Studies On Quality Standard Of Jinju Jiedu Granules

Objective: To study the quality control of the Jinju Jiedu granule, a new form of Jiedu decoction of herbal medicine.Methods: The prescription of JINJU alexipharmic granule has the eight components of TCM. Here, the scientific studies have been conducted based on the prescription composition, physicochenical properties and extraction process, combined with Chinese pharmacopoeia and documents preparation quality analysis research. The four components of JINJU granule, including radix angelico sinensis, radix scutellariae, radix paeoniae rubra and radix bupleuri, were qualitatively analyzed by the thin layer chromatography(TLC) separately. Several conditions of the analysis, such as selection of solvent, staining method, etc, were optimized. The Hexane/ethyl acetate(9: 1) was selected as the agent for radix angelico sinensis and observed under ultraviolet light. The Ethyl acetate/butanone/formic acid/water(5: 3: 1: 1) combined with 2 % ferric chloride in ethanol was for radix scutellariae,and colored with heat. The Chloroform/ethyl acetate/methanol/formic acid(40: 5: 10: 0.2) combined with 5% vanillin sulfuric acid in ethanol was for radix paeoniae rubra, and heated color. The Bupleurum chloroform/methanol/water(13: 7: 2) with 5% vanillin sulfuric acid in ethanol for radix bupleuri. Further, a method based on high-performance liquid chromatography/ultraviolet spectroscopy was developed using gradient elution on a C18 column and radix scutellariae, active constituent of scutelloside was measured at wavelength 277 nm. Finally, the scutelloside's content was determined from three batch of finished product of JINJU alexipharmic granule, and the quality control was evaluated.Results: The results of qualitative analysis showed that the same color spots were found compared to the positive control for radix angelico sinensis, radix scutellariae, radix paeoniae rubra and radix bupleuri, and no spot on the negative control. The determination of the active ingredient scutelloside(C21H18O11) of JINJU alexipharmic granule shows that the analytic method meets the testing requirements. The concentration of scutelloside is more than 7.01 m.g-1. Three batch of finished productcontent is 8.7462 mg.g-1, 8.7933 mg.g-1, and 8.7581 mg.g-1, respectively. The general quality control of JINJU alexipharmic granule is in accordance to the requirements of Chinese pharmacopoeia granules under the related projects.Conclusions: The qualitative and quantitative analysis indicated that the developed quality standard for JINJU alexipharmic granule is simple and easy, strong specificity and reproducible, and could be used for quality control to evaluate JINJU alexipharmic granule.