Validation of Microbial Limit Test Methods of Tongmai Tangyanming Capsule

[ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microbiological limits of non-sterile products were verified. [ Results] Tongmai Tangyanming Capsule has a strong inhibitory effect on Bacillus subtilis and Candida albicans. The antimicrobial activity was significantly eliminated after increasing the diluent （ 1 ： 20） ; and the recoveries were in the range of 0.5 -2 when the total quantities of aerobic microbes were determined by dilution method （1：20）. When the total quantities of mould and yeast were determined by dilution method （1：20）, the recoveries were from 0.5 to 2, and Escherichia coli, cholate-tolerant Gram-negative bacteria and Salmonella can be detected by the test solution dilution method. [ Condusions] With the plate method, the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent, and conventional method was used for examination of control bacteria including E. coli, cholatetolerant Gram-negative bacteria and Salmonella. This method has been proved effective for microbial limit test of Tongmai Tangyanming Capsule, and can effectively control the quality of the preparation. The method is accurate and reliable.

Validation of Microbial Limit Test Methods of Compound Gangbangui Capsule

[Objectives] This study was conducted to establish a method for microbial limit test of Compound Gangbangui Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiological limits of non-sterile products were verified. [Results]Compound Gangbangui Capsule has a strong inhibitory effect on S. aureus,and the antimicrobial activity was significantly eliminated after increasing the diluent（ 1∶ 20）; and the recoveries were in the range of 0. 5-2. 0 when the total quantities of aerobic microbes were determined by dilution method（ 1∶ 20）. When the total quantities of mould and yeast were determined by conventional method（ 1∶ 20）,the recoveries were from 0. 5 to 2. 0,and Escherichia coli can be detected in experimental groups by the test solution dilution method. [Conclusions]With the plate method,the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent and conventional method,respectively,and control bacteria,E. coli was examined by conventional method. This method has been proved effective for microbial limit test of Compound Gangbangui Capsule,and can effectively control the quality of the preparation. The method is accurate and reliable.

Establishment of Microbial Limit Test Methods for Two Hospital Preparations

[Objectives] This study was conducted to establish microbial limit test methods for traditional Chinese medicine preparations Yunpi Granules and Bupi Qiangli Paste. [Methods] According to General Rules of Part IV of Chinese Pharmacopoeia, applicability tests were conducted on microbial limit test methods for the above two traditional Chinese medicine preparations by the plate method. [Results] The established methods showed recovery values in the range of 0.5-2.0 for both experimental strains, and the control bacteria could be detected in the experimental group, but not in the negative control group. [Conclusions] The microbial limit test methods were reliable for the two traditional Chinese medicine preparations and could be used for quality control.

Applicability of Microbial Limit Test Method for Qingyan Zhisou Powder

[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,General Rules 1105-1107 of Part IV of Chinese Pharmacopoeia,2020.[Results]Qingyan Zhisou Powder had a strong bacteriostatic effect on Pseudomonas aeruginosa.After increasing the dilution ratio(1:40),the bacteriostatic effect was obviously eliminated.When the total number of aerobic microbes was determined by the test liquid dilution method(1:40),the recovery values were in the range of 50%-200%;and when using the test liquid(1:10)to determine the total number of mold and yeasts,the recovery ranged from 50%to 200%.Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria were detected by both the routine method and dilution method in experimental groups.[Conclusions]The microbial limit test of Qingyan Zhisou Powder adopted the test liquid dilution method,and the routine method could be used for the test of Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria.The applicability test of the method is feasible,with scientific and accurate results,and the method can effectively control the quality of the preparation and is recommended for popularization.

Methodology Validation of Microbial Limit Test of Bupi Qiangli Ointment

[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.

Validation for Microbial Limit Test Method of Compound Yu E Nose Drops

[Objectives] This study was conducted to establish a method for microbial limit test of Compound Yu E Nose Drops.[Methods] According to the Chinese Pharmacopoei (General Rules in the fourth part of the 2015 edition),the microbial limit test method for Compound Yu E Nose Drops was verified.[Results] Compound Yu E Nose Drops has a strong inhibitory effect on Staphylococcus aureus and Bacillus subtilis,and the inhibitory activity was significantly eliminated after increasing the diluent (1∶ 20).The recoveries were all in the range of 0.5-2.0 when the total quantities of aerobic microbes were determined by the dilution method (1∶ 20).When the total quantities of mould and yeast were determined by the conventional method,the recoveries were both in the range of 0.5-2.0.When examining control bacteria,Escherichia coli,S.aureus and Pseudomonas aeruginosa can all be detected in the test groups by the test liquid dilution method.[Conclusions] For Compound Yu E Nose Drops,the total quantities of aerobic microbe can be counted by the dilution method;the quantities of mould and yeast can be examined by the conventional plate method;and the conventional method can be used for control microbe examination.

