盐酸头孢卡品酯颗粒微生物限度检查方法适用性试验的研究

Study on applicability test of microbial limit inspection method for cefcapene pivoxil hydrochloride granules

目的:建立盐酸头孢卡品酯颗粒微生物限度检查方法。方法:按《中国药典》2020年版四部通则1105和1106的规定,对盐酸头孢卡品酯颗粒进行微生物限度方法学适用性试验。头孢卡品酯对细菌生长具有较强的抑制作用,需氧菌总数和控制菌采用薄膜过滤并加入头孢菌素酶法,霉菌和酵母菌采用平皿法进行试验,加入试验菌回收并且计算回收率。结果:需氧菌、霉菌及酵母菌的回收率均在0.5~2范围内,控制菌检查同样符合规定。结论:采用薄膜过滤与加入头孢菌素霉相结合的方法,可用于盐酸头孢卡品酯颗粒微生物限度检查。

Objective:To establish the microbial limit test method for cefcapene pivoxil hydrochloride granules.Methods:According to provisions 1105 and 1106 of the four general chapters of the 2020 edition of the《Chinese Pharmacopoeia》,the microbial limit methodological applicability test of cefcapene pivoxil hydrochloride granules was carried out.Cefcapene pivoxil had a strong inhibitory effect on bacterial growth.The total number of aerobic and control bacteria were filtered bya membrane,and the cephalosporinase method was added.The mold and yeast were tested by the flat dish method.The test bacteria were added,and the recovery rate was calculated.Results:The recovery rates of aerobic bacteria,mold,and yeast were within the range of 0.5 to2,and the control bacteria inspection also complied with the regulations.Conclusion:The combination of membrane filtration and cephalosporin can be used for microbial limit inspection of cefcapene pivoxil hydrochloride granules.