螺旋藻多糖脂质体包封率的测定

目的建立螺旋藻多糖(APSP)脂质体包封率的测定方法。方法用阴离子交换树脂分离脂质体和游离的APSP,采用分光光度法测定脂质体中APSP的含量,并计算包封率。结果阴离子交换树脂对溶液中游离APSP吸附后的洗脱率达到95.4%,含量测定方法的线性范围为0~5.714μg/mL(r=0.999 7),日内和日间精密度的RSD均小于2%(n=5),方法回收率为98.8%(n=5),APSP脂质体的平均包封率为23.9%。结论此法简便、可行。     

Monte Carlo面积拟合分光光度法同时测定安痛定注射液中各组分的含量

Monte Carlo方法是一种数值计算方法。它既能求解确定性的数学问题,又能求解随机性的问题。本文应用Monte Carlo面积拟合算法,用微机对安痛定注射液的紫外光谱数据进行处理,不经分离测定了该制剂的巴比妥、氨基比林、安替比林三组分含量。平均回收率分别为99.1±1.1(CV);99.6±1.3(CV)和99.7±1.0%(CV)。     

因子分析分光光度法在多组分复方制剂中的应用

因子分析分光光度法在多组分的系统中,可用来推断出系统中组分的个数及系统中各组分在各样品中的浓度。本文采用因子分析法的目标检测法对两组分的复方磺胺甲氧吡嗪片,用微机对其紫外光谱数据进行处理。结果表明,回收率分别为102.0%和102.7%,平均标准差小于2.2%。并对三组分样品(复方扑热息痛片)的模拟数据进行了处理,其结果也较理想。     

因子分析分光光度法在多组分复方制剂中的应用

因子分析分光光度法在多组分的系统中,可用来推断出系统中组分的个数及系统中各组分在各样品中的浓度。本文采用因子分析法的目标检测法对两组分的复方磺胺甲氧吡嗪片,用微机对其紫外光谱数据进行处理。结果表明,回收率分别为102.0%和102.7%,平均标准差小于2.2%。并对三组分样品(复方扑热息痛片)的模拟数据进行了处理,其结果也较理想。     

Excess free energy approach to the estimation of solubility in mixed solvent systems I: Theory

An approach is developed by which the solubility of an organic compound in mixed solvents may be estimated. In this approach, an expression for the excess Gibbs free energy of mixing for multicomponent solvent systems was used to obtain parameters characteristic of the interaction between the solvents. A fairly simple equation which predicts the solubility of a solute in a binary solvent system over the entire solvent composition range was then derived. The equation may be partitioned into terms that contain (a) pure solvent solubilities, (b) solvent-solvent interaction contributions, and (c) contributions from the solute-mixed solvent interactions. The required data are the molar volume of the solute, the pure solvent solubilities, and, theoretically, one experimentally determined solubility in a solvent mixture. The equation can be easily extended for systems with three or more solvents.     

Dissolution and assaying of multicomponent tablets by chemometric methods using computer-aided spectrophotometer

Dissolution of three component tablets containing paracetamol (APAP), propyphenazone (PP), and caffeine (CAF) was carried out by USP paddle method. Three chemometric methods; inverse least square (ILS), principal component regression (PCR) and partial least squares (PLS) were applied to simultaneous assay of APAP, PP and CAF in tablets. The PCR, PLS and ILS methods were applied to simultaneous dissolution APAP, PP and CAF in tablets using a double beam UV-Vis spectrophotometer without any chemical separation and any graphical treatment of the overlapping spectra of three drugs. Twenty two mixture solutions in different concentrations were prepared in simulated gastric juice (SGJ, USP) for the chemometric calibrations as training set. The absorbance data matrix was obtained by measuring the absorbance at 14 wavelength points (from 222.5 to 292.5 nm) with the intervals of 5 nm (Deltalambda=5 nm) in the spectral region between 200 and 310 nm. Training set and absorbance data were used for the calibrations of chemometric methods. The developed calibrations were tested for the previously prepared solutions of mixture of three drugs for the validation of the assay method. The chemometric calculations were performed by using the 'MAPLE VRSQUO; software. The results of three chemometric methods were statistically compared with each other. These chemometric calibrations were successfully applied to the content uniformity and dissolution of the multicomponent tablets without any separation procedure. The synthetic mixtures of three drugs were used for the validity of the calibrations. Means recoveries (percent) and relative standard deviation of PLS, PCR and ILS methods were found to be 100.1+/-0.6, 101.4+/-1.6 and 100.1+/-0.6 for APAP; 100.9+/-3.2, 102.0+/-3.3 and 100.9+/-3.2 for PP; 99.9+/-3.5, 101.6+/-3.3 and 99.9+/-3.2 for CAF, respectively. Dissolution profiles of three component tablets were performed. More than 95% of drugs were dissolved within 15 min. All of the three-chemometric methods in this study can be satisfactorily used for the quantitative analysis and for dissolutions test of multicomponent dosage form.     

