Microbial Limit Test Of Antimicrobial Drugs Abstract

Microbial limit test law is such a method that accesses the degree of microbial contamination on non-obligatory sterilization preparations as well as its raw and auxiliary materials. The law check mainly includes the number of bacteria, mold, yeast and certain restricting bacteria. It is a necessary tool for detection of microorganism and restricting bacteria content in drug, which provide necessary theoretical foundation for pharmaceutical production, inspection and supervision.In this research, eight heat-clearing and detoxifying drugs were tested respectively using microbial limit test law to identify and optimize the best detection methods of bacteria, mold and yeast count in line with quality requirements of pharmacopoeia.In Qizhiweitong Particles, culture medium dilution method was adopted for microbial limit test to clarify number of bacteria, mold and yeast. Three independent parallel experiment results showed that the recovery rates on both experimental group and thinner control group were higher than 70%;Same dection method was tested on Compound Danshen Tablets. The recovery rate of two specific bacterium, staphylococcus aureus and bacillus subtilis is lower than 70%, indicating that the drug had some inhibitory effect on certain bacterium, resulting in culture medium dilution method failure on testing bacteria, mold and yeast count. Instead, membrane filtration method was revalidated to identify the feasibility on colony counting. The results showed that the recovery rates of experimental group and thinner control group were higher than 70%, so that the membrane filtration would eliminate the influence of antibacterial compositions. On this basis, for Compound Danshen Tablets the new double membrane filtration method was carried on the colony count and compared with traditional membrane filtration method, and the results showed that the double membrane filtration method performed better on colony count of staphylococcus aureus and bacillus subtitles than the membrane filtration method. The method is better to remove the drug antibacterial compounds, and more accurate for colony count, so that the effect of microbial limit examination double membrane filtration method can be used for counting bacteria, mold and yeast. Six detoxification drugs including Rhizoma Coptidis Tablet contain various degree of antimicrobial compounds, which belongs to the antibacterial drugs, so the double membrane filtration method would be a better choice for counting bacteria, mold and yeast. The results showed that the experimental group and the thinner control group would achieve higher than 70% bacteria recovery rate, conforming to the requirement of pharmacopoeia. In conclusion, double membrane filtration method would be an efficient microbial limit test law to identify number of bacterial, mold and yeast for detoxification drugs.On the microbial limit test law, control bacterium were detected in positive control group with bacterium addition and vice versa, which meets China medical dictionary provision. As a result, the culture medium dilution method can be used on Qizhiweitong Particles, while the double membrane filtration method can be used on six detoxifying drugs such as Compound Danshen Tablets and Rhizoma Coptidis Tablet for control bacterium examination.