聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究

张广军; 林玲; 陈丽娜; 高保安; 陈建明

doi:10.3969/j.issn.1006-0111.2015.02.006

留言板

尊敬的读者、作者、审稿人, 关于本刊的投稿、审稿、编辑和出版的任何问题, 您可以本页添加留言。我们将尽快给您答复。谢谢您的支持!

姓名
邮箱
手机号码
标题
留言内容
验证码

x 关闭永久关闭

应中央军委要求，2022年9月起，《药学实践杂志》将更名为《药学实践与服务》，双月刊，正文96页；2023年1月起，拟出版月刊，正文64页，数据库收录情况与原《药学实践杂志》相同。欢迎作者踊跃投稿！

聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究

张广军, 林玲, 陈丽娜, 高保安, 陈建明

文章导航 > 药学实践与服务 > 2015 > 33(2): 119-121,175

张广军, 林玲, 陈丽娜, 高保安, 陈建明. 聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究[J]. 药学实践与服务, 2015, 33(2): 119-121,175. doi: 10.3969/j.issn.1006-0111.2015.02.006

引用本文:

ZHANG Guangjun, LIN Ling, CHEN Lina, GAO Baoan, CHEN Jianming. Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(2): 119-121,175. doi: 10.3969/j.issn.1006-0111.2015.02.006

Citation:

ZHANG Guangjun, LIN Ling, CHEN Lina, GAO Baoan, CHEN Jianming. Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(2): 119-121,175. doi: 10.3969/j.issn.1006-0111.2015.02.006

聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究

doi: 10.3969/j.issn.1006-0111.2015.02.006

1.
第二军医大学药剂学教研室, 上海 200433
2.
天士力帝益药业有限公司, 江苏淮安 223002
3.
第二军医大学药剂学教研室, 上海 200433;天士力帝益药业有限公司, 江苏淮安 223002

基金项目: 上海市纳米专项(12nm0501000)

Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions

1.
Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China
2.
Tasly pharmaceutical Co., Ltd, Huai'an 223002, China
3.
Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China;Tasly pharmaceutical Co., Ltd, Huai'an 223002, China

摘要: 目的建立多西他赛的含量测定方法;考察自制的聚乙二醇(PEG)400介导的多西他赛脂肪乳剂与市售的多西他赛注射液稀释液的稳定性。方法建立高效液相色谱法测定含量;在室温条件下采用膜过滤法, 以过滤液的含量、pH值以及过滤前的粒径为指标, 考察PEG400介导的多西他赛脂肪乳剂与市售的多西他赛注射液的稀释液随时间变化的稳定性。结果多西他赛在1~256μg/ml的浓度范围内线性关系良好, 回归方程:Y=21.199X+20.488, r=0.9999;自制PEG400介导的多西他赛脂肪乳剂分散液, 室温下24h内过滤液的含量、pH值以及过滤前的粒径均未见明显变化。观察市售多西他赛注射液的生理盐水稀释液, 2h发现有药物析出, 过滤液含量明显下降。结论自制PEG400介导的多西他赛脂肪乳剂的分散稳定性远优于市售多西他赛注射液的生理盐水稀释液, 大大提高了临床用药的安全性。
- 聚乙二醇400 /
- 多西他赛脂肪乳剂 /
- 多西他赛注射液 /
- 稀释稳定性
Abstract: Objective To establish HPLC method to detect docetaxel and compare the stability of a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel with docetaxel injection saline dilutions. Methods HPLC method was established to detect docetaxel concentration. The stability of a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel saline dilutions were investigated by drug concentration pH value and particle size using membranes filtration method. Results The linear range of docetaxel was 1256 μg/ml, regression equation was Y = 21.199 X + 20.488, r = 0.999 9. The drug concentration pH value and particle size of polyethylene glycol mediated lipid nanoemulsion of docetaxel was stable at room temperature in 24 hours. However the docetaxel injection saline dilutions was discovered drug precipitation in about two hours after preparation and the drug concentration was significant decreased in the filtration of docetaxel injection saline dilutions. Conclusion The novel polyethylene glycol mediated lipid nanoemulsion of docetaxel was a new stable docetaxel formulation and significantly increased the safety in clinical.
- polyethylene glycol /
- docetaxel /
- lipid nanoemulsion /
- saline dilutions

[1]	元英进,葛志强,冯霞.抗癌新药紫杉醇和多烯紫杉醇[M].北京:化学工业出版社,2002:5-10.
[2]	张先林.抗肿瘤药多西紫杉醇制剂的应用研究近况[J].药学进展,2006,30(11):516-517.
[3]	朱雷,沈琦.多西他赛注射液制备及质量控制[J].西北药学杂志,2010,25(2):121-123.
[4]	Baker SD, Zhao M, He P, et al. Simultaneous analysis of docetaxel and the formulation vehicle polysorbate 80 in human plasma by lipid chromatography/tandem mass spectrometry[J].Analyt Biochem,2004,324:276-284.
[5]	张晓庆,刘明忠,张利斌.注射用多西他赛与不同溶媒配伍稳定性的研究[J].药学服务与研究,2007,7(2):150-151.
[6]	Jing X, Deng L, Gao B,et al. A novel polyethylene glycol mediated lipid nanoemulsion as drug delivery carrier for paclitaxel[J/OL].Nanomedicine, (2013-08-20)[2013-11-26]. http://dx.doi.org/10.1016/j.nano.2013.07.018.
[7]	Han J,Davis SS,Papandreou C,et al.Design and evaluation of an emulsion vehicle for paclitaxel I physicochemical properties and plasma stability[J].Pharm Res,2004,21(9):1573-1580.

