摘要
目的制备富马酸伊布利特注射液,建立有关物质和含量测定方法,并考察其稳定性和安全性。方法优化处方组成与制备工艺,采用高效液相色谱法测定有关物质和含量,影响因素试验、加速试验和长期试验考察其稳定性,血管刺激性试验、溶血性试验以及过敏性试验评价其用药的安全性。结果富马酸伊布利特检测浓度在4.2～20.1μg.mL-1线性关系良好(r=0.999 7),其平均回收率为99.9%,RSD为0.61%。恒温加速试验6个月和长期留样试验12个月,其性状、pH值、溶液颜色、有关物质、可见异物、含量等均未见明显改变。结论该制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。
Objective To prepare ibuitlide fumarate injection, establish an HPLC method to determine the content and relevant substances, and investigate its stability and safety. Methods Isotonic regulator dosage, pH value, and ster ilization temperature were determined to optimize the prescription and preparation technology. The content of ibuitlide fumarate and that of its relevant substances were determined by HPLC. Stress test, accelerated test, and long-term test were used to study its stability. The safety was evaluated by testing the vessel stimulation, haemolyticus, and hypersensitivity. Results The linear range of ibuitlide fumarate was 4. 2--20.1μg · mL 1 （r=0. 999 7）, and the average recovery was 99.9% with RSD of 0.61%. No obvious changes were observed after 6 months of accelerated test or 12 months of long-term storage test. Conclusion The preparation formulation is reasonable with simple and conven- lent preparation technique, accurate quality control, good stablility, and safe application.
出处
《中南药学》
CAS
2012年第2期110-113,共4页
Central South Pharmacy
