商業(yè)派生菌株與標(biāo)準(zhǔn)菌株的區(qū)別
發(fā)布時(shí)間：
2022-12-27
作者：
商業(yè)派生菌株與標(biāo)準(zhǔn)菌株的區(qū)別
《中國(guó)藥典》2015版——《9203 藥品微生物實(shí)驗(yàn)室質(zhì)量管理指導(dǎo)原則》中提出：藥品微生物檢驗(yàn)用的試驗(yàn)菌應(yīng)來(lái)自認(rèn)可的國(guó)內(nèi)或國(guó)外菌種保藏機(jī)構(gòu)的標(biāo)準(zhǔn)菌株，或使用與標(biāo)準(zhǔn)菌株所有相關(guān)特性等效的可以溯源的商業(yè)派生菌株。這里所提到的商業(yè)派生菌株是指由標(biāo)準(zhǔn)菌株派生而來(lái)的，可以直接用作工作菌株，一般不可再次進(jìn)行傳代。
商業(yè)派生菌株與標(biāo)準(zhǔn)菌株的區(qū)別：從技術(shù)角度來(lái)講，標(biāo)準(zhǔn)菌株都是從國(guó)家認(rèn)可的機(jī)構(gòu)或者國(guó)外菌種保藏機(jī)構(gòu)購(gòu)買得到的，為0代菌種的凍干粉，在使用前需要進(jìn)行復(fù)蘇、傳代、鑒定和保藏等工作，并且在使用前需要提前一天進(jìn)行活化，并且需要梯度稀釋后對(duì)其進(jìn)行計(jì)數(shù)定量；而商業(yè)派生菌株則是由標(biāo)準(zhǔn)菌株派生出來(lái)的，通常為凍干形式，一般是3~5代菌種，它的特點(diǎn)是不需要進(jìn)行活化、傳代、鑒定和保藏，即得即用，無(wú)需進(jìn)行提前活化和梯度稀釋，按照廠家提供的說(shuō)明書操作即可得到所需數(shù)量的菌液，大大節(jié)省了微生物實(shí)驗(yàn)室工作人員的工作負(fù)擔(dān)。從文件管理方面來(lái)講，使用標(biāo)準(zhǔn)菌株時(shí)，從標(biāo)準(zhǔn)菌株到標(biāo)準(zhǔn)儲(chǔ)備菌株，再到工作菌株，這一系列的使用過(guò)程均應(yīng)有相應(yīng)的程序文件和記錄，相關(guān)的人員一定要進(jìn)行必要的培訓(xùn)，具備齊全的培訓(xùn)記錄；而使用商業(yè)派生菌株則只需要由生產(chǎn)廠家提供質(zhì)檢報(bào)告和溯源性報(bào)告，保證其與標(biāo)準(zhǔn)菌株所有相關(guān)特性等效，同時(shí)保證其可溯源性。除此之外，與商業(yè)派生菌株相比，標(biāo)準(zhǔn)菌株的使用過(guò)程中對(duì)于硬件設(shè)施及耗材的投入相對(duì)較大，成本也并不比商業(yè)派生菌株低。
在微生物檢驗(yàn)領(lǐng)域，商業(yè)派生菌株的應(yīng)用范圍和標(biāo)準(zhǔn)菌株并無(wú)明顯區(qū)別，可用于藥檢中的靈敏度試驗(yàn)、促生長(zhǎng)試驗(yàn)、無(wú)菌檢查、培養(yǎng)基適用性檢查、控制菌檢查等；食品檢驗(yàn)的定量、定性對(duì)照、培養(yǎng)基質(zhì)控等；化妝品微生物檢驗(yàn)質(zhì)量控制。
青島日水微生物培養(yǎng)基
"Chinese pharmacopoeia" 2015 edition, the 9203 pharmaceutical microbiology laboratory quality management guiding principles put forward: in the microbiological test bacteria should be from recognised standard strains of domestic or foreign culture collection agencies, or the use of standard strains of all related features equivalent business derived strain can be traced back. The commercially derived strains mentioned here are derived from standard strains, which can be used directly as working strains, and are generally not transmitted again.
Business derived the difference between the strain and standard strain: from a technical perspective, standard strains were approved by the state agency or foreign culture collection agencies purchase, 0 generation strains producing, before using the need for recovery, batches, identification and preservation, such as work, and need one day in advance before use is activated, and the need to count after gradient dilution quantitative; While business derived strain is derived by the standard strains, usually in the form of lyophilized form, is commonly 3 ~ 5 strains of generation, its characteristic is don't need to be activated, batches, identification and preservation, for a quick box, need for activation and gradient dilution in advance, according to the manual operation can be supplied by the manufacturer to get the required number of bacteria liquid, greatly save the microbiology laboratory staff workload. From the file management ways, using standard strains, from standard strains to reserve strains, strain to work, the use of the series process shall have the corresponding program files and records, related personnel must make the necessary training, have complete training records; Commercial derivative strains are only required by the manufacturer to provide quality inspection reports and traceability reports to ensure that they are equivalent to all relevant features of the standard strain and to ensure traceability. In addition, compared with commercial derivative strains, the use of standard strains is relatively large for hardware facilities and consumables, and the cost is not lower than that of commercial derivative strains.
In the field of microbiological examination, the application scope of business derived strain and standard strain and no obvious difference between, can be used to test the sterility test of sensitivity test, the growth test, applicability, medium inspection, control bacteria inspection, etc.; Quantitative, qualitative control and medium quality control of food inspection; Quality control of cosmetics microorganism inspection.