论文部分内容阅读
目的:制备复方灵草益肺胶囊,对其质量标准进行研究,并考察其稳定性。方法:以原料药材粉末直接灌装制备胶囊,考察性状,对其成分进行鉴别,并检查水分、重金属、砷盐、崩解时限、重量差异及微生物限度,同时通过加速试验、室温留样观察试验考察制剂的稳定性。结果:本品各项检查均符合要求,且在采用模拟上市包装条件下,加速试验6个月和室温留样观察24个月,各项考察指标与0月比较,均基本上无明显变化。结论:本品制备工艺简便、可行,质量可控,稳定性良好。
Objective: To prepare compound Lingcao Yifei capsule, study its quality standard, and investigate its stability. METHODS: Capsules were prepared by directly filling raw materials with medicinal powders. Their properties were examined, their components were identified, and moisture, heavy metals, arsenic salts, disintegration time, weight differences, and microbial limits were examined. Accelerated tests and observations at room temperature were also observed. The stability of the formulation was examined. Results: All the tests of this product were in compliance with the requirements. Under the conditions of using the simulated and listed packaging, the accelerated test for 6 months and the sample left at room temperature were observed for 24 months. There was no significant change in the inspection indicators compared with the month of January. Conclusion: This product preparation process is simple, feasible, controllable quality and good stability.