三七白芨口腔膜剂的制备与质量控制
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摘要
目的制备三七白芨口腔膜剂并对该制剂进行质量控制。方法采用单因素法,以成膜时间及膜外观性能为考察指标,对壳聚糖、聚乙烯醇等6种膜材及其复合膜进行筛选;采用正交设计试验法筛选三七白芨口腔膜剂的最佳处方;采用HPLC对膜剂中人参皂苷Rg1、人参皂苷Rb1、人参皂苷Re及三七皂苷R1进行含量测定。结果对成膜材料进行筛选,聚乙烯醇、海藻酸钠作为成膜材料较为理想;三七白芨口腔膜剂最优处方为聚乙烯醇-海藻酸钠的质量比为1∶2,在膜浆中的浓度是3%,甘油在膜浆的浓度是6%;人参皂苷Rg1、人参皂苷Rb1、人参皂苷Re及三七皂苷R1在0.05～2.0 mg·mL-1内与峰面积呈良好的线性关系。结论三七白芨口腔膜剂的处方设计合理,制备工艺稳定可靠,质量可控。本研究可为三七白芨口腔膜剂的新剂型开发提供实验依据。
Objective To prepare and control the quality of the Sanqi Baiji oral membrane. Methods Six membranes and their composite membranes were screened by single factor method with film formation time and film appearance performance as indicators. The orthogonal design screened out the best prescription for the Sanqi Baiji oral membrane. The content of ginsenosides Rg1, Rb1, Re and notoginsenoside R1 in the film was determined by HPLC. Results Polyvinyl alcohol and sodium alginate were confirmed to be ideal filmforming materials by screening. The optimal prescription for the Sanqi Baiji oral membrane: the concentration of polyvinyl alcohol-alginate with mass ratio of 1 ∶ 2 was 3% in the membrane, and the concentration of glycerol was 6% in the membrane. The Rg1, Rb1 and Re of ginsenosides and the R1 of notoginsenoside showed a good linearity at 0.05-2.0 mg·mL-1. Conclusion The prescription design of Sanqi Baiji oral membrane is reasonable, the preparation is stable and reliable, and the quality is controllable. This study provides experimental basis for the development of new dosage forms of Sanqi Baiji oral film.
Objective To prepare and control the quality of the Sanqi Baiji oral membrane. Methods Six membranes and their composite membranes were screened by single factor method with film formation time and film appearance performance as indicators. The orthogonal design screened out the best prescription for the Sanqi Baiji oral membrane. The content of ginsenosides Rg1, Rb1, Re and notoginsenoside R1 in the film was determined by HPLC. Results Polyvinyl alcohol and sodium alginate were confirmed to be ideal filmforming materials by screening. The optimal prescription for the Sanqi Baiji oral membrane: the concentration of polyvinyl alcohol-alginate with mass ratio of 1 ∶ 2 was 3% in the membrane, and the concentration of glycerol was 6% in the membrane. The Rg1, Rb1 and Re of ginsenosides and the R1 of notoginsenoside showed a good linearity at 0.05-2.0 mg·mL-1. Conclusion The prescription design of Sanqi Baiji oral membrane is reasonable, the preparation is stable and reliable, and the quality is controllable. This study provides experimental basis for the development of new dosage forms of Sanqi Baiji oral film.
引文
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[11]蔡君,王淑英.黄芪总皂苷口腔黏附缓释片的处方筛选及体外释放度测定[J].广州中医药大学学报,2012,29(3):310-314.
[12]谢向阳,李旸,李银科,等.盐酸利多卡因口腔黏附片的处方研究[J].中国药师,2012,15(10):1404-1407.
[13]陈雅慧,傅春升,孙爱萍,等.三七总皂苷制剂研究进展[J].中南药学,2018,16(6):812-816.
[14]中国药典2015年版.四部[S]. 2015:125.
[15]李华凌,翟光喜,焦玉举,等.尼索地平口腔黏附片的制备及影响因素考察[J].中国新药杂志,2007,16(10):783-787.
[16]许冬冬,李永吉,吕邵娃,等.胰岛素口腔黏附片黏附力的考察[J].黑龙江医药,2010,23(4):516-518.
[2]赵文昌,宋丽军,许健煌.天然高分子白芨多糖在药物制备中的应用[J].今日药学,2010,20(3):2-3.
[3]冯陆冰,潘西芬,孙泽玲.三七的药理作用研究进展[J].中国药师,2008,11(10):1185-1187.
[4]张龙霏,胡晶红,张永清.白及药理研究进展[J].中国现代中药,2014,16(1):83-89.
[5]陶阿丽,金耀东,刘金旗,等.中药白芨化学成分、药理作用及临床应用研究进展[J].江苏农业科学,2013,41(11):6-9.
[6]杨慧,何东升,李亚楠,等.口腔膜剂制备工艺的研究进展[J].药学研究,2018,37(7):413-415.
[7]刘宪勇,刘世军,孙克明,等.口腔膜剂的研究与应用进展[J].中国药房,2015,26(10):1420-1423.
[8]柯瑾,姚鹏,李伦宇,等.丹参祛痘涂膜剂制备工艺及其抗炎作用[J].中南药学,2017,15(12):1704-1708.
[9]赵锐帆,潘雯,冯斌,等.盐酸米诺环素单向释放膜的制备及质量控制[J].中南药学,2017,15(2):187-191.
[10]庄硕,杨辛欣,赵娜,等.复方甲硝唑人工牛黄口腔贴片的研制[J].中国医药工业杂志,2016,47(9):1171-1176.
[11]蔡君,王淑英.黄芪总皂苷口腔黏附缓释片的处方筛选及体外释放度测定[J].广州中医药大学学报,2012,29(3):310-314.
[12]谢向阳,李旸,李银科,等.盐酸利多卡因口腔黏附片的处方研究[J].中国药师,2012,15(10):1404-1407.
[13]陈雅慧,傅春升,孙爱萍,等.三七总皂苷制剂研究进展[J].中南药学,2018,16(6):812-816.
[14]中国药典2015年版.四部[S]. 2015:125.
[15]李华凌,翟光喜,焦玉举,等.尼索地平口腔黏附片的制备及影响因素考察[J].中国新药杂志,2007,16(10):783-787.
[16]许冬冬,李永吉,吕邵娃,等.胰岛素口腔黏附片黏附力的考察[J].黑龙江医药,2010,23(4):516-518.