Evaluating quality of 5% glucose infusion prepared in field condition

Nội dung text: Evaluating quality of 5% glucose infusion prepared in field condition

1. Journal of military pharmaco-medicine n 08-2017 EVALUATING QUALITY OF 5% GLUCOSE INFUSION PREPARED IN FIELD CONDITION Nguyen Minh Tuan*; Nguyen Minh Chinh*; Tran The Tang** SUMMARY Objectives: To evaluate some quality parameters of 5% glucose infusion prepared in field condition. Method: Using the manual “The guideline for preparation of intravenous fluids in field condition” (method 1) and “Vietnamese Pharmacopoeia IV” (method 2). Results: 19 infusions met the requirements of description; 86.29% (277/321 bottles) of the bottles were applied method 1 and 85.67% (275/321 bottles) were used method 2, both of which met the requirements of appearance; pH ranged from 4 to 6 (method 1) and from 4.06 to 6.05 (method 2); glucose concentration ranged from 4.80 to 5.30% (method 1) and from 4.90 to 5.34% (method 2); 5-hydroxymethyl furfural (5-HMF) limit ranged from 0.0483 to 0.2117; no bacterial endotoxin was detected in the tested samples. Conclusion: The Guideline for preparation of intravenous fluids in field condition can be used to control the 5% glucose infusion in field condition. * Keywords: Infusion; 5% glucose; Field condition. INTRODUTION MATERIAL AND METHODS 1. Materials and instruments. Infusion preparation in field condition is a very important activity in the war. It is a * Materials : 500 mL bottles of 5% glucose big challenge to assure the quality of infusion infusion which were prepared in field not only due to a lack of instruments, condition. unqualified climate and polluted water, but * Instruments: the modern instruments and control methods The polarimetre, the refracmetre, the can not be applied as well. Consequently, pH meter, the UV-Vis spectrophotometer, it is neccessary to have a method used the pH - indicator paper (pH from 1 to 14). for evaluation the quality of 5% glucose 2. Resseach methods. infusion quickly and ensure reliability. * Evaluating the quality of 5% glucose In this research, evaluating the quality of infusion by method 1 [3]: 5% glucose infusion was prepared according to the Guideline for infusion preparation in The 5% glucose infusion was assessed field condition (method 1), compared to the based on four indicators: description, Vietnamese Pharmacopoeia IV (method 2). appearance, pH, concentration. The results demonstrated that the Guideline - Description: Observe the color of the solution. can be used as a good method to control - Appearance: Observe the bottles on infusion quality in field condition. battery light. * Vietnam Military Medical University ** Department of Military Medicine Corresponding author: Nguyen Minh Tuan (nguyenmtuan63@gmail.com) Date received: 23/03/2017 Date accepted: 26/09/2017 153
2. Journal of military pharmaco-medicine n 08-2017 - pH: Observe the change of the glucose - Appearance: Observe the 5% glucose solution colors into pH - indicator paper and solution bottles in the LED light. compare with standard colors scale. - pH: Work at 25 0C with apparatus. - The concentration: Observe the - 5-HMF limit: Measure two solutions concentration of glucose solution presented (glucose material solution and glucose on division line of the refracmetre. infusion) at a wave length of 284 nm. * Evaluating quality of 5% glucose - The concentration of glucose was infusion by method 2: calculated using the following equation: The 5% glucose infusion was assessed W = (α - α0) x 0. 9477 based on six indicators: description; w: Gram (g) per 100 mL glucose solution. appearance; pH; concentration; 5-HMF, α: Specific rotation of 5% glucose solution. limitation of bacterial endotoxin. α0: Specific rotation of blank sample. - Description: Observe the solution - The bacterial endotoxin: Do an experiment glucose colors. with Lysat reagent. RESULTS AND DISCUSSION 1. Comparison of the description, appearance of 5% glucose infusion between method 1 and method 2. Table 1: The outcomes of description, appearance in the 5% glucose solution. Index Description (bottle) Appearance (bottle) Method 1 Method 2 Method 1 Method 2 Preparations Passed Failed Passed Failed Passed Failed Passed Failed 1 14 0 14 0 14 5 14 5 2 16 0 16 0 16 3 16 3 3 15 0 15 0 15 4 15 4 4 17 0 17 0 17 2 17 2 5 14 0 14 0 14 5 14 5 6 17 0 17 0 17 2 16 3 7 15 0 15 0 15 4 15 4 8 17 0 17 0 17 2 17 2 9 16 0 16 0 16 3 16 3 10 17 0 17 0 17 2 17 2 11 17 0 17 0 17 2 16 3 12 18 0 18 0 18 1 17 1 154
