冠心病患者使用三种硝酸甘油片疗效的差异性分析

Differential analysis of the efficacy of nitroglycerin tablets in patients with coronary heart disease

目的以硝酸甘油片为研究对象,拟定不同厂家产品体外溶出度测定方案,同时开展临床疗效的评价,从临床研究部分和药学研究部分两方面证实药品一致性评价的重要性,为体外溶出度曲线一致性评价提供临床疗效的数据支持,为指导患者合理、经济、有效用药提供一种药物质量评价方法。方法从当地市场上购买3个厂家不同价格的规格为5 mg的硝酸甘油片进行研究:(1)采用光纤传感过程分析技术建立硝酸甘油片溶出度检测的方法,并比较不同厂家生产的硝酸甘油片体外溶出度行为。(2)心绞痛患者拟按照性别、年龄与民族进行分组,每组30例,在服用不同厂家生产的硝酸甘油片后进行心电图等指标监测,观察不同厂家硝酸甘油片的起效时间和疗效。(3)临床服药后的心电图变化与症状的缓解与体外溶出度的变化进行比较。结果仿制药品质量与原研药物存在显著性差异。结论生产工艺的不同导致药物的主要成分在体内的溶出度和吸收速度的差异,最终导致血药浓度不同。

Objective The dissolution rate and metabolism of nitroglycerin from different manufacturers were compared.To provide the data support of clinical curative effect for the conformance evaluation of dissolution curve in vitro,and provide a method for evaluating the quality of drugs for the rational,economical and effective use of drugs.Finally,it provided scientific basis for rational pricing of drugs and drug purchase in hospitals.Methods This study purchased 3 manufacturers of the specifications of 5 mg of nitroglycerin tablets from local market.①The method of detecting the dissolution of nitroglycerin tablets was established by using the optical fiber sensing process analysis technique,and the dissolution behavior of nitroglycerin tablets produced by different manufacturers was compared.②Angina patients were to be grouped according to gender,age and nationality,with 15~20 persons in each group.After the patient took the nitroglycerin tablets produced by different manufacturers,the monitoring of electrocardiogram and other indicators was conducted to observe the effective time and effect of nitroglycerin tablets from different manufacturers.③The changes of ECG and the relief of symptoms and the dissolution rate in vitro of 3 manufacturers of nitroglycerin tablets were compared.Results There are significant differences between the quality of generic and original drug.Conclusion Due to the different production process,the main components of the drug have different dissolution and absorption rate in the body,resulting in different drug concentration.