| 摘要: |
| 目的：以红花生药粉为研究对象，深入探讨2种辐照灭菌技术应用于中药生药粉的适宜范围及其优缺点，以期为后期红花生药粉在实际生产应用中选择合适的灭菌方法提供参考。方法：研究不同辐照剂量（0、2、4、6、8、10 kGy）的60Co-γ辐照和电子束辐照对其性状、微生物限度、指标成分含量及指纹图谱的影响。根据不同辐照剂量，优化红花生药粉的2种辐照灭菌加工工艺。结果：对比不同辐射源、剂量下红花原生药粉的性状、含菌量、药典成分含量和指纹图谱，在10 kGy剂量内，在60Co-γ辐照灭菌和电子束辐照灭菌后，红花的性状变化无显著性差异。低剂量（2 kGy）辐照条件下即能达到国家药品卫生标准细菌总数，贮藏3个月后发现，辐照剂量越大检出微生物总数越少，说明辐照剂量的增加有利于红花原生药粉的贮藏，且相同剂量条件下60Co-γ辐照灭菌效果较电子束辐照灭菌效果好。红花生药粉经2、6、8、10 kGy 60Co-γ辐照和电子束辐照后，在10 kGy剂量下红花电子束辐照在10 kGy内变化差异不显著，红花经10 kGy 60Co-γ辐照后其成分羟基红花黄色素A含量发生一定变化，因此建议红花60Co-γ辐照剂量应控制在0~8kGy内。 |
| 关键词: 红花 生药粉 辐照灭菌 工艺 实验研究 |
| DOI： |
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| Effect of two irradiation methods on sterilization of Carthamus tinctorius crude drug powder |
| ZHOU Shishi,LIAO Xin,LI Penghui |
| (Hunan Center for Drug Evaluation and ADR Monitoring，Changsha 410013，Hunan，China;Hunan Academy of Chinese Medicine，Changsha 410006，Hunan，China) |
| Abstract: |
| Objective：To investigate the application of two irradiation sterilization techniques in traditional Chinese medicine (TCM) crude drug powder in terms of scope of application，advantages，and disadvantages with Carthamus tinctorius crude drug powder the research object，and to provide a reference for selecting appropriate sterilization methods in the production of Carthamus tinctorius crude drug powder.Methods：The methods of 60Co-γ irradiation and electron beam irradiation at different doses (0，2，4，6，8，and 10 kGy) were analyzed from the aspects of their influence on properties，microbial limit，content of marker components，and fingerprint.The two irradiation sterilization processes for Carthamus tinctorius crude drug powder were optimized based on the different irradiation doses.Results：The samples of Carthamus tinctorius crude drug powder treated by irradiation with different sources and doses were compared in terms of properties，bacteria content，content of components in Chinese Pharmacopoeia，and fingerprint，and within the dose of 10 kGy，there was no significant change in the properties of Carthamus tinctorius after 60Co-γ irradiation or electron beam irradiation.Low-dose (2 kGy) irradiation could meet the national drug hygienic standard for total bacterial count，and after 3 months of storage，the observation showed that total microbial count decreased with the increase in irradiation dose，suggesting that the increase in irradiation dose might help with the storage of Carthamus tinctorius crude drug powder and that 60Co-γ irradiation had a better sterilization effect than electron beam irradiation under the same dose.Conclusion：After 60Co-γ irradiation or electron beam irradiation at a dose of 2，6，8，and 10 kGy，there is no significant change in Carthamus tinctorius crude drug powder within the dose of 10 kGy.There is a certain change in the content of hydroxysafflor yellow A after 60Co-γ irradiation at a dose of 10 kGy，and therefore，the dose of 60Co-γ irradiation should be controlled within the range of 0-8 kGy. |
| Key words: Carthamus tinctorius crude drug powder irradiation sterilization process experimental study |
