4种中药注射剂大分子富集液的重复给药毒性实验研究

Repeated Dose Toxicity of Four Traditional Chinese Medicine Injections Rich in Macromolecules

目的以清开灵、丹参、双黄连、灯盏细辛4种注射液的大分子富集液为研究对象,以发现中药注剂大分子物质的潜在毒性。方法采用分子筛将注射剂原液制备成10K大分子富集液。家兔随机分为空白对照组、原液组、大分子富集液组,用红外耳温仪每天测量静脉给药前和给药后2h耳温,称量体重变化,连续观察5d。将动物进行取血液检测血常规、血生化、体温、体重,其中3只处死检测脏器系数并进行病理切片;余下动物停药继续观察5d。结果给药5d,大分子富集液组动物的体重下降;白细胞、粒细胞、血小板和血生化指标(GPT和GOP)都有不同程度的升高;体温有不同程度的升高;对家兔肝肾组织均有不同程度的损害。停药5d有一定程度的恢复。结论中药注射液中的大分子物质对家兔具有一定的肝肾毒性。

Objective Four kinds of Traditional Chinese Medicine Injections （TCMIs） including Qingkailing, Danshen, Shuanghuanglian, D engzhanxixin rich in macromolecules were investigated to find their potential toxicity, and to prove that macromolecular substances was one of the most important causes. Methods Four injections rich in macromolecules（ ＇1 0 k） were prepared with molecular sieves. Rabbits were randomly divided into blank control group, original injection group, and injection rich in macromolecule group. Rabbits’ temperature was recoded with an ultra-red ear thermometer, and their weight was also measured, before and 2 hours after intravenous administration every day. Intravenous administration was arranged once a day for 5 days. Then, 3 animals in every group were sacrificed, and their blood and organs were collected. Routine blood test, blood biochemistry assay, organ coefficient, body temperature, weight, and pathological investigation were made. The remaining animals without administration were used to observe recovery for additional 5 days. Results The results of blood tests showed that, in injections rich in macromolecules groups administrated for 5 days, some values of blood routine test （white blood cell, granulocyte, and platelet） and blood biochemical assay （GPT and GOP） increased to some extent; rabbit ’ s weight decreased; body temperature increased; some injuries were found in liver and kidney tissue. However, the abnormal value or injueries recovered to some textent. Conclusion The results suggested that, macromolecular substances were harmful for liver and kidney function in rabbit.