硫酸氢氯吡格雷片的制备及其体外评价  

Preparation and in Vitro Evaluation of Clopidogrel Bisulfate Tablet

作　　者：关展姬 韦翔予 甄维聪 谭翘楚 傅晓仪 王俊哲 Guan Zhanji;Wei Xiangyu;Zhen Weicong;Tan Qiaochu;Fu Xiaoyi;Wang Junzhe(Guangzhou Baiyunshan Tianxin Pharmaceutical Co.,Ltd.,Institute of Medicine,Guangzhou 510000,China)

机构地区：[1]广州白云山天心制药股份有限公司药物研究院,广东广州510000

出　　处：《广东化工》2021年第15期75-77,共3页Guangdong Chemical Industry

摘　　要：采用先热熔制粒后干压制粒的制备工艺来制备硫酸氢氯吡格雷片。通过流化床一步制粒,整粒后加入适量润滑剂,再用干法制粒机进行制粒,总混,压片,包衣等工序得到的硫酸氢氯吡格雷片在4个溶出介质中的溶出曲线与参比制剂的溶出曲线的f2值均大于50,提示二者体外溶出行为相似。此法制得的颗粒可压性、流动性好而且不容易粘冲模,且自制片剂加速6个月和长期12个月留样的稳定性考察中,含量、溶出度、硬度、杂质Ⅰ等关键质量指标无明显变化,证明其稳定性好。The preparation process of first hot melt granulation followed by dry pressing granulation is used to prepare clopidogrel bisulfate tablets. One-step granulation through a fluidized bed, adding an appropriate amount of lubricant after the granulation, and then granulating with a dry granulator, total mixing,tableting, coating, etc. The clopidogrel bisulfate tablets obtained in 4 dissolution media The f2 value of the dissolution curve of the dissolution curve and the dissolution curve of the reference preparation is greater than 50, indicating that the dissolution behavior of the two in vitro is similar. The granules prepared by this method have good compressibility and fluidity and are not easy to stick to the die, and self-made tablets accelerate the stability of 6 months and long-term 12-month retention samples. The key factors such as content, dissolution, hardness, impurity I, etc. There is no obvious change in the quality index, which proves its good stability.

关 键 词：硫酸氢氯吡格雷片 热熔干法制粒 粘冲模 体外溶出 F2因子 

分 类 号：TQ[化学工程]