培养基促生长试验和适用性检查的区别

发布时间:

2022-12-24

作者:

微生物培养基生产厂家 青岛


培养基促生长试验和适用性检查的区别

培养基的适用性检查是中国药典2015版四部,1105和1106中规定,测试前需进行培养基的适用性检查。为什么大家会对培养基适用性检查和促生长是不是一个概念感到困惑
,很大一部分原因在于此二者非常接近,培养基适用性检查其实是包含了促生长实验但有时又不仅仅是促生长实验。

为了帮助大家更清楚地理解这二者之间的区别和联系,我们需要把培养基分成计数用培养基和控制菌检查用培养基来看。

一. 对于计数用培养基(胰酪大豆胨琼脂培养基和胰酪大豆胨液体)即Ch. P1105中所用的上述两种培养基,其培养基适用性检查就是促生长实验。但是在
1105中,并没有用促生长这个词,而是只用了计数用培养基适用性检查这样的表述。

笔者认为此处所谓的适用性检查就是促生长实验的理由有二:
一,实验就是以证明培养基可以促进目标的生长为目的;
二,控制菌检查用培养基

此时的培养基适用性检查已经不是简单的促生长测试了。

1106中规定控制菌检査用培养基的适用性检查项目包括促生长能力、抑制能力及指示特性的检查。之所以会有抑制能力及指示特性检查是因为控制菌的检测原理即为依赖于培养基的选择性特异性来检出目标菌同时也需要避免假阳性。见下图上半部分。(这里的特性实际上如果对照计数用培养基部分,可以近似的理解成培养基的适用性检查,检查的目的是看培养基本身的特性)

以上即为培养基适用性检查和促生长实验关系的阐述,对于仅需要符合中国药典要求的同行来说,只需要使用培养基适用性检查这个词,就不会有问题。实际上USP中是没有培养基适用性这个词的,只有方法的适用性。培养基的检查要么就是促生长,要么就是促生长和抑制能力同时要求。

适用性从USP的角度,更多是针对方法,而不是培养基。培养基适用性检查是中国药典的说法,促生长试验对于计数用培养基可理解成是适用性检查的全部要求,但对于控制菌检查用培养基的适用性检查而言,GPT只是一部分,还需要包括对培养基抑制能力的要求。

The difference between growth promoting test and applicability test of culture medium
The applicability test of the medium is stipulated in the four, 1105 and 1106 of the 2015 edition of Chinese Pharmacopoeia.
The applicability check of the base. Why do you feel confused about the applicability of culture media and the promotion of growth?
A large part of the reason is that the two are very close. The applicability test of the medium actually includes a growth promoting experiment.
Sometimes it's not just a growth promoting experiment.
In order to help you understand clearly the difference and connection between the two, we need to divide the culture medium into counting culture.
The culture medium is used to examine the culture medium and control bacteria.
1. For counting medium (casein soy peptone agar medium and casein soy peptone liquid)
That is, the above two kinds of medium used in Ch. P1105, and its applicability test is growth promoting experiment. But in the case of
1105, the word "promoting growth" is not used. Instead, only counting is used to check the applicability of the medium.
The upper half of the map.
The author thinks that the so-called applicability check here is two reasons for promoting growth test.
First, experiments aim at proving that the medium can promote the growth of the target.
Two, the culture medium for control bacteria examination
At this time, the applicability test of medium is no longer a simple growth promoting test.
1106 the applicability of the culture medium for control bacteria examination includes the growth promoting ability, inhibition ability and indication.
A sexual examination. The inhibition and indication characteristics are checked because the detection principle of control bacteria relies on Yu Pei.
The selectivity and specificity of the base group to detect target bacteria also need to avoid false positives. See the upper half of the picture. (here
In fact, if the counter count is used in the culture medium, the applicability of the medium can be approximately understood.
The purpose is to look at the characteristics of the training of the basic body.
The above is the elaboration of the relationship between the applicability test of the medium and the growth promoting experiment.
For peers, there is no problem just checking the word with the applicability of the medium.
In fact, there is no applicability of the medium in USP, only the applicability of the method. The examination of the medium is either
It is to promote growth, or to promote growth and inhibit the ability at the same time.
From the perspective of USP, applicability is more about methods than media. The examination of the applicability of the culture medium is the Chinese Pharmacopoeia
The growth promoting test is considered to be the requirement of applicability check for counting medium, but for control.
GPT is only part of the applicability test of the culture medium, and the ability to inhibit the culture medium is also needed.
Requirement。

e ability to inhibit the culture medium is also needed. Requirement。