陈琼等

摘要：考察影响复方半边莲滴丸制备工艺的各因素，确定复方半边莲滴丸最佳制备工艺条件。在单因素考察的基础上，以滴丸的外观、重量差异、溶散时限为考察指标，采用正交试验设计对影响复方半边莲滴丸成型工艺的药物与基质比、冷凝介质温度、滴速等因素进行考察，优选复方半边莲滴丸的制备工艺。结果表明，最佳成型工艺为：以液状石蜡为冷凝介质，干浸膏与基质比1∶2，基质与基质比1∶4，药液温度70 ℃，冷凝介质温度5 ℃，滴速40滴/min，该工艺制备的滴丸外观圆整度良好，硬度较好，色泽均一。复方半边莲滴丸优选的制备工艺简单、可行、重现性好。

关键词：复方半边莲；滴丸；制备工艺；正交试验

中图分类号：R283.6 文献标识码：A 文章编号：0439-8114（2015）12-2975-03

DOI：10.14088/j.cnki.issn0439-8114.2015.12.043

Optimization on the Preparation Process of Compound Lobelia Dropping Pills

CHEN Qiong，LIANG Li-xiang，LI Qing-qing，GUO Ya-qiong，YANG Jun-jie

（ Xinyang Engineering Research Center for the exploitation of Chinese Medicine Resources/Xinyang Key Laboratory of Detection and analysis of Chinese Medicine/Xinyang College of Agriculture and Forestry， Xinyang 464000， Henan，China）

Abstract： The factors which affected the preparation of compound lobelia dropping pills and establish the optimal preparation process were studied based on single factor test. Appearance，weight difference and dissolution time were used as comprehensive evaluation indicators to optimize the preparation process by orthogonal design，taking proportion of drug and substrate，the temperature of cooling medium and drops rate as factors. The optimal preparation conditions for the pills were as follows： condending medium was liquid paraffin wax，proportion of dry extract and substrate was 1：2，PEG4000： PEG6000 was 1：4， the temperature of drug liquid and cooling medium were 70℃ and 5℃， respectively， drops rate was 40 d/ min. Dropping pills prepared by the optimal process have good appearance，appropriate hardness，uniformal color. The preparation process is simple，feasible and reproducible.

Key words：compound lobelia； dropping pills； preparation process； orthogonal design

复方半边莲注射液为河南同源制药有限公司独家生产的中药注射液品种，由半边莲（Lobelia chinensis）、半枝莲（Scutellaria barbata）、白花蛇舌草（Hedyotis diffusa）组成，具有清热解毒、消肿止痛的功效，临床用于治疗多发性疖肿、扁桃腺炎、乳腺炎等症，亦可配合用于肿瘤化疗，还可治疗小儿支气管肺炎、小儿或成人急性呼吸道感染、外感高热等症[1]，四季抗病毒合剂复方半边莲注射液预防和治疗急性角膜炎具有明显的疗效[2]。但由于注射液存在不安全因素，如致过敏、致休克等[3-5]，为提高复方半边莲注射液的安全性且又能保证其速效的特性，本试验对其剂型进行改革，采用超声提取波[1]，正交试验设计将其制成口服给药的滴丸剂，填补了国内复方半边莲滴丸剂型的空白，为复方半边莲注射液的剂型改革提供试验依据。……