| 摘要: |
| 目的:对中药口崩片体外崩解时间测定方法进行研究,筛选重现性、分辨率、体内外相关性好的评价方法。方法:采用自制和常用方法测定实验样品(空白和中药口崩片)的体外崩解时间,与口腔内崩解时间比较,评价不同方法测定结果的重现性、分辨率、体内外相关性等。结果:不同方法测定同一类型口崩片具有不同崩解时间。量筒静态法、崩解仪改良法均有缺陷,测定结果与口腔内崩解时间偏离较大；自制崩解装置能较真实地测试口崩片的崩解性能,测定的崩解时间接近口腔内崩解时间,终点判断明确,重现性、分辨率均优于其他方法,体内外相关性良好。结论:自制崩解装置适合测定口崩片(包括中药口崩片)的体外崩解时间,可作为质量控制参考方法。 |
| 关键词: 中草药 口腔崩解片 崩解时间 中药分析化学 |
| DOI：10.3724/SP.J.1008.2009.0846 |
| 投稿时间：2009-01-15修订日期：2009-05-04 |
| 基金项目: |
|
| Determination method for in vitro disintegrating time of oral disintegrating tablets of Chinese herbal drug |
| TONG Ye1,DING Xue-ying1,GAO Jing1,CAI Zhen2,GAO Shen1* |
| (1.Department of Pharmaceutics,School of Pharmacy,Second Military Medical University,Shanghai 200433,China;2.Pharmacy Department,Changhai Hospital,Second Military Medical University,Shanghai 200433) |
| Abstract: |
| Objective:To develop methods for determining the disintegration time of oral disintegrating tablets (ODTs) of Chinese herbal drug,and to select the evaluation method with good reproducibility,resolving power,and in vivo and in vitro correlation.Methods: Several placebo ODTs and Chinese herbal drug ODTs were prepared.Their in vitro disintegration time was determined by self-developed method and routine methods,and the results were compared with the oral disintegration time.The reproducibility,resolving power,and the correlation between in vivo and in vitro of those methods were evaluated.Results: Different determination methods obtained different disintegration results of the same tablet.Graduated cylinder and improved disintegration apparatus both had shortcomings and their determination results were very different from that of the oral disintegration time.Our self-developed disintegration device could better determine the disintegration ability of the ODTs,and the result was closer to the oral disintegration time,with clear end point of disintegration and better reproducibility,resolving power,and the in vivo and in vitro correlation compared with other methods.Conclusion: Our self-developed device is suitable to determine in vitro disintegration time of ODTs,and may serve as a reference for quality control of ODTs. |
| Key words: Chinese herbal drugs orally disintegrating tablets disintegration time analytical chemistry(TCD) |
