Disinfectants play a central role in the reduction and elimination of potential contamination in the manufacture of sensitive products such as pharmaceuticals, medical devices and cosmetics. Their effectiveness or spectrum of action depends on the active ingredients used, the type of microorganisms they are used against and the conditions of use. This article provides a brief overview of the most common active ingredients in disinfectants and their effectiveness against various microorganisms. It should also be pointed out at this point that these are generally hazardous substances and that the safety of users must always be taken into account when handling disinfectants and the relevant specifications must be observed.

 

在药品、医疗器械和化妆品等敏感产品的生产过程中，消毒剂在减少和消除潜在污染方面发挥着核心作用。它们的有效性或作用谱取决于所使用的活性成分、它们用于对抗的微生物类型和使用条件。本文简要介绍了消毒剂中最常见的活性成分及其对各种微生物的有效性。在这一点上还应该指出，这些通常是有害物质，在处理消毒剂时必须始终考虑到用户的安全，并必须遵守相关规范。

 

1. Alcohols (ethanol, isopropanol (2-propanol), n-propanol (1-propanol), etc.)

醇类(乙醇、异丙醇(2-丙醇)、正丙醇(1-丙醇)等)

 

Alcohols such as ethanol and isopropanol are widely used active ingredients in disinfectants, which are used in concentrations of 60% to 90%. They mainly work by denaturing proteins and dissolving lipids in the cell membrane of microorganisms. Alcohols are often used when rapid disinfection is required, as they are usually available as ready-to-use disinfectants and are effective against many microorganisms with a short contact time. Another aspect in favour of alcohol-based disinfectants is the problem of residues of many other active substances, particularly on surfaces with product contact or when used in the vicinity of products. Undenatured alcohol/water solutions do not leave any residues on the surface, provided they do not contain any other additives such as surfactants or wetting agents.

 

乙醇和异丙醇等醇类是消毒剂中广泛使用的活性成分，其浓度为60%至90%。它们主要通过使蛋白质变性和溶解微生物细胞膜中的脂质来起作用。当需要快速消毒时，通常使用酒精，因为它们通常是现成的消毒剂，并且在短时间内对许多微生物有效。支持酒精类消毒剂的另一个方面是许多其他活性物质残留的问题，特别是在与产品接触的表面或在产品附近使用时。未变性的酒精/水溶液不会在表面留下任何残留物，前提是它们不含任何其他添加剂，如表面活性剂或润湿剂。

Effectiveness: Very effective against a wide range of bacteria, including gram-positive and gram-negative bacteria. They are also effective against many viruses, especially enveloped viruses such as influenza and coronaviruses. However, alcohol is less effective against non-enveloped viruses such as norovirus and has little to no effectiveness against bacterial spores and some fungi.

 

功效：对多种细菌非常有效，包括革兰氏阳性和革兰氏阴性细菌。它们对许多病毒也有效，尤其是流感和冠状病毒等包膜病毒。然而，酒精对诺如病毒等非包膜病毒效果较差，对细菌孢子和某些真菌几乎没有效果。

 

2. Chlorine compounds (sodium hypochlorite, chloramine-T, chlorine dioxide )

氯化合物(次氯酸钠、氯胺-T、二氧化氯)

 

Chlorine compounds, especially sodium hypochlorite, are strong oxidising agents that kill microorganisms by releasing hypochlorous acid.

 

氯化合物，特别是次氯酸钠，是强氧化剂，通过释放次氯酸杀死微生物。

Efficacy: Chlorine compounds are extremely effective against a wide range of microorganisms, including bacteria, viruses (both enveloped and non-enveloped), fungi and spores. However, their effectiveness is reduced by organic matter such as blood or dirt, so the surface should be cleaned before applying chlorine compounds. They can also have a corrosive effect on metals and cause skin and respiratory tract irritation if used incorrectly.

