CAJ | 학술논문

基于线性方程组数学分离模型建立在线过程检测复方缬沙坦氢氯噻嗪片溶出度方法。分别扫描缬沙坦和氢氯噻嗪的紫外吸收光谱，两组分在最大吸收波长处完全重叠。根据朗伯比尔定律吸光度加和性原理，分别测定两组分在最大吸收波长处的吸光系数，建立线性方程组数学分离模型，采用光纤传感过程分析技术（FODT ）检测缬沙坦氢氯噻嗪片的溶出度，并与HPLC法相比较。在规定的溶出介质中，两种成分同时实时测定，并且FODT累积溶出度与HPLC法相比较结果无显著性差异（p＞0.05）。不同批次药物的溶出行为一致，说明制剂工艺稳定，均匀度好。溶出曲线显示缬沙坦溶出快于并高于氢氯噻嗪，且30 min时两组分的溶出度均大于80％符合美国药典规定。结果表明，应用线性方程组数学分离模型结合FODT 法可实现复方缬沙坦氢氯噻嗪片中双组分溶出度的同时检测，并可提供双组分的溶出过程曲线和全部溶出数据，直观反映各组分在各溶出时段的快慢，为此药建立标准提供依据。与 HPLC法单点数据相比优势明显，更有利于药品评价和抽验质量分析。
기우선성방정조수학분리모형건립재선과정검측복방힐사탄경록새진편용출도방법。분별소묘힐사탄화경록새진적자외흡수광보，량조분재최대흡수파장처완전중첩。근거랑백비이정률흡광도가화성원리，분별측정량조분재최대흡수파장처적흡광계수，건립선성방정조수학분리모형，채용광섬전감과정분석기술（FODT ）검측힐사탄경록새진편적용출도，병여HPLC법상비교。재규정적용출개질중，량충성분동시실시측정，병차FODT루적용출도여HPLC법상비교결과무현저성차이（p＞0.05）。불동비차약물적용출행위일치，설명제제공예은정，균균도호。용출곡선현시힐사탄용출쾌우병고우경록새진，차30 min시량조분적용출도균대우80％부합미국약전규정。결과표명，응용선성방정조수학분리모형결합FODT 법가실현복방힐사탄경록새진편중쌍조분용출도적동시검측，병가제공쌍조분적용출과정곡선화전부용출수거，직관반영각조분재각용출시단적쾌만，위차약건립표준제공의거。여 HPLC법단점수거상비우세명현，경유리우약품평개화추험질량분석。
A method for on-line monitoring the dissolution of Valsartan and hydrochlorothiazide tablets assisted by mathematical separation model of linear equations was established .UV spectrums of valsartan and hydrochlorothiazide were overlapping com-pletely at the maximum absorption wavelength respectively .According to the Beer-Lambert principle of absorbance additivity , the absorptivity of Valsartan and hydrochlorothiazide was determined at the maximum absorption wavelength ,and the dissolubil-ity of Valsartan and hydrochlorothiazide tablets was detected by fiber-optic dissolution test (FODT ) assisted by the mathematical separation model of linear equations and compared with the HPLC method .Results show that two ingredients were real-time de-termined simultaneously in given medium .There was no significant difference for FODT compared with HPLC (p>0.05) .Due to the dissolution behavior consistency ,the preparation process of different batches was stable and with good uniformity .The dissolution curves of valsartan were faster and higher than hydrochlorothiazide .The dissolutions at 30 min of Valsartan and hydrochlorothiazide were concordant with US Pharmacopoeia .It was concluded that fiber-optic dissolution test system assisted by the mathematical separation model of linear equations that can detect the dissolubility of Valsartan and hydrochlorothiazide simultaneously ,and get dissolution profiles and overall data ,which can directly reflect the dissolution speed at each time .It can provide the basis for establishing standards of the drug .Compared to HPLC method with one-point data ,there are obvious ad-vantages to evaluate and analyze quality of sampling drug by FODT .