原料药维生素C微生物限度检查法的研究

建立了原料药维生素C的微生物限度检查法,包括细菌数、霉菌及酵母菌数及控制菌的检查。样品采用药典规定的常规法、薄膜过滤法进行微生物限度方法学验证,在进行控制菌-大肠菌群方法验证时,采用碳酸钠中和样品酸性,来进行检测方法验证。     

复方色甘酸钠鼻喷剂微生物限度检查方法的研究

目的:建立复方色甘酸钠鼻喷剂微生物限度检查方法。方法:按照2010年版《中国药典》附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查方法进行验证。采用薄膜过滤法对细菌、霉菌及酵母菌计数,采用薄膜过滤法对控制菌的检查方法进行方法学验证。结果:细菌、霉菌及酵母菌的回收率均大于70%。在控制菌的检查中,各阳性菌均检出,阴性对照无菌生长。结论:建立的复方色甘酸钠微生物限度检查方法可靠、准确、全面。该方法用于复方色甘酸钠鼻喷剂的微生物限度检查。     

生物制品用原辅料微生物限度检测方法的验证

目的建立生物制品用原辅料(乳糖、葡萄糖、明胶、淀粉、胰酶、纯化水)微生物限度检查法,并进行验证。方法分别采用平皿法及薄膜过滤法检测上述6种原辅料的微生物限度,并按设立的验证试验方法,在供试品中加入5种标准菌,测定标准菌的回收率。结果大肠埃希菌、金黄葡萄球菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种标准菌在上述6种原辅料供试品溶液中的平均回收率均大于80%,符合《中国药典》二部(2005版)中要求大于70%的合格标准。结论平皿法适用于检测乳糖、葡萄糖、明胶、淀粉、胰酶等原辅料的微生物限度,薄膜过滤法适用于检测纯化水的微生物限度。     

R2A培养基的应用及有效期的验证

验证R2A琼脂培养基替代营养琼脂、玫瑰红钠琼脂培养基应用于工艺用水微生物限度检查的可行性及R2A琼脂培养基平皿成品的有效期.方法:采用薄膜过滤法进行工艺用水微生物限度检查;对R2A琼脂培养基平皿进行培养基pH值、外观、适用性(灵敏度)和无菌性检查以确定有效期.结果:R2A培养基可应用于工艺用水微生物限度检查;所制成的平...     

异烟肼片微生物限度检查法的建立

建立一种适用于异烟肼片的微生物限度检查方法,并对方法进行验证。需氧菌、霉菌和酵母菌总数计数法、控制菌(大肠埃希菌)检查均采用薄膜过滤法,供试液浓度为1∶10。需氧菌总数、霉菌和酵母菌总数计数法方法验证各试验菌的回收试验结果均在0.5～2.0之间,大肠埃希菌检查法适用性试验符合要求。该方法可行性强,适用于异烟肼片的微生物限度检查。     

薄膜过滤法在药品微生物限度检查中的应用

薄膜过滤法是《中华人民共和国药典》2000版附录收录的微生物限度检验中的方法之一,其对于抑菌强的药品具有有效的消除效果,具有简便、快速、易操作的特点,被应用于多种药品的微生物检验。     

关于制药设备清洁验证中表面微生物擦拭取样方法和检验方法的验证实验

《药品生产质量管理规范》（2010年版）实施前,在制药设备的清洁验证中仅仅要求对化学残留的取样方法进行验证。而实施后新增了对表面微生物取样和检验方法验证的要求。建立了制药设备表面微生物擦拭取样回收率的验证方法,采用316L不锈钢板作载体,以金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌作为细菌的代表,白色念珠菌、黑曲霉作为真菌的代表,采取擦拭取样法,通过薄膜过滤法回收微生物,计算回收率。同时建立检测制药设备表面微生物限度的检验方法。     

氯雷他定糖浆微生物限度方法学验证

目的:建立氯雷他定糖浆的微生物限度检查方法。方法:采用《中国药典》2015年版四部"非无菌产品微生物限度检验方法"规定的平皿法、培养基稀释法,验证确认所采用的方法是否适合该药品的微生物限度检查。结果:细菌、霉菌及酵母菌数测定采用平皿法;控制菌采用培养基稀释法,5种试验菌的回收率均在0.5～2范围内。结论:该方法可用于氯雷他定糖浆的微生物限度检查。     

薄膜过滤法在膏霜类化妆品微生物检验中的应用研究

采用薄膜过滤法去除化妆品中防腐剂的抗菌活性，完善膏霜类化妆品微生物检验方法。该方法可以有效地去除化妆品中防腐剂的抗菌作用，使加菌回收率达到满意的效果，方法准确、可靠。     

