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五味子总木脂素胃漂浮片的制备及质量评价 Δ

邹 翔 ，宫 甜，朱室儒，周 林，吴 双，尹贻静，曲中原 ，李文兰（哈尔滨商业大学药学院/抗肿瘤天然药物教
＊
#
育部工程研究中心，哈尔滨 150076）

中图分类号 R284.1；R944.4 文献标志码 A 文章编号 1001-0408（2020）11-1336-06
DOI 10.6039/j.issn.1001-0408.2020.11.09

摘 要 目的：研究五味子总木脂素胃漂浮片的制备工艺，并对所制片剂进行质量评价。方法：在单因素试验的基础上，以羟丙基
甲基纤维素（HPMC）K15M比例、NaHCO3比例、微晶纤维素比例为考察因素，以胃漂浮片的起漂时间、持漂时间、累积释放率作为
评价指标进行正交试验，优化五味子总木脂素胃漂浮片处方。对所制五味子总木脂素胃漂浮片的性状、片重差异、漂浮性能和累
积释放率进行检查；采用薄层色谱法进行定性鉴别，采用高效液相色谱法和紫外分光光度法测定该制剂中五味子醇甲和总木脂素
的含量。结果：五味子总木脂素胃漂浮片最优制备处方比例为五味子总木脂素浸膏23％、HPMC K15M 20％、微晶纤维素40％、
NaHCO3 15％、十八醇 1％、聚乙烯吡咯烷酮 1％。所制五味子总木脂素胃漂浮片各项检查结果均符合 2015 年版《中国药典》（四
部）项下“0101片剂”相关规定。薄层色谱鉴别结果显示，供试品溶液色谱中与五味子醇甲对照品、五味子对照药材及原药材色谱
相应的位置上显相同颜色的主斑点，阴性对照无干扰。含量测定结果显示，五味子总木脂素胃漂浮片中五味子醇甲和总木脂素的
平均含量分别为3.187、19.617 mg，初步制定该片剂每片中五味子醇甲含量不得低于2.50 mg、总木脂素含量（以五味子醇甲计）不
得低于15.50 mg的限度。结论：五味子总木脂素胃漂浮片的制备工艺稳定、可行，质量可控。
关键词 五味子总木脂素；胃漂浮片；五味子醇甲；处方优化；质量评价；鉴别；含量测定

Preparation and Quality Evaluation of Gastric Floating Tablets of Schisandra chinensis Total Lignans
ZOU Xiang，GONG Tian，ZHU Shiru，ZHOU Lin，WU Shuang，YIN Yijing，QU Zhongyuan，LI Wenlan（College
of Pharmacy/Engineering Research Center of Natural Anticancer Drugs， Ministry of Education， Harbin
University of Commerce，Harbin 150076，China）

ABSTRACT OBJECTIVE：To study the preparation technology of gastric floating tablets of Schisandra chinensis total lignans
（SCTL），and evaluate the quality of prepared tablets. METHODS：Based on single factor test，the orthogonal experiment was
conducted to optimize the formulation of SCTL gastric floating tablets with the contents of hydroxypropylmethylcellulose（HPMC）
K15M，NaHCO3 and microcrystalline cellulose as the factors，using starting time，holding time and cumulative release rate of
gastric floating tablets as evaluation indexes. The properties，weight difference，floatability and accumulative release rate of the
prepared SCTL gastric floating tablets were determined. The gastric floating tablets were qualitatively identified by TLC，and the
contents of schisandrin A and total lignans were determined by HPLC and UV spectrophotometry. RESULTS：The optimal
formulation of SCTL gastric floating tablets was made up of 23％ SCTL extract，20％ HPMC K15M，40％ microcrystalline
cellulose， 15％ sodium bicarbonate， 1％ octadecyl alcohol and 1％ polyvinylpyrrolidone. The results of detection of this
preparation were in line with the related provisions of“0101 tablet”stated in 2015 edition of Chinese Pharmacopoeia（part Ⅳ）.
TLC indicated that the chromatogram of the test sample showed the main spots of same color as the corresponding positions of the
chromatogram of schizandrol A control，Schisandra chinensis reference substance and raw material，while the negative control has
no interference. Content determination results shows that the average content of schizandrol A and total lignans in SCTL gastric
floating tablets is 3.187，19.617 mg. It was preliminarily formulated that the content limitation of schizandrol A in one tablet should
not be less than 2.50 mg，and the content of total lignans （calculated by schizandrol A） should not be less than 15.50 mg.
CONCLUSIONS：The preparation technology of SCTL gastric floating tablets is stable，feasible and controllable in quality.
KEYWORDS Schisandra chinensis total lignans；Gastric floating tablets；Schizandrol A；Formulation optimization；Quality
evaluation；Indentification；Content determination

五味子为木兰科植物五味子[Schisandra chinensis （Turcz.）Baill.]的干燥成熟果实，又称北五味子 。中医
[1]
Δ 基金项目：黑龙江省科技重大专项（No.GA19C107） 常用五味子治疗久嗽虚喘、遗尿、尿频、久泻不止、自汗
＊研究员，博士生导师，博士。研究方向：抗肿瘤天然药物。电 盗汗、内热消渴、心悸失眠等病症 。五味子含有木脂素
[2]
话：0451-84866922。E-mail：zou8663202@163.com
类、有机酸类、挥发油类等成分 [3-4] 。现代药理学研究表
# 通信作者：教授，博士生导师，博士。研究方向：中药药效物质
基础及中药炮制。电话：0451-84838207。E-mail：qiuqiuqu@163.com 明，五味子木脂素类成分具有保肝利胆、镇静催眠、抗过

·1336 · China Pharmacy 2020 Vol. 31 No. 11 中国药房 2020年第31卷第11期