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|本期目录/Table of Contents|

4种去大分子中药注射剂的稳定性研究(PDF)

《云南中医学院学报》[ISSN:1000-2723/CN:53-1048/R]

期数:
2016年04期
页码:
20-25
栏目:
方药研究
出版日期:
2016-08-01

文章信息/Info

Title:
Stability of Traditional Chinese Medicine Injection Was Improved by Removing Macromolecules
作者:
云宇12侯肖霖1殷华1柯瑾1段为钢1
1. 云南中医学院,云南 昆明 650500;2. 昆明医科大学,云南 昆明 650500
Author(s):
YUN Yu12 HOU Xiaolin1 YIN Hua1 KE Jin1 DUAN Weigang1
1. Yunnan University of Traditional Chinese Medicine, Kunming 650500, China;2. Kunming Medical University, Kunming 650500, China
关键词:
中药注射剂 大分子物质 稳定性 澄明度 吸收光谱
Keywords:
traditional Chinese medicine injection macromolecules stability clarity absorption spectrum
分类号:
R286
DOI:
10.19288/j.cnki.issn.1000-2723.2016.04.005
文献标识码:
A
摘要:
目的观察中药注射剂去大分子物质后,澄明度方面的稳定性能否明显提高。方法用不同孔径(3k、10k、30k)分子筛去除4种上市中药注射剂(清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液)大分子物质分别制备不同的去大分子中药注射液。检查各去大分子注射液蛋白质和缩合鞣质杂质后,分别取10mL 4种去大分子注射液和原液于60℃恒温放置30d,动态观察其颜色变化,以可见波长(400~800nm)吸收曲线下面积反映综合颜色变化。第30天取0.5mL用30k超滤膜截留沉淀,拍照观察。结果去大分子注射液的蛋白质和缩合鞣质杂质明显减少,4种不同条件去大分子中药注射剂的颜色明显浅于相应的原液,在30d 60℃恒温条件下其变色程度均较原液浅,产生的沉淀明显较原液少。结论去除大分子物质后,这4种中药注射剂的稳定性得到明显改善。
Abstract:
Objective To observe stability of Traditional Chinese Medicine Injection(TCMI) when the macromolecular substances were removed. Methods Four TCMIs(Qingkailing Injection, Shuanghuanlian Injection, Danshen Injection and Dengzhanxixin Injection) approved by China Food and Drug Administration(CFDA) were introduced in the study. Protein and condensed tannin in the macromolecule-free injections were tested. The macromolecular substances were removed with molecular sieves of different pores(3k, 10k, and 30k), and different TCMIs free of macromolecules were obtained. Ten milliliter of samples including different TCMIs free of macromolecules and the original TCMIs was added into tubes with lids and kept at 60℃ for 30 days. The visible absorption spectrum of the sample was scanned with a multi-plate reader(from 400-800nm), and the area under the spectrum was calculated to valuate its clarity. On the 30th day, 0.5mL sample was drawn, and the macromolecular substances and precipitation were trapped on a sieve(30 k). Results The macromolecule-free injections contained less protein and condensed tannin. The color of TCMI free of macromolecules was much lighter than that of the original one, the clarity of TCMI free of macromolecules was better than that of the original one also during the 30 days, and precipitation in the TCMI free of macromolecules trapped on the sieve was much less. Conclusion The stability of the TCMI free of macromolecules is better than that of the original one.

参考文献/References

[1] 柯瑾,张陆勇,殷华,等. 大分子物质对中药注射剂的安全性影响[J]. 中成药,2014,36(4):855-859.
[2] 段为钢,张陆勇. 提高中药注射剂安全性的技术策略[J]. 中成药,2012,34(11):2201-2205.
[3] 王萌,任晓亮,刘虹. 中药注射剂稳定性研究进展[J]. 辽宁中医杂志,2014,41(6):1294-1297.
[4] 黄江虹. 影响中药注射剂稳定性的相关因素研究[J]. 时珍国医国药,2007,18(5):1271-1272.
[5] 段为钢,李奇峰,柯瑾. 中药注射剂有效性及“毒性”的物质基础分析[J]. 医学与哲学(临床决策论坛版),2011,32(8):56-57,60.
[6] 段为钢. 中药注射剂安全性的技术思考[J]. 云南中医学院学报,2009,32(6):12-13.
[7] 段为钢,柯瑾,李奇峰,等. 蛋白质包被PVDF膜吸附法检查中药注射剂缩合鞣质[J]. 中成药,2011,33(11):1916-1919.
[8] Duan W.,Li Q.,Ke J. Detection of Trace Protein in Chinese Materia Medica Injections by Use of Polyvinylidene Fluoride Membrane[J]. Conference on Environmental Pollution and Public Health(CEPPH2011),2011:19-21.
[9] 任永申,张萍,杜晓曦,等. 基于HPLC指纹图谱的茵栀黄注射液质量一致性和稳定性研究[J]. 中草药,2008,39(6):837-841.
[10] 方兴华,沈伟群. 应重视中药注射剂的澄明度质量[J]. 中国药业,1999,8(3):28-29.
[11] 聂宗生. 中药注射剂澄明度的影响因素分析及对策[J]. 中国医药指南,2013,11(14):666-667.
[12] 胥勤,余建军,熊晓明,等. 不同增溶剂的参麦注射液稳定性考察[J]. 中国实验方剂学杂志,2014,20(14):30-33.

备注/Memo

备注/Memo:
* 基金项目: 国家自然科学基金(81160495,81560645) 收稿日期: 2016 - 06 - 28 作者简介: 云宇(1978-),女,海南文昌人,副教授,医学博士,主要从事药理学研究。△通信作者:段为钢,E-mail:deardwg@126.com
更新日期/Last Update: 2016-07-20