 

功效：氯化合物对多种微生物非常有效，包括细菌、病毒(包膜和非包膜)、真菌和孢子。然而，它们的效果会被血液或污垢等有机物质降低，所以在使用氯化合物之前应该清洁表面。如果使用不当，它们还会对金属产生腐蚀作用，并引起皮肤和呼吸道刺激。

 

3. Aldehydes (formaldehyde, glutardialdehyde, glyoxal, etc.)

醛类(甲醛、戊二醛、乙二醛等)

 

Aldehydes act by alkylating proteins, nucleic acids and other cell components, which leads to the inactivation of microorganisms. Due to their potential to endanger human health (obstructive respiratory diseases, germ cell mutagenicity, carcinogenicity), aldehydes are no longer used in many countries, or only in certain cases.

 

醛通过烷基化蛋白质、核酸和其他细胞成分来起作用，从而使得微生物失活。由于醛类化合物可能危害人类健康(阻塞性呼吸系统疾病、生殖细胞诱变性、致癌性)，许多国家不再使用醛类化合物，或仅在某些情况下使用。

Effectiveness: Aldehydes are highly effective against bacteria, viruses, fungi and spores. Due to their strong effectiveness, they are often used in the sterilisation of medical devices. However, they are also potentially toxic and can cause allergic reactions and respiratory problems. Their use therefore requires special precautions, including adequate ventilation and protective clothing.

 

功效：醛类物质对细菌、病毒、真菌和孢子非常有效。由于其强大的有效性，它们经常用于医疗器械的消毒。然而，它们也有潜在的毒性，可能引起过敏反应和呼吸问题。因此，使用它们需要特别的预防措施，包括适当的通风和防护服。

 

4. Cationic and amphoteric compounds (quaternary ammonium compounds (QAC), e.g. benzalkonium chloride, guanidines e.g. chlorhexidine, octendin, amphoteric surfactants)

阳离子和两性化合物(季铵盐化合物(QAC)，如苯扎氯铵、胍类（如氯己定，辛嘌呤，两性表面活性剂）)

 

Many of these products act on the cell membrane of microorganisms. QAVs, such as benzalkonium chloride, act by disrupting the cell membranes of microorganisms, leading to a loss of cell integrity. However, QAVs, for example, tend to form a residue film on the surface when used regularly, which can lead to sticking effects.

 

这些产物中的许多作用于微生物的细胞膜。季铵盐化合物，如苯扎氯铵，通过破坏微生物的细胞膜而起作用，导致细胞完整性的丧失。然而，以季铵盐化合物为例，当经常使用时，往往会在表面形成残留膜，从而导致粘附效应。

Efficacy: They are effective against Gram-positive bacteria, some Gram-negative bacteria and enveloped viruses. However, their efficacy against non-enveloped viruses, spores and some fungi is limited. QAVs are often used in surface disinfectants and have the advantage of being less irritating and odourless. It is now also known that microorganisms may develop resistance to QAVs (based on altered membrane transporters (efflux pump) that release the active substance from the cell), which could limit their long-term use.

 

功效：对革兰氏阳性菌、部分革兰氏阴性菌及包膜病毒有效。然而，它们对非包膜病毒、孢子和某些真菌的功效有限。季铵盐化合物通常用于表面消毒剂，具有较少刺激性和无味的优点。现在也知道，微生物可能会对季铵盐化合物(基于改变的膜转运蛋白(外排泵)，从细胞中释放活性物质)产生耐药性，这可能会限制它们的长期使用。

 

5. Oxidants/oxygen scavengers (ozone, hydrogen peroxide, peracids (peracetic acid))

氧化剂/氧气清除剂(臭氧、过氧化氢、过氧酸(过氧乙酸))

 

While ozone tends to be used to treat water, peracetic acid or hydrogen peroxide are also used to disinfect surfaces and production facilities. The effect is based on the release of oxygen radicals, i.e. the products are strong oxidising agents. The oxygen radicals act on the cell membrane or cell wall or on the virus capsule. Unfortunately, the high oxidising power can also affect sensitive surfaces and lead to corrosion, for example. The decomposition of peracetic acid also produces acetic acid in addition to oxygen and water, which can lead to unpleasant odours for the user. Here too, the safety of the user must always be taken into account during use.

