本文關(guān)鍵詞：中藥制劑質(zhì)量控制的方法模式分析與研究，，由筆耕文化傳播整理發(fā)布。

中藥制劑質(zhì)量控制的方法模式分析與研究

Analysis and study on quality control methods and modes of traditional Chinese medicine preparations

[1] [2] [3] [4] [5] [6] [7] [8]

WU Zhenfeng,ZHENG Qin,YANG Ming,YUE Pengfei,HU Pengyi,TANG Mei,HOU Liwei,ZOU Wenquan（1.Key Laboratory of Modern Preparation of Traditional Chinese Medicine,Ministry of Education, Ji

[1]江西中醫(yī)學(xué)院現(xiàn)代中藥制劑教育部重點實驗室,江西南昌330004; [2]成都中醫(yī)藥大學(xué),四川成都610075; [3]四川大學(xué),四川成都610065

文章摘要：中藥制劑的質(zhì)量控制問題是關(guān)乎其療效、安全性和穩(wěn)定性的關(guān)鍵問題�，F(xiàn)代分析手段的應(yīng)用及新學(xué)科的發(fā)展一定程度上促進了中藥制劑質(zhì)量控制水平的提高,但長期以來,我國中成藥的質(zhì)量控制仍處于較低的水平,很多中成藥的質(zhì)量標準形同虛設(shè),不能有效控制藥品的質(zhì)量,保證其療效與安全。該文系統(tǒng)分析了影響中藥制劑質(zhì)量的可能因素和質(zhì)量控制的現(xiàn)狀,探討中藥制劑質(zhì)量控制改善的可能途徑和新方法,助推中藥制劑的質(zhì)量控制水平提高與模式轉(zhuǎn)變,以力求保證制劑安全、有效及質(zhì)量可控。

Abstr：The quality control of traditional Chinese medicine（TCM） preparations is a key issue related to their curative effect,safety and stability.The application of modern analytical means and the development of new disciplines improve the quality control of TCM preparations to some extent.For a long time,however,the quality control level of TCM preparations remains low and the quality standards exist in name only unable to effectively control drug quality and ensure therapeutic effect and safety.The essay makes a systematic analysis on possible factors impacting TCM preparations and current situation of quality control and discusses possible approaches and new methods for improving quality control of TCM preparations,in order to give an impetus to the quality control standards and the mode evolvement of TCM preparations and ensure safety,efficiency and quality controllability of TCM preparations.

文章關(guān)鍵詞：

Keyword：:traditional Chinese medicine preparation quality control multi-component fingerprint biochemical effect metabolomics

課題項目：國家“重大新藥創(chuàng)制”科技重大專項（2009ZX09310-005）; 公益性行業(yè)科研專項”（200807038）; 江西省自然科學(xué)基金項目（2010GQY0179）; 江西省教育廳科技項目（GJJ11549）

  本文關(guān)鍵詞：中藥制劑質(zhì)量控制的方法模式分析與研究，由筆耕文化傳播整理發(fā)布。