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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 To study the preparation process of Nao De Sheng injection and to conduct safety test. Methods The effects of different dosages of EDTA-2Na and activated carbon on the contents of five main active ingredients were investigated. The dosage of Nao De Sheng was prepared. The results showed that when the dosage of EDTA-2Na was 0.4 g L-1 and the amount of activated carbon was 0.5 g L-1, there was no significant decrease in the main active ingredients. The results of safety test showed that the preparations had low blood vessel irritation, no hemolysis and anaphylaxis. The LD50 of male mice were (542.6 ± 23.1) mg · kg-1, (549.9 ± 38.2) mg · kg-1, Mice were intraperitoneally injected with LD50, with the mean of (492.4 ± 27.3) mg · kg-1 and (564.8 ± 27.5) mg · kg-1 respectively. Conclusion trial of brain injection is safe and reliable.