赤丹丸微生物限度检查方法适用性研究

目的建立医院制剂赤丹丸的微生物限度检查方法。方法根据四部通则1105-1107,2020年版《中国药典》的规定,采用常规法和稀释法计算赤丹丸中各个菌株的回收比,并对控制菌进行检查。结果赤丹丸有较强的抑菌性,当采用1∶100稀释法时,各试验菌株的回收比均在0.5~2范围内,常规法检出相应的控制菌。结论赤丹丸采用1∶100稀释法用于需氧菌总数、霉菌及酵母菌总数的计数,常规法用于控制菌的检查。

复方冬凌草含片微生物限度检查方法学研究

目的建立适用于复方冬凌草含片的微生物限度检查方法,以保证其质量和安全性。这个方法要能测量需氧菌的数量、霉菌和酵母菌的数量,并且限制菌中的肠道埃希菌。方法根据《中华人民共和国药典(2020年版)》第四部分中通用规则1107的规定,本研究对该方法的适应性和回收效率进行了评估和测试。试验中,本研究采用常规法和稀释法,对复方冬凌草含片样品进行菌落计数。结果复方冬凌草含片具有显著的抑菌作用。利用标准方法进行测试,结果显示,复方冬凌草对各种细菌如青色链状真菌(pseudomonas aeruginosa)、枯草芽孢杆菌(bacillus subtilis)、金黄色葡萄球菌(staphylococcus aureus)及白色念珠菌(candida albicans)等有良好的抑制作用。同时,对黑色发霉体与酿酒酵母也有较好的控制能力。然而通过降低浓度的方法检测时,无论是需要空气的微生物还是发酵类生物都呈现出了较低水平,即低于或接近于0.5的比例值上限。在控制菌检查中,采用常规法检出了阳性菌。结论成功地建立了一种适用于复方冬凌草含片微生物限度检查的稀释法。该方法能可靠地评估复方冬凌草含片的微生物质量,并为其合规生产提供了可行的检测方案。

午时茶颗粒微生物限度检查方法的验证

按照《中华人民共和国药典》(2020年版四部)要求,采用平皿倾注法(1∶10,1∶20,1∶50,1∶100)和常规培养基体积直接接种法对午时茶颗粒进行微生物计数方法和控制菌检查方法适用性试验,通过计算3批次的试验菌回收比值筛选需氧菌总数计数、霉菌和酵母菌总数计数方法.当采用平皿倾注法(1∶10)时,各试验菌回收比值均在0.5~2.0范围内.控制菌阳性对照组生长良好,经革兰氏染色显微镜检查和生化鉴定试验,符合试验菌形态学和生化特性.研究建立的方法准确可行,重现性好,可用于午时茶颗粒的微生物限度检查.

于氏解郁调肝散微生物限度检测方法考察

(目的)建立于氏解郁调肝散的微生物限度检测方法,加强于氏解郁调肝散的质量控制。(方法)依据2020版《中国药典》中非无菌制剂微生物限度检测法进行方法适用性考察。(结果)采用1∶1000稀释法测定需氧菌总数,采用1∶10稀释法测定霉菌和酵母菌总数,各实验菌回收率在0.5~2之间;三种控制菌大肠埃希菌、沙门菌、耐胆盐革兰阴性菌均可采用常规接种法,结果符合要求。(结论)研究建立的微生物限度检测方法,准确、重复性好,可用于于氏解郁调肝散的质量控制,为完善于氏解郁调肝散的质量标准提供了重要数据支持。

