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目的:探索γ-射线辐照灭菌对四妙君逸软膏有效成分的降解作用和灭菌前后指纹图谱的变化,为四妙君逸软膏能否采用γ-射线辐照灭菌提供依据。方法:HPLC测定四妙君逸软膏中延胡索乙素和三七总皂苷的含量,建立四妙君逸软膏HPLC指纹图谱分析方法,比较同一批和不同批次四妙君逸软膏γ-射线辐照灭菌前后延胡索乙素和三七中三种皂苷总量的变化,以及指纹图谱相对保留时间和相对峰面积的改变。结果:γ-射线辐照灭菌前后延胡索乙素含量基本上无变化(P>0.05);三七中三种皂苷总量无改变(P>0.05);比较γ-射线辐照灭菌与未灭菌软膏在280 nm处的HPLC指纹图谱,相对保留时间变化有统计学意义(P<0.05),相对峰面积变化无统计学意义(P>0.05),特征峰减少了1个,即C8号峰在辐射灭菌图谱中消失,C6、C9、C14号峰相对峰面积明显减小,C12号峰相对峰面积增大。结论:γ-射线辐照灭菌对四妙君逸软膏中延胡索乙素含量和三七中三种皂苷总量无影响;四妙君逸软膏可采用γ-射线辐照灭菌法灭菌。
OBJECTIVE: To explore the degradation of the active ingredient of Si Miao Jun Yi ointment and the change of the fingerprint before and after sterilization by γ-ray irradiation sterilization, and provide the basis for whether Siliujunyi ointment can be sterilized by γ-ray irradiation. Methods: The contents of tetrahydropalmatine and Panax notoginseng saponins in Simiao Junyi Ointment were determined by HPLC. The HPLC fingerprinting method of Simiao Junyi ointment was established. Γ-ray irradiation of Simiao Junyi ointment of the same batch and different batches was compared The changes of the total amount of tetrahydropalmatine and the three saponins before and after sterilization, as well as the relative retention time and relative peak area of the fingerprint. Results: The content of tetrahydropalmatine was almost unchanged before and after γ-ray irradiation (P> 0.05). The total amount of three saponins in Panax notoginseng was no change (P> 0.05). Compared with γ-ray irradiation sterilization The relative retention time of the sterilized ointment at 280 nm was statistically significant (P <0.05), and the relative peak area was not significantly different (P> 0.05). The characteristic peak was reduced by 1 Peak disappeared in the radiation sterilization spectrum, C6, C9, C14 peak relative area was significantly reduced, C12 peak relative area increased. CONCLUSION: γ-ray irradiation sterilization has no effect on the content of tetrahydropalmatine and the total amount of the three saponins in Simaojun Yili Ointment. The Si Miao Junyi ointment can be sterilized by γ-ray irradiation sterilization.