复方氨酚葡锌分散片处方及其制备工艺研究.PDF

复方氨酚葡锌分散片处方及其制备工艺研究 李萌，孟昭珂，丁仲杰(杭州民生药业集团有限公司，杭州 310011) 摘要：目的 研究复方氨酚葡锌分散片的制备工艺和最佳处方。方法 以崩解时间为考察指标，采用单因素试验和正交 设计试验，对复方氨酚葡锌分散片的处方进行优化。结果 按优化处方工艺制备的复方氨酚葡锌分散片，符合分散片的 质量要求，并且其溶出较普通片快。结论 本法研制的复方氨酚葡锌分散片处方合理、工艺可行，适合工业化生产。 关键词：复方氨酚葡锌分散片；崩解时间；正交设计；溶出度 中图分类号：R943.3 ；R944.4 文献标志码：B 文章编号：1007-7693(2010)03-0235-05 Investigation on the Formula of Compound Paracetamol and Zinc Gluconate Dispersed Tablets LI Meng, MENG Zhaoke, DING Zhongjie(Hangzhou Minsheng Pharmaceutical Group Co. Ltd., Hangzhou 310011, China) ABSTRACT ：OBJECTIVE To investigate the preparation technique and the optimal formulation of compound paracetamol and zinc gluconate dispersed tablets. METHODS The formula of compound paracetamol and zinc gluconate dispersed tablets were optimized in terms of disintegration time by studying single factor and orthogonal design tests. RESULTS The products formulated with the optimum techniques met the quality specification of dispersed tablets. And they obviously dissolved faster than the common tablets. CONCLUSION This prescription and technology of compound paracetamol and zinc gluconate dispersed tablets are reasonable, effective and suitable for industrial production. KEY WORDS ：compound paracetamol and zinc gluconate dispersed tablets; disintegration time; orthogonal design; dissolubility 复方氨酚葡锌分散片是由部颁标准 WS1- 本品每片含对乙酰氨基酚 100 mg、葡萄糖酸锌 (X-150)-97Z 收载的复方氨酚葡锌片改剂型而成。 70 mg 、盐酸二氧丙嗪 1 mg 和板蓝根浸膏粉 作者简介：李萌，女，硕士，工程师 Tel: (0571E-mail: limeng2236@163.com 中国现代应用药学2010 年 3 月第 27 卷第 3 期 Chin JMAP, 2010 March, Vol.27 No.3 ·235 · 250 mg ，相当于 2 片市售复方氨酚葡锌片，该复 2.1.3 填充剂种类选择 本品为中西药组成的复 方制剂具有解热、镇痛、抗病毒和平喘等作用， 方，含板蓝根浸膏粉，粘性较大，需要加合适的 适用于普通感冒的