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The aniracetam gamma-lactam brain function improving drug, the chemical name 1 - (4 - methoxybenzoyl) -2 - pyrrolidone, it can be through the blood-brain barrier selective effect on brain cells, protecting brain function to improve learning and memory, clinically used for the treatment of cerebrovascular disease, memory loss and senile dementia. Aniracetam compared with similar drugs piracetam has a rapid onset of effect, and low toxicity, memory impairment caused by cerebrovascular diseases have a certain effect. This article aims to develop a new dosage form in Aniracetam - dispersible tablets. This article was first established by High Performance Liquid Chromatography Determination of the dispersible tablets Aniracetam and related substances UV spectrophotometric determination of aniracetam dispersible tablets in vitro dissolution. HPLC results of method validation, Aniracetam 20.04μg ∥ ml to 200.4μg/ml concentration range a good linear relationship, the regression equation: A = 15841.0 57711.5C., R = 0.9999 (n = 7), the average recovery rate in 99 % to 101% of the between RSD lt; 0.27%, instrument precision and days stability are good, RSD were 0.08%, 0.90%, in line with the the dispersible tablets Aniracetam determination requirements; LOQ was 18ng minimum of The detection limit of 5 ng, impurity peak in the sample treated with acid, alkali, oxidizing agent, high-temperature test, after the destruction of the main component peak separation Dispersible tablets were found. aniracetam requirements to the determination of related substances. UV methodological study results show that, in 0.1 mol / L HCl solution, Aniracetam, in 2.0 to 12.0μg/ml concentration range, a linear relationship between absorbance and concentration is good, on A = 0.0495C-7.33 × 10-4, R: 0.9999, good precision, stable solution within 8 hours, the average recovery rate of between 99% -102%, in line with the requirements dissolution determination. Secondly, the type of evaluation indicators, the type and dosage of the disintegrant were investigated, and the kind of the lubricant dosage, particle size, granulation, pressure, disintegrants Add-way and other factors of aniracetam tablet quality of impact, while the dissolution medium, the dissolution speed of aniracetam dispersible tablets dissolution. Experimental results show that the prescription with the amount of PVPP aniracetam dispersible tablets dissolution greatest impact; granulation process, the particle size, the tableting pressure, disintegrants Add method of process conditions on the release rate of aniracetam dispersible tablets also significantly impact; media and speed the dissolution rate of aniracetam dispersible tablets had no significant effect. The reproducibility of experimental results show that, The dispersible tablets prescription Aniracetam rationality, the stability of the preparation process, three batches of samples dissolution are - good and consistent with the listed sample. In addition, by influencing factor experiment (strong light, high temperature, high humidity) were studied the dispersible tablets Aniracetam preliminary stability. The results show that the dispersible tablets Aniracetam light, high temperature and high humidity conditions are stable. Constant temperature accelerated stability study of the indicators no significant change: room temperature to stay kind of study 18 months, stable product quality, further aniracetam dispersible tablets have good stability. The results of this study aniracetam dispersible tablets listed large-scale industrial production has laid a sound basis for, dispersible tablets of this formulation development provides a systematic method has practical value and theoretical significance.
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