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[目的]对复方丹参片建立一个全面的、正确的微生物限度检查方法。[方法]按照中国药典2005版微生物限度检查方法对复方丹参片(糖衣片和薄膜衣片)分别进行验证试验。[结果]复方丹参片中的成分对细菌中的金黄色葡萄球菌和枯草芽胞杆菌都有较强的抑制作用,对大肠埃希菌、白色念珠球菌和黑曲霉菌的抑制作用不明显。[结论]复方丹参糖衣片的细菌计数方法可采用培养基稀释法;薄膜衣片则需要采用离心沉淀法和培养基稀释法联用;二者的霉菌及酵母菌计数方法为常规法;控制菌检查也可采用常规法检验。
[Objective] To establish a comprehensive and correct microbial limit test for compound Danshen tablets. [Method] The compound Danshen tablets (sugar-coated tablets and film-coated tablets) were respectively tested in accordance with the Chinese Pharmacopoeia 2005 edition of Microbial Limit Test. [Result] The components in compound Danshen tablets had a strong inhibitory effect on Staphylococcus aureus and Bacillus subtilis in bacteria, but not on Escherichia coli, Candida albicans and Aspergillus niger. [Conclusion] The bacterial count method of compound Salvia miltiorrhiza tablet can be diluted by culture medium. The film-coated tablets need centrifugal sedimentation method and culture medium dilution method. The method of counting mold and yeast is the conventional method, Inspection can also be used routine inspection.