润喉清咽口崩片的处方筛选与含量测定
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摘要
目的:筛选润喉清咽口崩片的制备工艺与处方,建立润喉清咽口崩片中儿茶素、表儿茶素的含量测定方法。方法:选取粉末直接压片法制备润喉清咽口崩片,以硬度、脆碎度、口感、崩解时间为主要评价指标,对崩解剂、润滑剂、填充剂进行单因素筛选实验,采用L_9(3~3)正交试验设计优化处方;采用高效液相色谱法测定润喉清咽口崩片中儿茶素、表儿茶素的含量,采用CAPCELL PAK C_(18)色谱柱,以0. 04 mol/L枸橼酸溶液-N,N-二甲基甲酰胺-四氢呋喃(45∶8∶2)为流动相,检测波长为280 m,流速1. 0 m L/min,柱温25℃;检测波长280 nm。结果:润喉清咽口崩片最佳处方制备的润喉清咽口崩片外观和口感良好,60 s内可完全崩解。儿茶素在0. 148 6～2. 972 g范围内线性关系良好,r~2=0. 999 9 (n=5),表儿茶素在0. 103～2. 06 g范围内呈良好的线性关系,r~2=0. 999 6(n=5)。平均回收率分别为98. 49%,98. 56%,RSD分别为1. 33%,1. 87%。结论:优化得到的润喉清咽口崩片处方合理,工艺可行,崩解迅速,口感良好,质量可控。
Objective: To screen the preparation technology and prescription of Runhou Qingyan orally disintegrating tablets,and to establish the method for determination of content of catechin and epicatechin in Runhou Qingyan orally disintegrating tablets. Methods: The Runhou Qingyan orally disintegrating tablets was prepared by powder direct compression method. The hardness,friability,mouthfeel and disintegration time were the main evaluation indexes for single-factor screening experiments of the disintegrants,lubricants and fillers. L_9 (3~3) orthogonal experimental design was used for the optimization prescription,and high performance liquid chromatography (HPLC) was applied for the determination of Runhu Qingyan orally disintegrating tablets catechin,epicatechin content with the CAPCELL PAK C18 column,0. 04 mo L/L citrus citric acid solution-N,N-dimethylformamide-tetrahydrofuran (45:8:2) as the mobile phase at a detection wavelength of 280 m,a flow rate of 1. 0 m L/min and a column temperature of 25 ℃. Results: The best prescription of Runhou Qingyan orally disintegrating tablets had good appearance and taste,which can be completely disintegrated in 60 s. The content of catechin had a good linear relationship in the range of 0. 1486 mg-2. 972 mg with r = 0. 9999 (n = 5),and the content of epicatechin had a good linear relationship in the range of 0. 103 mg-2. 06 mg,r = 0. 9998 (n = 5). The average recovery rates in the 2 groups were 98. 49% and 98. 56%,and RSDs of which were 1. 33% and 1. 87%. Conclusion: Optimized Runhou Qingyan orally disintegrating tablets prescription is rational,and the process is feasible. The disintegration is rapid,which has good taste and adjustable quality.
Objective: To screen the preparation technology and prescription of Runhou Qingyan orally disintegrating tablets,and to establish the method for determination of content of catechin and epicatechin in Runhou Qingyan orally disintegrating tablets. Methods: The Runhou Qingyan orally disintegrating tablets was prepared by powder direct compression method. The hardness,friability,mouthfeel and disintegration time were the main evaluation indexes for single-factor screening experiments of the disintegrants,lubricants and fillers. L_9 (3~3) orthogonal experimental design was used for the optimization prescription,and high performance liquid chromatography (HPLC) was applied for the determination of Runhu Qingyan orally disintegrating tablets catechin,epicatechin content with the CAPCELL PAK C18 column,0. 04 mo L/L citrus citric acid solution-N,N-dimethylformamide-tetrahydrofuran (45:8:2) as the mobile phase at a detection wavelength of 280 m,a flow rate of 1. 0 m L/min and a column temperature of 25 ℃. Results: The best prescription of Runhou Qingyan orally disintegrating tablets had good appearance and taste,which can be completely disintegrated in 60 s. The content of catechin had a good linear relationship in the range of 0. 1486 mg-2. 972 mg with r = 0. 9999 (n = 5),and the content of epicatechin had a good linear relationship in the range of 0. 103 mg-2. 06 mg,r = 0. 9998 (n = 5). The average recovery rates in the 2 groups were 98. 49% and 98. 56%,and RSDs of which were 1. 33% and 1. 87%. Conclusion: Optimized Runhou Qingyan orally disintegrating tablets prescription is rational,and the process is feasible. The disintegration is rapid,which has good taste and adjustable quality.
引文
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[15]严莺.HPLC波长切换联合梯度洗脱法同时测定冰梅上清丸中儿茶素、表儿茶素、去芹糖桔梗皂苷E、桔梗皂苷E和桔梗皂苷D3[J].实用药物与临床,2017,20(9):1082-1085.
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[2]徐先祥.儿茶素的药理作用研究综述[J].郑州轻工业学院学报:自然科学版,2012,27(4):60-64.
[3]齐有胜,孙毅坤,刘为萍.单味中药抗流感病毒研究进展[J].中国实验方剂学杂志,2017,23(14):210-218.
[4]陈书媛,戴申,龚雨顺.儿茶素类化合物抑菌作用及其作用机制的研究进展[J].食品安全质量检测学报,2017,8(9):3316-3322.
[5]李伟伟,史建俊,牛江秀.吡罗昔康口崩片处方优化及质量评价[J].长江大学学报:自然科学版,2015,12(25):20-22.
[6]邓姗姗,凌家俊,邵悦.正交设计优化参附口崩片处方[J].中医药导报,2015,21(18):41-43.
[7]任熙玲,王燕.枳术口崩片制备工艺的研究[J].陕西中医,2012,33(9):1225-1227.
[8]王博妍.盐酸苯海拉明口崩片的制备工艺及质量控制研究[J].黑龙江科技信息,2013,15(5):33.
[9]国家药典委员会.中华人民共和国药典[S]北京:中国医药科技出版社,2015:118,120.
[10]都胜男,刘辉,张芸,等.银杏叶口崩片的制备和含量测定[J].中国药师,2013,16(12):1819-1822.
[11]郑平,时颖,王文忠.增损八珍口崩片处方的优化[J].现代中药研究与实践,2013,27(2):42-44.
[12]陈程,罗国平,冯锁民,等.葛根总黄酮口崩片的制备工艺研究[J].应用化工,2015,44(11):2165-2166.
[13]万华根.盐酸苯海拉明口崩片制备工艺探讨[J].江西中医药,2012,43(6):68-69.
[14]原月.奥美拉唑口崩片的制备及质量控制[J].黑龙江科技信息,2014,16(18):37-37.
[15]严莺.HPLC波长切换联合梯度洗脱法同时测定冰梅上清丸中儿茶素、表儿茶素、去芹糖桔梗皂苷E、桔梗皂苷E和桔梗皂苷D3[J].实用药物与临床,2017,20(9):1082-1085.
[16]谢静,韦杰,周璐炜,等.一测多评法测定心脑健胶囊(片)中6种儿茶素[J].中成药,2017,39(3):523-527.
[17]刘子明,李国华.HPLC法测定黑豆皮中原儿茶酸、表儿茶素的含量[J].食品研究与开发,2016,37(11):150-152.