5种假药片的鉴定及有关药品质量标准的修订建议

Identification of five false drugs and the suggestion for the revision of their quality standards

目的 :对盐酸小檗碱片、安乃近片、醋酸地塞米松片、醋酸泼尼松片和肌苷片的 5种假药进行鉴定 ,并对有关质量标准提出修订建议。方法 :采用 HPL C法并与中国药典收载的有关方法比较。结果 :用 HPL C法检出 6 0余批造假产品。结论 :HPL C法专属性更强 ,结果更可靠。

OBJECTIVE:To identify five forged products of Berberine Hydrochloride Tablets,Metamizole Sodium Tablets,Dexamethasone Acetate Tablets,Prednison Acetate Tablets and Inosin Tablets and suggest revising their quality standards.METHOD:The identifications were carried out by HPLC methods and the results were compared with those by Chinese Pharmacopoeia's methods.RESULTS:60 batches of forged products had been checked.CONCLUSION:The specificity of the HPLC methods are better and more riliable.Current quality standards of related drugs should be revised.