肉豆蔻酸异丙酯在药品微生物检验样品前处理中的应用研究

Study on the Application of Isopropyl Myristate in the Pretreatment of Pharmaceutical Microbiology Testing Samples

该研究考察了肉豆蔻酸异丙酯(IPM)在非水溶性制剂的微生物限度检查样品前处理中的应用情况。首先,采用加菌回收法测定IPM在经前处理的供试品样品中对微生物生长、检出的影响,结果显示其对微生物的毒性可忽略不计,不影响污染微生物的检出。随后,采用IPM对5种非水溶性制剂进行样品前处理,并进行微生物限度方法适用性试验研究。结果显示,IPM对非水溶性制剂有良好的溶解性。经IPM处理的非水溶性供试品通过溶解-萃取转化为水溶性供试品,可采用薄膜过滤法消除药品抑菌性,建立相应品种的简便微生物限度检验方法。该研究显示了IPM在非水溶性制剂供试液制备中良好的应用前景,以及其用于特殊基质样品前处理的潜力。

This study investigated the application of isopropyl myristate(IPM)in sample pretreatment for the microbial limit test of water-insoluble preparations.First,the effect of IPM on the growth and detection of microorganisms in the pretreated test sample was determined by the bacteria-adding recovery method.The results showed that its toxicity to microorganisms could be ignored and IPM did not affect the detection of contaminated microorganisms.Subsequently,IPM was used for sample pretreatment of five water-insoluble preparations,and the applicability of the microbial limit method was tested.The results showed that the insoluble preparations could be well dissolved in IPM.The water-insoluble test samples treated with IPM were converted into water-soluble test samples through dissolution-extraction process.The membrane filtration method can be used to eliminate the bacteriostasis of drugs and establish a simple microbial limit test method for corresponding varieties.This study shows that IPM has a good application prospect in the preparation of test solutions of water-insoluble preparations and its potential for the pretreatment of special matrix samples.