Chinese drugs of clinical and pharmaceutical research with the quality control samples.docVIP

 PAGE \* MERGEFORMAT 13 Chinese drugs of clinical and pharmaceutical research with the quality control samples [Keywords:] Chinese drugs, research using samples, quality control Chinese clinical trials of new drugs and pharmaceutical research involving a wide range of content, the need for a large number of experimental studies. Test data obtained through these studies to explore, understand and confirm drug safety, efficacy and quality control. For research use good quality control samples, using samples of uniform quality research is a correct understanding of drug safety, effectiveness, quality control of the premises, but also conducive to the problems during the test were analyzed. the author of the current drugs of clinical medicine samples for testing and pharmaceutical research attention in the quality control analysis and discussion of preliminary matters, for reference. 1 clinical trials of quality control samples Clinical trials generally the scale of production samples should be used for active ingredients or preparation made parts, can be above the pilot or pilot-scale samples [1]. Clinical trial samples for toxicology and clinical efficacy before use samples, the medicinal material base should be little change. in various stages of clinical trials, the quality of samples should in principle be consistent with the quality of future large-scale production are basically the same samples. 1.1 Preparation of samples 1.1.1 Ⅰ clinical trial According to regulations, should be the main phase Ⅰ clinical trial are the following cases: ① prescription medicines or toxic materials not of the standard, ② non-clinical safety trials resulted in a significant toxicity and other clinical safety concerns, ③ effective component preparation, ④ the new injection of Chinese medicine [2]. These drugs often lack people with a historical reference or security concerns, the need for new drugs to explore the tolerance study. Although Ⅰ clinical trial e