[1]	杨嘉宁, 赵一颖, 肖伟. 七味脂肝方对非酒精性脂肪性肝炎动物模型的药效学评价 . 药学实践与服务, 2024, 42(9): 389-398. doi: 10.12206/j.issn.2097-2024.202404096
[2]	孙丹倪, 黄勇, 张嘉宝, 王培. 代谢相关脂肪性肝病的无创诊断与药物治疗 . 药学实践与服务, 2024, 42(10): 411-418. doi: 10.12206/j.issn.2097-2024.202403049
[3]	迟文雅, 袁艳, 李伟林, 吴茼妤, 俞媛. 负载骨髓间充质干细胞/白藜芦醇脂质体的水凝胶支架用于创伤性脑损伤治疗 . 药学实践与服务, 2024, 42(): 1-8. doi: 10.12206/j.issn.2097-2024.202406034
[4]	张艺昕, 关欣怡, 王博宁, 闻俊, 洪战英. 二氢吡啶类钙离子拮抗药物手性分析及其立体选择性药动学研究进展 . 药学实践与服务, 2024, 42(8): 319-324. doi: 10.12206/j.issn.2097-2024.202308062
[5]	陈炳辰, 王思真, 郭贝贝, 杨峰. 紫杉醇棕榈酸酯的合成及其脂质体的制备与处方研究 . 药学实践与服务, 2024, 42(9): 379-384, 410. doi: 10.12206/j.issn.2097-2024.202404062
[6]	戴菲菲, 傅翔, 陈琼年, 俞苏纯. 上海某二级医院革兰阴性菌流行特征的回顾性分析 . 药学实践与服务, 2024, 42(): 1-5. doi: 10.12206/j.issn.2097-2024.202305005
[7]	崔亚玲, 吴琼, 马良煜, 胡北, 姚东, 许子华. 肝素钠肌醇烟酸酯乳膏中肌醇烟酸酯皮肤药动学研究 . 药学实践与服务, 2024, 42(): 1-5. doi: 10.12206/j.issn.2097-2024.202404006
[8]	舒飞, 孙蕊, 宋凯, 张元林, 闫家铭, 舒丽芯. 粉-液双室袋产品综合评估 . 药学实践与服务, 2024, 42(): 1-5. doi: 10.12206/j.issn.2097-2024.202312009
[9]	毛智毅, 王筱燕, 陈晓颖, 汤逸斐. 度拉糖肽联合二甲双胍对肥胖型2型糖尿病患者机体代谢、体脂成分及血清脂肪因子的影响 . 药学实践与服务, 2024, 42(7): 305-309. doi: 10.12206/j.issn.2097-2024.202305032
[10]	陈炳辰, 佟达丰, 万苗, 闫飞虎, 姚建忠. UPLC-MS/MS法测定小鼠血浆中紫杉醇脂肪酸酯前药及其药代动力学研究 . 药学实践与服务, 2024, 42(8): 341-345. doi: 10.12206/j.issn.2097-2024.202404082
[11]	李想, 陆鸿远, 张明玉, 高欢, 姚东, 许子华. 米格列醇激活UCP1介导棕色脂肪对冷暴露小鼠损伤的研究 . 药学实践与服务, 2024, 42(): 1-6. doi: 10.12206/j.issn.2097-2024.202404005
[12]	王鹏, 陈顺, 赵逸, 高守红, 王志鹏. 卡培他滨致小鼠手足综合征模型的建立及评价 . 药学实践与服务, 2024, 42(9): 385-388, 398. doi: 10.12206/j.issn.2097-2024.202308045
[13]	丁千雪, 尚圣兰, 余梦辰, 余爱荣. 机器学习在肾病综合征患者他克莫司个体化用药中的应用 . 药学实践与服务, 2024, 42(6): 227-230, 243. doi: 10.12206/j.issn.2097-2024.202310007
[14]	瞿文君, 白若楠, 崔力, 周琰. 基于联合库存的公立医院多院区药品采购模式分析 . 药学实践与服务, 2024, 42(7): 315-318. doi: 10.12206/j.issn.2097-2024.202401002
[15]	姚小静, 计佩影, 陆峰, 施国荣, 傅翔. 表面增强拉曼光谱法快速测定尿液中曲马多的研究 . 药学实践与服务, 2024, 42(): 1-5. doi: 10.12206/j.issn.2097-2024.202401072

