利巴韦林片人体生物等效性研究和临床应用的分析-制药工程专业论文.docxVIP

山东大学碗1二学位论文t。分别为(22．36±3．28)h和(21．57±2．42)h，无。，分别为 山东大学碗1二学位论文 t。分别为(22．36±3．28)h和(21．57±2．42)h，无。，分别为 (2．00±0．00)h和(1．98±0．1 1)h，￡。。分别为(0．80±0．12) u g·ml“和(0．85±0．22)u g·ml～，爿UCo～7：分另0为(15．77±3．90) u g·ml’。·h。和(15．1 2±2．98) u g·ml“·h～，AUC．～。分别为 (17．75±4．47)p g·ml“·h“和(16．75±3．42)u g·ml。‘·h一。试 验制剂利巴韦林片相对生物利用度，为104．71％±16．49％。多因素 方差分析显示，试验制剂和参比制剂口服双交叉试验主要药代动力 学参数无显著性差异。双单侧t检验和(1-2 a)置信区间分析显 示个体间、周期间和制剂间符合生物等效的假设，即山东齐都药业 有限公司开发研制的利巴韦林片剂与江西汇仁药业有限公司生产 的利巴韦林片剂具有生物等效性，为生物等效制剂。 利巴韦林临床应用的分析总共纳入6项试验研究，共有4604 名患者资料，样本量由18至511例不等。其中5项试验涉及利巴 韦林与聚乙二醇干扰素或普通干扰素联合治疗丙型肝炎，4项试验 涉及利巴韦林联合聚乙二醇干扰素与聚乙二醇干扰素单药治疗丙 型肝炎。经Meta分析得出结论，利巴韦林联合聚乙二醇干扰素治 疗丙型肝炎48周可以获得持续病毒学应答率达到50％以上，疗效 优于利巴韦林联合干扰素或聚乙二醇干扰素单药治疗的临床方案。 关键词；利巴韦林；生物等效性；高效液相色谱法；丙型肝炎； Meta分析 些查叁兰竺!兰些丝皇 些查叁兰竺!兰些丝皇 一一—— Study on the Bioequivalence in human body and the analysis of clinical use of ribavirin Tables SpeciaIization：Pharmaceutical Engineering Postgraduate：Baiqian Jing Supervisor：Senior Pharmacist Wen Zhou Prof． Fengshan Wang ABSTRACT Backgrounds：Hepatitis C is a global pandemic．It was reported by World Health Organization(WHO)that the global infection rate of hepatitis C virus(HCV)was about 3 percent and the infected people was estimated at more than 0．17 billion．Ribavirin oral dosage forms are one of the important known therapeutic drugs．The ribavirin tablets prepared by Shandong Qidu Pharmaceutical Co．Ltd．is the new-drug of chemical drugs class VI．The study of the drug’s bioequivalence is the basis of new drug approval and its clinical application．The clinical use of the Ribavirin combined with PEG-interferon(PEG-INF)in treating hepatitis C was analyzed to provide references for the rational use of the drugs． Obj ectives：The bioequiValence of ribavirin tested preparation and reference preparation was studied in this paper，which would provide evidences for new drug approval and clinical use． The clinical curative effeet of the combined ribavirin and PEG．INF to treat hepatitis C was evaluated and analyzed，which would promote the ra