摘要
为研究右布洛芬脂肪乳注射液并建立分析方法,对右布洛芬原料药稳定性及原辅料相容性等进行研究以筛选处方。建立了一种反相高效液相色谱法,可测定右布洛芬含量及杂质。通过高温、高湿、强光照条件考察原料药及原辅料混合物的有关物质特性。制备含15羟基硬脂酸聚乙二醇酯(Kolliphor HS 15)不同浓度的右布洛芬脂肪乳注射液,考察剂型的质量。结果发现:线性范围为2.0~50.0μg/mL(R^2=0.9999);原料药对热不稳定,原辅料混合物有关物质均小于1.0%;含Kolliphor HS 150.5%的右布洛芬脂肪乳注射液溶液稳定,有关物质小于1.0%。本研究不仅建立了适用于右布洛芬测定的分析方法,还确认了右布洛芬与所选择辅料无配伍禁忌,筛选的处方可满足质量要求,为产品进一步研究提供了数据支持。
We aim to establish an analytical method and evaluate the stability of raw material and drug-excipient interactions for the development of dexibuprofen fat emulsion injection,to screen the formulation.We established a reverse phase high performance liquid chromatography(RP-HPLC)method,to test the assay and related substances of dexibuprofen.Meanwhile,we analyzed the related substances of raw material and drug-excipient interactions under the conditions of high temperature,high humidity and strong light.We also studied the quality of the dexibuprofen fat emulsion injection that was produced by different content of 15-hydroxy-stearic acid macrogol ester(Kolliphor HS 15).The linear range was 2.0-50.0μg/mL(R^2=0.9999).The raw material was sensitive to high temperature.The related substances from drug-excipient interactions were all below 1.0%.The dexibuprofen fat emulsion produced by the formulation of 0.5%Kolliphor HS 15 was uniform,and less than 1.0%impurity.We not only established a suitable analytical method for dexibuprofen,but also verified that there was no drug-excipient interactions between dexibuprofen and excipients,screened formulation that could meet the requirement.These data will support the further product development.
作者
钱一忖
曹青日
QIAN Yicun;CAO Qingri(College of Pharmaceutical Sciences,Soochow University,Suzhou 215123,China)
出处
《生物加工过程》
CAS
2020年第3期363-368,380,共7页
Chinese Journal of Bioprocess Engineering
