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Objective To establish a method to quantify serum fat-soluble vitamins by liquid chromatography-tandem mass spectrome-try and evaluate their performance in preliminary clinical application.Methods The contents of fat-soluble vitamin in serum were quantified by liquid chromatography-tandem mass spectrometry.The samples were collected from 1 113 pregnant women from November 2022 to November 2023 at the Obstetrics Clinic of the First Affiliated Hospital of Soochow University.The method of liquid chromatog-raphy-tandem mass spectrometry for determination of fat-soluble vitamins in serum was validated referring to"Consensus of method de-velopment and validation of liquid chromatography-tandem mass spectrometry in clinical laboratories".Results The linear ranges of vitamin A,E,D2,D3 and K1 in serum were from 40 to 4 000 ng/mL,0.5 to 50 μg/mL,2 to 200 ng/mL,5 to 250 ng/mL and 0.1 to 10 ng/mL,respectively.The detectable limit was 2.50 ng/mL,0.10 ng/mL,0.40 ng/mL,1.00 ng/mL and 0.02 ng/mL,respec-tively.The limit of quantitation was 10.00 ng/mL,0.50 ng/mL,1.00 ng/mL,5.00 ng/mL and 0.10 ng/mL,respectively.The intra-batch coefficient of variation(CV)and inter-batch CV were all less than 15％.The rate of recovery was 91.25％to 107.18％,90.00％to 105.51％,92.88％to 107.87％,93.36％to 107.40％and 90.20％to 104.40％,respectively.The various fat-soluble vitamins in ser-um remained stable within 7 days under-20 ℃.The levels of fat-soluble vitamins in serum of pregnant women were detected by liquid chromatography-tandem mass spectrometry.There were significant differences of the levels and distributions for various fat-soluble vita-mins in the pregnant women in different age groups(P＜0.05),and the levels of fat-soluble vitamins gradually increased with the age.Conclusion The basic performance of the liquid chromatography-tandem mass spectrometry verified in this experiment was in line with the evaluation criteria,thus it should be highly sensitive and accurate for analyzing the contents of various fat-soluble vitamins in serum.
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OBJECTIVE: To analyze the levels of homocysteine, 9 kinds of vitamins including folic acid in patients with type 2 diabetes mellitus, so as to provide basis for the early detection and intervention of diabetic nephropathy. METHODSE: A total of 416 patients with type 2 diabetes were divided into nephrotic group and non-nephrotic groups, and subjects were included in the same period of physical examination as the physical examination group. The elderly physical examination group was selected by age. The serum homocysteine (Hcy), folic acid and vitamin (Vit) A, D, E, B1, B2, B6, B12 and C levels of all subjects were collected retrospectively. Differences between different groups were analyzed by ANOVA, and Pearson correlation analysis was used to analyze the correlation between different index levels and GFR or ACR. RESULTS: The levels of folic acid, and Vit D, B1, B2, B12 and C in the disease groups were significantly different from those in the physical examination group, but only Vit D levels decreased and Vit B12 levels increased comparing with those in the elderly physical examination group (P<0.05). There were differences in Hcy, and Vit A, D, E and B6 levels between nephrotic group and non-nephrotic group (P<0.05). The changes of these indexes may be related to the occurrence of nephrosis, but the influence of age cannot be excluded. Hcy, Vit A and D levels were significantly correlated with GFR and ACR (P<0.01). CONCLUSION: Hcy is related to the occurrence of nephropathy, which may be a reference index for early detection of diabetic nephropathy. Folic acid, Vit B2, B6, B12, C and other water-soluble vitamins have been taken as supplymentin diabetic patients. Fat soluble such as Vit A, D, and E also related to the occurrence of nephropathy in varying degrees, and the supplement of these vitamins may benefit.
