医院制剂乳腺增生丸的微生物限度检查及影响因素分析

Microbial limit examination and influence factor analysis of hospital preparation mammary gland hyperplasia pills

目的:建立医院制剂乳腺增生丸的微生物限度检查方法适用性试验,并根据检查结果进行影响因素分析,进一步提高产品质量。方法:根据《中国药典》2020年版四部通则1105—1107,采用1∶100稀释法测定需氧菌总数,常规法测定霉菌和酵母菌总数及检查控制菌是否存在。对近5年中国医科大学附属盛京医院制剂室生产的共265批次乳腺增生丸微生物限度检查结果进行汇总,分析乳腺增生丸微生物限度与丸剂水分、晾丸时紫外线照射时间、75%乙醇擦拭设备次数的关系,并检查乳腺增生丸中13种中药饮片的微生物限度。结果:乳腺增生丸共有20批次检出需氧菌,需氧菌总数随着水分的降低而减少,晾丸时紫外线照射时间2 h、使用75%乙醇擦拭设备2次,需氧菌总数、霉菌和酵母菌总数均小于10 cfu·g^(-1),控制菌均未检出。中药饮片中,红花、蒲公英的微生物检出结果较为严重。结论:该文所采用的方法可用于乳腺增生丸微生物限度检查,生产时应严格控制乳腺增生丸的影响因素;建立了中药饮片微生物限度标准,可为逐步提高医院制剂产品质量提供参考。

OBJECTIVE To perform the suitability test of microbial limit test method for mammary gland hyperplasia pills,and analyze the influencing factors of the test results for the problems encountered in the actual production process.METHODS Verification was conducted according to the general principle 1105—1107 described in the Part Ⅳ of Chinese Pharmacopoeia(2020 edition).The 1∶100 dilution method was used to count the total number of oxygen bacteria,and the conventional method was used to count the total number of mold and yeast,and check the presence of the control bacteria.The microbial limit test results of 265 batches of mammary gland hyperplasia pills produced in the Shengjing Hospital of China Medical University in the past five years were summarized.The relationships between the microbiological limit of mammary gland hyperplasia pills and the water content of pills,the time of ultraviolet irradiation and the number of wiping equipment with 75% ethanol were analyzed.The microbial limits of 13 TCM decoction pieces in mammary gland hyperplasia pills were analyzed.RESULTS Aerobic bacteria were detected in 20 batches of mammary gland hyperplasia pills.The total number of aerobe in mammary gland hyperplasia pills reduced with the decrease of water content.The total number of aerobic bacteria,mold and yeast was less than 10 cfu·g-1 when the UV irradiation time was two hours and 75% ethanol was used to wipe the equipment twice,the control bacteria was not detected.Among 13 TCM decoction pieces,the results of microbiological detection of safflower and dandelion were more serious.CONCLUSION The method adopted in this paper can be used for the microbial limit test of mammary gland hyperplasia pills.The moisture of mammary gland hyperplasia pills,and the influencing factors of mammary gland hyperplasia pills should be strictly controlled during production;the microbial limit standard of Chinese herbal pieces should be established to provide reference for gradually improving the quality of hospital preparations.