复方肿节风喷雾合剂成型工艺及中试研究  

Molding process and pilot study on the Fufang Zhongjiefeng mixture

作　　者：袁荣献[1] 刘天翔 曾真[1] 梁会[1] 

机构地区：[1]贵阳中医学院第二附属医院,贵州贵阳550001 [2]贵州省建筑医院,贵州贵阳550003

出　　处：《中医临床研究》2016年第31期34-36,共3页Clinical Journal Of Chinese Medicine

基　　金：贵州省中医药管理局中医药;民族医药科学技术课题研究资助项目(编号QZYY2011-26)

摘　　要：目的：将原剂型汤剂改为合剂，建立复方肿节风合剂成型工艺及中试研究方法。方法：确定剂型选择依据，通过加速试验、稳定性试验，以及防腐剂的选择及用量、相对密度、pH值等因素的考察，结合中试研究的结果，建立复方肿节风合剂成型工艺。结果：新工艺选择0.05%浓度的羟苯乙酯作为防腐剂，相对密度为1.14，pH范围定为3.5～5.5。结论：新工艺条件稳定可行，适合批量生产。Objective: Decoction of the original formulation was changed to mixture, in order to establish molding process and pilotstudy methods of the Fufang Zhongjiefeng mixture. Methods: Criteria for selecting dosage form was determined. Based on accelerated test,stability test, the selection and amount of factors, the relative density, pH and other preservatives, combined with the results of the pilotstudies, molding process of the Fufang Zhongjiefeng mixture was established. Results: 0.05% ethylparaben was selected as preservative;the relative density was 1.14; and pH range was 3.5 ～ 5.5. Conclusion: The new process conditions was stable, feasible, and suitable formass production.

关 键 词：复方肿节风合剂 成型工艺 中试研究 

分 类 号：R284[医药卫生—中药学]