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.
在藥品、醫(yī)療器械和化妝品等敏感產(chǎn)品的生產(chǎn)過程中，消毒劑在減少和消除潛在污染方面發(fā)揮著核心作用。它們的有效性或作用譜取決于所使用的活性成分、它們用于對(duì)抗的微生物類型和使用條件。本文簡(jiǎn)要介紹了消毒劑中最常見的活性成分及其對(duì)各種微生物的有效性。在這一點(diǎn)上還應(yīng)該指出，這些通常是有害物質(zhì)，在處理消毒劑時(shí)必須始終考慮到用戶的安全，并必須遵守相關(guān)規(guī)范。
1. Alcohols (ethanol, isopropanol (2-propanol), n-propanol (1-propanol), etc.)
醇類(乙醇、異丙醇(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.
乙醇和異丙醇等醇類是消毒劑中廣泛使用的活性成分，其濃度為60%至90%。它們主要通過使蛋白質(zhì)變性和溶解微生物細(xì)胞膜中的脂質(zhì)來起作用。當(dāng)需要快速消毒時(shí)，通常使用酒精，因?yàn)樗鼈兺ǔＪ乾F(xiàn)成的消毒劑，并且在短時(shí)間內(nèi)對(duì)許多微生物有效。支持酒精類消毒劑的另一個(gè)方面是許多其他活性物質(zhì)殘留的問題，特別是在與產(chǎn)品接觸的表面或在產(chǎn)品附近使用時(shí)。未變性的酒精/水溶液不會(huì)在表面留下任何殘留物，前提是它們不含任何其他添加劑，如表面活性劑或潤(rùn)濕劑。
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：對(duì)多種細(xì)菌非常有效，包括革蘭氏陽性和革蘭氏陰性細(xì)菌。它們對(duì)許多病毒也有效，尤其是流感和冠狀病毒等包膜病毒。然而，酒精對(duì)諾如病毒等非包膜病毒效果較差，對(duì)細(xì)菌孢子和某些真菌幾乎沒有效果。
2. Chlorine compounds (sodium hypochlorite, chloramine-T, chlorine dioxide )
氯化合物(次氯酸鈉、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，特別是次氯酸鈉，是強(qiáng)氧化劑，通過釋放次氯酸殺死微生物。
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：氯化合物對(duì)多種微生物非常有效，包括細(xì)菌、病毒(包膜和非包膜)、真菌和孢子。然而，它們的效果會(huì)被血液或污垢等有機(jī)物質(zhì)降低，所以在使用氯化合物之前應(yīng)該清潔表面。如果使用不當(dāng)，它們還會(huì)對(duì)金屬產(chǎn)生腐蝕作用，并引起皮膚和呼吸道刺激。
3. Aldehydes (formaldehyde, glutardialdehyde, glyoxal, etc.)
醛類(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.
醛通過烷基化蛋白質(zhì)、核酸和其他細(xì)胞成分來起作用，從而使得微生物失活。由于醛類化合物可能危害人類健康(阻塞性呼吸系統(tǒng)疾病、生殖細(xì)胞誘變性、致癌性)，許多國(guó)家不再使用醛類化合物，或僅在某些情況下使用。
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：醛類物質(zhì)對(duì)細(xì)菌、病毒、真菌和孢子非常有效。由于其強(qiáng)大的有效性，它們經(jīng)常用于醫(yī)療器械的消毒。然而，它們也有潛在的毒性，可能引起過敏反應(yīng)和呼吸問題。因此，使用它們需要特別的預(yù)防措施，包括適當(dāng)?shù)耐L(fēng)和防護(hù)服。
4. Cationic and amphoteric compounds (quaternary ammonium compounds (QAC), e.g. benzalkonium chloride, guanidines e.g. chlorhexidine, octendin, amphoteric surfactants)
陽離子和兩性化合物(季銨鹽化合物(QAC)，如苯扎氯銨、胍類（如氯己定，辛嘌呤，兩性表面活性劑）)
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.
