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发表于 2016-2-4 09:00:41
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中国药典2015非无菌药品的微生物限度计数和美国药典及欧洲药典统一了,看看其他药典是怎么说
Water-Soluble Products— Dissolve or dilute (usually a 1 in 10 dilution is prepared) the product to be examined in Buffered Sodium Chloride–Peptone Solution pH 7.0, Phosphate Buffer Solution pH 7.2, or Soybean–Casein Digest Broth. If necessary, adjust to a pH of 6 to 8. Further dilutions, where necessary, are prepared with the same diluent.
从英文原文来看用的是1 in 10,而不是1:10,。考虑到中文和英文可能习惯不一样,所以这里也就别纠结了
那么话说回来,1 in 10 到底怎么配?看看USP凡例的解释(EP同样也有)
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with, or 1 part by weight of a solid shall be dissolved in, a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)”means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.
从上面解释来看,1 in 10对于液体来说就是1体积的样品用稀释液定容到10体积,对于固体,就是1重量的样品溶解并定容到10体积,这里注意g对应ml,kg对应L,以此类推
其实类似的解释在中国药典的凡例也有,例如:
从上面也可以看出,这里的解释和USP/EP类似。但是注意,USP对情况规定的很详细到底是用in还是符号:,情况是不一样的,而中国药典用了1→10,还用了个等,这就非常不严谨了。举个例子,例如配流动相A:B=1:2对于USP来说就很简单1体积的A混合2体积的B,而对于中国药典来说,这个“:”到底在不在凡例描述的“等”里面?
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