氨酚伪麻那敏片处方工艺的正交实验及其质量标准研究

An investigation on quality standard and screening of formulation of AFWMNM tablet by orthogonal experiment

目的:筛选氨酚伪麻那敏片最佳处方组成及生产工艺并建立片剂的含量测定方法。方法:以辅料中低取代羟丙基纤维素 (L S- HPC)、吐温 - 80淀粉和淀粉为 3因素 ,每因素取 3水平 ,选用 L9(34 )表 ,以对乙酰氨基酚的溶出度参数 Td为指标进行正交试验 ,确定最佳处方组成及生产工艺。用反相高效液相色谱法同时测定片剂中的对乙酰氨基酚和盐酸伪麻黄碱的含量。结果 :辅料中的 L S- HPC和淀粉是影响片剂中对乙酰氨基酚溶出度的主要因素 (P <0 .0 5 ) ,吐温 - 80淀粉影响不显著 (P >0 .0 5 )。最佳处方组成为每片含对乙酰氨基酚 0 .32 g、盐酸伪麻黄碱0 .0 3g、马来酸氯苯那敏 0 .0 0 2 g、L S- HPC0 .73g、吐温 - 80淀粉 0 .0 2 g和淀粉 0 .1g。含量测定方法简便、准确 ,对乙酰氨基酚和盐酸伪麻黄碱的平均回收率分别为 (10 0 .2 5± 0 .6 6 ) %和 (10 1.97± 1.31) %。结论:氨酚伪麻那敏片处方具有辅料价廉易得、有效成分溶出快、制备工艺简单及质量稳定等特点。

Objective: To screen the best formulation composition of AFWMNM tablet and to establish an analysis method of measuring the content of AFWMNM tablet. Method: The L-9(3+4) orthogonal table and the parameter of dissolution degree(Td) was employed to select the best formulation by means of LS-HPC, starch, and tween-80-starch as the three main factors in which all factors been selected of three levels. The RP-HPLC method was employed to determine the content of acetaminophen and pseudoephedrine hydrochloride in AFWMNM tablet simultaneously. Results: The experimental results indicated that LS-HPC and starch were the chief factors of influencing dissolution of tablet (P<0.05),and tween-80-starch had no statistic significance (P>0.05). The best formulation was composed of acetaminophen: 0.32 g, pseudoephedrine hydrochloride: 0.03 mg, chlorphenamine maleate: 0.002 g, LS-HPC: 0.73 g, starch: 0.1 g, tween 80-starch: 0.02 g. The analytical method was convenient and accurate. The average rate of recovery of acetaminophen and pseudoephedrine hydrochloride were of (100.25±0.66)% and (101.97± 1.31)% , respectively. Conclusion: The formulation had merits of low price of accessories, rapid dissolution of utility component, simple of manufacture technique, and stable in quality and so on.