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Sains Malaysiana 48(5)(2019): 1043–1054
http://dx.doi.org/10.17576/jsm-2019-4805-13
Superolein Based
Intravenous Lipid Emulsion 20% w/w Physicochemical Characterization,
Stability and Its Effect on Liver Status (Superolein berasaskan
Emulsi Lipid Intravena 20% w/w Pencirian Fizikokimia, Kestabilan
dan Kesannya pada Keadaan Hati) MOHD. HAZ
HAIRUL
AMRAN1,2,
MOHD.
FAIRUZ
DANIK1,
MOHD.
SHAKRIE
PALAN
ABDULLAH3,4,
MOHD.
HANIF
ZULFAKAR1
& AHMAD FUAD SHAMSUDDIN1,5* 1Centre for Drug Delivery
Research, Faculty of Pharmacy, Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory,
Malaysia 2Parenteral Nutrition
Unit, Department of Pharmacy, Hospital Kuala Lumpur, 50300 Kuala
Lumpur, Federal Territory, Malaysia 3Department of Pharmacy,
Faculty of Medicine, 50603 Kuala Lumpur, Federal Territory,
Malaysia 4Pharmacy Service
Division - Enforcement Pharmacy, Kelantan State Health Department,
Wisma Persekutuan Kota Bharu, Jalan Bayam, 15590 Kota Bharu,
Kelantan, Malaysia 5Faculty of Pharmacy
and Health Sciences, Universiti Kuala Lumpur Royal College of
Medicine, 30450 Ipoh, Perak Darul Ridzuan, Malaysia Received: 16 October
2018/Accepted: 25 March 2019 ABSTRACT Long chain triglycerides (LCT)
from soya oil have been reported to cause hepatic abnormalities
among patients receiving parenteral nutrition. A new source
for LCT is
needed to support current therapy. The aims of this study were
to develop a good and stable superolein oil based intravenous
lipid emulsion 20% (SoLE), and to determine its effect on liver
status of an animal model. The emulsion was prepared using superolein
oil and medium chain triglyceride oil (1:1), 1.2 g lecithin
and homogenized by high pressure homogenization method. The
physical stability study was performed based on real-time, accelerated,
force degradation and environmental degradation. Chemical stability
was measured based on fatty acids and vitamin E contents, peroxide
value and acidity value. As the animal model, three rabbits
were administered with 1.5 g/kg SoLE for 5 h and repeated daily
for three days. The SoLE was found to have good physicochemical
characters: 229.07±1.57 nm of particle size; 0.00% of particle
> 5 μm; 342.00±1.00 mOsm/kg of osmolarity; -46.67±4.40
mV of zeta potential; 1.72±0.04 cP of viscosity; 7.83±0.06 of
pH; 0.80±0.06 kcal/g calorie; 1.74±0.05 mEqO2/kg of peroxide value; and 0.03±0.01%
of acidity value, and excellent physicochemical stabilities
for up to six months of storage at various temperatures and
conditions. The level of plasma lipid and plasma liver enzymes
profiles of the rabbits remained statistically unchanged. This
study has successfully developed a stable SoLE 20% and it was
found to be safe to the liver of the animal model. Keywords: Animal model; intravenous
lipid emulsion; physicochemical; stability; superolein oil ABSTRAK Trigliserida rantaian panjang
(LCT)
daripada minyak kacang soya telah dilapor menyebabkan keabnormalan
hepatik dalam kalangan pesakit yang menerima nutrisi parenteral.
Sumber baharu untuk LCT
diperlukan bagi menyokong terapi semasa. Tujuan
kajian ini adalah untuk membangunkan emulsi lipid intravena
20% (SoLE) berasaskan minyak superolein yang baik dan stabil
dan menentukan kesannya terhadap status hati model haiwan. Emulsi
telah disediakan dengan menggunakan minyak superolein dan minyak
trigliserida rantaian sederhana (1: 1), 1.2 g lesitin dan dihomogenkan
dengan kaedah penghomogenan tekanan tinggi. Kajian kestabilan
fizikal dijalankan berdasarkan masa sebenar, dipercepat, degradasi
paksa dan degradasi persekitaran. Kestabilan kimia dihitung
berdasarkan kandungan asid lemak, kandungan vitamin E, nilai
peroksida dan nilai keasidan. Sebagai model haiwan, tiga ekor
arnab diberikan 1.5 g/kg SoLE selama 5 jam dan diulang setiap
hari selama tiga hari. SoLE didapati mempunyai sifat fizikokimia
yang baik iaitu 229.07±1.57 nm saiz zarah, 0.00% zarah bersaiz
melebihi 5 μm, 342.00±1.00 mOsm/kg osmolariti, -46.67±4.40
mV potensi zeta, 1.7 ±0.04 cP kelikatan, 7.83±0.06 pH, 0.80±0.06
kcal/g kalori, 1.74±0.05 mEqO2/kg nilai peroksida dan 0.03±0.01%
nilai keasidan serta kestabilan fizikokimia pula adalah cemerlang
sehingga enam bulan penyimpanan pada pelbagai suhu dan keadaan.
Tahap profil lipid plasma dan enzim hati plasma haiwan yang
dikaji kekal tidak berubah secara statistik. Kajian ini telah
berjaya membangunkan SoLE 20% yang stabil dan selamat kepada
hati model haiwan. Kata kunci: Emulsi lipid intravena; kestabilan fizikokimia; minyak
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