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目的观察60钴-γ射线辐照对纯中药制剂生骨胶囊的灭菌效果。方法采用细菌定量和定性检测方法,对辐照前后生骨胶囊细菌总数、霉菌总数和灭菌效果进行检测。结果经过6 kGY剂量的60钴-γ射线辐照,生骨胶囊微生物限量检测指标符合国家药典规定,灭菌率达到了99%~100%。辐照前后胶囊外壳及内容物色泽未发生变化,物理性状、水分、崩解时限、装量差异、含量测定等各项指标均符合质量标准规定。结论用6 kGy的60钴γ-射线辐照对纯中药制剂生骨胶囊进行灭菌可达到安全、方便、有效的要求。
Objective To observe the sterilization effect of 60 cobalt-γ ray irradiation on the pure Chinese traditional medicine preparation. Methods Bacterial quantitative and qualitative detection methods were used to detect the total number of bacteria, the total number of molds and the sterilization effect of Shenggu Capsules before and after irradiation. Results After the 6 kGY dose of 60Co-γ-ray irradiation, the limit detection index of Shenggu capsule was in line with the national pharmacopoeia, and the sterilization rate reached 99% -100%. Before and after irradiation, the color of the capsule shell and its contents did not change. All the indexes of physical properties, water content, disintegration time, loading capacity and contents were in accordance with the quality standards. Conclusion It is safe, convenient and effective to sterilize Shenggu Capsule with 6 kGy 60Co γ-ray irradiation.