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一项关于通过自动注射器给药的丁丙诺啡与手动注射给药相比,利用大鼠血液学和生化指标进行安全性评估的研究。

A study on the safety evaluation of buphrenorphine administered through an autoinjector compared with manual injection using haematological and biochemical variables in rats.

作者信息

Sheela D, Vijayaraghavan R, Senthilkumar S

机构信息

Saveetha Medical College and Hospital, Saveetha University, Chennai, Tamil Nadu, India.

出版信息

Hum Exp Toxicol. 2017 Sep;36(9):901-909. doi: 10.1177/0960327116674528. Epub 2016 Oct 20.

Abstract

Buprenorphine drug cartridge was made for autoinjector device for use in emergency and critical situations to reduce the morbidity and mortality. Water-filled cartridges were prepared and buprenorphine was injected aseptically in the cartridge, to make 0.05 and 0.10 mg/mL. Rats were injected intraperitoneally, buprenorphine (0.3 and 0.6 mg/kg), repeatedly with the autoinjector and compared with manual injection (7 days and 14 days) using various haematological and biochemical parameters. No significant change was observed in the body weight, organ to body weight ratio and haematological variables in any of the experimental groups compared with the control group. Except serum urea and aspartate aminotransferase, no significant change was observed in glucose, cholesterol, triglycerides, bilirubin, protein, albumin, creatinine, uric acid, alanine aminotransferase, gamma glutamyltransferase and alkaline phosphatase. The autoinjectors deliver the drugs with spray effect and force for faster absorption. In the present study, the autoinjector meant for intramuscular injection was injected intraperitoneally in rats, and the drug was delivered with force on the vital organs. No significant difference was observed in the autoinjector group compared to the manual group showing tolerability and safety of the buphrenorphine autoinjector. This study shows that buprenorphine autoinjector can be considered for further research work.

摘要

丁丙诺啡药筒是为自动注射器装置制造的,用于紧急和危急情况,以降低发病率和死亡率。制备了充水药筒,并将丁丙诺啡无菌注入药筒中,制成0.05和0.10mg/mL的溶液。使用自动注射器对大鼠腹腔注射丁丙诺啡(0.3和0.6mg/kg),并重复注射,同时与手动注射组(7天和14天)进行比较,采用各种血液学和生化参数。与对照组相比,任何实验组的体重、器官与体重比和血液学变量均未观察到显著变化。除血清尿素和天冬氨酸转氨酶外,葡萄糖、胆固醇、甘油三酯、胆红素、蛋白质、白蛋白、肌酐、尿酸、丙氨酸转氨酶、γ-谷氨酰转移酶和碱性磷酸酶均未观察到显著变化。自动注射器以喷雾效果和压力给药,以促进更快吸收。在本研究中,将用于肌肉注射的自动注射器腹腔注射到大鼠体内,药物以压力作用于重要器官。与手动注射组相比,自动注射器组未观察到显著差异,表明丁丙诺啡自动注射器具有耐受性和安全性。本研究表明,丁丙诺啡自动注射器可考虑用于进一步的研究工作。

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