Evaluation of the quality of olanzapine orally disintegrated tablets by multiple dissolution curves

Objective: To investigate the dissolution behavior similarity between Self-made praeparatum and reference praeparatum in different pH menstruum,using the Olanzapine Orally Disintegrating Tablets listed in abroad as the reference praeparatum. Methods: The dissolution curve of olanzapine in Self-made praeparatum and reference praeparatum was measured,the similarity of the dissolution curve was evalued by F2 similar factor. Results: The single-point dissolution of both Self-made praeparatum and reference praeparatum within 15 min was more than 85%. Conclusion: Self-made praeparatum and reference praeparatum were similar in dissolution behavior.

CFD simulation with enhancement factor of sulfur dioxide absorption in the spray scrubber

A model describing the absorption process of SO2 into limestone slurry with a spray scrubber is presented. Both the physical performance of the spray liquid in the scrubber and the involved chemical reactions are analyzed in the model. A con- tinuous concentration change of H+ was solved by iterative coupling using Matlab, and it was found that there was a remarkable influence on the concentration of the other elements in the process of SO2 absorption. The calculations show that the enhancement factor exponentially grows with an increasing value of pH and logarithmically decays with an increasing value of the driving force. To verify the accuracy of the model, experiments were also carried out, and the results suggest that the model, after combining the physical performance of the spray and the enhancement factor, can more precisely describe SO2 absorption in a spray scrubber. Furthermore, a commercial computational fluid dynamics (CFD) tool is used to perform several simulations which describe and clarify the effects of variables on SO2 absorption. The results of numerical simulation can provide a basis for further design and optimization of the scrubber.

多条溶出曲线对奥氮平口崩片质量的评价

目的:以美国Lilly上市的奥氮平口崩片作为参比制剂,考察分析在不同pH值溶出介质中自研制剂与参比制剂体外溶出数据的相似性。方法:首先测定出自研制剂与参比制剂的溶出曲线;再利用f_2相似因子法对所测定溶出曲线的相似性来进行分析评价。结果:在15min以内,发现在不同pH值溶出介质中自研制剂与参比制剂的溶出量均大于85%。结论:自研制剂和参比制剂的溶出数据相似。

不同厂家羟苯磺酸钙胶囊溶出曲线相似性研究

采用篮法(转速为100 rpm)、紫外分光光度法(检测波长300 nm)测定3种国产羟苯磺酸钙胶囊与进口参比制剂在4种溶出介质中不同取样时间点的溶出样品吸光度,计算累积溶出百分率,并绘制溶出曲线。同时采用f 2相似因子法和溶出效率(DE)比较各溶出曲线的相似性。结果表明,在4种溶出介质中,不同厂家羟苯磺酸钙胶囊与进口参比制剂溶出曲线不一致。

基于系统统计分析的复方氨酚烷胺片溶出曲线相似性研究

评价国内15家复方氨酚烷胺片生产企业产品溶出曲线相似性。按照普通口服固体制剂溶出度试验技术指导原则,分别以pH值1. 2、pH值4. 0和水为溶出介质,考察复方氨酚烷胺片溶出状况,并通过计算相似因子(f2)和SPSS聚类分析方法评价溶出曲线相似性。聚类分析结果与相似因子分析结果一致,提示企业F溶出行为异常。本文为聚类分析评价溶出曲线相似性模型建立提供了参考。

不同厂家富马酸喹硫平片在5种溶出介质中溶出曲线的比较

目的:通过比较不同来源的富马酸喹硫平片的体外溶出曲线,为其质量一致性评价提供参考。方法:以0.01 mol·L^(-1)盐酸、0.1 mol·L^(-1)盐酸、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水分别作为溶出介质,体积为900 mL,采用桨法,转速为50 r·min^(-1),进行富马酸喹硫平片的溶出考察,采用HPLC法测定富马酸喹硫平的含量,并计算累积溶出量,绘制溶出曲线,采用相似因子(f_(2))法评价溶出曲线的相似性。结果:不同来源参比制剂在5种溶出介质中,15 min累积溶出量均≥85%或f_(2)均>50,溶出曲线相似,溶出行为一致。不同来源国产仿制制剂在5种溶出介质中,厂家B在0.1 mol·L^(-1)盐酸介质中、厂家A生产的100和200 mg规格在pH 6.8磷酸盐缓冲液介质中,与原研进口参比制剂相比,f_(2)<50,溶出曲线存在不相似的情况。其余批次溶出曲线相似,溶出行为一致。结论:不同来源的参比制剂溶出曲线相似,溶出行为均一致;少数国产仿制制剂与原研进口参比制剂在非药典溶出度检查项目规定的溶出介质中存在溶出行为不完全一致的情况,仍需结合具体的生物等效性试验以及其他药学指标进行一致性的全面评估。

采用不同介质中的溶出曲线评价硫酸氢氯吡格雷片的内在质量

目的比较硫酸氢氯吡格雷片仿制药与原研药在4种不同溶出介质中溶出曲线的相似性。方法分别以pH 2.0盐酸缓冲液、pH 4.5磷酸盐缓冲液、pH 6.8磷酸盐缓冲液和水为溶出介质测定2种片剂的体外溶出曲线,并采用?2相似因子法考察其相似性。结果在4种不同溶出介质中,2种片剂溶出曲线的?2值分别为56,80,78和75。结论 2种片剂的体外溶出曲线在4种不同溶出介质中均相似。

阿苯达唑原料药粒度对其片剂体外溶出度的影响

目的研究原料药粒度分布对阿苯达唑片溶出的影响,考察仿制片与原研药的体外溶出曲线一致性。方法通过对原料药进行不同处理,对比仿制片与原研药的溶出曲线相似因子f^(2)值。结果控制原料药粒度d(0.5)为5~10μm,d(0.9)为10~20μm,可使仿制片与原研药的体外溶出相似。结论确定适宜的原料药粒度控制范围,产品稳定性良好。