| 引用本文:李洋1，王秀丽2.润喉清咽口崩片的处方筛选与含量测定[J].世界中医药,2019,(01):. |
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| 润喉清咽口崩片的处方筛选与含量测定 |
| Prescription Selection and Content Determination of Runhou Qingyan Orally Disintegrating Tablets |
| 投稿时间：2018-02-28 |
| DOI：10.3969/j.issn.1673-7202.2019.01.014 |
| 中文关键词: 润喉清咽口崩片 处方筛选 含量测定 |
| English Keywords:Runhou Qingyan orally disintegrating tablets Prescription screening Content determination |
| 基金项目:国家中医药管理局临床中药学重点学科项目；国家中医药管理局临床药学重点学科项目（ZP0101YX001） |
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| 中文摘要: |
| 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L9(33)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 C18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 mL/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，r2=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，r2=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。 |
| English Summary: |
| 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.L9 (33) 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 moL/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 mL/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. |
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