酚麻美敏口腔崩解片中四组分的体外溶出速率的实验研究  

Study on the Dissolution Rate of Four Ingredients from "Paracetamol,Pseudoephedrine Hydrochloride,Dextromethorphan Hydrobromide and Chlorphenamine Maleate Orally Disintegrating Tablets"

作　　者：翁水旺[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《中国现代应用药学》2007年第3期219-221,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的研究酚麻美敏口腔崩解片中四组分的体外溶出速率的方法。方法选用小杯法，溶剂为水，对乙酰氨基酚的溶出量采用分光光度法测定;氢溴酸右美沙芬、马来酸氯苯那敏、盐酸伪麻黄碱的溶出量采用高效液相色谱法同时测定。结果浓度依次为对乙酰氨基酚2.0-20.0μg·mL^-1，氢溴酸右美沙芬5.203-26.02μg·mL^-1，马来酸氯苯那敏0.982-4.910μg·mL^-1，盐酸伪麻黄碱14.94-74.70μg.mL^-1范围内与各自的峰面积呈良好的线性关系，r分别为0.999 9，0.999 9，0.999 8，0.999 9。平均回收率依次为对乙酰氨基酚98.4%，RSD为0.84%;氢溴酸右美沙芬100.2%，RSD为1.02%;马来酸氯苯那敏99.4%，RSD为1.82%;盐酸伪麻黄碱97.8%，RSD为1.05%。该药3批样品10 min溶出量均在90%以上。结论本方法用于酚麻美敏口腔崩解片中四组分的溶出度测定切实可行。OBJECTIVE To study the dissolution rate in vitro of four ingredients from ＂paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate orally disintegrating tablets＂. METHODS The small glass cup method was used as the stirring element. The solvent was water. The dissolution rate of paracetamol was determined by UV, and the dissolution rate of dextromethorphan hydrobromide, pseudoephedrine hydrochloride and chlorphenamine maleate were determined by HPLC. RESULTS The calibration curves were linear in the range of 2.0 - 20.0 μg·mL^-1 for paracetamol, r = 0.999 98 ; 5. 203 - 26.02 μg·mL^-1 for dextromethorphan hydrobromide, r = 0. 999 9; 0.982 - 4. 910 μg·mL^-1 for chlorphenamine maleate, r = 0.999 8; 14.94 - 74.70 μg·mL^-1 for pseudoephedrine hydrochloride, r = 0.999 9, respectively. The average recoveries were 98.4% with RSD 0.84%, 100.2% with RSD 1.02%, 99.4% with RSD 1.82%, 97.8% with RSD 1.05% for four above mentioned components, respectively. The average dissolution amounts of drug for three batches were above 90% in 10 min. CONCLUSION The method is good for the dissolution determination of four ingredients in ＂paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate orally disintegrating tablets＂.

关 键 词：酚麻美敏口腔崩解片 对乙酰氨基酚 氢溴酸右美沙芬 马来酸氯苯那敏 盐酸伪麻黄碱 溶出度 

分 类 号：R927.1[医药卫生—药学]