基于对照制剂和光释光法检测牛黄清胃丸~(60)Co-γ射线辐照情况
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摘要
目的:采用光释光法建立牛黄清胃丸~(60)Co-γ辐照的检测方法,以未经辐照的对照制剂为参考,评价样品辐照情况。方法:参照欧盟标准(EN)13751:2002,利用SURRC PPSL辐照食品筛查系统,无需前处理,直接检测样品辐照情况。结果:测定值可以反映样品是否经过辐照,阴性对照无干扰。18个厂家的49批次样品PSL值在223~163 756,可初步推测部分被测样品经过~(60)Co-γ辐照灭菌处理。结论:所建方法操作简便、快速、经济,可为牛黄清胃丸的质量控制和安全用药提供参考。
Objective:To establish a photostimulated luminescence(PSL) method for the detection of ~(60)Co-γ irradiated Niuhuang Qingwei pills,and evaluate the irradiation situation of samples by using the irradiation-free pills as reference.Methods:Based on European standard of EN 13751:2002,the irradiation condition of samples was detected directly without pretreatment using the SURRC(PPSL) system as the analyzer.Results:The measured values could reflect the irradiation of samples without interference from the negative sample.The PSL values of 49 bathes of samples from 18 manufacturers were within 223-163 756,which indicted that all the investigated samples were sterilized by ~(60)Co-γ irradiation.Conclusion:The proposed method is simple,fast and economic,which provides reference for the quality control and safe use of Niuhuang Qingwei pills.
Objective:To establish a photostimulated luminescence(PSL) method for the detection of ~(60)Co-γ irradiated Niuhuang Qingwei pills,and evaluate the irradiation situation of samples by using the irradiation-free pills as reference.Methods:Based on European standard of EN 13751:2002,the irradiation condition of samples was detected directly without pretreatment using the SURRC(PPSL) system as the analyzer.Results:The measured values could reflect the irradiation of samples without interference from the negative sample.The PSL values of 49 bathes of samples from 18 manufacturers were within 223-163 756,which indicted that all the investigated samples were sterilized by ~(60)Co-γ irradiation.Conclusion:The proposed method is simple,fast and economic,which provides reference for the quality control and safe use of Niuhuang Qingwei pills.
引文
1李计萍.γ射线辐照灭菌法在中药及其制剂中应用现状和相关问题讨论[J].中国中药杂志,2007,32(19):2078-2081
2 孙建宇.60Co-γ射线辐照灭菌在中药及制剂中的应用研究[J].中国药师,2006,9(5):464-465
3 游强蓁,李雪松,贺云杰,等.人参等中药材辐照灭菌前后质量对比研究[J].天津药学,2017,29(5):15-21
4 张世才,李奉勤,史冬霞,等.辐照灭菌在中药方面的应用研究进展[J].中国药业,2009,18(20):76-77
5 孙建宇,陈红梅,李兆奎,等.60Co-γ射线辐照对赤芍和黄芩有效成分的影响[J].中国药师,2007,10(8):777-778
6 位鸿,金珠,李秉钧.钴60-γ射线辐射对骨痹颗粒中淫羊藿苷含量的影响[J].中国现代应用药学,2006(s3):893-894
7 原国家食品药品监督管理总局.国家食品药品监督管理总局关于发布中药辐照灭菌技术指导原则的通告(2015年第86号)(2015-11-09)[2018-01-09]. http://samr. cfda. gov. cn/WS01/CL0087/135252. html
8 原卫生部药品标准[S].中药成方制剂.第1册. 1988. 38
9 聂黎行,张烨,王赵,等.光释光法检测牛黄清心丸(局方)60Co-γ辐照情况[J].食品与药品,2018,20(1):6-9
10 黄晓婧,周晓英.成都地区中药钴-60辐照情况调研报告[J].中国药物评价,2017,34(1):33-35
11 陈佳,金红宇,田金改,等.60Co-γ射线灭菌后中药材中的辐照残留考察[J].药物分析杂志,2012,32(9):1694-1696
12 European Standard EN 13751. Foodstuffs Detection of irradiated food using photostimulated luminescence[S]. European Committee for standardization,2002
13 乔蓉霞,张国跃,杨瑞瑞.光刺激发光法筛查检测牛黄上清制剂的辐照残留[J].中国医药导刊,2011,13(7):1280-1281
14 白羽.60Co-γ射线辐照对中药化学成分影响及辐照中药鉴定的热释光分析法研究[D].长春:吉林大学博士学位论文,2014
15 聂黎行,戴忠,马双成.中药对照制剂研制指导原则和技术要求[J].中国中药杂志,2017,42(19):3672-3675
16 白洁,迟玉明,金红宇,等.《中药辐照灭菌技术指导原则》解读[J].中成药,2017,39(7):1537-1538
2 孙建宇.60Co-γ射线辐照灭菌在中药及制剂中的应用研究[J].中国药师,2006,9(5):464-465
3 游强蓁,李雪松,贺云杰,等.人参等中药材辐照灭菌前后质量对比研究[J].天津药学,2017,29(5):15-21
4 张世才,李奉勤,史冬霞,等.辐照灭菌在中药方面的应用研究进展[J].中国药业,2009,18(20):76-77
5 孙建宇,陈红梅,李兆奎,等.60Co-γ射线辐照对赤芍和黄芩有效成分的影响[J].中国药师,2007,10(8):777-778
6 位鸿,金珠,李秉钧.钴60-γ射线辐射对骨痹颗粒中淫羊藿苷含量的影响[J].中国现代应用药学,2006(s3):893-894
7 原国家食品药品监督管理总局.国家食品药品监督管理总局关于发布中药辐照灭菌技术指导原则的通告(2015年第86号)(2015-11-09)[2018-01-09]. http://samr. cfda. gov. cn/WS01/CL0087/135252. html
8 原卫生部药品标准[S].中药成方制剂.第1册. 1988. 38
9 聂黎行,张烨,王赵,等.光释光法检测牛黄清心丸(局方)60Co-γ辐照情况[J].食品与药品,2018,20(1):6-9
10 黄晓婧,周晓英.成都地区中药钴-60辐照情况调研报告[J].中国药物评价,2017,34(1):33-35
11 陈佳,金红宇,田金改,等.60Co-γ射线灭菌后中药材中的辐照残留考察[J].药物分析杂志,2012,32(9):1694-1696
12 European Standard EN 13751. Foodstuffs Detection of irradiated food using photostimulated luminescence[S]. European Committee for standardization,2002
13 乔蓉霞,张国跃,杨瑞瑞.光刺激发光法筛查检测牛黄上清制剂的辐照残留[J].中国医药导刊,2011,13(7):1280-1281
14 白羽.60Co-γ射线辐照对中药化学成分影响及辐照中药鉴定的热释光分析法研究[D].长春:吉林大学博士学位论文,2014
15 聂黎行,戴忠,马双成.中药对照制剂研制指导原则和技术要求[J].中国中药杂志,2017,42(19):3672-3675
16 白洁,迟玉明,金红宇,等.《中药辐照灭菌技术指导原则》解读[J].中成药,2017,39(7):1537-1538