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近来中药注射剂的发展已成为医药有关部门大家议论的中心,今年5月在武汉召开的《中成药研究》编委会上也讨论到这个问题,同时也听到一些不同的看法,归纳起来大致有三种:一种认为目前的中药注射剂绝大多数都有质量问题,而且历史上中医没用过注射剂,国外也没有中药注射剂,不应研究、发展和生产。另一种认为中药只有在提取到单纯的有效成分才能考虑制备注射剂;再一种则认为中药注射剂制备困难,控制质量也不易,但应深入研究,整顿提高。我比较赞成第三种意见,具体理由如下,供大家进一步讨论参考。一、对目前中药注射剂现状的分析中药注射剂应该是指以一种或多种中药为原料,经过合理的提取工艺,制成符合注射剂要求的产品,必需有可靠的疗效及安全性,在规定的贮存期内稳定性良好。未经研究任意把中药水煎液或水煎酒沉处理过的溶液装入安瓿,是不能称为中药注射剂的。
Recently, the development of traditional Chinese medicine injections has become the center of discussion of the relevant departments of medicine. In May this year, the editorial board of “Chinese Medicine Research” held in Wuhan also discussed this issue. At the same time, I also heard some different opinions, and summed it up roughly three times. Species: One thinks that the vast majority of current Chinese medicine injections have quality problems, and that in history, Chinese medicine has not used injections, and there is no Chinese medicine injection abroad, and should not be researched, developed and produced. Another kind of thinking that traditional Chinese medicine can only consider the preparation of injections after the extraction of a simple active ingredient; the other is that the preparation of traditional Chinese medicine injections is difficult, and the quality of control is not easy, but it should be in-depth research, rectification and improvement. I am in favor of the third opinion. The specific reasons are as follows for further discussion and reference. First, the analysis of the current status of traditional Chinese medicine injections Traditional Chinese medicine injections should refer to one or more kinds of traditional Chinese medicines as raw materials, through a reasonable extraction process, made of products that meet the requirements of injections, must have reliable efficacy and safety, in the provisions of Good stability during storage period. Without the study, any solution containing traditional Chinese medicine decoction or decoction liquor was loaded into the ampoule and could not be called as a Chinese medicine injection.