| Objective: Compound Ejiao paste has been used to clinical for many years.The paste composed of Asini coril colla, Astragali radix, Lycii fructus and other traditional chinese medicinal materials, it has the effect of Invigorating qi and blood, nourishing Yin and moistening lung and so on,the clinic function mainly for the treatment of qi and blood deficiency. Based on the physico-chemical properties and pharmacological functions of these medicinal material main chemical composition, in this study we preliminary research the preparation techniques of the paste,and establish the quality standard, so as to establish the foundation for the future clinical application.Methods : In the studies on its preparation techniques, first, we select the best decoction process by orthogonal trial.Then comparison test was used to select the best concentration technics and supplementary material types.In the studies on its quality standard,the thin layer chromatography(TLC) method was established to identify Asini coril colla, Astragali radix, Lycii fructus.Atomic absorption method is used to determination of the content of copper, cadmium, lead, arsenic, mercury in preparation.Finally, with HPLC-ELSD method for determining the content of astragaloside, with HPLC method for determination of glycine, alanine, Lhydroxyproline and L-proline.And three batches of samples were investigated stress testing, accelerated testing and long-term testing.Results :The best preparation conditions Compound Ejiao paste is weighting and taking the 7 drugs according to the prescription except Asini coril colla,10 times of water quantity, 3 times for decoction, 1.5 hours for each time,merging decoction,filtration,the filtrate should be concentrated into extractum with relative density1.03-1.10(20 ?),standby.Ass-hide glue research into fine powder,Will the extractum heating and pour into Asini coril colla fine powder, Melt mixture,standby.When the sugar refining,add the medicine into still warm sugar,still well,made from 1000 g.The studies on its quality standard indicated that the TLC for identifying Asini coril colla,Astragali radix, Lycii fructus is simple and practicable, and negative control sample has no interference in TLC.The results of the checks of this preparation were in line with the Pharmacopoeia. Copper, lead, arsenic, mercury, cadmium and harmful elements content is within the scope of the security.With HPLC-ELSD method for determining the content of astragaloside, with HPLC method for determination of glycine, alanine, L- hydroxyproline and L- proline,the contents were 12.46 ? g/ml ~124.6 ? g/ml for glycine,23.62 ? g/ml ~236.2 ? g/ml for alanine,8.47 ? g/ml ~84.7 ? g/ml for L-hydroxyproline,19.14?g/ml~191.4?g/ml for L- proline respectively,the linear relation between peak area and concentration of the amino acids were good(r=0.9999,n=6).The recoveries were 97.91% for glycine,97.77% for alanine,97.67% for L-hydroxyproline,97.65% for L- proline respectively, RSD were1.70% ? 1.18% ?1.31%?1.29% respectively(n=9).When the concentration of astragaloside was within the range of 58.27?g/ml~582.7?g/ml,logarithm function of astragaloside had good linear relationship with logarithm function of its peak area(r=0.9999,n=6),the recovery of matrine was 97.71%, RSD=10.72%(n=9).By influencing factor test, accelerated test and long-term test, three batches of character, identification, examination and content determination of samples were within the rules.Conclusion :The preparation technics of the Compound Ejiao paste are reasonable and feasible. The quality standard is stable and can be used to control the quality of the product. |
PDF Full Text Request