从非无菌的药物咳配方中分离的金黄色葡萄球菌分子遗传学和生物化学特征:对遗传多样性的洞察
Kajal Sharma1, Sonika Bakshi1, Paruv Sachdeva1
1Department of Allied Health Sciences, Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab, 140401, India.
咳糖中的细菌污染可能会带来风险. 虽然大多数样本符合质量标准,但有些样本显示出有关水平,强调需要严格的制造实践和持续的质量控制来确保产品安全.
科学领域:
- 微生物学 微生物学
- 制药品质量控制 制药品质量控制
- 细菌遗传学 细菌遗传学
背景情况:
- 非无菌的咳糖生产对用户和产品完整性构成风险.
- 细菌污染是制药制剂的一个重大问题.
- 确保口服液体药物的微生物质量对于公共卫生至关重要.
研究的目的:
- 评估来自印度旁遮普邦的咳糖样本的细菌质量.
- 为了识别和量化药品糖中的微生物污染物.
- 评估是否符合细菌负载的已确定的药典标准.
主要方法:
- 在2024年1月至6月期间收集了15个咳糖样本进行分析.
- 采用膜过 (0.45μm) 和各种亚格基媒介用于微生物隔离.
- 利用格拉姆染色,生物化学测试和16S-rRNA基因测序来进行隔离物识别.
主要成果:
- 73.33%的样本低于美国药典 (USP) 的限值 (<103 CFU/mL).
- 一个样本 (6.66%) 超过了USP限制,三个 (20%) 接近限制.
- 在一种超出USP标准的糖中鉴定出金黄色葡萄球菌;观察到高哈普洛型和核酸多样性.
结论:
- 大多数咳糖显示可接受的微生物质量.
- 受污染的样本表明制造过程中的潜在问题.
- 建议严格遵守良好的制造实践 (GMP) 和持续的质量监测.
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