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目的:研究柠檬酸对难溶性药物长春西汀控释片制备及体外释放的影响。方法:将柠檬酸和长春西汀以一定摩尔比的处方溶出度为指标,确定处方中柠檬酸与长春西汀比例制备控释片,并在一定的释放介质中考察柠檬酸对释放度的影响,确定最优处方,并在不同的释放介质中考察释放行为,以HPLC法检测长春西汀,考察释放液中柠檬酸对长春西汀稳定性的影响。结果:长春西汀的溶解度随着柠檬酸量的增加而增加;包衣成片在0.5%SDS水溶液中释放的趋势与片芯在水中的溶出趋势相似;HPLC检测释放液中没有降解物峰出现。结论:长春西汀的溶解度呈pH依赖性;释放介质中有一定数量的氢离子通过了,从而影响药物长春西汀的释放,提示选择适宜的释放介质对评价处方的重要性;不同释放介质中的释放和色谱检测结果进一步证明加入柠檬酸不会改变原料药的性质。
Objective: To study the effect of citric acid on the preparation and in vitro release of vinpocetine controlled-release tablets. Methods: Citric acid and vinpocetine were dissolved in a certain molar ratio of prescription as an indicator to determine the proportion of citric acid and vinpocetine in the preparation of controlled release tablets, and in a certain release medium citric acid on the release of degree of influence , To determine the optimal prescription, and in different release media to examine the release behavior, HPLC detection of vinpocetine, to investigate the release of citric acid on the stability of vinpocetine. Results: The solubility of vinpocetine increased with the increase of the amount of citric acid. The tendency of the released tablets in 0.5% SDS aqueous solution was similar to that of the tablet core in water. . CONCLUSION: The solubility of vinpocetine is pH-dependent; a certain amount of hydrogen ions are released in the release medium, which affects the release of vincristine. It suggests that the choice of suitable release medium is of importance for the evaluation of prescription. In different release media The release and chromatographic results further confirm that the addition of citric acid does not alter the properties of the drug substance.