活血通络搽剂微生物计数法方法学适用性试验中菌种加入方式的研究

Study on Microorganism Introduction Method in Suitability Test of Microbial Enumeration Test for Huoxue Tongluo Liniment

目的:比较《中国药典》2010年版与《中国药典》2015年版微生物计数法中不同的菌种加入方式对试验结果的影响。方法:以活血通络搽剂为研究对象,分别按照《中国药典》2010年版及《中国药典》2015年版中不同菌种加进行各试验菌株回收值的测定,并比较各试验菌株回收值的差异。结果:活血通络搽剂按照《中国药典》2010年版细菌、霉菌及酵母菌计数法中的菌液加入方式进行试验,各试验菌回收值均达到了0. 5~2. 0;而按照《中国药典》2015年版微生物计数法中的菌液加入方式进行试验,枯草芽孢杆菌和金黄色葡萄球菌回收值都明显降低。结论:样品本身的抑菌活性、供试液制备及实验过程对试验菌株都会产生影响。根据《中国药典》2015版,活血通络搽剂微生物计数法选择在供试液里加入试验菌株更为合理。

Objective:To compare the effects of different microorganism introduction method in the Microbial Limit Test of the Chinese Pharmacopoeia 2010 Edition and 2015 Edition.Methods:The recovery values of the strains were calculated and compared respectively by the microorganism introduction method according to the Chinese Pharmacopoeia 2010 Edition and 2015 Edition,Huoxue Tongluo liniment as the subjects for investigation.Results:Using the method of adding strains proposed by Chinese values of Bacillus subtilis and Staphylococcus aureus are significantly reduced.Conclusion:The antibacterial activity of the sample itself,the preparation of the sample solution and the experimental process all have effects for the test strains.It is a reasonable method to add the tested strain to the sample solution for Huoxue Tongluo liniment according to Chinese Pharmacopoeia 2015 Edition.