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胶囊剂装量差异检查方法探讨
The Stduy The Determination Of Uniformity Of Weight For Capsules
【摘要】 目的:探讨一种新的胶囊剂装量差异检查方法。方法:统计学方法。结果:胶囊剂装量差异检查不仅应以变异系数(CV)作为衡量整体离散程度的参数,而且还应以"持平"了的限度范围来衡量个体的装量。结论:计算装量差异的公式为(装量为0.3g及其以下):W±W/0.3×1.96×0.0109g。根据对十个品种三十个批次的样品检查结果表明,本法能较客观和全面地反映出胶囊剂装量差异的优劣。
【Abstract】 OBJECTIVE:Study a new method for determination of uniformity of weight for capsules.METHOD:Statistics methods.RESULTS:The determination of uniformity of weight for capsules should not only with variation coefficient(CV),but also the "holding evenly" limits.CONCLUSION:Formula that calculation the limits for the uniforimity of weight for capsules is:(pack to measure to 0.3 gs and its below) W±W/0.3×1.96×0.0109 g According to the results of ten specieses 310 batch sample for the determination of the uniformity of weight for capsules,this method can reflect the uniformity of weight for capsules objectively and completely.
- 【文献出处】 中国现代应用药学 ,Chinese Journal of Modern Applied Pharmacy , 编辑部邮箱 ,2002年S1期
- 【分类号】R944
- 【被引频次】1
- 【下载频次】141