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培養(yǎng)基促生長試驗和適用性檢查的區(qū)別

發(fā)布時間:

2022-12-24

作者:

微生物培養(yǎng)基生產(chǎn)廠家 青島


培養(yǎng)基促生長試驗和適用性檢查的區(qū)別

培養(yǎng)基的適用性檢查是中國藥典2015版四部,1105和1106中規(guī)定,測試前需進(jìn)行培養(yǎng)基的適用性檢查。為什么大家會對培養(yǎng)基適用性檢查和促生長是不是一個概念感到困惑
,很大一部分原因在于此二者非常接近,培養(yǎng)基適用性檢查其實是包含了促生長實驗但有時又不僅僅是促生長實驗。

為了幫助大家更清楚地理解這二者之間的區(qū)別和聯(lián)系,我們需要把培養(yǎng)基分成計數(shù)用培養(yǎng)基和控制菌檢查用培養(yǎng)基來看。

一. 對于計數(shù)用培養(yǎng)基(胰酪大豆胨瓊脂培養(yǎng)基和胰酪大豆胨液體)即Ch. P1105中所用的上述兩種培養(yǎng)基,其培養(yǎng)基適用性檢查就是促生長實驗。但是在
1105中,并沒有用促生長這個詞,而是只用了計數(shù)用培養(yǎng)基適用性檢查這樣的表述。

筆者認(rèn)為此處所謂的適用性檢查就是促生長實驗的理由有二:
一,實驗就是以證明培養(yǎng)基可以促進(jìn)目標(biāo)的生長為目的;
二,控制菌檢查用培養(yǎng)基

此時的培養(yǎng)基適用性檢查已經(jīng)不是簡單的促生長測試了。

1106中規(guī)定控制菌檢査用培養(yǎng)基的適用性檢查項目包括促生長能力、抑制能力及指示特性的檢查。之所以會有抑制能力及指示特性檢查是因為控制菌的檢測原理即為依賴于培養(yǎng)基的選擇性特異性來檢出目標(biāo)菌同時也需要避免假陽性。見下圖上半部分。(這里的特性實際上如果對照計數(shù)用培養(yǎng)基部分,可以近似的理解成培養(yǎng)基的適用性檢查,檢查的目的是看培養(yǎng)基本身的特性)

以上即為培養(yǎng)基適用性檢查和促生長實驗關(guān)系的闡述,對于僅需要符合中國藥典要求的同行來說,只需要使用培養(yǎng)基適用性檢查這個詞,就不會有問題。實際上USP中是沒有培養(yǎng)基適用性這個詞的,只有方法的適用性。培養(yǎng)基的檢查要么就是促生長,要么就是促生長和抑制能力同時要求。

適用性從USP的角度,更多是針對方法,而不是培養(yǎng)基。培養(yǎng)基適用性檢查是中國藥典的說法,促生長試驗對于計數(shù)用培養(yǎng)基可理解成是適用性檢查的全部要求,但對于控制菌檢查用培養(yǎng)基的適用性檢查而言,GPT只是一部分,還需要包括對培養(yǎng)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。