汽车内存放环境对药品质量的影响

目的了解汽车内存放环境对药品质量的影响。方法按2005版中国药典标准对收集于汽车内的8种药品进行含量及微生物限度检测。结果注射用头孢唑啉钠及已启封氯霉素滴眼剂含量分别为标示量的87.2%和137.4%;已启封21金维他、复合维生素B片、六味地黄丸及复方鲜竹沥液等微生物限度检查均不合规定,其中,复方鲜竹沥液检出大肠埃希菌。结论汽车内存放药品,可严重影响药品质量。     

Evaluation of the antimicrobial action of honey against Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, Salmonella enteritidis, Listeria monocytogenes and Aspergillus niger. Evaluation of its microbiological charge

The evaluation of the microbiological charge present in Costa Rican samples as the evaluation of its antimicrobial activity over different microorganisms, including those associated to wound infections, will allow to emit criteria referred to its use in therapeutic treatments, specially as alternative therapy for cases involving antibiotic resistant bacteria. The microbiological charge of 25 honey samples, acquired in Costa Rican markets was evaluated through several indicators including total plate aerobic count, total plate anaerobic count, total aerobic spore count, total anaerobic spore count and molds and yeast count. Also, samples were inoculated in tubes with chopped meat media and plated in egg yolk agar in order to determine the presence of Clostridium botulinum. For the antimicrobial activity evaluation, the diffusion method in Muller Hinton agar was performed, testing different honey concentrations (100, 75, 50, 25, 12,5 and 6,25 % v/v) against Staphylococcus aureus (ATCC 25923), Staphylococcus epidermidis (UCR 2902), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC25922), Salmonella enteritidis (ATCC 13076), Listeria monocytogenes (ATCC 19116) and Aspergillus niger. The results obtained for the microbiological characterization of honey show that 91% of samples had counts equal or lower than 1,0 x 10(1) CFU/g. No positive result was obtained for the isolation of C. botulinum. 24 of the samples analyzed inhibited the growth of S. aureus even in a 25% v/v concentration, nevertheless, A. niger was no inhibited by any of the samples tested.     

面膜类化妆品微生物检验方法适用性考察

对面膜类化妆品的微生物检验方法适用性进行考察,结果表明,当采用培养基稀释法0.5mL/皿测定菌落总数及霉菌和酵母菌总数,采用现行的《化妆品安全技术规范》 2015年版方法检查控制菌时,各菌回收率均能达到要求。建议在检验前针对不同化妆品种类优化微生物计数和控制菌检查方法,提高样品中潜在微生物的阳性检出率。     

关于《化妆品卫生规范》（2007年版）中菌落总数测定方法的探讨

参考《中国药典》微生物检验的验证方法,以金黄色葡萄球菌、枯草芽孢杆菌和大肠埃希菌三株菌为验证菌株,分别采用营养琼脂培养基和卵磷脂、吐温80一营养琼脂培养基,对7个化妆品进行了菌落总数检验方法的验证。结果表明,卵磷脂和吐温8U可以作为中和剂部分消除化妆品中防腐剂的抑菌作用。只有2个样品适用于目前《化妆品卫生规范》2007年版的菌落总数检验方法。对于另外5个样品,分别建立了适合于它们的菌落总数检验方法。     

Bacteriological evaluation of fresh tilapia (Oreochromis niloticus) coming from the northern region of Costa Rica

The following work presents an evaluation of the normal and pathogenic flora associated to tilapia (Oreochromis niloticus), since there are no previous national studies referred to the microbiological quality of this product. The total aerobic plate count, lactic bacteria, Enterococcus sp and Aeromonas sp and fecal and total coliform count, and the presence of Listeria sp and Salmonella spp from the external surface of tilapias were evaluated. A total of 50 samples, coming from San Carlos and Ca?as zones were transported in ice to the Food and Water Microbiology Laboratory, Universidad de Costa Rica, where the laboratory analysis were performed, according to the methodology presented by de American Public Health Association, 1998. The results obtained confirm the microbiological freshness of the product when the analysis was performed, although coliform levels were unacceptable. Listeria sp was not found, but the isolation of Salmonella spp. confirms the fecal contamination of water where the tilapia is grown, aside of the Public Health concern. Also, it was found a high number of Aeromonas sp, as part of its normal flora, so we recommend including this genus in the quality standards for fresh fish. According to the data obtained, there was no significant difference (95% confidence) between the total plate count, fecal and total coliforms, Enterococcus sp. and Aeromonas sp. from the samples coming from the zones of San Carlos and Ca?as.     

