摘要
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。
AIM To evaluate accuracy and rationality of tablets splitting in nifedipine, atenolol, hydrochlorothiazide and captopril （NAH） treatment for hypertensive patients in primary clinical unit. METHODS Tablet cutter was utilized to split these pills into quarter or one eighth, and then European Pharmacopoeia （EP） and other standards was adopted to evaluate the accuracy of tablets spittin, expected weight （EW） and real wegtht （RW）, mean weight loss percentage, and friability. RESULTS When these tablets split into quarter, they could not meet the accuracy subdivision of EP standards. There was significant difference when compared EW1/4 with RW1/4, such as nifedipine tablets produced by Xiangxue Pharmaceutical Company, atenolol tablets produced by Zhongyang Pharmaceutical Company or Wanma Pharmaceutical Company, and hydrochlorothiazide tablets produced by Yunpeng Pharmaceutical Company. All tablets met the mean weight loss percentage ≤ 3%, however part of tablets could not meet the requirement of friability. When these tablets split into one eighth, they could not meet the accuracy subdivision of EP standards. There was significant difference when compared EW1/8 with RW1/8, such as nifedipine tablets produced by Xiangxue Pharmaceutical Company and atenolol tablets produced by Wanma Pharmaceutical Company. Meanwhile, mean weight loss percentage and friability could not meet the related regulation. CONCLUSION In the NAH treatment for hypertensive patients in primary clinical unit, the accuracy of tablets spitting and other indicators can not meet the requirements. It should be solved urgently to improve rational drug use.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2012年第7期421-424,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
广东省清远市科技计划项目(编号:2009A020)
关键词
高血压
片剂
分剂量
方案评价
hypertension
tablets
tablet splitting
program evaluation
