鹿药的质量标准研究
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篇名: 鹿药的质量标准研究
TITLE:
摘要: 目的:建立鹿药的质量标准。方法:从原植物形态、性状特征、显微特征、薄层色谱(TLC)等方面对药材进行定性鉴别;测定药材的水分、灰分、浸出物;采用高效液相色谱法测定药材中(25S)-17α-羟基-5α-螺甾烷-9-烯-3β-O-β-D-葡萄吡喃糖基-(1→2)-[β-D-木吡喃糖基(1→3)]-β-D-葡萄吡喃糖基(1→4)-β-D-半乳吡喃糖苷(SJ-13)的含量,色谱柱为Waters SunFire C18,流动相为乙腈-水(35 ∶ 65,V/V),流速为1.0 mL/min,检测波长为203 nm,柱温为20 ℃,进样量为10 μL。结果:原植物为多年生草本植物,高30~60 cm;药材表面呈棕色至棕褐色,具皱纹;显微特征为表皮1列细胞;药材粉末呈灰黄色,含大量草酸钙针晶。药材样品的TLC图斑点大部分清晰,分离度好;药材中水分为5.26%~8.88%,总灰分为4.60%~28.86%,酸不溶性灰分为1.56%~23.39%,水浸出物为23.84%~51.26%,醇浸出物为22.65%~57.36%;SJ-13检测进样量线性范围为8.92~31.22 μg(r=0.999 9),精密度、稳定性、重复性试验的RSD均小于1%,加样回收率为97.0%~99.2%(RSD=0.8%,n=6),耐用性试验的RSD均小于1%,10批药材样品中SJ-13的含量范围为4.40~29.80 mg/g。结论:初步拟定鹿药药材中水分不得过11%,总灰分不得过35%,酸不溶性灰分不得过28%,水浸出物不得少于19%,醇浸出物不得少于18%,SJ-13含量不得少于4.40 mg/g;该试验所建标准可用于鹿药的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard of Smilacina japonica. METHODS: S. japonica was identified qualitatively in respects of original plant morphology, character, microscopic identification, TLC, etc. The moisture, ash and extract of medicinal materials were determined. The content of (25S)-17α-hydroxy-5α-spirostane-9-ene-3β-O-β-D-glucopyranoyl-(1→2)-[β-D-xylanosyl(1→3)]-β-D-glucopyranoyl(1→4)-β-D-galactopyranoside(SJ-13) was determined by HPLC. The determination was performed on Waters SunFire C18 column with mobile phase consisted of acetonitrile-water(35 ∶ 65,V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 203 nm and the column temperature was 20 ℃. The sample size was 10 μL. RESULTS: The original plant was perennial herbal, with height of 30-60 cm. The surface of the medicinal material was brown to brownish brown, with wrinkle and 1 row cells in epidermis. The powder of medicinal material was grayish yellow and contained large amount of acicular crystal. TLC spots were clear and well-separated. The content of moisture was 5.26%-8.88%; the content of total ash was 4.60%-28.86%; the acid-insoluble ash was 1.56%-23.39%, water extract was 23.84%-51.26% and alcohol extract was 22.65%-57.36%. The linear range of SJ-13 were 8.92-31.22 μg(r=0.999 9). RSDs of precision, stability and reproducibility tests were all lower than 1%. The average recoveries were 97.0%-99.2%(RSD=0.8%,n=6). RSD of durability test was lower than 1%. The content of SJ-13 was 4.40-29.80 mg/g in 10 batches of medicinal samples. CONCLUSIONS: The content of water, total ash, acid insoluble components should not exceed 11%, 35%, 28%; the content of water extract, alcohol extract and SJ-13 should not be less than 19%, 18% and 4.40 mg/g, respectively. Established standard can be used for the quality control of S. japonica.
期刊: 2018年第29卷第20期
作者: 崔誉文,刘银环,热萨莱提·图尔孙,毛昭琦,宋小妹
AUTHORS: CUI Yuwen,LIU Yinhuan,Resalaiti·TUERSUN,MAO Zhaoqi,SONG Xiaomei
关键字: 鹿药;质量标准;显微特征;薄层色谱法;含量测定;高效液相色谱法
KEYWORDS: Smilacina japonica; Quality standard; Microscopic identification; TLC; Content determination; HPLC
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