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目的探讨胶囊封口技术是否能够解决易挥发、易氧化、易吸湿药物的稳定性问题。方法通过对胶囊封口次数及封口干燥时间的考察,优化封口工艺;并以质量分数、吸湿增重等量化指标对特定药物封口前后胶囊剂质量稳定性进行评价。结果包衣液黏度为(130±5)mPa.s,封口速度为(75±5)r/min,对胶囊封口2次,封口后置25℃、相对湿度60%条件下干燥4 h,封口效果较好;经稳定性考察,封口胶囊中维生素C为(95.88±1.33)%,高于未封口胶囊,封口葡萄糖胶囊吸湿率为(0.32±0.06)%,未封口葡萄糖胶囊为(0.27±0.05)%;封口前后胶囊释放行为无明显差异;乙醇残留量为11.7μg/粒,丙酮未检出。结论胶囊封口技术可以提高易挥发、易氧化、易吸湿药物制剂的稳定性。
Objective To investigate whether capsule sealing technology can solve the problem of stability of easily volatile, easily oxidized and hygroscopic drugs. Methods The number of sealed capsules and drying time were optimized to optimize the sealing process. The quality stability of the capsules before and after the given drugs were evaluated by the quantitative indexes such as mass fraction, moisture absorption and weight gain. Results The viscosity of the coating solution was (130 ± 5) mPa.s, the sealing speed was (75 ± 5) r / min, the capsules were sealed twice, sealed at 25 ℃ and relative humidity of 60% for 4 h. (95.88 ± 1.33)%, which was higher than that of unsealed capsules (0.32 ± 0.06%) and that of unsealed glucose capsules was (0.27 ± 0.05) )%. There was no significant difference in the release behavior between the capsules before and after sealing. The ethanol residue was 11.7 μg / tablet, but acetone was not detected. Conclusion Capsule sealing technology can improve the stability of volatile, easily oxidized and easily absorbed drug formulations.