合成色素赤藓红对明胶空心胶囊质量的影响

Study on the Effect of Synthetic Pigment Erythrosine on the Quality of Gelatin Hollow Capsules

研究合成色素赤藓红对明胶空心胶囊质量的影响,考察赤藓红在明胶空心胶囊中添加量的安全范围及可能的质量风险。采用的方法为,用蘸胶法制备不同赤藓红含量的明胶空心胶囊,以性状、崩解时限、溶出度、水分和赤藓红含量为检测指标,进行质量考察,同时进行胶囊的稳定性研究。取得以下结果:在高温条件下胶囊较为稳定,在高湿度条件下,赤藓红可引起明胶空心胶囊粘度上升,崩解时间延长,溶出率下降,水分增加,导致胶囊崩解时限、溶出度和水分不符合药典规定;在强光照射条件下,赤藓红容易褪色,赤藓红的含量降低,且胶囊粘度下降;加速条件下,胶囊的粘度不断上升,赤藓红的含量逐步下降,崩解时间延长,溶出下降。得到的结论为,合成色素赤藓红耐热性好,耐光性差,具有吸湿性,其用量对明胶空心胶囊稳定性影响较大,赤藓红添加量≤0.05%时,稳定性符合药典要求,故应用时要严格控制用量,以降低不合格风险。

Objective:To study the effect of synthetic pigment Erythrosine on the quality of gelatin hollow capsules,and to investigate the safety range and possible quality risk of Erythrosine dosage in gelatin hollow capsules.Methods:Gelatin hollow capsules with different content of Erythrosine were prepared by dipping gelatin,and their properties,disintegration time,dissolution,water content and Erythrosine content were determined.The quality of the capsule was investigated and the stability of the capsule was studied.Results:The capsule was stable at high temperature.Under high humidity,Erythrosine could increase the viscosity of gelatin hollow capsule,prolong the disintegration time,decrease the dissolution rate and increase the water content,which led to the disintegration time limit,dissolution and water content of the capsule did not meet the requirements of pharmacopoeia.Under strong light,Erythrosine was easy to fade,its content decreased and the viscosity of the capsule decreased.Under accelerated conditions,the viscosity of the capsule gradually increased,and the content of Erythrosine gradually decreased.The disintegration time prolonged and the dissolution decreased.Conclusion:The synthetic pigment Erythrosine has good heat resistance,poor light resistance and hygroscopicity.Its dosage has great influence on the stability of gelatin hollow capsules.When the dosage of Erythrosine is less than 0.05%,the stability meets the requirements of pharmacopoeia.Therefore,the dosage should be strictly controlled in order to reduce the risk of unqualification.