Study on the preparation technology and quality standard of Xiangsha Pingwei Gel Paste
Objective To modify Xiangsha Pingwei Pills to gel paste,to screen the optimal prescription and preparation technology,and to establish the quality standard.Methods The volatile oil and extract were extracted by water-alcohol double extraction method.The orthogonal test method was used to optimize the prescription according to the evaluation indexes of initial adhesion,holding adhesion and comprehensive sense.The qualitative identification of Aucklandiae Radix,Citri Reticulatae Pericarpium,Glycyrrhizae Radix et Rhizoma and Atractylodis Rhizoma in the prescription was selected by thin-layer chromatography(TLC),and the content determination method of magnolol and honokiol was established by high-performance liquid chromatography(HPLC).Results The optimal prescription was 10.0 g of mixed extract,16.0 g of water,18.0 g of glycerol,0.2 g of povidone K90,2.4 g of sodium polyacrylate,0.6 g of sodium carboxymethyl cellulose,0.5 g of aluminum hydroxide and citric acid,and 1.2 g of micro powder silica gels.The TLC chromatograph of Aucklandiae Radix,Citri Reticulatae Pericarpium,and Glycyrrhizae Radix et Rhizoma had clear spots and good separation,and the negative samples showed no interference.The magnolol and honokiol content determination method had good specificity,the linear ranges were 9.98~149.70 µg·mL-1(r=0.999 1),and 10.10~150.60 µg·mL-1(r=0.999 9),respectively,the average recovery were 100.03%and 102.52%respectively,and the RSD values were 1.74%and 1.23%,respectively.The total average content of magnolol and honokiol in each paste was 3.8 mg.Conclusion According to the optimized prescription and preparation process,the product has good formability and adhesion,suitable drug loading and stable quality,and can meet the needs of clinical and production.
Xiangsha Pingwei Gel Pastethin-layer chromatographyhigh-performance liquid chromatographypreparation technologyquality standard