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�ܳ��ȼ������жϷ����Ľ���������������ıȽ�
����ƽ 1 ����СӢ 2 ��κ��ƽ 1 �����ض� 1
JIANG Xiong-ping1 �� FU Xiao-ying2 �� WEI Li-ping1 �� JIN Shou-dong1
(1.<>Institute for Drug and Instrument Control of PLA, Beijing 100166,<> China; 2.<>Health Department of General Logistics Department of PLA, Beijing 100842, <>China
Abstract��
OBJECTIVE To establish a criterion for dissolution by variables. METHODS To derive the criterion formula A=|M-D|+��/(e|M-D|��b+1)+kS by using probability theory and Statistics��and to compare between criteria by variables and by attributes. RESULTS The criterion by variables was the strictest one. The second was the criterion of Ch.P(2005). The third was the criterion of USP32. The repeat test rates from low to high were Ch.P(2005)��Criterion by variables and USP32 respectively. The sample contents were 6.43��7.82-7.98��11.60 for Ch.P(2005)��Criterion by variables and USP32. CONCLUSION The criterion by variables could control the uniformity of dissolution��and was stricter than criteria by attributes.
JIANG Xiong-ping,
FU Xiao-ying,
WEI Li-ping etc
. To Establish a Criterion for Dissolution by Variables and Comparison with Criteria by Attributes[J] Chinese Pharmaceutical Journal, 2009,V44(23): 1825-1829
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[1]
<>Ch.P(2005) Vol II ���й�ҩ�� 2005 ��� . �������� S �� .2005: Appendix 73.
[2]
XIN H H. <>Sampling Test Technologies ���������鼼���� [M]. Beijing : China Metrology Publishing House, 2005.9.
2009, Vol. 44 