這些產(chǎn)物中的許多作用于微生物的細(xì)胞膜。季銨鹽化合物，如苯扎氯銨，通過破壞微生物的細(xì)胞膜而起作用，導(dǎo)致細(xì)胞完整性的喪失。然而，以季銨鹽化合物為例，當(dāng)經(jīng)常使用時(shí)，往往會(huì)在表面形成殘留膜，從而導(dǎo)致粘附效應(yīng)。
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：對(duì)革蘭氏陽性菌、部分革蘭氏陰性菌及包膜病毒有效。然而，它們對(duì)非包膜病毒、孢子和某些真菌的功效有限。季銨鹽化合物通常用于表面消毒劑，具有較少刺激性和無味的優(yōu)點(diǎn)?，F(xiàn)在也知道，微生物可能會(huì)對(duì)季銨鹽化合物(基于改變的膜轉(zhuǎn)運(yùn)蛋白(外排泵)，從細(xì)胞中釋放活性物質(zhì))產(chǎn)生耐藥性，這可能會(huì)限制它們的長(zhǎng)期使用。
5. Oxidants/oxygen scavengers (ozone, hydrogen peroxide, peracids (peracetic acid))
氧化劑/氧氣清除劑(臭氧、過氧化氫、過氧酸(過氧乙酸))
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.
雖然臭氧往往被用來處理水，但過氧乙酸或過氧化氫也被用來消毒表面和生產(chǎn)設(shè)施。效果是基于氧自由基的釋放，即產(chǎn)品是強(qiáng)氧化劑。氧自由基作用于細(xì)胞膜或細(xì)胞壁或病毒囊。不幸的是，高氧化能力也會(huì)影響敏感表面并導(dǎo)致腐蝕。過氧乙酸的分解除了產(chǎn)生氧氣和水外，還會(huì)產(chǎn)生乙酸，這會(huì)給使用者帶來難聞的氣味。在這里，在使用過程中也必須始終考慮到用戶的安全。
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：過氧化氫對(duì)細(xì)菌、病毒、真菌和孢子有效。它在分解成水和氧氣時(shí)不會(huì)留下殘留物，對(duì)環(huán)境的危害較小。然而，它會(huì)引起皮膚和眼睛的刺激，并且在高濃度時(shí)具有腐蝕性。
6. Phenols and phenolic compounds
酚類和酚類化合物
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.).
酚類物質(zhì)破壞細(xì)胞膜，使微生物體內(nèi)必需的酶和蛋白質(zhì)失活。在許多國(guó)家，出于生態(tài)和健康原因，它們不再使用，或僅在特定的特殊情況下(消毒痰液、切斷的身體部位等)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:酚類物質(zhì)對(duì)細(xì)菌(尤其是革蘭氏陽性細(xì)菌)、真菌和某些病毒有效。然而，它們對(duì)抗孢子的效果有限。酚類物質(zhì)通常用于醫(yī)院，但其毒性和潛在的令人不快的氣味導(dǎo)致其受歡迎程度下降。
Conclusion 結(jié)論
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.
消毒劑的選擇取決于具體的應(yīng)用，目標(biāo)微生物(是用于生產(chǎn)，如果是，例如生產(chǎn)病毒疫苗，還是用于實(shí)驗(yàn)室，如果是生物安全級(jí)別)，以及環(huán)境條件(表面材料，空氣交換率(干燥速度)，殘留物要求)。雖然一些活性成分，如醇和氯化合物具有廣泛的功效，但其他活性成分，如季銨鹽化合物或兩性表面活性劑，更適合于特定應(yīng)用。嚴(yán)格遵守使用和安全說明，以確保消毒劑發(fā)揮最大功效，并將健康風(fēng)險(xiǎn)降到最低，這一點(diǎn)也很重要。在實(shí)踐中，將不同的活性物質(zhì)組合或在不同的情況下使用或輪換使用(見EU GMP指南附錄1)是有用的，以實(shí)現(xiàn)全面消毒并避免適應(yīng)性或耐藥性的形成。
