硫酸氢氯吡格雷片剂的体外溶出度测定

Study on the dissolution of Clopidogrel bisulfate tablets in vitro

目的以原研厂家的市售品为参比制剂,测定自制硫酸氢氯吡格雷片剂的溶出曲线,并比较体外溶出行为的相似性。方法参考USP31-NF26版硫酸氢氯吡格雷片剂质量标准,分别测定规定时间点的累积溶出度,采用f2因子来评价体外溶出行为的相似性。结果自制品和参比制剂在30min内,累积溶出度均达到90%以上,符合规定的限度(80%);当参比制剂平均溶出度分别为60%和85%的两个时间点时,自制片和参比片溶出度比较,分别相差8.2%和5.2%。结论自制硫酸氢氯吡格雷片剂和参比制剂体外溶出行为一致。

OBJECTIVE To determine the dissolution curve of self-made clopidogrel bisulfate tablets and commercial tablets,and compare the dissolution similarity in vitro. METHODS The accumulated dissolutions of the self-made tablets and reference preparations were assayed by the quality specification of clopidogrel bisulfate tablets in USP31-NF26,and the similarity of dissolution in vitro was estimated according to f2 . RESULTS The accumulated dissolutions of the self-made tablets and reference preparations reached to...