利福昔明口服混悬剂的稳定性。

Department of Clinical Sciences, College of Pharmacy, University of Michigan Hospitals and Health Centers, 1500 East Medical Center Drive, Ann Arbor, MI 48105-5247, USA.

Am J Health Syst Pharm. 2010 Feb 15;67(4):287-9. doi: 10.2146/ajhp090206.

PURPOSE

The stability of extemporaneously prepared rifaximin oral suspensions was studied.

METHODS

An oral suspension of rifaximin 20 mg/mL was prepared by thoroughly grinding six 200-mg tablets of rifaximin in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 15, 30, and 60 days. After further dilution to an expected concentration of 20 microg/mL with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and pH was tested on each day of analysis. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point and defined as retention of at least 90% of the initial concentration of rifaximin.

RESULTS

At least 99% of the initial rifaximin remained throughout the 60-day study period in both preparations. There were no detectable changes in color, odor, taste, or pH and no visible microbial growth in any sample.

CONCLUSION

Extemporaneously prepared suspensions of rifaximin 20 mg/mL in 1:1 mixtures of Ora-Plus with either Ora-Sweet or Ora-Sweet SF were stable for at least 60 days when stored in 2-oz amber plastic bottles at room temperature.

目的

研究了利福昔明口服混悬剂的稳定性。

方法

将 6 片 200mg 的利福昔明片剂在玻璃研钵中充分研磨，制成 20mg/mL 的利福昔明口服混悬剂。将 30 毫升 Ora-Plus 和 30 毫升 Ora-Sweet 或 Ora-Sweet SF 混合，加入粉末中，使最终体积为 60 毫升。每种制剂制备 3 个相同的样品，放入 2 盎司琥珀色塑料瓶中，并配有儿童安全盖，在室温（23-25°C）下储存。在制备后立即和 7、15、30 和 60 天时，用微量移液器从每个瓶子中取出 1 毫升样品。进一步用流动相稀释至预期浓度 20μg/mL 后，使用稳定性指示高效液相色谱法对样品进行重复检测。目视检查样品是否有任何颜色变化，并在分析的每一天测试 pH 值。稳定性通过评估每个时间点剩余初始浓度的百分比来确定，并定义为保留至少 90%的初始利福昔明浓度。