分剂量药品质量一致性研究

Study on the Quality Consistency of Divided Tablets

目的考察口服药品分剂量质量准确性,为临床合理使用分剂量药品提供参考。方法对中国医科大学附属盛京医院口服摆药中使用量大、分剂量规格多且有代表性的9种药品36种分剂量规格进行一致性研究,依据《中华人民共和国药典》2015年版药品质量标准判断分剂量药品的质量是否合格。结果9种分剂量药品的36种分剂量规格,仅有酒石酸美托洛尔片和比索洛尔片1/2分剂量规格符合《中华人民共和国药典》2015年版药品质量要求,其余药品分剂量规格的质量均不合格。结论分剂量药品质量基本不能满足《中华人民共和国药典》2015年版对口服用药的质量要求。临床亟需多剂型、多剂量规格药品满足安全用药需求。

Objective To evaluate the accuracy of divided tablets and to provide references for reasonable application of divided tablets in clinic.Methods Quality analysis was performed in 9 kinds of tablets(36 divided tablets in total)which have various divided specification and often administer for patients.According the standard of Chinese Pharmacopoeia,we determine whether the quality of divided drugs meet the qualification.Results Among the 36 divided tablets,only metoprolol tartrate tablets and bisoprolol tablets half-tablets meet the standard of《Chinese pharmacopoeia》,other divided tablets all failed.Conclusion Divided tablets can not meet the quality standard of the《Chinese Pharmacopoeia》.More types of dosage forms to meet the needs of patients with safe medication.