Studies On The Preparation Process, Quality Standard And Technology Design Of Wanbikang Granules

Objective Wanbikang Granules(WBKG)are a compound Chinese Medicinal Material preparation developed on the base of a clinically proved recipe,which contains six kinds of medicinal materials,such as Radix Astragali,Radix Angeliacae Sinensis,Rhizoma Chuanxiong,Cortex Moutan,Cortex Acanthopanacis,Radix Glycyrrhizae.The prescription was proved to be of remarkable curative effect when it was applied to treat Rheumatoid arthritis.In this paper the preparation process and quality standard of the compound preparation were studied so as to establish the foundation for the further study on treating osteoarthritis with Chinese Medicine.Methods In the studies on its preparation process,orthogonal trial was adopted to select extraction and purification conditions,and comparison test was applied to select the proportion and type of the auxiliary materials.In the studies on its quality standard,the thin layer chromatography(TLC)method was established to identify Radix Astragali,Radix Angeliacae Sinensis,Rhizoma Chuanxiong,Cortex Moutan and the high performance liquid chromatography(HPLC)method was established to determine the content of AstragalosideⅠ(ASⅠ)in Radix Astragali. The technology design of extraction plant and preparation plant were investigated according to studies of the WBKG preparation technology and the Good Manufacturing Practice of Drugs(GMP).Results In the studies on the preparation process,the optimal extraction method was as follows;Radix Angeliacae Sinensis,Rhizoma Chuanxiong and Cortex Moutan were extracted with 10-fold water for 5 hours by Steam distillation,theRadix Astragali,Cortex Acanthopanacis and Radix Glycyrrhizae were decocted with 8-fold water for 2 times,2 hour per time;The extracted solution should be concentrated into dense extractum which relative density as 1.30～1.35(60℃),and then the extractum should be dried and crashed into fine powder.Starch,β-Cyclodextrin(β-CD) inclusion were added with 80%ethyl alcohol to prepare the WBKG..The studies on its quality standard indicated that the TLC for identifying Radix Astragali,Radix Angeliacae Sinensis,Rhizoma Chuanxiong and Cortex Moutan is simple and practicable.A good linear relationship between the concentration and peak area of AS I was found within the range of 53.0～848.0μg·ml^-1,the average recovery was 97.97%, RSD=2.47%(n=6).Conclusion The preparation process of the WBKG is reasonable and feasible. The quality standard can be used to control the quality of the product.The design of technology can provide the important foundation for Engineering of Granules production.