15种医院口腔抑菌制剂微生物限度检查方法的建立

目的建立15种医院口腔抑菌制剂的微生物限度检查方法。方法以醋酸氯己定口崩片、醋酸氯己定洗剂、复方替硝唑溶液、碘甘油、甲醛甲酚涂剂、硼酸甘油涂剂、人工唾液、脱敏糊剂、干髓糊剂、锌麝酚醛糊剂、牙周塞糊剂、甲硝唑膜、复方克林霉素膜、多聚甲醛新失活剂、多聚甲醛牙髓失活剂为样品(制剂1-15),按2020年版《中国药典(四部)》通则1105,1106,1107项下方法,采用平皿法、薄膜过滤法和培养基稀释法,对5种常见菌(金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉)进行回收试验,并进行控制菌(金黄色葡萄球菌、铜绿假单胞菌和大肠埃希菌)检查方法适用性试验。结果制剂1-5、9-11、14-15需氧菌总数检查均采用薄膜过滤法,其余制剂均采用平皿法;制剂1-3、6-8、12-13霉菌和酵母菌检查均采用平皿法,其余制剂均采用薄膜过滤法,试验菌回收比均在0.5~2.0范围内;控制菌检查,制剂1-3、5、9-11、14-15均采用薄膜过滤法,其余制剂均采用培养基稀释法,试验组相应阳性菌均能正常检出。结论所建立的方法适用于此15种医院口腔抑菌制剂的微生物限度检查。

2种军队医院制剂微生物限度检查方法的建立

目的建立新肾炎胶囊和炎黄保肾胶囊2种军队医院制剂方便有效的微生物限度检查方法,并对该方法进行验证。方法按《中国药典》2020年版(四部)通则1105、1106检查法,采用中和法(中和剂为10 mol·L^(-1) NaOH)进行方法适用性试验,计算试验菌回收比值。结果采用中和剂10 mol·L^(-1) NaOH调节pH 7.0无菌氯化钠-蛋白胨缓冲液的pH值为8.0,并结合培养基稀释法,可消除新肾炎胶囊和炎黄保肾胶囊的抑菌作用,使各试验菌回收比值均在0.5~2.0,符合《中国药典》要求。结论中和法(中和剂为10 mol·L^(-1) NaOH)可用于2种医院制剂的微生物限度检查。

罗红霉素胶囊微生物限度检查方法适用性研究

目的通过微生物适用性试验,建立罗红霉素胶囊的微生物限度检查方法。方法按照2020年版《中国药典(四部)》通则1100生物检查法要求,采用平皿法、薄膜过滤法并使用中和剂稀释等方法开展回收试验,进行微生物计数检查、控制菌检查方法研究。结果采用中和剂稀释联合分膜的薄膜过滤法,可有效去除罗红霉的抑菌作用,回收率达到要求。结论所建立的检查方法符合药典要求,可作为罗红霉素胶囊的微生物限度检查方法。

散结粉微生物限度检查方法学研究

文章旨在构建散结粉的微生物限度检查方法,依据《中国药典》2020版四部通则1105、1106中的实验方法展开研究。当需氧菌总数的计数采用常规法(1∶10供试液,m/V),霉菌和酵母菌总数的计数采用稀释法(1∶50供试液,m/V)进行时,回收率为0.5~2.0,而当控制菌检查采用常规检查法进行时,阳性对照组生长良好,阴性对照组无菌落生长。由此可知,联合使用常规法和稀释法的微生物计数法可以有效消除散结粉中微生物的抑菌作用,有利于检出潜在污染微生物。

通宣理肺片微生物限度检查方法适用性验证

目的:按照《中华人民共和国药典》2020年版对通宣理肺片进行微生物限度检查方法适用性试验研究并建立其方法。方法:本研究依据《中国药典》2020年版四部通则1105及1106,对通宣理肺片进行计数方法和控制菌检查方法的适用性试验。结果:通宣理肺片采用倾注法1∶100稀释级验证需氧菌总数、霉菌和酵母菌总数,回收率在0.5~2范围内;采用常规法验证大肠埃希菌、耐胆盐革兰阴性菌、沙门菌,检出阳性菌,阴性对照未检出。结论:本次验证方法可作为通宣理肺片微生物限度的检查方法。

阿奇霉素干混悬剂微生物限度检查方法选择原则

目的 比较阿奇霉素干混悬剂不同微生物检验方法的优势与劣势,并提出方法选择原则。方法 采用常规法、中和法、稀释结合中和法以及薄膜过滤结合中和法等13种方法对阿奇霉素干混悬剂进行微生物限度方法适用性研究。结果 可采用稀释结合中和法(1:500供试液1 ml平均倾注5个皿)或稀释结合薄膜过滤结合中和法(1:100供试液,冲500 ml/膜)进行需氧菌总数计数。结论 从仪器耗材成本、操作便利性、污染风险角度,阿奇霉素干混悬剂检验应首选稀释结合中和法;从检验灵敏度方面应首选稀释、薄膜过滤结合中和法。

