|本期目录/Table of Contents|

[1]钱一忖,曹青日.右布洛芬脂肪乳注射液的分析方法及处方筛选[J].生物加工过程,2020,18(03):363-368.[doi:10.3969/j.issn.1672-3678.2020.03.014]
 QIAN Yicun,CAO Qingri.Analytical method and formulation screening of dexibuprofen fat emulsion injection[J].Chinese Journal of Bioprocess Engineering,2020,18(03):363-368.[doi:10.3969/j.issn.1672-3678.2020.03.014]
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右布洛芬脂肪乳注射液的分析方法及处方筛选()
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《生物加工过程》[ISSN:1672-3678/CN:32-1706/Q]

卷:
18
期数:
2020年03期
页码:
363-368
栏目:
出版日期:
2020-05-30

文章信息/Info

Title:
Analytical method and formulation screening of dexibuprofen fat emulsion injection
文章编号:
1672-3678(2020)03-0363-06
作者:
钱一忖曹青日
(苏州大学 药学院,江苏 苏州 215123)
Author(s):
QIAN Yicun CAO Qingri
(College of Pharmaceutical Sciences, Soochow University, Suzhou 215123,China)
关键词:
右布洛芬脂肪乳注射液反相高效液相色谱Kolliphor HS 15稳定性原辅料相容性处方筛选
分类号:
TQ460.6;R971+.1【additional_page=380】
DOI:
10.3969/j.issn.1672-3678.2020.03.014
文献标志码:
A
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2.0~50.0 μg/mL(R2=0.999 9); 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 15 0.5%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。
Abstract:
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 2.0-50.0 μg/mL(R2=0.999 9).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.

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相似文献/References:

[1]钱一忖,曹青日.右布洛芬脂肪乳注射液的分析方法及处方筛选[J].生物加工过程,2020,18(03):363.[doi:10.3969/j.issn.1672-3678.2020.03.014]
 QIAN Yicun,CAO Qingri.Analytical method and formulation screening of dexibuprofen fat emulsion injection[J].Chinese Journal of Bioprocess Engineering,2020,18(03):363.[doi:10.3969/j.issn.1672-3678.2020.03.014]

备注/Memo

备注/Memo:
收稿日期:2019-08-21修回日期:2019-09-18
作者简介:钱一忖(1980—),男,江苏张家港人,硕士,研究方向:药物新剂型; 曹青日(联系人),副教授,E-mail:qrcao@suda.edu.cn
引文格式:钱一忖,曹青日.右布洛芬脂肪乳注射液的分析方法及处方筛选[J].生物加工过程,2020,18(3):363-368.
QIAN Yicun,CAO Qingri.Analytical method and formulation screening of dexibuprofen fat emulsion injection[J].Chin J Bioprocess Eng,2020,18(3):363-368..
更新日期/Last Update: 2020-03-30