 

虽然臭氧往往被用来处理水，但过氧乙酸或过氧化氢也被用来消毒表面和生产设施。效果是基于氧自由基的释放，即产品是强氧化剂。氧自由基作用于细胞膜或细胞壁或病毒囊。不幸的是，高氧化能力也会影响敏感表面并导致腐蚀。过氧乙酸的分解除了产生氧气和水外，还会产生乙酸，这会给使用者带来难闻的气味。在这里，在使用过程中也必须始终考虑到用户的安全。

Effectiveness: Hydrogen peroxide is effective against bacteria, viruses, fungi and spores. It leaves no residue as it decomposes into water and oxygen and is less harmful to the environment. However, it can cause skin and eye irritation and is corrosive in high concentrations.

 

功效：过氧化氢对细菌、病毒、真菌和孢子有效。它在分解成水和氧气时不会留下残留物，对环境的危害较小。然而，它会引起皮肤和眼睛的刺激，并且在高浓度时具有腐蚀性。

 

6. Phenols and phenolic compounds

酚类和酚类化合物

 

Phenols destroy cell membranes and inactivate essential enzymes and proteins within microorganisms. In many countries, they are no longer used for ecological and health reasons or only in defined exceptional cases (disinfection of sputum, severed body parts, etc.).

 

酚类物质破坏细胞膜，使微生物体内必需的酶和蛋白质失活。在许多国家，出于生态和健康原因，它们不再使用，或仅在特定的特殊情况下(消毒痰液、切断的身体部位等)才使用。

Effectiveness: Phenols are effective against bacteria (especially gram-positive bacteria), fungi and some viruses. However, their effectiveness against spores is limited. Phenols are commonly used in hospitals, but their toxicity and potentially unpleasant odours have led to a reduction in their popularity.

 

功效:酚类物质对细菌(尤其是革兰氏阳性细菌)、真菌和某些病毒有效。然而，它们对抗孢子的效果有限。酚类物质通常用于医院，但其毒性和潜在的令人不快的气味导致其受欢迎程度下降。

Conclusion 结论

The choice of disinfectant depends on the specific application, the target microorganisms (is it for production and if so which - e.g. production of viral vaccines or is it for the laboratory - if so which Bio Safety Level), and the environmental conditions (surface materials, air exchange rates (drying speed), residue requirements). While some active ingredients such as alcohols and chlorine compounds have broad efficacy, others, such as QAVs or amphoteric surfactants, are more suitable for specific applications. It is also important to follow the instructions for use and safety carefully to ensure maximum effectiveness of the disinfectant and minimise health risks. In practice, it can be useful to combine different active substances or to use them in different scenarios or to rotate them (see Annex 1 of the EU GMP guidelines) in order to achieve comprehensive disinfection and avoid adaptations or resistance formation.

 

消毒剂的选择取决于具体的应用，目标微生物(是用于生产，如果是，例如生产病毒疫苗，还是用于实验室，如果是生物安全级别)，以及环境条件(表面材料，空气交换率(干燥速度)，残留物要求)。虽然一些活性成分，如醇和氯化合物具有广泛的功效，但其他活性成分，如季铵盐化合物或两性表面活性剂，更适合于特定应用。严格遵守使用和安全说明，以确保消毒剂发挥最大功效，并将健康风险降到最低，这一点也很重要。在实践中，将不同的活性物质组合或在不同的情况下使用或轮换使用(见EU GMP指南附录1)是有用的，以实现全面消毒并避免适应性或耐药性的形成。

 

 

来源：GMP干货

关键词： 消毒剂