肉豆蔻饮片微生物计数检查方法研究及其在霉变过程中菌落总数的测定
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摘要
目的:研究肉豆蔻饮片微生物限度检查的方法,分析不同霉变程度肉豆蔻饮片需氧菌、霉菌及酵母菌菌落总数的变化趋势。方法:参照2015年版《中国药典》四部"通则1105非无菌产品微生物限度检查:微生物计数法"进行方法的建立和验证,采用建立的方法对霉变过程中的肉豆蔻饮片进行微生物计数。结果:肉豆蔻饮片对方法适应性验证的5种菌均有抑制作用,需采用培养基稀释法进行检验。随着霉变程度加大,肉豆蔻饮片需氧菌、霉菌、酵母菌菌落总数均呈升高趋势,且加速0-6天时增长缓慢,6-9天呈爆发式增长,9-39天匀速增长。结论:该方法可用于肉豆蔻饮片的微生物计数。建议对易霉变药材肉豆蔻增设需氧菌、霉菌、酵母菌总数限值,以保障用药安全。
Objective: To establish the method of microbiological limit test of Myristicae Semen, and to analyze the trend of the total number of aerobic bacteria, molds, and yeast colonies in different levels of mildew. Methods: General Rule1105 Microbial Limit Test for Non-sterile Products: Microbial count in Chinese Pharmacopoeia(2015 edition)was referred and applied to establish and validate the method, which afterwards was used to conduct microbiological counting of the nutmeg cut pieces in the mildew process. Results: The Myristicae Semen had inhibitory effects on the five kinds of bacteria in the method validation. The medium dilution method was used for testing. With the development of moldiness,the total number of aerobic bacteria, molds, and yeast colonies in the moldy decoction pieces showed an increasing trend,and the growth rate was slower at 0 to 6 days, and the explosive growth was observed at 6 to 9 days, and the average increasing rate was 9 to 39 days. Conclusion: This method can be used for microbiological counting of Myristicae Semen.It is recommended to increase the total number of aerobic bacteria, molds, and yeasts in the nutmeg which is quite likely to mildew once in poor or inappropriate storage condition. Therefore, in order to ensure the safety of medication microbiological indexes should be also supervised.
Objective: To establish the method of microbiological limit test of Myristicae Semen, and to analyze the trend of the total number of aerobic bacteria, molds, and yeast colonies in different levels of mildew. Methods: General Rule1105 Microbial Limit Test for Non-sterile Products: Microbial count in Chinese Pharmacopoeia(2015 edition)was referred and applied to establish and validate the method, which afterwards was used to conduct microbiological counting of the nutmeg cut pieces in the mildew process. Results: The Myristicae Semen had inhibitory effects on the five kinds of bacteria in the method validation. The medium dilution method was used for testing. With the development of moldiness,the total number of aerobic bacteria, molds, and yeast colonies in the moldy decoction pieces showed an increasing trend,and the growth rate was slower at 0 to 6 days, and the explosive growth was observed at 6 to 9 days, and the average increasing rate was 9 to 39 days. Conclusion: This method can be used for microbiological counting of Myristicae Semen.It is recommended to increase the total number of aerobic bacteria, molds, and yeasts in the nutmeg which is quite likely to mildew once in poor or inappropriate storage condition. Therefore, in order to ensure the safety of medication microbiological indexes should be also supervised.
引文
1落楠.药典委发文说明饮片微生物限度检查法起草情况.中国医药报, 2018, 03, 30(001).
2 国家药典委员会网站.对《中国药典》2020年版“中药饮片微生物限度检查方法”及“无菌药品微生物限度标准”(增修订草案)起草情况的说明http://www.chp.org.cn/view/ff80808161653a930163f2090751422a?a=GZWJ.
3 张子英,伊乐,爱民,等.肉豆蔻挥发油对大鼠心肌的保护作用.内蒙古中医药, 2013, 32(13):123-124.
4 王阳,马瑞莲,马睿婷,等.蒙药肉豆蔻挥发油对大鼠心肌缺血再灌注损伤的保护作用.内蒙古医学院学报, 2010, 32(2):124-128.
5 孙婷婷.肉豆蔻挥发油抗抑郁作用及机制研究.郑州:河南中医学院, 2014.
6 贾天柱,李洁,周粮,等.肉豆蔻不同炮制品止泻作用及急性毒性比较.中国中药杂志, 1997(4):24-26.
7 贾天柱,沙明,曹爱民,等.肉豆蔻不同炮制品挥发油中丁香酚类成分测定.中国中药杂志, 1997(8):27-28+64.
8 袁子民,刘欢,王静.肉豆蔻及炮制品醇提取物的止泻及抗炎作用研究.时珍国医国药, 2015, 26(12):2910-2911.
9 张慧,王静,袁子民,等.肉豆蔻总木脂素纯化工艺及其抗炎活性研究.中国中医药信息杂志, 2017, 24(6):83-86.
