Applicability test of microbial limit test for Yanhuanglian suppository

doi:10.14088/j.cnki.issn0439-8114.2023.01.028

Abstract

Abstract: According to the requirements of 1105, 1106 and 1107 in the fourth part of the Chinese Pharmacopoeia （2020）,the applicability of the microbial counting method and control bacteria test for Yanhuanglian suppository was studied. The applicability research experiment in a sequential, scientific and reasonable way was carried out. The method of aerobic bacterial count was optimized by comparing the advantages of the sample solution dilution plate method and sample solution dilution membrane filtration method. The results showed that the total number of aerobic bacteria of Yanhuanglian suppository was determined by the method of dilution plate of sample solution （1∶200）, the Staphylococcus aureus test was carried out by dilution method （1 000 mL）, the Pseudomonas aeruginosa was detected by the routine method （100 mL TSB）. The method adopted was in accordance with the relevant provisions of general principles of the fourth part of the Chinese Pharmacopoeia （2020）,the reference method of preparation and applicability test of sample solution was provided for the suppository with bacteriostatic action and partial prescription components.

Key words: Yanhuanglian suppository, hospital preparation, suitability test, microbiological counting, Staphylococcus aureus

CLC Number:

R927.33

PANG Yun-juan, PANG Lan-ying, ZENG Jin, LIU Kang-lian, LIANG Xiao-ling, LONG Wen-zhou, XIAO Ping. Applicability test of microbial limit test for Yanhuanglian suppository[J]. HUBEI AGRICULTURAL SCIENCES, 2023, 62(1): 162-166.

References

[1] 诸葛明丽,蒋伟哲,肖萍,等.岩黄连直肠栓抗炎镇痛作用实验研究[J].中国民族民间医药杂志,2019(9):11-13.
[2] 肖萍,林彩霞,盘冰洁,等.岩黄连栓治疗慢性盆腔炎大鼠的药效学研究[J].中南药学,2019,17(12):2052-2058.
[3] 张成,姚兴东,雷福厚.岩黄连中生物碱的研究进展[J].化工技术与开发,2020,49(12):9-13+18.
[4] 张占江,黄浩,郭晓云,等.瑶药岩黄连研究概况[J].植物学研究,2020,9(4):424-430.
[5] 余姣娇,邱志霞,刘秋燕,等.岩黄连的研究进展[J].药学研究,2018,37(6):342-345+360.
[6] 诸葛明丽,农慧亮,黄兴振,等.岩黄连直肠栓质量标准研究[J].中国药业,2013,22(12):87-89.
[7] 张周菊,刘文志,周松迪,等.中药复方前列康栓不同基质配方的比较研究[J].湖北中医药大学学报,2012,14(2):37-39.
[8] 马亚萍,黄一平,王瑢.复方退热栓的制备及质量控制[J].中国药房,2016,27(13):1828-1831.
[9] 杨晓晖,吴桐,左军.苦参栓制备工艺考察[J].中医药信息,2014(2):78-80.
[10] 国家药典委员会.中国药典2020年版[S].四部.北京:中国医药科技出版社,2020:1105-1107.
[11] 诸葛明丽,蒋伟哲,肖萍,等.壮药岩黄连研究进展[J].海峡药学,2019,31(5):31-34.
[12] 丘倩倩,韦志鹏,吴丽敏,等.中药岩黄连总碱的体外抗菌实验研究[J].科技与创新,2020(9):43-44.
[13] 庞云娟,樊文研,刘康连,等. 珍黄胶囊微生物限度检查方法适用性试验的研究[J].中成药,2018,40(3):711-715.
[14] 李趣嫦,曾璞,肖建光,等.50种中成药微生物限度检查法的适用性试验及结果分析[J].药物分析杂志,2017,37(12):2214-2223.
[15] 陆蓓,凌明,赵建英.栓剂的微生物限度检查法的验证[J].中国药事,2006,20(3):167-168.
[16] 陆蓓,凌明,赵建英.几种栓剂的微生物限度检查法的验证[J].西北药学杂志,2006,21(3):121-122.
[17] 庞云娟,樊文研,刘康连,等.药品微生物限度检查方法学验证的研究进展[J].中成药,2017,39(10):2137-2140.
[18] 刘康连,庞云娟,周晓婷.5种同名异型中药制剂微生物限度检查法的建立与结果分析[J].中成药,2017,39(7):1515-1518.
[19] 肖中元,周玲,杨红涛,等.异烟肼片微生物限度检查法的建立[J].山东化工,2019,48(15) :111-112.
[20] 董自艳,易大为,张亚杰.利福平胶囊的微生物限度检查方法的研究[J].中国抗生素杂志,2019,44(2):233-236.
[21] 钱文静,张玫.麝香祛风湿油微生物限度检查方法的验证[J].药学与临床研究,2008,16(5):415-418.
[22] 胡亚英,马欣,陈睿,等.复黄片微生物限度检查方法适用性探究[J].中成药,2020,42(3):788-791.
[23] 张秀花,刘艳平,任仲丽,等.连花清瘟胶囊微生物限度检查方法的建立[J].中成药,2021,43(7):1869-1872.
[24] 潘震宇,汤茜,李瑞莲.硝酸布康唑栓微生物限度检查方法适用性试验研究[J].中国药事. 2017,31(1):43-48.
[25] 刘戈,邱唯佳,费夷敏.替硝唑栓微生物限度检查方法适用性试验研究[J].上海医药,2016,37(13):73-76.
[26] 郭晓焕. 硝酸布康唑栓微生物限度检查方法适用性试验研究[J].海峡药学,2017,29(7):83-84.
[27] 张明君,哈丽旦·苏莱曼,李海芳.健阴栓微生物限度检查方法适用性试验及体外抑菌作用研究[J].中国医院用药评价与分析,2019,19(7):853-855.
[28] 吴经耀. 保妇康栓微生物限度检查方法验证实验[J].亚太传统医药,2019,15(7):62-64.
[29] 张小华,马新换,汪付田,等. 2种医院制剂微生物限度检查方法学适用性研究[J].中国药事,2019,33(8):949-953.