前言 止痛化?Y胶囊荣获了“吉林省名牌产品”、“妇科疾病类十强产品”（2011）、“行业典范 百姓安全用药”（卫计委2012）及“行业品牌值得信赖产品”（卫计委2013）等多项荣誉，是名副其实的中药大品种，但是综观该品种的科研历史及应用，存在着中医药行业产品众所周知的五大瓶颈问题：临床定位宽泛、药效物质不清、作用机制不明、制药工艺粗放、质控水平低下。因此深入开展其二次开发是十分必要的。 本书针对止痛化?Y胶囊物质基础不清楚、质量控制水平不高、药理作用及机制不明确及临床适应证宽泛、优势不突出等问题，利用现代药物的研究手段及方法，深入开展了药学、药效学、入血成分及临床再评价等研究。围绕提高止痛化?Y胶囊的质量，从新工艺剂量筛选入手，科学设置工艺品质调控点及质控指标，精准控制工艺参数，实现了批次间一致性目标；将化学组成、药效物质及入血成分及指纹图谱的研究结果整合到质量检测标准，显著提升了药品质控水平，为大幅度提高中成药质量标准提供了技术支撑；从药理学角度阐释了止痛化?Y胶囊多组分、多通路、多靶点及多途径的整合调节机制；通过大量的临床研究结果，确定了止痛化?Y胶囊的临床科学定位。 本书为广大的中药制剂研究人员、临床医生提供了深入了解及应用止痛化?Y胶囊的科学依据，希望能使读者有所收获。 编者 2018年10月于长春 Foreword Zhitong Huazheng capsule, which has been awarded ‘Jilin Province Name-brand Products’, ‘Top 10 Products for Gynecology Diseases’2011, ‘Industry Model, Public Safe Medication’National Health and Family Planning Commission of China（NHFPC, 2012 and ‘Industrial Brand Trustworthy Products’ NHFPC, 2013, is a A variety with large sales of traditional Chinese medicine. However, the development and the application of this drug shares the five common issues known as the bottleneck of the traditional Chinese medicinal products： lack of focus clinical target, ambiguous pharmacophore, unclear mechanism, low-grade production process, low-level quality control. Thus, revisit the properties of this drug in depth is extreme necessary. This book focuses on the issues of the Zhitong Huazheng capsule in terms of ambiguous pharmacophore, low-level quality control, uncertain mechanism, unclear clinical target and non-prominent advantages. We employs state-of-art technologies and methodologies of modern drug development to study the pharmacy, pharmacodynamics, plasma composition of the drug metabolites and clinical revaluation. In order to improving the quality of the Zhitong Huazheng capsule, we screened the formulation, properly set the process quality control point and index, precisely controlled the process parameters and successfully achieved reproduction among different batches. While incorporating the chemical composition, pharmacophore, plasma component and fingerprint spectra, the quality control standard of the drug was improved significantly. This protocol may provide support for further improving the quality of the traditional Chinese medicine. Pharmacodynamics studies revealed the synergistic regulation mechanism of the Zhitong Huazheng capsule involving multi-component, multi-pathway, multi-target and multi-function. We also determined the proper clinical target through clinical trials of large samples. This book provides scientific evidences of understanding and applying the Zhitong Huazheng capsule for the investigators of traditional Chinese medicine and clinical doctors. We sincerely hope the reader benefit from this book. Editor Changchun, October 2018
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