2015年版《中国药典》新增药用辅料滑石粉的研究现状

Research Status of Talc as a Newly Added Pharmaceutic Adjuvant in 2015 Edition of Chinese Pharmacopoeia

滑石粉作为2015年版《中国药典》的新增药用辅料,已被广泛应用于现代制剂。通过查阅国内外文献,对滑石粉在制剂中的应用情况进行分析,具体包括用作分散剂、崩解剂、润滑剂、抗黏剂、包粉衣层、助滤剂、提高药物临界相对湿度以及抑制或促进药物释放等。与此同时,总结了滑石粉在目前应用过程中存在的问题,例如滑石粉对主药晶型的影响、中成药中使用滑石粉作为辅料的争议性、滑石粉与卵巢癌的相关性。在此过程中发现滑石粉作为药用辅料具有优良的应用前景,为滑石粉的后期研究与应用提供理论支持。

Talc has been widely used in modern pharmaceutical preparations as a new pharmaceutical excipients in the 2015 edition of Chinese Pharmacopoeia. In this paper, the application of talc in preparation, including dispersant, disintegrating agent, lubricant, anti-sticking agent, coating layer and filter aid, to improve the critical relative humidity as well as to inhibit or promote the release of drugs were reviewed. At the same time, it summarizes the existing problems in the application process of talc. In the process of creating this paper, it is found that talc has excellent application prospect as a pharmaceutical excipient. This paper will provide theoretical support for later research of talc.