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目的:考察匹伐他汀钙片在不同pH值条件下的稳定性。方法:选择碳酸氢钠、磷酸氢二钠、L-精氨酸作为p H调节剂,制备匹伐他汀钙片,分别与未加pH调节剂的处方进行影响因素比较,以片剂的外观、含量、有关物质为指标考察其稳定性。结果:pH调节剂为碳酸氢钠、磷酸氢二钠、L-精氨酸及未加pH调节剂的处方的pH值分别为9.20、7.86、7.25及6.44。根据影响因素结果知加入碳酸氢钠及未加pH调节剂的处方在高温、光照条件下有关物质增加较加入磷酸氢二钠、L-精氨酸显著,含量亦降低明显。结论:匹伐他汀钙片在pH值为7-8左右时,较为稳定。
Objective: To investigate the stability of pitavastatin calcium tablets under different pH conditions. Methods: Sodium bicarbonate, disodium hydrogen phosphate and L-arginine were selected as p H modifier to prepare pitavastatin calcium tablets. The influencing factors were compared with those without pH modifier. The appearance, Content, related substances as an indicator of its stability. Results: The pH adjusting agents were sodium bicarbonate, sodium phosphate dibasic, L-arginine and no pH modifier. The pH values were 9.20, 7.86, 7.25 and 6.44, respectively. According to the results of the results known to add sodium bicarbonate and no pH regulator prescription at high temperatures, light conditions, compared with the increase of substances related to the addition of dibasic sodium phosphate, L-arginine significantly, the content also decreased significantly. Conclusion: Pitavastatin calcium tablets are stable at pH around 7-8.