4种去大分子中药注射剂的稳定性研究

Stability of Traditional Chinese Medicine Injection Was Improved by Removing Macromolecules

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10m L 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0.5m L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。

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 maeromolecules 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~C 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.SmL 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 macromoleeules trapped on the sieve was much less. Conclusion The stability of the TCMI free of macromoleeules is better than that of the original one.