ABSTRACT
Objective To prepare samples of proficiency testing （PT） containing live Staphylococcus aureus with drug matrix in microbial PT program of drug testing， and to evaluate the laboratory capability of microbiology tests in China. Methods Two kinds of PT samples containing living bacteria with drug matrix were prepared and evaluated. The results of laboratories participated in PT program and their response to the survey questionnaire were collected and analyzed. Results The homogeneity and stability of the PT samples complied with the requirements of CNAS-CL03： 2010. Samples could be stored stably for at least 6 months at -20 ℃. Among 63 laboratories participating in PT program， 53 laboratories （84.1%） achieved satisfactory results. The satisfaction rate was 94.1% （16/17） in 17 government laboratories （27.0% of total 63 laboratories）， 81.4% （35/43） in 43 pharmaceutical quality control laboratories （68.3% of total 63 laboratories）， and 66.7% （2/3） in 3 non-government laboratories （4.8% of total 63 laboratories）， respectively. Conclusion The government laboratories performed better than pharmaceutical quality control laboratories in microbiology tests of drug， and the testing abilities of some pharmaceutical laboratories needs to be improved. The preparation and application of microbial samples in drug matrix could provide evaluation tools for drug testing laboratories in microbiology.
ABSTRACT
Objective To prepare samples of proficiency testing （PT） containing live Staphylococcus aureus with drug matrix in microbial PT program of drug testing， and to evaluate the laboratory capability of microbiology tests in China. Methods Two kinds of PT samples containing living bacteria with drug matrix were prepared and evaluated. The results of laboratories participated in PT program and their response to the survey questionnaire were collected and analyzed. Results The homogeneity and stability of the PT samples complied with the requirements of CNAS-CL03： 2010. Samples could be stored stably for at least 6 months at -20 ℃. Among 63 laboratories participating in PT program， 53 laboratories （84.1%） achieved satisfactory results. The satisfaction rate was 94.1% （16/17） in 17 government laboratories （27.0% of total 63 laboratories）， 81.4% （35/43） in 43 pharmaceutical quality control laboratories （68.3% of total 63 laboratories）， and 66.7% （2/3） in 3 non-government laboratories （4.8% of total 63 laboratories）， respectively. Conclusion The government laboratories performed better than pharmaceutical quality control laboratories in microbiology tests of drug， and the testing abilities of some pharmaceutical laboratories needs to be improved. The preparation and application of microbial samples in drug matrix could provide evaluation tools for drug testing laboratories in microbiology.
ABSTRACT
Traditional Chinese medicine (TCM) suppositories, as an important way of administration, have been widely used in clinical practice. Based on the data mining of the clinical application of TCM suppository therapy, the technical specification (draft) for clinical external application of TCM suppositories has been formed after repeated argumentation by experts of the external treatment branch, including clinical indications, contraindications, pre-medication evaluation, pre-medication preparation, application method, dosage, frequency, time, precautions, adverse reactions and countermeasures, etc. It is expected to standardize the clinical application of TCM suppositories, improve curative effect of this preparation and reduce its adverse reactions.