不同大黄制剂微生物限度检查方法的研究

Study on microbial limit test methods of different rhubarb preparations

目的建立保肾片、新保肾片、肾炎宁片3种大黄制剂方便有效、操作简单的微生物限度检查方法。方法采用平皿法、稀释法、薄膜过滤法、中和法对3种大黄制剂进行微生物限度检查方法的研究,比较了稀释法、薄膜过滤法和中和法去除3种大黄制剂抑菌性的能力。结果保肾片和新保肾片对金黄色葡萄球菌有一定的抑制作用,可用稀释法或采用3%聚山梨酯80和0.3%卵磷脂作为中和剂消除抑菌性。肾炎宁片的抑菌性较强,采用中和剂时,肾炎宁片的1∶10供试液仍有抑菌性,需采用1∶50稀释级供试液消除抑菌性。结论3%聚山梨酯80和0.3%卵磷脂可作为中和剂用于3种大黄制剂的微生物限度检查。

Objective To establish a convenient,effective and simple method for microbial limit test of three kinds of rhubarb preparations,namely Baoshen Tablets,Xinbaoshen Tablets and Shenyanning Tablets.Methods The microbial limit test methods of three kinds of rhubarb preparations were studied by plate method,dilution method,membrane filtration method and neutralization method.The antibacterial activities of three kinds of rhubarb preparations were compared by dilution method,membrane filtration method and neutralization method.Results Baoshen Tablets and Xinbaoshen Tablets had certain inhibitory effect on Staphylococcus aureus.The antimicrobial activity could be eliminated by dilution method or by using 3%polysorbate 80 and 0.3%lecithin as neutralizer.Shenyanning Tablets had strong antibacterial effect,the 1∶10 test solution of Shenyanning Tablets still had antibacterial activity when the neutralizer was used,so the 1∶50 dilution test solution was needed to eliminate the antibacterial activity.Conclusion 3%polysorbate 80 and 0.3%lecithin can be used as neutralizer for the microbial limit test of three rhubarb preparations.