Development and validation of chemometrics-assisted spectrophotometric and liquid chromatographic methods for the simultaneous determination of two multicomponent mixtures containing bronchodilator drugs

Three methods are developed for the determination of two multicomponent mixtures containing guaiphenesine (GU) with salbutamol sulfate (SL), methylparaben (MP) and propylparaben (PP) [mixture 1]; and acephylline piperazine (AC) with bromhexine hydrochloride (BX), methylparaben (MP) and propylparaben (PP) [mixture 2]. The resolution of the two multicomponent mixtures has been accomplished by using numerical spectrophotometric methods such as partial least squares (PLS-1) and principal component regression (PCR) applied to UV absorption spectra of the two mixtures. In addition HPLC method was developed using a RP 18 column at ambient temperature with mobile phase consisting of acetonitrile-0.05 M potassium dihydrogen phosphate, pH 4.3 (60:40, v/v), with UV detection at 243 nm for mixture 1, and mobile phase consisting of acetonitrile-0.05 M potassium dihydrogen phosphate, pH 3 (50:50, v/v), with UV detection at 245 nm for mixture 2.The methods were validated in terms of accuracy, specificity, precision and linearity in the range of 20-60 microg ml(-1) for GU, 1-3 microg ml(-1) for SL, 20-80 microg ml(-1) for AC, 0.2-1.8 microgml(-1) for PP and 1-5 microg ml(-1) for BX and MP. The proposed methods were successfully applied for the determination of the two multicomponent combinations in laboratory prepared mixtures and commercial syrups.     

系数倍率分光光度法测定去痛片中三种组分

本文提出以苯巴比妥与辅料的混合溶液为参比,来消除它们的干扰,从而使去痛片成为相当三种组分混合物的测定。然后,利用系数倍率法消除氨基比林、非那西丁、咖啡因间的相互干扰,从而分别测定了去痛片中这三种成分的含量。氨基比林、非那西丁、咖啡因的平均回收率分别为99.3%、99.3%、99.1%,变异系数分别为0.30%、0.34%和0.56%。与药典法对照,两种方法不存在显著性差异(P=0.95)。     

Second-derivative spectrophotometric assay of pseudoephedrine, ibuprofen and loratadine in pharmaceuticals

In this paper the second-derivative spectrophotometric method for the simultaneous determination of pseudoephedrine (CAS 90-82-4) in the combinations with ibuprofen (CAS 15687-27-1) and loratadine (CAS 79794-75-5) is described. Optimal conditions for the quantitative analysis of coated tablets (Test I) and tablets (Test II) were settled. The second-derivative order of the spectra in ethanol with the wavelength modulation was used. For the quantitative assay for all of the investigated substances in the laboratory mixture or in respective pharmaceutical dosage forms the "zero-crossing" technique was applied. The authors propose this second-derivative spectrophotometry for a rapid, simple, precise and accurate determination of the mentioned tests or a corresponding multicomponent mixture.     

大力克--异丙嗪合剂的制备及质量控制

目的: 在小儿磺胺嘧啶合剂处方的基础上研制大力克--非那根合剂,并建立质量标准.方法: 用酸碱滴定法测定磺胺嘧啶的含量,用紫外分光光度法测定甲氧苄啶的含量.结果: 磺胺嘧啶、甲氧苄啶的平均回收率分别为99.76%和99.90%,RSD分别为0.29%和0.58%.结论: 该制剂配方合理,质量可控,可减少小儿用药次数,值得推广.