反向解析法在盐酸普萘洛尔片一致性评价中的应用  

Application of Reverse Analytical Method in the Evaluation of Propranolol Hydrochloride Tablets Consistency

作　　者：柏植政 周卫[2] 丁逸梅[1,3] BAI Zhizheng;ZHOU Wei;DING Yimei(School of Pharmacy,Nanjing University of Technology,Nanjing 210009,China;China Pharmaceutical U-niversity,Nanjing 210009,China;Jiangsu Institute of Pharmaceutical Research,Nanjing University of Technology,Nanjing 210009,China)

机构地区：[1]南京工业大学药学院,南京210009 [2]中国药科大学,南京210009 [3]南京工业大学江苏省药物研究所有限公司,南京210009

出　　处：《药学与临床研究》2018年第3期179-182,共4页Pharmaceutical and Clinical Research

摘　　要：目的:反向解析法确定盐酸普萘洛尔片处方中的关键参数—硬脂酸镁与硬脂酸比例,指导一致性评价处方研究。方法:运用衍生化气相色谱法-原子吸收法对原研处方进行反向解析,测定硬脂酸镁与硬脂酸比例。结果:衍生化气相色谱法测得,硬脂酸在56~104μg·mL^(-1)浓度范围内线性良好,γ=0.999 1,平均回收率为90.06%,RSD为4.02%;棕榈酸在56~104μg·mL^(-1)的浓度范围内线性关系良好,γ=0.999 2,平均回收率为90.12%,RSD为3.97%。原子吸收法(AAS)测得,镁离子浓度范围在0.5~20μg·mL^(-1)内线性良好,γ=0.999 2。以该方法测定的硬脂酸与硬脂酸镁比例处方,在p H1.2介质中的溶出曲线与原研片比较,f2值=90.0。结论:反向解析关键指标硬脂酸与硬脂酸镁比例可有效指导盐酸普萘洛尔片处方筛选。Objective： To determine the ratio of magnesium stearate/stearic acid in the prescription of propranolol hydrochloride tablets by a reverse analytical method, and to guide the consistency evaluation of prescription. Methods： A derivative gas chromatography-atomic absorption method was used to reversely analyze the original prescription. The ratio of magnesium stearate/stearic acid was determined and the prescription was studied. Results： The specificity of the derivatized gas chromatography was good. The linearity was good for stearic acid in the range of 56-104 μg·mL^（-1）（γ=0.999 1） with the average recovery at90.06%（RSD=4.02%）, and for palmitic acid in the range of 56-104 μg·mL^（-1）（γ=0.999 2） with the average recovery at 90.12%（RSD =3.97%）. With the atomic absorption method, magnesium ion concentration was linear in the range of 0.5-20 μg·mL^（-1）. The dissolution profile of self-made tablets based on the reversely analyzed ratio of stearic acid/magnesium stearate was comparable to that of the original ones with f2 value up to 90.0. Conclusion： The reverse analysis of the key indicators of stearic acid/magnesium stearate ratio can effectively guide the prescription of propranolol hydrochloride tablets.

关 键 词：反向解析法 盐酸普萘洛尔片 衍生化气相色谱法 AAS 硬脂酸 硬脂酸镁 

分 类 号：R927.1[医药卫生—药学]