脑得生注射液的研制及安全性试验

Preparation of naodesheng injection and its safety test

目的研究脑得生注射液的制备工艺,并进行安全性试验。方法考察不同用量的EDTA-2Na和活性炭对5种主要药效成分含量的影响,确定其用量,制备脑得生注射液。结果经测定,当EDTA-2Na的用量为0.4 g L-1、活性炭的用量为0.5 g L-1时,各主要药效成分无显著下降。安全性试验结果表明本制剂血管刺激性小、无溶血和过敏反应,小鼠静脉注射LD50雄、雌分别为(542.6±23.1)mg·kg-1、(549.9±38.2)mg·kg-1,小鼠腹腔注射LD50雄、雌分别为(492.4±27.3)mg·kg-1、(564.8±27.5)mg·kg-1。结论试制的脑得生注射液安全、可靠。

Objective Prepare naodesheng injection(NDSI) and do its safety test. Methods Study different amounts of EDTA-2Na and active carbon for the influence of five effective components to confirm their amounts to prepare naodesheng injection. Results When amounts of EDTA-2Na and active carbon were respectively 0.04% and 0.05%,the contents of five effective components had no remarkably drop. The results of the safety test indicated the naodesheng injection had no allergy effect and hemolysis phenomenon and significant stimulation effect on vessel. The intravenous LD50in male and female mice were(542.6±23.1) mg·kg-1and(549.9±38.2) mg·kg-1,respectively. The intraperitoneal LD50in male and female mice were 492.4±27.3mg·kg-1and 564.8±27.5mg·kg-1,respectively. Conclusions Under this test's condition,naodesheng injection is safe and stable.