陶巧凤, 钟大放, 罗旭, 王玺. 美国药典ⅩⅪ版片剂含量均匀度检验方案的统计特性分析J. 药学学报, 1987, 22(3): 212-216.
引用本文: 陶巧凤, 钟大放, 罗旭, 王玺. 美国药典ⅩⅪ版片剂含量均匀度检验方案的统计特性分析J. 药学学报, 1987, 22(3): 212-216.
TAO Qiao-Feng, ZHONG Da-Fang, LUO Xu , WANG Xi, . STUDY OF THE STATISTICAL CHARACTERISTICS OF THE USP ⅩⅪ CONTENT UNIFORMITY SAMPLING PLAN FOR TABLETSJ. Acta Pharmaceutica Sinica, 1987, 22(3): 212-216.
Citation: TAO Qiao-Feng, ZHONG Da-Fang, LUO Xu , WANG Xi, . STUDY OF THE STATISTICAL CHARACTERISTICS OF THE USP ⅩⅪ CONTENT UNIFORMITY SAMPLING PLAN FOR TABLETSJ. Acta Pharmaceutica Sinica, 1987, 22(3): 212-216.

美国药典ⅩⅪ版片剂含量均匀度检验方案的统计特性分析

STUDY OF THE STATISTICAL CHARACTERISTICS OF THE USP ⅩⅪ CONTENT UNIFORMITY SAMPLING PLAN FOR TABLETS

  • 摘要: 本文根据实测片剂批的含量分布曲线,采用计算机模拟随机抽样方法对USP ⅩⅪ版片剂含量均匀度检验方案诸统计特性进行了分析,并与USP ⅩⅩ版相应方案的统计特性比较,获得了一系列定量结果。结果表明,由于引入统计量RSD,属于计数—计量混合型的USP ⅩⅪ版方案,在判断可靠性上优于属于计数型的USP ⅩⅩ版方案。

     

    Abstract: Based on the two content distribution curves obtained by assaying domestic tablets which contain very small amounts of active ingredients, we have studied some of the statistical characteristics of the USP ⅩⅪ content uniformity sampling plan for tablets and compared them with those of the USP ⅩⅩ by means of computer simulation. Some quantitative results have been obtained, which showed that the decision accuracy of the USP ⅩⅪ content uniformity sampling plan is much better than that of the USP ⅩⅩ plan. Owing to the introduction of RSD the USP ⅩⅪ plan become a mixed, by-attribute and by-variable sampling plan, while the USP ⅩⅩ plan belongs to the realm of the pure by-attribute type.

     

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