests of Compound Huwei Granules were conducted.The results of acute oral toxicity test,genotoxicity test and 28-day oral toxicity test in rats did not show any toxic side effects,confirming that the product is safe and meets the requirements of health food.The functional results showed that the symptoms of gastric mucosal injury in rats were significantly reduced after the administration of this product by gavage,which proved that Compound Huwei Granules has an auxiliary protective function against gastric mucosal injury.