降压片微生物限度检查方法研究

Study on Microbial Limit Test Method of Jiangya Tablet

目的:对降压片的微生物限度检查方法进行研究。方法:通过研究降压片成分的抑菌特性,按《中国药典》2015年版四部通则1105、1106、1107进行微生物限度检查方法适用性试验。结果:利用聚山梨酯80的中和作用,采用增大稀释液和培养基体积方法进行试验,计数方法适用性试验中,稀释液对照组与菌液对照组菌落数比值、试验组减去供试品对照组菌落数与菌液对照组菌落数比值均在0.5~2之间;控制菌检查方法适用性试验均能检出阳性对照菌。结论:能够消除抑菌成分干扰且所添加中和剂对微生物生长无影响,重现性好,确保检测结果的有效性和准确性。

Objective To develop microbiological examination method of the Chinese Pharmacopoeia （Ch. p） 2015 Edition for Jiangya tablet. Methods According to the 4th general rules1105, 1106 and 1107 of 2015 Edition, the method suitability test both of microbial counting and control bacterial examination in three batches of smples after studying the antibacterial properties of the Jiangya tablet. Results With expanding liquid volume and polysorbate 80 being taken, the colony ratio between the control group and the microbial group was in the range of 0. 5 - 2. And the colony ratio between the test group minus sample group and microbial group was between 0. 5 and 2 in the counting suitability test of aerobic bacteria, which was also taken of mould and yeast. Meanwhile the control bacteria were detected in the test group. Conclusion The bacteriostasis interference of Jiangya tablet was eliminated by the methods which had been described above and the methods were feasible and reproducible.