伤痛克酊微生物限度检查方法建立

Establishment of Microbial Limit Inspection Method of Pain Tincture

目的:建立伤痛克酊中国药典2015版微生物限度检查方法。方法:采用《中国药典》2015年版四部"1105和1106"项下方法对伤痛克酊进行微生物限度检查方法适用性试验。结果:取1∶10供试液,采用薄膜过滤法测定需氧菌总数、平皿法(1 m L/皿)测定霉菌和酵母菌总数时,试验组回收率比值均在《中国药典》2015年版规定的0.5~2范围之内;铜绿假单胞菌检查用胰酪大豆胨液体培养基为100 m L时,金黄色葡萄球菌检查采用薄膜过滤法,培养基用量为100 m L时,实验组均能检出试验菌。结论:伤痛克酊需氧菌总数测定采用薄膜过滤法、霉菌和酵母菌总数测定采用平皿法(1 m L/皿),铜绿假单胞菌检查用胰酪大豆胨液体培养基为100 m L,金黄色葡萄球菌检查采用薄膜过滤法,培养基用量为100 m L的方法适用于此药品的微生物限度检查,能真实反应其微生物污染情况,有效保证药品质量,降低微生物安全风险。

Objective To establish a method for microbial limit examination of Chinese Pharmacopoeia （2015 edition） about Pain tincture . Methods Microbial limit inspection method suitability test about Pain tincture was carried out according to ＂1105 and 1106＂ in four version of Chinese Pharmacopoeia （ 2015 Edition）. Results From 1 to 10 for the test solution, using the membrane filter method on the determination of the total number of aerobe, AGAR method （1 mL/dish） determination of the total number of mold and yeast, the recovery rate in the experimental group were range of 0. 5 - 2 in the provisions of China Pharmacopoeia （2015 edition） ; control bacteria were examined when Pseudomonas aeruginosa check with pancreatic dairy soy peptone liquid medium for 100 mL, Staphylococcus anreus, check the membrane filtration method is adopted and medium dosage were 100 mL. Conclusion Determination of the total number of aerobe in Pain tincture using the membrane filter method, Determination of the total number of mold and yeast using the method of AGAR （1 mL/dish） ; Pseudomonas aeruginosa check with pancreatic dairy soy peptone liquid medium for 100 mL, Staphylococcus aureus, check the membrane filtration method is adopted, Medium dosage for 100 mL method, the method Suitable for microbial limit examination of the drug, can reflect the microbial contamination condition, effectively guarantee the quality of drugs, reduce microbial safety risk.