点击查看大图

计量

文章访问数: 2793
HTML全文浏览量: 307
PDF下载量: 313
被引次数: 0

聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究

doi: 10.3969/j.issn.1006-0111.2015.02.006

1. 第二军医大学药剂学教研室, 上海 200433

2. 天士力帝益药业有限公司, 江苏淮安 223002

3. 第二军医大学药剂学教研室, 上海 200433;天士力帝益药业有限公司, 江苏淮安 223002

基金项目: 上海市纳米专项(12nm0501000)

收稿日期: 2013-11-26
修回日期: 2014-03-16

关键词:

摘要: 目的建立多西他赛的含量测定方法;考察自制的聚乙二醇(PEG)400介导的多西他赛脂肪乳剂与市售的多西他赛注射液稀释液的稳定性。方法建立高效液相色谱法测定含量;在室温条件下采用膜过滤法, 以过滤液的含量、pH值以及过滤前的粒径为指标, 考察PEG400介导的多西他赛脂肪乳剂与市售的多西他赛注射液的稀释液随时间变化的稳定性。结果多西他赛在1~256μg/ml的浓度范围内线性关系良好, 回归方程:Y=21.199X+20.488, r=0.9999;自制PEG400介导的多西他赛脂肪乳剂分散液, 室温下24h内过滤液的含量、pH值以及过滤前的粒径均未见明显变化。观察市售多西他赛注射液的生理盐水稀释液, 2h发现有药物析出, 过滤液含量明显下降。结论自制PEG400介导的多西他赛脂肪乳剂的分散稳定性远优于市售多西他赛注射液的生理盐水稀释液, 大大提高了临床用药的安全性。

English Abstract

Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions

1. Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China

2. Tasly pharmaceutical Co., Ltd, Huai'an 223002, China

3. Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China;Tasly pharmaceutical Co., Ltd, Huai'an 223002, China

Received Date: 2013-11-26
Rev Recd Date: 2014-03-16

Keywords:

Abstract: Objective To establish HPLC method to detect docetaxel and compare the stability of a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel with docetaxel injection saline dilutions. Methods HPLC method was established to detect docetaxel concentration. The stability of a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel saline dilutions were investigated by drug concentration pH value and particle size using membranes filtration method. Results The linear range of docetaxel was 1256 μg/ml, regression equation was Y = 21.199 X + 20.488, r = 0.999 9. The drug concentration pH value and particle size of polyethylene glycol mediated lipid nanoemulsion of docetaxel was stable at room temperature in 24 hours. However the docetaxel injection saline dilutions was discovered drug precipitation in about two hours after preparation and the drug concentration was significant decreased in the filtration of docetaxel injection saline dilutions. Conclusion The novel polyethylene glycol mediated lipid nanoemulsion of docetaxel was a new stable docetaxel formulation and significantly increased the safety in clinical.

引用本文:

Citation:

ZHANG Guangjun, LIN Ling, CHEN Lina, GAO Baoan, CHEN Jianming. Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(2): 119-121,175. doi: 10.3969/j.issn.1006-0111.2015.02.006

全文HTML

参考文献 (7)

下载: 全尺寸图片幻灯片

返回文章

用微信扫码二维码

分享至好友和朋友圈

主管、主办: 中国人民解放军海军军医大学地址: 上海市杨浦区国和路325号邮政编码: 200433

电话: （021）81871324,81871397 E-mail: yxsjzzs@163.com

网站备案号沪ICP备05003363号-1

本系统由北京仁和汇智信息技术有限公司开发

留言板

聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究

doi: 10.3969/j.issn.1006-0111.2015.02.006

Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions

计量

出版历程

聚乙二醇400 介导的多西他赛脂肪乳剂与多西他赛注射液的稀释稳定性研究

doi: 10.3969/j.issn.1006-0111.2015.02.006

1. 第二军医大学药剂学教研室, 上海 200433 2. 天士力帝益药业有限公司, 江苏 淮安 223002 3. 第二军医大学药剂学教研室, 上海 200433;天士力帝益药业有限公司, 江苏 淮安 223002

English Abstract

Stability comparison between a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel injection saline dilutions

1. Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China 2. Tasly pharmaceutical Co., Ltd, Huai'an 223002, China 3. Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China;Tasly pharmaceutical Co., Ltd, Huai'an 223002, China

全文HTML

目录

1. 第二军医大学药剂学教研室, 上海 200433

2. 天士力帝益药业有限公司, 江苏淮安 223002

3. 第二军医大学药剂学教研室, 上海 200433;天士力帝益药业有限公司, 江苏淮安 223002

1. Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China

2. Tasly pharmaceutical Co., Ltd, Huai'an 223002, China

3. Department of Pharmaceutics, Second Military Medical University, Shanghai 20043, China;Tasly pharmaceutical Co., Ltd, Huai'an 223002, China