YAO Jun-na, DU Mao-bo, Yi Hong, et al. Conformance Assessment of Dissolution Curves of Compound Artemether Lumefantrine Tablets [J]. Chinese journal of experimental traditional medical formulae, 2018, 24(15): 43-50.
YAO Jun-na, DU Mao-bo, Yi Hong, et al. Conformance Assessment of Dissolution Curves of Compound Artemether Lumefantrine Tablets [J]. Chinese journal of experimental traditional medical formulae, 2018, 24(15): 43-50. DOI: 10.13422/j.cnki.syfjx.20181416.
Objective: To assess the conformance of dissolution behavior of artemether and lumefantrine in compound artemether lumefantrine tablets in four different dissolution media in this study. Method:According to the second method of determination and release in Chinese Pharmacopoia(2015 edition)
the dissolution curves of artemether and lumefantrine in the four dissolution media of water
pH 1.2(0.1 mol·L-1 hydrochloric acid solution of 1% benzyl chloride of dimethyl alkyl amine)
pH 2.5(hydrochloric acid solution of three hydroxymethyl aminomethane) and pH 4.5(hydrochloric acid solution of sodium hydroxide and citric acid)were determined by high performance liquid chromatography (HPLC) and ultraviolet and visible (UV) spectrophotometry respectively. The method of similarity factor(f2) was used to compare the similarities of dissolution curves of the imitation preparation and the reference preparation. Result:Among the four dissolution media
the similarity factors between the imitation preparations were from 90 to 96
which meant that the production process was stable;the similarity factors between the imitation preparation and the control preparation were from 52 to 71
all greater than 50
which meant that the dissolution curves were similar to each other. Conclusion:The dissolution curves are consistent between the imitation formulations and control formulations in vitro
which provide the basis for further study of the imitation preparations.