固体分散技术制备人参强心滴丸最佳工艺研究.docVIP

固体分散技术制备人参强心滴丸最佳工艺研究 　　[摘要] 目的 确定人参强心滴丸最佳成型工艺。 方法 采用熔融法，将药材提取物分散于熔融的基质中混合均匀，滴于不相混溶的冷凝液中，以滴丸的圆整度、硬度、均匀度、粘连、丸重变异系数作为综合评定指标，采用正交试验L9（34）优选滴丸最佳成型工艺。 结果 最佳成型工艺为药物浸膏∶基质＝1∶2，基质PEG 4000与PEG 6000配比为1∶1，药料温度为80℃，冷凝液为液体石蜡，冷凝柱长度为120 cm。 结论 本试验筛选出的滴丸最佳成型工艺成型率高，所制滴丸符合规定，适合于实验室制备和小批量生产。 　　[关键词] 人参强心滴丸；正交试验；固体分散技术；成型工艺 　　[中图分类号] R944.9[文献标识码] A[文章编号] 1673-7210（2012）03（c）-0104-03 　　Study on the optimum reparation technics of Renshen Qiangxin Dropping Pills by solid dispersion technique 　　WANG Pengying1 CHEN Lin2 WU Chaoyang2 LI Chunhua3 ZHANG Yixin3 　　1.College of Pharmacy in Xishan Campus, Hebei Medical University, Hebei Province, Shijiazhuang 050200, China; 2.College of Postgraduate, Hebei Medical University, Hebei Province, Shijiazhuang 050091, China; 3.College of Chinese Materia Medica, Hebei Medical University, Hebei Province, Shijiazhuang 050091, China 　　[Abstract] Objective To establish the optimum preparation process for Renshen Qiangxin Dropping Pills. Methods By using melting method, the herbal extract was dispersed in the molten matrix, and dropped in immiscible liquid. Hardness, roundness, equitability, adhesion and the coefficient of variability of Renshen Qiangxin Droping Pills were the evaluation index to study the optimum technological conditions by orthogonal design test. Results The optimized preparation process was as follows: drug ratio was 1∶2 with the matrix; PEG 4000∶PEG 6000 of 1∶1 was optimal base; the dripping temperature was 80℃; the height of freeze-pillar was 120 cm. Conclusion The Renshen Qiangxin Dropping Pills made by this technology have good properties of shaping. This method is in line with provisions, and suitable for laboratory preparation and small batch production. 　　[Key words] Renshen Qiangxin Dropping Pills; Orthogonal design; Solid dispersion; Preparation technology 　　人参强心滴丸由人参、丹参、生地、蟾酥等四味中药组成，是在中医理论指导下结合临床实践筛选的有效方药。具有益气养阴，活血强心的功效，对充血性心力衰竭具有良好的治疗效果。将中医临床有效验方开发制成中药新制剂，一直是药剂工作的重要任务。因此，本实验采用固体分散技术，以亲水性载体PEG类作基质对人参强心滴丸制备工艺进行研究，并对影响滴丸成