复合万科米辛化口服溶液稳定性的分析:使用商业产品制备的配方与使用纯活性成分制备的配方之间的比较
Jose David Arroyo-Solorzano1, Stefanny Martínez-Carpio1, Jeimy Blanco-Barrantes2
1Pharmacy Department, Hospital Clínica Bíblica, San José, CRI.
Cureus
|October 14, 2025
概括
复合口服万科米辛的稳定性可以延长到冷藏90天或室温30天. 缓冲对于保持功效和防止沉在这些C. difficile感染治疗中至关重要.
科学领域:
- 制药科学 制药科学
- 微生物学 微生物学
- 临床药房 临床药房
背景情况:
- 口服万科米辛是治疗困难杆菌感染的首要治疗方法.
- 目前的复合口服万科米辛溶液具有有限的14天的过期日期 (BUD).
- 延长BUD可以提高患者的便利性和药房的效率.
研究的目的:
- 评估和比较复合型万科米辛化口服溶液的物理化学和微生物稳定性.
- 为了评估从纯活性药物成分 (API) 制备的配方与商业注射产品之间的稳定性差异.
- 为了确定储存条件 (室温与冷藏) 对稳定性的影响.
主要方法:
- 使用USP简单糖制备了两种12.5 mg/mL的万科米辛化配方:一种来自纯的API (用酸缓冲),一种来自商业注射产品.
- 溶液在室温 (20°C) 或冷藏 (2-8°C) 的HDPE瓶中保存90天.
- 稳定性被评估使用HPLC用于强度,pH监测和USP<61>/<62>用于微生物学测试.
主要成果:
- 这两种配方在微生物学上稳定了90天,达到USP限制,没有检测到大肠杆菌.
- 冷藏的溶液保持了90天的功效和物理稳定性.
- 在室温下,API配方在60天后失去了>10%的功效;商用产品在90天后显示了>10%的降解和沉. 缓冲溶液保持pH值在USP规范范围内.
结论:
- 复合万科米辛化口服溶液在冷藏时最长90天,在室温储存时至少30天是稳定和安全的.
- 建议使用缓冲剂来维持pH值,防止降水,确保稳定性.
- 将BUD延长到冷藏90天或室温30天,可以支持灵活的配药,并优化药房的工作流程.
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