A bioequivalence evaluation of long-chain triacylglycerol/medium-chain triacylglycerol emulsion in beagle dogs
10.3760/cma.j.issn.1674-635X.2017.06.001
- VernacularTitle:仿制物理混合中长链脂肪乳剂与原研药Beagle犬生物学一致性评价
- Author:
Mingwei ZHU
1
;
Zhuming JIANG
;
Jingsheng LIU
;
Dakui LI
;
Wei LIU
;
Danian TANG
;
Dan MEI
;
Xiaoxiao LI
;
Suodi ZHAI
;
Fang FANG
;
Junmin WEI
;
Jinduo CAO
Author Information
1. 100730,北京医院普外科
- Keywords:
Equivalence evaluation;
Fat emulsions,intravenous;
Long-chain triacylglycerol;
Medium-chain triacylglycerol;
Safety study
- From:
Chinese Journal of Clinical Nutrition
2017;25(6):329-334
- CountryChina
- Language:Chinese
-
Abstract:
Objective Long-chain triacylglycerol (LCT) by three producers,each mixed with the same medium-chain triacylglycerol (MCT),were compared with the brand MCT/LCT in causing focal necrosis of hepatocytes in beagle dogs (a bioequivalence evaluation).Methods 21 beagle dogs (male,0.7-1.5 years old,10-15 kg) were used in this study.According to the sources of the LCT,the animals were divided into Group A (LCT made in China),Group B (LCT made in Japan),Group C (LCT made in Germany),and the control group (the brand 10％ MCT/LCT).Central venous port was placed via the lumber vein of the animals under general anesthesia.After 2 weeks of rehabilitation,MCT/LCT was administered through this port for 28 days at 9 g/ (kg · d) [while the routine dose used clinically was 1 g/ (kg · d)].The laboratory indexes and the pathomorphism of the liver and kidney were studied single blindly.Results Laboratory tests,including liver and kidney function,blood coagulation function and lipid metabolism,did not identify differences among emulsions with different sources of LCT.Liver biopsy at day 28 showed no focal necrosis in Group C and the control group;there was minor damage in Group B;and Group A had obvious liver necrosis.and the pathological findings of other organs are similar.No significant difference was observed in biopsies of other organs.Conclusions Emulsions with different sources of LCT varied in their damage to the liver.Generics with LCT of higher quality were equivalent to the brand MCT/LCT in terms of safety.
