五味子总木脂素胃漂浮片的制备及质量评价(1)
中圖分类号 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
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., 百拇医药(邹翔 宫甜 朱室儒 周林 吴双 尹贻静 曲中原 李文兰)
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
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., 百拇医药(邹翔 宫甜 朱室儒 周林 吴双 尹贻静 曲中原 李文兰)