消肿止痛凝胶微生物限度检查方法的建立

目的建立消肿止痛凝胶2020年版中国药典微生物限度检查方法,并进行方法适用性试验。方法根据《中国药典》2020年版四部的非无菌药品微生物限度检查进行方法适用性试验。结果采用1∶50供试液检查需氧菌总数,采用常规倾注法检查霉菌和酵母菌总数,试验组的回收率均在50%~200%范围内;金黄色葡萄球菌和铜绿假单胞菌检查使用常规法,均能检出相应控制菌。结论消肿止痛凝胶中含抑菌成分,采用1∶50供试液检查需氧菌总数,采用常规法进行霉菌和酵母菌总数和控制菌检查,方法简便,结果可靠。

明胶空心胶囊的微生物限度检查方法适用性试验研究

目的:对明胶空心胶囊进行微生物限度检查方法适用性试验研究,为药品企业制订药用胶囊壳的质量控制验收标准以及胶囊生产企业建立明胶空心胶囊的微生物限度检查方法提供参考。方法:依据《中国药典》2020年版四部通则1105、1106,对30批明胶空心胶囊进行计数方法和控制菌检查方法的适用性试验。结果:需氧菌总数、霉菌和酵母菌总数均采用平皿法,控制菌大肠埃希菌有28批采用常规法,2批采用培养基稀释法,控制菌沙门菌有27批采用常规法,3批采用培养基稀释法。有2批明胶空心胶囊对金黄色葡萄球菌、大肠埃希菌、沙门菌等细菌有着异常强的抑菌作用。结论:不同生厂厂家的明胶空心胶囊抑菌作用有一定差异,需进一步完善和规范明胶空心胶囊的微生物限度检查方法及其质量安全控制标准。

复方黄连素片微生物限度检查方法的研究

目的建立复方黄连素片微生物限度检查法。方法按照《中华人民共和国药典》2020年版四部规定,采用平皿倾注法、降低检品供试液浓度法、降低检品供试液浓度联合薄膜过滤法等办法依次进行微生物限度检查方法的适用性实验。结果需氧菌计数采用薄膜过滤法,霉菌和酵母菌计数采用降低检品供试液浓度的方法,药品标准规定必须检查的三种控制菌采用常规浓度直接接种法。结论本实验拟定的检查方法步骤简单、花费时间短。

速康宁滴眼液和速康宁滴鼻液的生物检查方法适用性研究

目的建立速康宁滴眼液和速康宁滴鼻液的生物检查方法,并评估检查方法的适用性。方法参照《中华人民共和国药典》,采用薄膜过滤法对速康宁滴眼液进行无菌检查,采用倾注平皿法和薄膜过滤法对速康宁滴鼻液进行微生物限度检查,采用直接接种法和薄膜过滤法对速康宁滴鼻液进行控制菌检查,并对上述方法进行适用性试验。结果以0.9%无菌氯化钠溶液作为冲洗剂(总冲洗量为300 mL)进行薄膜过滤法检测,可以对速康宁滴眼液中的大肠埃希菌、生孢梭菌、白色念珠菌、黑曲霉菌进行无菌检查;分别以0.9%无菌氯化钠溶液及含0.1%(体积比)聚山梨酯80的0.9%无菌氯化钠溶液作为冲洗剂(总冲洗量为500 mL)进行薄膜过滤法检测,可对速康宁滴眼液中的金黄色葡萄球菌、枯草芽孢杆菌进行无菌检查。以含0.1%(体积比)聚山梨酯80的0.9%无菌氯化钠溶液作为冲洗剂(总冲洗量为500 mL)进行薄膜过滤法检测,可以对速康宁滴鼻液中的需氧菌(铜绿假单胞菌、金黄色葡萄球菌、枯草芽孢杆菌)进行微生物限度检查及控制菌检查,采用倾注平皿法可以对速康宁滴鼻液中的霉菌和酵母菌(白色念珠菌和黑曲霉菌)进行微生物限度检查。结论速康宁滴眼液的无菌检查、速康宁滴鼻液的需氧菌微生物限度检查及控制菌检查均可采用薄膜过滤法,速康宁滴鼻液的霉菌及酵母菌微生物限度检查可采用倾注平皿法。上述检查方法实用简便、准确可靠且重现性好。