10 王远志,李宏志.两种肉豆蔻挥发油对人癌细胞体外增殖影响的比较研究.辽宁中医杂志, 2008(6):847-848.
11 裴凌鹏,崔箭.维药肉豆蔻体内抗肿瘤及其免疫调节作用的实验研究.中国民族民间医药, 2009, 18(3):23-24.
12 谢小梅,陈资文,陈和利,等.花椒、肉豆蔻防霉作用实验研究.时珍国医国药, 2001(2):100-101.
13 Gupta A D, Vipin K B, Vikash B, et al. Chemistry, antioxidant and antimicrobial potential of nutmeg(Myristica fragrans Houtt). J Genet Eng Biotechnol, 2013, 11(1):25-31.
14 袁子民,刘欢,贾天柱,等.肉豆蔻及炮制品醇提取物的抗氧化作用.长春中医药大学学报, 2015, 31(5):930-932.
15 Adiani V, Gupta S, Chatterjee S, et al. Activity guided characterization of antioxidant components from essential oil of Nutmeg(myristica fragrans). J Food Sci Technol, 2015, 52(1):221-230.
16 唐裕芳,曾永德,张妙玲.商品肉豆蔻挥发油化学组成及抑菌活性研究.湘潭大学自然科学学报, 2014, 36(4):56-62.
17 国家药典委员会编.中华人民共和国药典2015年版四部.北京:中国医药科技出版社. 2015.
18 秦筱茂,郭顺星.药材霉菌及霉菌毒素污染现状分析.中国中药杂志, 2011, 36(24):3397-3404.
19 李闽真,马群飞,傅武胜.市售中药材霉菌污染情况和优势种群分布的研究.中国卫生检验杂志, 2013, 23(17):3351-3356.
2 国家药典委员会网站.对《中国药典》2020年版“中药饮片微生物限度检查方法”及“无菌药品微生物限度标准”(增修订草案)起草情况的说明http://www.chp.org.cn/view/ff80808161653a930163f2090751422a?a=GZWJ.
3 张子英,伊乐,爱民,等.肉豆蔻挥发油对大鼠心肌的保护作用.内蒙古中医药, 2013, 32(13):123-124.
4 王阳,马瑞莲,马睿婷,等.蒙药肉豆蔻挥发油对大鼠心肌缺血再灌注损伤的保护作用.内蒙古医学院学报, 2010, 32(2):124-128.
5 孙婷婷.肉豆蔻挥发油抗抑郁作用及机制研究.郑州:河南中医学院, 2014.
6 贾天柱,李洁,周粮,等.肉豆蔻不同炮制品止泻作用及急性毒性比较.中国中药杂志, 1997(4):24-26.
7 贾天柱,沙明,曹爱民,等.肉豆蔻不同炮制品挥发油中丁香酚类成分测定.中国中药杂志, 1997(8):27-28+64.
8 袁子民,刘欢,王静.肉豆蔻及炮制品醇提取物的止泻及抗炎作用研究.时珍国医国药, 2015, 26(12):2910-2911.
9 张慧,王静,袁子民,等.肉豆蔻总木脂素纯化工艺及其抗炎活性研究.中国中医药信息杂志, 2017, 24(6):83-86.
10 王远志,李宏志.两种肉豆蔻挥发油对人癌细胞体外增殖影响的比较研究.辽宁中医杂志, 2008(6):847-848.
11 裴凌鹏,崔箭.维药肉豆蔻体内抗肿瘤及其免疫调节作用的实验研究.中国民族民间医药, 2009, 18(3):23-24.
12 谢小梅,陈资文,陈和利,等.花椒、肉豆蔻防霉作用实验研究.时珍国医国药, 2001(2):100-101.
13 Gupta A D, Vipin K B, Vikash B, et al. Chemistry, antioxidant and antimicrobial potential of nutmeg(Myristica fragrans Houtt). J Genet Eng Biotechnol, 2013, 11(1):25-31.
14 袁子民,刘欢,贾天柱,等.肉豆蔻及炮制品醇提取物的抗氧化作用.长春中医药大学学报, 2015, 31(5):930-932.
15 Adiani V, Gupta S, Chatterjee S, et al. Activity guided characterization of antioxidant components from essential oil of Nutmeg(myristica fragrans). J Food Sci Technol, 2015, 52(1):221-230.
16 唐裕芳,曾永德,张妙玲.商品肉豆蔻挥发油化学组成及抑菌活性研究.湘潭大学自然科学学报, 2014, 36(4):56-62.
17 国家药典委员会编.中华人民共和国药典2015年版四部.北京:中国医药科技出版社. 2015.
18 秦筱茂,郭顺星.药材霉菌及霉菌毒素污染现状分析.中国中药杂志, 2011, 36(24):3397-3404.
19 李闽真,马群飞,傅武胜.市售中药材霉菌污染情况和优势种群分布的研究.中国卫生检验杂志, 2013, 23(17):3351-3356.