J4 ›› 2010, Vol. 9 ›› Issue (2): 11-13.

• 药学 • 上一篇    下一篇

复方岩白菜素滴丸制备工艺研究

  

  1. 1.贵阳医学院,贵阳 550004;2.大理州中医医院,云南大理 671000;
    3.贵州省药品检验所,贵阳 550004
  • 收稿日期:2009-09-20 出版日期:2010-02-15 发布日期:2010-02-15
  • 作者简介:王燕,助理实验师,主要从事无机化学研究.

A Study of the Preparation Technology of Chlorphenamine Maleate Dropping Pills

  1. 1. Medical College of Guiyang, Guiyang 550004, China; 2. Chinese Medicine Hospital of Dali Prefecture, Dali,
    Yunnan 671000, China; 3.Pharmaceutical Inspect Institute of Guizhou Province, Guiyang 550004, China
  • Received:2009-09-20 Online:2010-02-15 Published:2010-02-15

摘要:

目的:确立复方岩白菜素滴丸的最佳制备工艺。方法:采用L9(34)正交试验法,以滴丸的溶散时限、圆整度、沉降情况、硬度、重量差异变异作为衡量指标,优选出滴丸的成型工艺。结果:最佳制备工艺为:聚乙二醇-6000为基质,药物与基质配比为1:2,药液温度70°C,液体石蜡为冷却剂,滴头内外径比2.0mm/3.0mm,滴速60滴/min,滴距6cm,冷却剂温度(8±0.3)°C。结论:该制备工艺可行,质量指标符合2005年版《中华人民共和国药典》滴丸剂质量标准。

关键词: 复方岩白菜素滴丸, 制备工艺, 聚乙二醇, 正交试验

Abstract:

Objective: To optimize the best preparation technology of ChlorphenamineMaleate dropping pills. Methods: It was
studied with L9(34)orthogonal design, dissolution, integrality, subside ,hardness and weight variation was used as evaluation indicator to select good dropping conditions. Results: The optimized preparation conditions were as follows: PEG 6000 was the optimal base,the proportion of optimal drugs to the bases being 1:2; the temperature of liquid was 70°C and liquid paraffin was condensate; the internal and external diameter of burette was 2. 0 mm and 3. 0 mm respectively; the dropping speed was 60 drop/min and the temperature of refrigerant was(8±0.3)°C; the dropping distance was 6 cm. Conclusion: The preparation technology was feasible, which met the criterion of Chinese Pharmacopoeia 2005.

Key words: ChlorphenamineMaleate dropping pills, preparation technology, polyglycol, orthogonal test

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