霸王花药材的质量标准研究

Study on quality standard for Hylocereus undatus

目的建立霸王花的质量标准,为其质量控制提供参考。方法取霸王花药材样品,进行性状观察、粉末显微鉴别、薄层色谱(TLC)鉴别,并按2020年版《中国药典》(四部)通则方法测定其中水分、总灰分、酸不溶性灰分、水溶性浸出物和醇溶性浸出物,采用高效液相色谱法检测其中山柰酚、异鼠李素的含量。结果霸王花药材为棕褐色或黄棕色的不规则长条束状;萼管扭曲呈条束状;花外侧鳞片皱缩,内侧着生多数雄蕊。其粉末呈棕绿色或棕黄色,可见花粉粒、导管、非腺毛等。供试品TLC图中,在对照品(山柰酚、异鼠李素)和对照药材色谱相应的位置上,显相同颜色的荧光斑点。15批霸王花药材样品中,水分、总灰分、酸不溶性灰分、水溶性浸出物、醇溶性浸出物分别为10.70%~12.23%、7.48%~11.29%、0.25%~0.70%、30.34%~49.91%、25.27%~36.92%,平均值分别为11.44%、9.51%、0.46%、40.13%、32.33%;山柰酚、异鼠李素的含量分别为1.787~3.785、0.597~2.211 mg/g。结论本研究在霸王花已有质量标准的基础上增加了显微鉴别、TLC鉴别、水分、灰分、浸出物等检查项。初步拟定霸王花药材中水分不得过13.0%,总灰分不得过12.0%,水溶性浸出物、醇溶性浸出物分别不得少于30.0%、25.0%;山柰酚、异鼠李素含量分别不得少于1.780、0.590 mg/g。所建质量标准可用于霸王花药材的质量控制。

OBJECTIVE To establish the quality standard of Hylocereus undatus,and to provide reference for its quality control.METHODS The sample of H.undatus medicinal materials was collected for character observation,powder microscopic identification and thin-layer chromatography(TLC)identification.Moisture content,total ash,acid-insoluble ash,water-soluble extracts and alcohol-soluble extracts were determined according to the corresponding methods in the general provisions of the 2020 edition of Chinese Pharmacopoeia(partⅣ).The contents of kaempferol and isorhamnetin in H.undatus were determined by high performance liquid chromatography.RESULTS The medicinal materials of H.undatus were in brown or yellowish brown irregular long bundles;the calyx tubes were twisted in bundles;the scales on the outside of the flower were shrunken,and many stamens were inserted on the inside.The powder was brown-green or brown-yellow,and pollen grains,ducts and non-glandular hairs were found.In the TLC diagram of test sample,fluorescent spots of the same color were displayed on the corresponding position of the chromatogram of substance control(kaempferol,isorhamnetin)and reference material.The moisture content,total ash,acid-insoluble ash,water-soluble extract and alcohol-soluble extract of the 15 batches of samples ranged from 10.70%to 12.23%,7.48%to 11.29%,0.25%to 0.70%,30.34%to 49.91%,and 25.27%to 36.92%,respectively.The average values were 11.44%,9.51%,0.46%,40.13%,32.33%,respectively.The contents of kaempferol and isorhamnetin were 1.787-3.785 and 0.597-2.211 mg/g,respectively.CONCLUSIONS This study add microscopic identification,TLC identification and inspection items such as moisture content,ash and extract on the basis of the existing quality standards of H.undatus.It is preliminarily proposed that the moisture content in H.undatus shall not exceed 13.0%and total ash content shall not exceed 12.0%,and the water-soluble extract and alcohol-soluble extract shall not be less than 30.0%and 25.0%respectively;the contents of kaempferol and isorhamnetin shall not be less than 1.780 and 0.590 mg/g,respectively.The established quality standard can be used for quality control of H.undatus.