| Summary: | 碩士 === 大仁科技大學 === 製藥科技研究所 === 105 === In recent decades, it has became a global tendency to apply the natural medicine, including traditional Chinese medicine (TCM), as supplemental and alternative medicine in the health care system. Chinese herbal wine (CHW) are often used for the treatment of cold chills, relieving pain and blood stasis in Chinese. CHW is classified as class B over-the-counter drugs according to Taiwan pharmaceutical regulation. It can be sold in drugstores and other consumption channels, even in network retail since June 30, 2015. CHW is the part of TCM, therefore, quality management and safety assessment on CHW can’t be ignored. To strengthen the quality management of CHW, the Department of Health, Executive Yuan in Taiwan had announced 22 standard formulations of CHW in 2001, which the manufacturers should comply with.
In this study, 16 articles published by Taiwan Health Administrators from 1987 to 2007 are surveyed, included are the variation in the identification of TCM raw materials and quantification of target compounds, manufactory process, and safety assessment. It was found that no matter how much the TCM raw material added, the difference in 1 mL origin CHW can reach up to 20 times. Therefore, the rational for the production of such CHW should be reevaluated. Further, the ratio of solvent to solute was tested in four standards CHW. The results show that some prescriptions can not be immersed in the solution, the total amount of herbs and the proportion of alcohol does not seem reasonable, the rationale for the manufacture of CHW is worth further study.
CHW is an important part in the development of TCM, which have a big market potential. Therefore, the regulations of CHW and its marketing information in China, Japan, and Korea are also collected and compared. We hope these results can warn and assist the industries, officers and research communities to establish better regulations for the production of high quality, safer, and more valuable CHW in Taiwan.
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