黄瓜中维生素C含量的测定

维生素C是人体所必需的营养物质之一,其含量是评定果实营养价值的重要参数之一。文章采用直接碘量法测定了黄瓜中维生素C的含量。结果表明黄瓜中Vit C的含量为0.08174 mg/g,加标回收率为98.52%～98.80%。说明黄瓜中Vit C含量较高,具有较大的营养价值。     

铬天青S分光光度法测定药物中的维生素C

利用维生素C的还原性将Fe3+还原为Fe2+,在pH值=4条件下,用铬天青S作Fe3+的显色剂,然后测量吸光度,从而建立了一种测定药物中维生素C的新方法.Fe3+-铬天青S的最大吸收在576nm,维生索C浓度在0-2mg/L范围内服从朗伯-比尔定律.其回归方程为A=0.0037C-0.0083,相关系数R为0.9989...     

Microbiological quality of home-made cheese produced in Costa Rica

The microbiological quality of 205 samples of home-made cheese prepared from raw milk in six rural zones of Costa Rica was studied. In addition to determining their microbiological quality, recommendations are also issued for reducing to a minimum, the deficient sanitary conditions under which they are produced. Collection of samples was done directly at the producing farms. The following microbiological analyses were then undertaken: Staphylococcus aureus, thermonuclease (TNase) positive. Determination of most probable number (MPN) of coliform organisms of fecal origin. Total count of molds and yeasts, and Enumeration of mesophilic aerobic bacteria. As the data revealed, all samples contained high counts of the four microorganisms investigated, therefore demonstrating the deficient microbiological quality of the home-made cheese. On the basis of results obtained, a series of practical recommendations are suggested to improve the poor sanitary conditions under which they are now prepared.     

Bacteriological evaluation of goat milk and cheese distributed in the Metropolitan Area of San José, Costa Rica

In the last years, there has been an increase in the production, industrialization and consumption of goat's milk and derivate products, including cheese, worldwide. Nevertheless, in Costa Rica there is no study of these products, reason why the objective of this work was to determine the microbiological characteristics of goat's milk and fresh cheese distributed in the Metropolitan Area of San José, Costa Rica, in order to evaluate its impact in the economical field and as a potential risk for Public Health. A total of 25 raw goat's milk samples, obtained by manual milking from 5 different producers tested in five different dates and 15 cheese samples, elaborated with pasteurized milk, commercially available and coming from three different producers were analyzed. The study included the analysis of spoilage bacteria (total aeobic count and lactic bacteria count), indicators of hygiene (total coliforms), fecal contamination (fecal coliforms), manipulation (Staphylococcus aureus) and pathogens (Listeria monocytogenes and Salmonella spp). High results were obtained for the total aerobic count and lactic bacteria count of the milk and cheese samples, showing a reduced shelf life. Total coliforms, in limits beyond the established ones by the Costa Rican legislation for human consumption raw milk, were found in 100% of milk samples, as well as for fecal coliforms in 76% of them. All cheese samples, except one, were negative for these indicators, suggesting good manufacturing practices. S. aureus counts were low and both Salmonella spp. and L. monocytogenes were not isolated from samples analyzed.     

Development of an intermediate moisture food from bean (Phaseolus vulgaris L.)

Beans consumption has been associated to reduction on chronic, non transmissible, diseases development. Generally, its consumption is less to the recommended and it is done principally as whole grain dishes. To increase the consumption, there is an especial interest in the use of new products. The main goal of this research was to design intermediate moisture bean purees (IMP) using soaked, cooked and grained Tortola bean, removing an important testa portion. In preparation of IMP two moisture levels, 25 and 30%, and two glycerol levels, 10 and 15%, were studied. Purees were preserved at ambient temperature (20 +/- 2 degrees C) for 30 days. Proximal analysis, phytate content and trypsin inhibitors were determined in the original non processed purees. IMPs were analyzed at preparation time and after 15 and 30 days of storage for moisture content, pH and water activity. Besides, microbiological analysis for total plate count on aerobic mesophile microorganisms, molds and yeast, total colifoms, fecal coliforms and Staphylococcus aureus, was carried out. Global quality and sensory acceptance was also determined. IMPs presented a(w) values between 0.800 and 0.844, a pH between 6.20 and 6.24 and the microbiological counting was negative or far below the accepted limits for more strict foods. IMPs presented good qualifications for global quality and were well accepted. Sensory parameters maintain their values during storage, except for color that in treatment with 30% moisture and 10% glycerol showed a light darkening. It is possible to elaborate intermediate moisture bean puree, with low level of antinutritional compounds, good quality and sensory acceptance and with adverse conditions for the development of food safety importance microorganisms.