辛伐他汀片剂质量一致性评价及干混悬制剂研究

发布时间：2018-03-07 10:00

本文选题：辛伐他汀　切入点：一致性评价　出处：《聊城大学》2017年硕士论文　论文类型：学位论文

【摘要】：辛伐他汀是治疗高血脂症的一线药物,上市的剂型主要是片剂,入选了首批仿制药一致性评价目录。本文主要研究了国产辛伐他汀片剂与原研药的质量一致性,并对辛伐他汀新型干混悬剂的处方工艺和稳定性进行了研究。具体研究内容如下:1.辛伐他汀片质量一致性研究任选两种国产仿制药辛伐他汀片与原研药开展一致性对比研究,通过考察辛伐他汀含量、有关物质、溶出度、晶型等指标,评价仿制药辛伐他汀片剂质量存在的差异。结果表明国产辛伐他汀片剂和原研药的含量和有关物质无显著差异,且均符合2015版中国药典规定。DSC和XRD分析显示2种仿制药与原研药也没有显著差异,但2种国产辛伐他汀片剂的溶出曲线与原研药不相似。2.辛伐他汀干混悬剂的研究采用等量递加法将原料药和辅料干粉混合均匀,以设计的正交实验,沉降体积比和再分散性试验结果为指标,筛选出最佳的处方,并通过高效液相色谱法测定自制混悬剂的含量、有关物质,建立溶出度测定的方法。通过粒径分布、Zeta电位的测定、pH计法测酸度以及影响因素和加速试验研究混悬剂的稳定性。结果表明,粒径分布和Zeta电位结果显示自制辛伐他汀干混悬剂稳定性一般;沉降体积比、再分散性、有关物质和含量等测定均符合2015版中国药典规定;影响因素和加速试验结果显示其在高温、高湿和高光照条件下基本稳定。
[Abstract]:Simvastatin is a first-line drug for the treatment of hyperlipidemia. The main dosage form on the market is tablets, and has been selected into the first batch of generic drug consistency evaluation catalogue. The quality consistency between domestic simvastatin tablets and original drugs was studied in this paper. The formulation process and stability of simvastatin dry suspension were studied. The content of the study was as follows: 1. The consistency of simvastatin tablets was studied. The quality of simvastatin tablets was evaluated by investigating the content of simvastatin, related substances, dissolution, crystal type and so on. The results showed that there was no significant difference in the content and related substances between domestic simvastatin tablets and original simvastatin tablets. In accordance with the Chinese Pharmacopoeia of 2015, the results of .DSC and XRD analysis showed that there was no significant difference between the two generic drugs and the original drugs. However, the dissolution curves of the two kinds of domestic simvastatin tablets were not similar to those of the original drugs. 2. The study of simvastatin dry suspension was carried out. The result of sedimentation volume ratio and redispersity test was used as the index to select the best prescription, and the content and related substances of self-made suspension were determined by high performance liquid chromatography (HPLC). A method for determination of dissolution was established. The acidity, influencing factors and accelerated test of suspension were determined by the method of particle size distribution and Zeta potential. The results showed that, The results of particle size distribution and Zeta potential showed that the stability of Simvastatin dry suspension was general, the sedimentation volume ratio, redispersibility, related substances and contents were all in accordance with the Chinese Pharmacopoeia. The influence factors and the accelerated test results show that it is stable under the conditions of high temperature, high humidity and high light.
【学位授予单位】：聊城大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：TQ460.6

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