Facultad de Ciencias Quimicas, Universidad Central del Ecuador, Quito, Ecuador.
Instituto de Investigacion en Salud Publica y Zoonosis, CIZ, Universidad Central del Ecuador, Quito, Ecuador.
Rev Peru Med Exp Salud Publica. 2020 Dec 2;37(3):431-437. doi: 10.17843/rpmesp.2020.373.4889.
To determine the microbiological quality of samples from processed natural products used for medicinal purposes and marketed in Quito, Ecuador.
Aerobic microorganisms, molds and yeasts were counted by conventional standardized techniques, according to the United States Pharmacopoeia (USP), in samples from 83 products. The microorganisms found were identified and their antimicrobial sensitivity was determined using the agar diffusion method.
The total aerobic microorganism count exceeded the specified limits in 17.0% of syrups, 27.0% of topical products and 43.0% of oral solids; the molds and yeasts count exceeded the limit in 33.0% of syrups, 7.0% of topical products and 36.0% of oral solids. Products for eye use did not pass the sterility test. The most frequently isolated bacterial genus was Bacillus, followed by Escherichia coli, Klebsiella and Enterobacter. Salmonella and Staphylococcus aureus were not found in any product, but potentially pathogenic microorganisms such as Pseudomonas were isolated in 40.0% of the eye drops. Enterobacter and Escherichia coli showed resistance to multiple compounds and Pseudomonas was not resistant to any antibiotic.
The microbiological quality of the products examined was not adequate. Potentially pathogenic and antibiotic resistant microorganisms were isolated from the samples. These products may not be suitable for distribution and consumption, even though many of them have sanitary registration. Control and regulation by the corresponding authorities is essential.
确定厄瓜多尔基多市用于药用的加工天然产品样本的微生物质量。
根据美国药典(USP),采用常规标准化技术对 83 种产品样本中的需氧微生物、霉菌和酵母菌进行计数。对发现的微生物进行鉴定,并采用琼脂扩散法测定其抗菌敏感性。
17.0%的糖浆、27.0%的局部用产品和 43.0%的口服固体制剂的总需氧微生物计数超过规定限度;33.0%的糖浆、7.0%的局部用产品和 36.0%的口服固体制剂的霉菌和酵母菌计数超过规定限度。用于眼部的产品未通过无菌试验。最常分离到的细菌属是芽孢杆菌,其次是大肠杆菌、克雷伯菌和肠杆菌。任何产品中均未发现沙门氏菌和金黄色葡萄球菌,但在 40.0%的滴眼剂中分离到了潜在的致病性微生物,如假单胞菌。肠杆菌和大肠杆菌对多种化合物具有耐药性,而假单胞菌对任何抗生素均无耐药性。
所检查的产品的微生物质量不合格。从样本中分离出了潜在的致病性和耐药性微生物。即使其中许多产品都有卫生注册,但这些产品可能不适合分销和消费。相应主管部门的控制和监管至关重要。