^(60)Co辐射灭菌对紫草油质量的影响  

Effect of^(60)Co Radiation Sterilization on Thequality of Oleum Lithospermi

作　　者：赵雪梅 钟密 Zhao Xuemei;Zhong Mi(Jiangyou City Hospital of Traditional Chinese Medicine,Jiangyou 621700,China)

机构地区：[1]江油市中医医院,四川江油621700

出　　处：《亚太传统医药》2024年第2期47-50,共4页Asia-Pacific Traditional Medicine

摘　　要：目的:考察三批次不同剂量^(60)Co辐射灭菌对院内制剂紫草油的性状、定性鉴别、含量测定、微生物限度检查等质量控制指标的影响,为紫草油实现最终灭菌提供参考。方法:根据2020版《中华人民共和国药典》、四川省药品监督管理局批准的质量标准SZBZ20081112要求,观察紫草油性状变化;采用薄层色谱法对紫草油与紫草对照药材进行定性鉴别;采用紫外分光光度法,检测羟基萘醌总色素含量,在520 nm波长处测定吸光度,按左旋紫草素(C6H16O5)的吸收系数(E1%1 cm)为242计;采用微生物计数法,进行需氧菌总数、霉菌和酵母菌总数、控制菌检查(金黄色葡萄球菌、铜绿假单胞菌)等微生物限度检测。结果:3 kgy、5 kgy、6 kgy辐射灭菌后的制剂均符合质量标准的要求,10 kgy、20 kgy辐射灭菌后的制剂不符合质量标准的要求。结论:^(60)Co辐射灭菌,具有灭菌作用显著、穿透力强、不需升高温度、无化学残留物、可实现带包装最终灭菌、操作简便等特点,能达到灭菌的效果,不影响紫草油质量,有实用价值。Objective:To investigate different doses of^(60)Co radiation sterilization on three batches oleum lithospermi,Test the control indexes such as Characters、Thin layer identification,Content determination,Microbiological limit test,To provide reference for the final sterilization of oleum lithospermi.Methods:Test the oleum lithospermiaccording to the 2020 edition of Chinese Pharmacopoeia and quality standard SZBZ20081112 approved by Sichuan Provincial Food and Drug Administrationm,Observe character change;Use thin layer chromatography(TLC)to identify the oleum lithospermi and its control herb of comfrey;Use ultraviolet spectrophotometry to determination the total pigment of hydroxynaphthoquinone,the absorbance was measured at 520 nm wavelength,and the absorption coefficient(E1%1cm)of levoshitin(C6H16O5)was 242;Use microbiological counting method to detect microbial limit,include the total number of aerobic bacteria,the total number of molds and yeasts,the control bacteria(Staphylococcus aureus,Pseudomonas aeruginosa).Results:3kgy,5kgy,and 6kgy,preparations after radiation sterilization conform to the requirements of quality standards,10kgy,20kgy radiation did not conform.Conclusion:The oleum lithospermi sterilized by^(60)Co radiation,which has a significant sterilization effect,strong penetration,no need to increase the temperature,no chemical residue,can realize the final sterilization with packaging,simple operation,and other characteristics.It can achieve the effect of sterilization,does not affect the quality of the preparation,and has practical value.

关 键 词：^(60)Co辐射灭菌 紫草油 含量测定 微生物限度检查 

分 类 号：R283[医药卫生—中药学]