Single-particle light scattering study of polyethyleneglycol-grafted poly(ureaurethane) microcapsule in ethanol

Microcapsules having polyethyleneglycol-grafted poly(ureaurethane) (PUU) membrane and di-2ethylhexyl phthalate core have been prepared, and the structure when they were suspended in dispersing ethanol have been studied by means of single-particle light scattering method. The PUU membrane was synthesized from monomers with aromatic functional groups (microcapsule MC110) and hexamethylene functional groups (microcapsule MC160). Because the outer and inner solvent passed through the membrane easily, the outside and inside of the membrane were the same at the equilibrium state. The thickness of the wall membrane was significantly smaller than that calculated from the overall weight ratio of the wall-forming material and the core solvents. It was attributed to low affinity of PUU membranes and ethanol.     

安胃片质量标准研究

对安胃片进行质量标准研究。采用薄层色谱法对安胃片中延胡索进行鉴别,并且采用高效液相色谱法对其中的延胡索乙素进行含量测定。色谱柱为Kromasil C18色谱柱（4.6mm×150mm,5μm）,流动相为甲醇-水（三乙胺调pH值为8.68,V：V=65：35）,检测波长为280nm,流速1.0mL/min,柱温为室温。结果显示在薄层色谱中均可检出延胡索特征斑点;延胡索乙素在0.18—1.47μg范围内线性关系良好,r=0.9999,平均加样回收率为97.49%（RSD=1.64%,n=6）。本方法简便可行、重复性好,能有效控制该制剂的质量。     

缓释片中新斯的明的含量测定

采用紫外分光光度法测定新斯的明缓释片中新斯的明的含量及对其稳定性进行研究。结果表明,新斯的明浓度在80—560μg.mL-1范围内与吸光度呈良好的线性关系,回归方程为：A=0.0016C-0.0089,r=0.9999;平均回收率为100.46%,RSD为0.89%（n=9）。该法简便、快速,重现性好,结果准确可靠。     

咖酚伪麻片中盐酸伪麻黄碱的含量

建立高效液相色谱法测定咖酚伪麻片中盐酸伪麻黄碱含量的方法。色谱柱为C18（150mm×4.6mm×5μm）,流动相为0.05mol/L磷酸二氢钠-甲醇（75∶25）,流速为1mL/min,检测波长为210nm。盐酸伪麻黄碱在0.2155—1.0776μg/g范围内线性良好,r=0.9999;盐酸伪麻黄碱的平均收率为100.92%,RSD值为0.41%（n=5）。此法操作简单,准确性好,可用于咖酚伪麻片中盐酸伪麻黄碱的含量测定。     

阿莫西林分散片溶出度光纤化学传感在线过程检测

采用双波长法消除赋形剂的干扰,利用六通道光纤化学传感原位过程分析仪(FOCSDT)在线监测阿莫西林分散片溶出度。FOCSDT的平均校准曲线方程为y=188.38x+0.7607,回归系数r为0.9998。阿莫西林分散片的溶出数据与中国药典(Ch.P)方法对照无显著性差异。FOCSDT法无需取液、稀释等手工操作,能实时监测药物溶出全过程,为速释制剂内在质量的检测提供良好的手段。     

Stability indicating method for famotidine in pharmaceuticals using porous graphitic carbon column

A simple, sensitive and rapid HPLC method was developed and validated for the simultaneous determination of famotidine (FMT) and related impurities in pharmaceuticals. Chromatographic separation was accomplished within 10 min on a porous graphitic carbon (PGC) column using 50:50 v/v ACN-water containing 0.5% pentane sulphonic acid (PSA) as the mobile phase. Separation was achieved with a flow rate of 1 mL/min and a detection wavelength of 265 nm. The calibration curves were linear over a concentration range of 1.5-100 microg/mL. The intra- and interday RSDs (n = 5) for the retention times and peak area were all less than 2%. The method was sensitive with an LOD (S/N = 3) of 0.1 microg/mL for FMT, imp. C and 0.05 microg/mL for imp. 2, A and D. All recoveries were greater than 98%. The method was demonstrated to be precise, accurate and specific with no interference from the tablet ingredients and separation of the drug peak from the peaks of the degradation products (oxidative degradation and acid and base degradation). The results indicated that the proposed method could be used for the determination of FMT in commercial dosage forms and as a stability-indicating assay.     

Combined wavelet transform-artificial neural network use in tablet active content determination by near-infrared spectroscopy

The pharmaceutical industry faces increasing regulatory pressure to optimize quality control. Content uniformity is a basic release test for solid dosage forms. To accelerate test throughput and comply with the Food and Drug Administration's process analytical technology initiative, attention is increasingly turning to nondestructive spectroscopic techniques, notably near-infrared (NIR) spectroscopy (NIRS). However, validation of NIRS using requisite linearity and standard error of prediction (SEP) criteria remains a challenge. This study applied wavelet transformation of the NIR spectra of a commercial tablet to build a model using conventional partial least squares (PLS) regression and an artificial neural network (ANN). Wavelet coefficients in the PLS and ANN models reduced SEP by up to 60% compared to PLS models using mathematical spectra pretreatment. ANN modeling yielded high-linearity calibration and a correlation coefficient exceeding 0.996.     

CPA矩阵分光光度法同时测定复方磺胺甲噁唑片两组分含量

应用 CPA矩阵分光光度法 ,不经分离直接测定复方磺胺甲唑片中两组分含量。选取 2 2 0、2 2 8、2 5 4、2 6 0、2 6 1nm5个波长作为 CPA矩阵程序的最佳波长点 ,磺胺甲唑的平均回收率和相对标准偏差分别为 :99.7%和 0 .85 % ;甲氧苄氨嘧啶为 99.9%和 1.1%。     

月桂酰基苹果酸酯胶束电动色谱-质谱法同时测定牛黄上清片中5种生物碱

建立了基于月桂酰基苹果酸酯的胶束电动色谱-质谱法同时分离测定牛黄上清片中黄连碱、小檗碱、药根碱、黄柏碱以及川芎嗪5种有效成分含量的新方法。以7.5 mmol/L月桂酰基苹果酸酯-15 mmol/L氨水-50 mmol/L醋酸铵(含12.5%的乙腈,pH=7.0)为电泳介质,未涂层弹性石英毛细管(88 cm×50 μm)为分离通道,50%异丙醇水溶液(含3 mmol/L乙酸)为鞘液,在25 kV的运行电压下,各组分可以在18 min内得到基线分离。各组分的浓度与其峰面积呈现良好的线性关系,迁移时间和峰面积的相对标准偏差均小于5%,样品中5种生物碱成分的样品加标回收率在96.0%～105%之间。该法简便、快速、准确、重现性好,可用于牛黄上清片中这5种有效成分含量的同时测定。     

RP-HPLC测定口腔崩解片中溴吡斯的明的含量

建立反相高效液相色谱法(RP-HPLC)测定口腔崩解片中溴吡斯的明的含量.色谱条件为Hypersil ODS2色谱柱(4.6mm×250mm,5μm),以乙腈-0.1％庚烷磺酸钠水溶液-三乙胺(10∶90∶0.5,pH值调至3.0)为流动相,检测波长270nm.澳吡斯的明质量浓度在50-250μg/mL范围内与峰面积线性关系良好(r=0.9999),平均加标回收率为99.5％(n=9),RSD为1.6％.结果表明,所建立的高效液相色谱法适用于口腔崩解片中溴吡斯的明含量的测定.