五指毛桃的质量标准研究

目的控制五指毛桃Fici Hirtae Radix药材质量,制订药材质量标准。方法通过植物形态、产地、历史沿革、功效、近年研究结果等的全面查考,修正《中国药典》1977年版五指毛桃药材的基原错误;采用性状、显微、薄层鉴别不同来源的商品药材;采用HPLC法测定药材中指标成分的量;按《中国药典》2010年版附录方法检测各检查项。结果五指毛桃药材基原并非极简榕Ficus simplicissima Lour.,而是粗叶榕Ficus hirta Vahl。20批五指毛桃商品药材中除规定药用部位粗叶榕的根外,有约40%非药用部位的茎枝样品;不同部位性状、显微特征及薄层色谱区别明显。药材中补骨脂素量为0.00848%~0.150%,佛手柑内酯为0.005 87%~0.026 3%,根类样品2种指标成分量显著高于非药用部位的茎枝样品。药材水分量为4.73%~8.27%,总灰分为2.58%~4.37%,酸不溶性灰分为0.054%~0.710%,醇溶性浸出物为6.23%~8.34%。结论修正《中国药典》1977年版五指毛桃药材基原错误,规范其药用部位为粗叶榕的根。建立的五指毛桃药材的质量标准可全面、有效地控制药材质量,为临床合理、有效、安全用药提供参考。

Study on quality standard of Fici Hirtae Radix

Objective To control the quality of Fici Hirtae Radix by establishing quality standards. Methods The origin mistakes of Fici Hirtae Radix in Chinese Pharmacopoeia (1977 edition) were modified by searching and mining plant morphology characters, distribution of origin, historical evolution, clinical efficacy and modern research, medicinal standards in different regions on Ficus hirta Vahl and Ficus simplicissima. Morphological identification, microscopical characteristics based on transverse section and powder, and thin layer chromatography were adopted to identify commercial medicinal materials of Fici Hirtae Radix from different sources. The content of psoralen and bergapten was determined by HPLC. Moisture content, total ash, acid-insoluble ash, and ethanol-soluble extractives were determined by methods described in appendices of Chinese Pharmacopoeia (2010 edition). Results The origin of Fici Hirtae Radix was not F. simplicissima Lour., but F. hirta Vahl. This study collected 20 Fici Hirtae Radix commercial medicines mixed 40% non-medicinal parts samples. TLC data, morphological characteristics and microscopic characteristics, both showed obvious distinction. The concentration of psoralen and bergapten showed the content of psoralen range from 0.008 48% to 0.150%, and the content of bergapten range from 0.005 87% to 0.026 3%, and the contents of two index components of Fici Hirtae Radix were significantly higher than the non-medicinal parts samples. The moisture content ranged from 4.73% to 8.27%, total ash ranged for 2.58% to 4.37%, acid insoluble ash ranged for 0.054% to 0.710%, ethanol-soluble extracts ranged for 6.23% to 8.34%. Conclusion This paper revised the origin error of Fici Hirtae Radix of Chinese Pharmacopoeia (1977 edition) that its specification medicinal part should be the roots of F. hirta, and established quality standards of Fici Hirtae Radix, and these methods could comprehensively and effectively control the quality of commercial medicinal materials of Fici Hirtae Radix. This study could provide evidence for rational, safe, and effective clinical application of Fici Hirtae Radix.