Investigation On The Stability Of Xuanfeiqingre Granules

Objectives: Estimate the stability of Xuanfeiqingre granules after variety of stability tests by determine chemical composition of the granule's ingredient Ephedrine, Citrusreticulate, Glycyrrhiza, Belamcan-da, Zhejiang fritillary and the quantity control of the indexes ephedrine, hesperidins and glycyrrhizic acid give base for predict the granule's shelf life, optimize the produce and condition of storage.Methods: The chemical compositions were determined by Think Layer Chromatography (TLC) method, The contents of above indexes were determined by reversed-phase HPLC method. The dosage form was carried of ① Long-term test: put the granules 18 months under the condition of (25±2)℃ and RH (60 ±10)%, take sample at the time according to the Pharmacopoeia to confirm it's shelf life.②Classical constant temperature test: put granules at different temperature of 60 ℃ , 70 ℃ ,80 ℃, 90 ℃ ,t ake sample at different time, the change of different indexes content at different time was determined to estimate the shelf life of the granules and using Diffuse Reflectance Spectroscopy(DRS) to obtain a quantitative color measurement.(3)Stress test: under the condition in the pharmacopoeia stress test, exposed the granules to high moisture (90 ± 5), high temperature (60℃) and tungsten lamp (4500Lx ± 500Lx)for 10 days with different packaging, determine the infuse of these condition to the granules by the result of different indexes. ④Moisture stability test: put the granules under relative humidity (RH) 30%, 40%, 50%,60% , 70%, 80% , 90% condition for 7 days, estimate this granules critical relative humidity (CRH). ⑤Accelerated test of the Pharmacopoeia: putsample with the packaging identical with marketing under temperature(40 ± 2) ℃ and RH(75 ± 5)% condition 6months, determine whether it qualified to apply for the clinical test and producing.Results: l)Result of TLC: the granules compositions stability by TLC is stable and there is not any difference between the experiment result and stability control standard. 2)Result of quantity control① Stress test make it certain that this granules ingredients have certain moisture stability, photo stability and temperature stability, this experiment also indicate that the medical using complex bag can improve the granules moisture stability.② The activate energies of different indexes was calculated based on Arrhinius formula and the shelf-life was predicted. 2.4(a) for ephedrine, 2.1 (a) for glycyrrhizic acid, 3.5(a) for hesperidins. 182 day for the indexes of the granules color measurement. ③ The result of accelerated test in the pharmacopoeia indicate the granules has the quality to apply for the clinical test and producing. ④Long-term experiment: quantity test give different shelf -life according to different indexes, when ephedrine to be index t25 0.9 is 1.76(0709), 3.8(0812), 4.4(0817)(a), when glycyrrhizic acid 4.1(0709), 2.3(0812), 4.3(0817)(a), when hesperidins 7.5(0709), 4.4(0812), 4.2(0817)(a). ⑤The CRH is 68.1%.Conclusion: After variety of stability test to the Xuanfeiqingre granules, determined its stability in different condition. Xuanfeiqingre granules is Chinese medicine composed of kinds of herb, belong to solid dosage form, which is multiple phase system. So there are kinds of factor influence its stability. There for by variety of indexes to estimate the stability of Chinese medicine may be the best way to measure shelf life.