BIT-10 抑菌剂

应用

BIT-10体外诊断试剂专用抑菌剂，本品的有效成分是10%的1,2-苯并异噻唑啉-3-酮 (1,2-Benzisothiazolin-3-one)，产品为无色或淡黄色透明液体，是一种高效的可用于临床

血细胞分析、生化分析和免疫分析试剂的抑菌剂，包含用于各种试剂、质控品、校准品、稀释液、清洗液和缓冲液等。由于该产品具有广泛的抑制微生物生长的效果、极佳的相容

性和稳定性、低毒并可生物降解，BIT-10抑菌剂成为一种理想的，可替代叠氮钠（易燃易爆剧毒品）、硫柳汞（含汞有机物）和庆大霉素（易产生耐药性）等传统抑菌剂

的新型抑菌产品。产品具有广泛的抑制微生物生长的效果、良好的相容性和稳定性、低毒并可生物降解，从而使诊断试剂具有更长的有效期和开瓶有效期。临床检验仪器在医院的

使用过程比较容易染菌，使用该抑菌剂对开瓶有效期的延长效果明显。

产品特点

BIT-10体外诊断试剂专用抑菌剂以其广谱活性、优越的兼容性和稳定性及其在使用浓度下的低毒性，成为体外诊断试剂中的理想高效防腐剂。与各种乳化剂、表面活性剂及

其他成分有着很好的配伍性，可以与任何比列的醇和水相溶。稳定性强，在-20℃至40℃储存一年无变化，有效成分可耐受150℃的高温。故具有长效的保护功能，能保护体系免

受细菌、霉菌和酵母菌等的侵蚀。该杀菌剂是当今世界新崛起的新一代工业杀菌剂之一，70年代有产品问世。80年代初英国帝国化学工业公司投资550万英镑发展了连续化生产工

艺。我国在1982年开始了该杀菌剂的合成研究，随后又成功地进行了工业化生产并取得了很好的应用效果。BIT原粉为固体粉末，熔点为156℃，25℃时水中溶解度为0.14%，90℃

时的溶解度为1.5%,但该品的钠盐或钾盐易溶于水，晶茂生物的BIT-10是用氢氧化钾溶液复配而成，从而使产品更稳定。可以和牛莎®PC异噻唑啉酮系列抑菌剂形成协同抑菌效

果。它的特点与优点包含但不限于

广谱、长效的杀灭多种细菌、真菌和酵母菌，达到良好的抑菌效果 

与各种乳化剂、表面活性剂及其它成分配伍性好，可以任何比列的醇和水等相溶 

稳定性强，在-20℃至40℃储存一年无变化，有效成分在150℃时也稳定 

适用pH范围广，与各种酶的可兼容性，不抑制抗体结合 

毒性低，不含重金属和卤素化合物 

对胺类化合物稳定 

不含甲醛，气味低，无VOC。

BIT-10体外诊断试剂专用抑菌剂是传统抑菌剂叠氮钠的替代品。叠氮钠曾经是体外 诊断试剂中最常用的防腐剂之一，在多数（碱性）情况下有较好的抑菌效果，但叠氮钠会 抑制辣根过氧化物酶（HRP）、超氧化物歧化酶等多种酶的活性，所以含有辣根过氧化物 酶的二抗中不可加入叠氮钠。同时，叠氮钠受热，接触明火、或受到摩擦、震动、撞击时 可发生爆炸；能与酸类剧烈反应产生爆炸性的叠氮酸，能与重金属及其盐类形成十分敏感 的化合物。叠氮钠和氰化物具有相似毒性，对细胞色素氧化酶和其它酶有抑制作用，并能使体内氧合血红蛋白形成受阻，导致死亡。由于叠氮钠易燃易爆和剧毒性双重性质作为危险化学，其采购，仓储，使用等环节国家都有特殊的监管要求，其使用范围越来越受限。BIT-10体外诊断试剂专用抑菌剂也用于替代硫柳汞，硫柳汞曾广泛应用于体外诊断试剂，它对革兰氏阳性和阴性菌均有很强的抑菌能力，为广谱抑菌剂，由于少量有机汞在理论上具有神经毒性，因此硫柳汞的使用安全问题深受人们的关注。

抑菌原理

BIT-10体外诊断试剂专用抑菌剂是一种广谱抑菌剂，BIT的杀菌机理是与卡松相同

即异噻唑啉酮类化合物对受体细胞膜和细胞壁具有极强的穿透能力，在穿透细胞外围后可

与细胞内含硫的蛋白质、酶或简单分子相互作用，使其S—N键断裂，从而与受体形成S— S键，破坏细胞的正常功能。很明显可得出异噻唑啉酮化合物的S—N键越弱越有利于抗

菌。但BIT-10相比于其他类型的抑菌剂更稳定，尤其是在碱性条件下。

抑菌浓度

BIT-10体外诊断试剂专用抑菌剂在蛋白含量小于10%的配方中，能起极好的防腐作用，其最小抑菌浓度（MIC）见下表。该产品可用于含有机物、非离子或阴阳离子表面活性剂、抗原抗体的体外诊断试剂中，上述组分不影响的抑菌效果，也不会彼此产生拮抗作用。可与大多数表面活性剂配伍。

