Jazmati Fatema Nour, Trefi Saleh, Ibrahim Ali, Bitar Yaser
Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, University of Aleppo, Aleppo, Syria.
Biochemistry and Microbiology Department, Faculty of Pharmacy, University of Aleppo, Aleppo, Syria.
Heliyon. 2022 May 6;8(5):e09366. doi: 10.1016/j.heliyon.2022.e09366. eCollection 2022 May.
Microbial contamination of syrups can bring clinical hazards to patients as well as physical and chemical changes in the product.
Studying the influence of the war on the Syrian pharmaceutical industry from a microbiological point of view by assessing the microbiological quality of syrup samples taken from Syrian pharmacies.
Fifty different syrups from 29 different companies having various manufacture dates were collected during validity period between 9-2019 and 6-2021 in Aleppo, Syria. Membrane filtration technique was performed to quantify microbial contamination of the collected syrup samples. This involved passing the samples through filter nitrocellulose membrane disks with a pore size of 0.45 μm then transferring the filter disks alongside any collected microorganisms into Tryptone Soya Agar, Sabouraud Dextrose agar, Xylose lysine Deoxycholate agar and Eosin Methylene Blue agar plates. Colonies observed on these plates were counted and the number of viable microbes in the original sample was expressed as colony forming units per milliliter (CFU/mL). Investigation of in all syrup samples and Salmonella in herbal syrup samples was also performed.
This study revealed that 28 syrups (56%) had no growth of either bacterial or fungal colonies; 33 syrups (66%) had no growth of bacterial colonies; 43 syrups (86%) had no growth of fungal colonies. On the other hand, 7 syrups (14%) exceeded the pharmacopoeial limit for bacterial growth and 6 syrups (12%) exceeded that for fungal growth. Furthermore, 5 syrup samples (10%) were on the high permissible limits for bacterial contamination and none for fungal contamination.All syrups were free from and all herbal syrups were free from . Taken together, out of the fifty syrups examined 13 syrups (26%) exceeded the pharmacopoeial limits and therefore pharmacopoeial accepted syrups constitute a percentage of (74%).
Although the majority of samples tested showed compliance with the pharmacopoeial limits of microbiological contamination, the small proportion of syrups in the Syrian market exceeding the pharmacopoeial limit is still concerning and reveals the implications of post-war conditions on the quality of manufacturing in the Syrian pharmaceutical industry. That said, it remained within the proper limits compared to studies conducted in other countries in similar situations.This study, therefore, highlights the need to apply the Good Manufacturing Practice (GMP) rules more strictly in order to limit microbiological contamination in pharmaceutical syrups to ensure the quality of products and safety of users. We suggest that further quality control studies are conducted on a larger scale and repeated more frequently.
糖浆的微生物污染会给患者带来临床危害，并导致产品发生物理和化学变化。
从微生物学角度研究战争对叙利亚制药行业的影响，通过评估从叙利亚药店采集的糖浆样本的微生物质量来进行研究。
在2019年9月至2021年6月的有效期内，于叙利亚阿勒颇收集了来自29家不同公司、生产日期各异的50种不同糖浆。采用膜过滤技术对采集的糖浆样本中的微生物污染进行定量。这包括将样本通过孔径为0.45μm的硝酸纤维素滤膜，然后将滤膜连同所收集的任何微生物一起转移到胰蛋白胨大豆琼脂、沙氏葡萄糖琼脂、木糖赖氨酸脱氧胆酸盐琼脂和伊红美蓝琼脂平板上。对这些平板上观察到的菌落进行计数，原始样本中活微生物的数量以每毫升菌落形成单位（CFU/mL）表示。还对所有糖浆样本中的 以及草药糖浆样本中的沙门氏菌进行了检测。
本研究表明，28种糖浆（56%）未出现细菌或真菌菌落生长；33种糖浆（66%）未出现细菌菌落生长；43种糖浆（86%）未出现真菌菌落生长。另一方面，7种糖浆（14%）细菌生长超过药典限量，6种糖浆（12%）真菌生长超过药典限量。此外，5个糖浆样本（10%）细菌污染处于高允许限度，真菌污染则无。所有糖浆均未检出 ，所有草药糖浆均未检出 。综合来看，在所检测的50种糖浆中，13种糖浆（26%）超过药典限量，因此药典认可的糖浆占比为（74%）。
尽管大多数测试样本显示符合微生物污染的药典限量，但叙利亚市场上超出药典限量的一小部分糖浆仍令人担忧，这揭示了战后状况对叙利亚制药行业生产质量的影响。也就是说，与其他国家在类似情况下进行的研究相比，其仍处于适当范围内。因此，本研究强调需要更严格地应用良好生产规范（GMP）规则，以限制药用糖浆中的微生物污染，确保产品质量和用户安全。我们建议进行更大规模且更频繁重复的进一步质量控制研究。
