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目的评价基层高血压硝苯地平、阿替洛尔、氢氯噻嗪和卡托普利(NAH)治疗方案片剂分剂量的准确性、合理性。方法采用药片切割器对4种片剂四等分和(或)八等分,参照《欧洲药典》及相关参考文献评价分剂量准确性、期望重量(EW)与实际重量(RW)的比较、平均损失百分比、脆碎度等指标。结果 NAH方案片剂分剂量成四等份时准确性均不符合《欧洲药典》准确性标准;EW_(1/4)与RW_(1/4)有显著差异的片剂有:香雪制药的硝苯地平片,中央制药、万马药业的阿替洛尔片,云鹏制药的氢氯噻嗪片;平均损失百分比符合≤3%的规定;部分片剂脆碎度不符合规定。分剂量成八等份时(不含氢氯噻嗪),均不符合《欧洲药典》准确性标准;EW_(1/8)与RW_(1/8)有显著差异的片剂有:香雪制药的硝苯地平片、万马药业的阿替洛尔片;平均损失百分比均不符合≤3%的规定;脆碎度均不符合规定。结论基层高血压NAH治疗方案4种片剂的分剂量准确性等指标不符合要求,此问题亟待解决以促进合理用药。
Objective To evaluate the accuracy and rationality of divided doses of nifedipine, atenolol, hydrochlorothiazide and captopril (NAH) regimens in patients with primary hypertension. Methods Four tablet aliquots and / or eight aliquots of four tablets were evaluated by tablet cutter. The accuracy of dose, the expected weight (EW) and the actual weight (RW) were evaluated according to the European Pharmacopoeia and related references. Average loss percentage, friability and other indicators. Results The accuracy of NAH tablets in four aliquots did not meet the accuracy of the European Pharmacopoeia. Tablets with significant differences between EW 1/4 and RW 1/4 were Benzoplan tablets, Central Pharmaceuticals, Manma medicine Atenolol tablets, Yunpeng pharmaceutical hydrochlorothiazide tablets; the average percentage of loss in line with the provisions of ≤ 3%; some of the tablets do not meet the requirements of friability. When the dosage was divided into eight equal parts (no hydrochlorothiazide), none of the tablets met the “European Pharmacopoeia” accuracy standard. Tablets with significant differences between EW 1/8 and RW 1/8 were: Plain film, horse medicine Atenolol tablets; average percentage loss did not meet the requirements of ≤ 3%; friability are not in line with the provisions. Conclusions The accuracy of sub-dose of four kinds of tablets of NAH treatment regimen does not meet the requirements. This problem needs to be solved urgently to promote rational drug use.