目的采用光纤药物溶出度实时测定仪考察不同厂家盐酸二甲双胍缓释片体外溶出度曲线.方法按照国家食品药品监督管理局标准YBH31132005规定的溶出度方法进行实时溶出曲线测定.结果本法监测药物溶出的全过程,显示药物实时溶出曲线图,可直接提取相关参数.结论光纤化学传感检测过程中不需要取样、过滤、补液等操作,简便易行,极大地节省了劳动强度,提高了测定的精密度和准确度,获得的数据信息完整,反映了药物在体外溶出的过程,替代了繁琐的传统测试方法.光纤化学溶出度过程监测法能够有效地监测固体制剂的体外溶出度,并能真实地反映药物溶出的全过程.

@@@@Objective To compare the qualities of Metformin hydrochloride tablets from different manufactures through the method of fiber-optic real time dissolution test.Method Taking the dissolution tests according to the China Food Drug Administration Standard YBH31132005.Results This procession analysis could test the whole process of drug and get dissolution graph.Conclusion This procession analysis can test the whole process of drug and get release graph.In the optical fiber chemistry examination process it does not need to takeasample,to filter,and to infusion fluid,briefness and feasible,enormously has saved the labor intensity,enhanced the determination accuracy and the accuracy,obtains the data message integrity,has reflected medicine process which dissolves invitro, has substituted the tedious traditional test method.This procession analysis can reflect the real dissolution of drug and obtain the total information.

目的：建立奋乃静片体外溶出度的原位过程分析方法。方法采用动态倍率系数法消除辅料对药物溶出的干扰，利用光纤药物溶出度实时测定仪（FODT）在线监测奋乃静片溶出度，并与《中国药典》进行对比。结果 FODT测定奋乃静片的过程溶出数据与《中国药典》方法对照无统计学差异，在10、17、60 min时溶出度绝对误差分别为4．15％、1．90％、1．53％。结论 FODT法无需手动取液、稀释等操作，结合相应的数学模型能实时监测药物溶出全过程，得到完整药物体外溶出曲线，为药物的内在质量评价提供了良好的检测手段。

Objective To develop an in-situ and process monitoring method for vitro dissolution rate of Per-phenazine tablets.Methods We adopted dynamic multiplying factor method to eliminate interference of excipient with the process of dissolution.We monitored the on-line dissolution rate of Perphenazine tablets by fiber optical chemical real-time sensor (FODT).Results The dissolution results of FODT hadn''t statis-tical difference compared with Chinese pharmacopoeia,and within 10,17,60 minutes the absolute error of dissolution was 4.15%,1.90% and 1.53%.Conclusion The method of FODT avoids the possible errors in the process of sampling and dissolution by hand.It can monitor the whole process of drug dissolution in combination with mathematical model and get a complete dissolution curve of drug in vitro.Therefore,it provides an effective means for evaluating the immanent quality of drug.

目的对孟鲁司特钠片进行全程的实时、原位在线溶出度测定,并与该品种现有标准溶出度测定结果进行比较。方法采用FODT-601光纤药物溶出仪,选择284/500 nm双波长法,消除辅料的干扰,按该品种现有标准溶出度检查项溶出条件,测试该药物溶出曲线,并将二者测得的溶出曲线进行比较。结果在1.0~12μg·mL-1范围内,浓度对应的溶出量(Q)%与吸光度(A)呈良好的线性关系,相关系数为0.9993;3个浓度的平均回收率为99.3%、98.9%、98.5%;对应的RSD分别为0.86%、1.02%、0.91%(n=18)。结论与现有标准方法相比,光纤药物溶出仪能连续提供药品溶出过程的信息,可更好的为药品生产工艺和内在质量提供有效的评价依据。

Objective To monitor the instantaneous dissolution of montelukast sodium tablets by fiber - optic dissolu-tion test system and comparison with state standard test method. Methods The dissolutions of six tablets were determined simultaneously with FODT - 601 fiber - optic medicine dissolution system. The interference of excipients was cancelled by two wavelengths 284 / 500 nm. The stripping curves were completed according to dissolution conditions of existent standard for dissolution detection,and compared the stripping curves. Results The calibration curve was linear in the range of 1. 0~ 12 μg·mL - 1(r = 0. 999 3). The average recoveries of three concentration were 99. 3% ,98. 9% ,98. 5% ,with corre-sponding RSD of 0. 86% ,1. 02% ,0. 91%(n = 18),respectively. Conclusion Compared with the state standard,the fiber- optic dissolution test system is capable of monitoring the real dissolution process of drug,and it was better to provide the efficient way for the drug productive

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(p0.05)。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。

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 diss