| 摘要: |
| 目的研制口服补液盐散(Ⅱ)泡腾片。方法以片重差异、硬度、崩解时限、压制情况为主要考察指标,通过单因素试验优化制备工艺和处方,并进行验证实验；对其性状、鉴别、崩解时限、酸度、含量测定等进行检测。结果确定以酸部分用无水乙醇制粒后与碱部分粉末混合法制备口服补液盐散(Ⅱ)泡腾片,优化处方为氯化钠(11.5%)、氯化钾(4.93%)、枸橼酸(6.21%)、碳酸氢钠(8.15%)、无水葡萄糖(65.7%)、聚乙二醇6000(3%)。以此处方制备口服补液盐散(Ⅱ)泡腾片的硬度为4.5 kg,崩解时限为175 s。结论本品处方与《中华人民共和国药典》规定口服补液盐散(Ⅱ)一致,无需额外添加泡腾剂,制备工艺简单、质量,稳定,可作为口服补液盐新品种开发使用。 |
| 关键词: 口服补液盐散(Ⅱ) 泡腾片 制备 质量控制 |
| DOI：10.3724/SP.J.1008.2011.0528 |
| 投稿时间：2010-10-21修订日期：2011-03-03 |
| 基金项目:国家重大新药创制专项(2008ZXJ09010-001, 2008ZXJ09013-001), 第二军医大学灾害医学专项课题. |
|
| Oral rehydration salt powder Ⅱ effervescent tablets: preparation and quality control |
| KOU You-li1,DING Xue-ying2,CHEN Hong3,ZHU Quan-gang1,GAO Jing2,GAO Shen1 |
| (1. Department of Pharmacy, Changhai Hospital, Second Military Medical University, Shanghai 200433, China; 2. Department of Pharmaceutics, School of Pharmacy, Second Military Medical University, Shanghai 200433, China; 3. Department of Pharmacy, Bethune International Peace Hospital, Shijiazhuang 050082, Hebei, China) |
| Abstract: |
| ObjectiveTo develop and prepare oral rehydration salt powderⅡ (ORSⅡ) effervescent tablets. MethodsTaking the mass/tablet, rigidity, disintegration time, and pressing status as the main indicators, we optimized the formulation and preparation process of the effervescent tablet by single factor test. The character, identification, disintegration time, acidity, and content determination of the tablets were also investigated. ResultsIt was found that the optimized preparation process of the effervescent tablets was to mix the acid part, which was granulated with ethanol, with the base part, and then compressed the mixture. The optimal formula was composed of: NaCl(11.5%), KCl(4.93%), C6H8O7(6.21%), NaHCO3(8.15%), C6H12O6(65.7%), and PEG-6000(3%).The rigidity of the prepared effervescent tablet was 4.5 kg and the disintegration time was 175 s. ConclusionThe formulation of the present product is consistent with the corresponding Chinese Pharmacopoeia monograph, requiring no additional effervescent; the preparation process is simple and the products are stable, and the product my be developed into a new oral rehydration salt formulation. |
| Key words: oral rehydration salts powder Ⅱ effervescent tablet preparation quality control |