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OBJECTIVE:To investigate the compatibility stability of Fat-soluble vitamin (Ⅱ)/Water-soluble vitamin for in-jection with common electrolytes. METHODS:Referring to clinical common dose,Fat-soluble vitamin (Ⅱ) for injection/Wa-ter-soluble vitamin for injection collective packing [containing Fat-soluble vitamin(Ⅱ) for injection 2 ampoules and Water-soluble for injection 1 ampoule] were respectively mixed with Glucose injection,Potassium chloride injection,Concentrated sodium chlo-ride injection,Sodium bicarbonate injection,Potassium aspartate injection,Potassium aspartate and magnesium aspartate injection, Sodium glycerophosphate injection,Multi-trace elements injection (Ⅱ) to obtain mixture A-H. At room temperature (25 ℃),these mixtures were investigated in terms of appearance,pH value,osmotic pressure molar concentration and the number of insolu-ble particles at 0,1,2,3,4 h. The contents of bacterial endotoxin were tested at 0,4 h. RESULTS:Within 4 h after mixing, there was no significant change in appearance of those mixtures;pH value of mixture H changed greatly (RSD=5.13%,n=5), and that of mixture D and G increased significantly. The osmotic pressure molar concentration of those mixtures had no significantly change(RSD<2%,n=5)and lower than 600 mOsmol/kg. The bacterial endotoxin tests of those mixtures were negative. Two and four hours after mixing,the number of insoluble particles ≥10 μm in mixture B was increased significantly;2,3,4 h after mix-ing,the number of insoluble particles ≥10 μm in mixture E,F,H were increased significantly;0 ,1,2,3,4 h after mixing,the number of insoluble particles ≥10 μm in mixture G was increased significantly. There was statistical significance in the number of insoluble particle ≥10 μm in above mixtures compared to mixture A at the same time point(P<0.05),but it was in line with the standard of 2015 pharmacopeia. One,two,three and four hours after mixing,the number of insoluble particle ≥10 μm in mixture D was increased significantly,there was statistical significance compared to mixture A at the same time point(P<0.05);the num-ber of insoluble particle ≥10 μm in mixture D was beyond prescribed scope of pharmacopeia at 2,3,4 h after mixing. Within 4 h after mixing,both the number of insoluble particle ≥10 μm in mixture C and the number of insoluble particle ≥25 μm in edch mixture had no significant change,in accordance with pharmacopeia standard. CONCLUSIONS:Fat-soluble vitamin (Ⅱ)/Wa-ter-soluble vitamin for injection is not suitable for mixing with Multi-trace elements injection(Ⅱ),Sodium glycerophosphate injec-tion or Sodium bicarbonate injection due to great change of pH value and the number of insoluble particles.
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OBJECTIVE:To evaluate the effects of PDCA cycle management method on clinical application of Fat-soluble vita-min for injection (Ⅱ). METHODS:By retrospective analysis,500 discharge medical records of Fat-soluble vitamin for injection (Ⅱ)were collected from our hospital during Jul.-Aug. in 2015(before intervention),Sep.-Oct. in 2015(after first intervention cy-cle),Nov.-Dec. in 2015(after second intervention cycle),respectively. RESULTS:After 2 PDCA cycles,the proportion Fat-solu-ble vitamin injection (Ⅱ) use without indication decreased from 65.4% to 39.2%;the reasonable rate of drug dosage increased from 53.2% to 97.2%,and that of usage increased from 96.4% to 99.8%;the reasonable rate of medication course increased from 69.6% to 96.6%;the reasonable rate of the clinical application of Fat-soluble vitamin injection (Ⅱ) increased from 18.8% to 56.4%,with statistical significance (P<0.05). CONCLUSIONS:PDCA cycle can effectively promote the clinical reasonable of Fat-soluble vitamin for injection(Ⅱ).
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A new method was developed for the determination of 11 fat_soluble vitamins ( A, D, E and K) and its derivatives in vitamin tablets by ultra performance convergence chromatography ( UPC2 ) . The mobile phase was the mixture of supercritical CO2 and acetonitrile at a flow rate of 1 mL/min. The separation was carried out on the Waters Acquity UPC2 HSS C18 SB 100 mm × 3. 0 mm i. d. , 1. 8 μm column. The UV detector was set at a wavelength of 284 nm. The limits of detection ( LOD) were 1. 5-2. 0 mg/L, and the calibration linear for VK1 , VK2 , VK3 and VB3 was 3-300 mg/L, linear for VA, VA palmitate, VA formic acid, VE, VE acetate, VD2 and VD3 was 5-300 mg/L, respectively. Its spiked recoveries were 97. 31%-98. 76%, and the relative standard deviations ( RSDs) were 0. 41%-0. 96%. The method is applicable for the determination of fat_soluble vitamins ( A, D, E and K) and Their derivatives in vitamin tablets.