产品存储

BIT-10体外诊断试剂专用抑菌剂贮存在阴凉处。容器保持紧闭，储存在干燥通风处。

Application

BIT-10 preservative is a colorless or pale yellow transparent liquid, which is an effective bacteriostatic agent for clinical blood cell analysis, biochemical analysis and immunoassay, including various reagents, quality control products, calibration products, diluents, cleaning solutions and buffers. Because the product has a wide range of the effect of inhibiting microbial growth, excellent compatibility and stability, low toxicity and biodegradability, BIT - 10 bacteriostatic agent as a kind of ideal, can replace sodium azide (drama) inflammable, explosive, thimerosal (including organic mercury) and gentamycin (yi resistance) traditional bacteriostatic agent such as a new type of antibacterial products. The product has a wide range of inhibition of microbial growth, good compatibility and stability, low toxicity and biodegradable, so that the diagnostic reagent has a longer period of validity and bottle opening validity. During the use of the clinical test instrument in the hospital, it is easy to catch bacteria. 

Advantage

BIT-10 preservative has become an ideal and effective preservative for in vitro diagnostic reagents due to its broad spectrum activity, excellent compatibility and stability, and low toxicity at the application concentration. It is compatible with all kinds of emulsifiers, surfactants and other components, and can be dissolved in any alcohol or water. Strong stability, stored at -20℃ to 40℃ for a year without change, the active ingredient can withstand the high temperature of 150℃.Therefore, it has a long-term protection function, and can protect the system from the erosion of bacteria, mold and yeast. The fungicide is one of the new generation of industrial fungicides rising in the world. In the early 1980s imperial chemical industries invested 5.5 million pounds to develop a continuous process. The study on the synthesis of this fungicide was started in 1982 in China. The original powder of BIT is a solid powder with a melting point of 156℃, a solubility of 0.14% in water at 25℃, and a solubility of 1.5% at 90℃. However, the sodium salt or potassium salt of the product is easily soluble in water. The BIT-10 of crystal albicide is compounded with potassium hydroxide solution, which makes the product more stable. And PC isothiazolinone series of antibacterial agents to form a synergisticantibacterial effect. Its features and advantages include but are not limited to： 

Broad-spectrum, long-acting kill a variety of bacteria, fungi and yeast, achieve good 

bacteriostatic effect 

is compatible with various emulsifiers, surfactants and other components, and can 

be dissolved in alcohol and water 

is stable, with no change at -20°C to 40°C for one year, and the active components 

are stable at 150°C 

is applicable to a wide range of pH, compatible with various enzymes, and does not 

inhibit the binding of antibodies 

is low toxicity and does not contain heavy metals or halogen compounds 

is stable to amines 

contains no formaldehyde, low odor and no VOC.

BIT-10 Preservative can replace Sodium Azide (NaN3) which widely applied to in vitro diagnostic reagents. In most cases (alkaline), Sodium Azide has a good antibacterial effect, but Sodium Azide can inhibit the activities of horseradish peroxidase (HRP), superoxide dismutase and other enzymes, so Sodium Azide cannot be added to the secondary antibody containing horseradish peroxidase. At the same time, Sodium Azide has the risks of explosion, very sensitive compounds with heavy metals and the risk of toxicity, inhibit cytochrome oxidase and other enzymes, and can block the formation of oxyhemoglobin in the body, leading to death. Due to the inflammable, explosive and highly toxic nature of Sodium Azide as a dangerous chemical, its procurement, storage, use and other links of the state have special regulatory requirements, its use is increasingly limited.  BND-10 Preservative can also replace Thimerosal, which was widely applied to in vitro diagnostic reagent, it for both gram positive and negative of strong antibacterial ability, as the broad-spectrum antibacterial agent, because a small amount of organic mercury in theory has the nerve toxicity, so the use of thimerosal security issues by the attention of people. 

Mechanism of Action

BIT-10 Preservative is a kind of broad spectrum antibacterial agent, the sterilization mechanism of BIT is the same as the assigned or different thiazole moiety ketone compounds of receptor cell membrane and cell wall with a strong penetration, after penetrate the cell periphery with cells containing sulphur proteins, enzymes, or simple molecular interaction, make its S -N key fracture, thus and receptor form S - S keys, destroy the normal function of cells. It is obvious that the weaker S - N bond of the isothiazolinone compound is beneficial to the antibacterial activity. But bit-10 is more stable than other antimicrobial agents, especially under alkaline conditions.

MIC

BIT-10 Preservative showed excellent anti-corrosion effect, its minimum inhibition concentration (MIC) as shown in the table below when the protein content of the reagents/solution is less than 10% of the formula. The product can be used for in vitro diagnostic reagents containing organic compounds, non-ionic or aniwonic surfactants and antigenic antibodies. The above components do not affect the antibacterial effect, nor do they produce antagonistic effects on each other. Compatible with most surfactants.

Storage

Store in cool place. Keep container tightly closed in a dry and well-ventilated place.