3. Journal of military pharmaco-medicine n 08-2017 13 17 0 17 0 17 2 17 2 14 18 0 18 0 18 1 18 1 15 16 0 16 0 16 3 16 3 16 9 0 9 0 9 0 8 0 17 8 0 8 0 8 1 8 1 18 8 0 8 0 8 1 8 1 19 8 0 8 0 8 1 8 1 Total 321 0 321 0 277 44 275 46 * Description: 321 bottles of 5% glucose infusion met requirement of description (100%). * Appearance: Based on method 1, 277 bottles passed (86.29%), 44 bottles failed (13.71%). Based on method 2, 275 bottles passed (85.67%), 46 bottles failed (14.33%), which was 2 bottles as many as method 1. Factors influence the appearance drug: The bottle was not clean enough, insoluble particulate matter was dropped into bottle when prepared, filter quality [4, 7]. The battery light can be used to control the appearance of infusion preparation in field condition [3]. 2. Comparison of pH and concentration of 5% glucose infusion between method 1 and method 2. Table 2: The outcomes of pH, concentration of 5% glucose infusion (n = 19). Index pH Concentration (%) Method 1 Method 2 Conclusion Times Method 1 Method 2 Colors pH pH 1 Lemon yellow 5 - 6 4.21 ± 0.02 5.00 ± 0.15 5.11 ± 0.02 Passed 2 Lemon yellow 5 - 6 5.42 ± 0.02 4.82 ± 0.04 5.12 ± 0.02 Passed 3 Lemon yellow 5 - 6 4.99 ± 0.08 4.90 ± 0.10 5.13 ± 0.03 Passed 4 Lemon yellow 5 - 6 5.18 ± 0.03 4.98 ± 0.08 4.90 ± 0.04 Passed 5 Lemon yellow 5 - 6 6.05 ± 0.07 5.20 ± 0.07 5.15 ± 0.03 Passed 6 Pale yellow 4 - 5 5.45 ± 0.20 5.00 ± 0.07 5.04 ± 0.03 Passed 7 Lemon yellow 5 - 6 5.42 ± 0.13 5.02 ± 0.08 5.03 ± 0.03 Passed 8 Pale yellow 4 - 5 5.17 ± 0.05 5.20 ± 0.07 5.19 ± 0.03 Passed 9 Pale yellow 4 - 5 5.34 ± 0.07 4.98 ± 0.13 5.12 ± 0.05 Passed 10 Lemon yellow 5 - 6 5.01 ± 0.05 4.80 ± 0.07 5.10 ± 0.04 Passed 155
4. Journal of military pharmaco-medicine n 08-2017 11 Lemon yellow 5 - 6 6.01 ± 0.10 5.10 ± 0.07 5.10 ± 0.04 Passed 12 Lemon yellow 5 - 6 5.59 ± 0.25 5.08 ± 0.08 5.19 ± 0.03 Passed 13 Lemon yellow 5 - 6 5.49 ± 0.08 5.04 ± 0.05 5.12 ± 0.05 Passed 14 Pale yellow 4 - 5 5.75 ± 0.15 5.00 ± 0.07 5.19 ± 0.03 Passed 15 Lemon yellow 5 - 6 5.03 ± 0.11 5.00 ± 0.10 5.02 ± 0.05 Passed 16 Pale yellow 4 - 5 4.06 ± 0.09 4.92 ± 0.08 5.19 ± 0.03 Passed 17 Lemon yellow 5 - 6 5.36 ± 0.09 4.90 ± 0.07 5.02 ± 0.05 Passed 18 Lemon yellow 5 - 6 5.99 ± 0.06 5.12 ± 0.08 5.01 ± 0.06 Passed 19 Pale yellow 4 - 5 5.82 ± 0.10 5.30 ± 0.07 5.34 ± 0.06 Failed * pH: Both of two results met requirements (pH from 3.5 to 6.5) [1, 2]. Among 19 samples, pH of 5% glucose solution ranged from 4 to 6 by method 1 (6 samples were pale yellow (pH from 4 to 5); 13 samples were lemon yellow (pH from 5 to 6)). Meanwhile all of them that were tested by method 2 represented pH value from 4.06 to 6.05. The pH - indicator paper met requirements of assesement of solution pH index, it may be replaced by the chemical reaction and the pH meter [4]. However, the pH - indicator paper was corresponding to the drugs with large pH limit. * Concentration: By the refracmetre, it was from 4.80 - 5.30%, 18 samples were from 4.80 - 5.20%, one sample was higher than stipulate (5.30%) [1]. By the polarimetre, it was from 4.90 - 5.34%, 18 samples were from 4.90 - 5.19%, one sample was higher than stipulate (5.34%) [1]. The refracmetre is a good instrument to quantify the glucose infusion concentration in field condition [5]. 3. Controlling 5-HMF limit and bacterial endotoxin in the 5% glucose solution by method 2. * 5-HMF limit: Table 3: The outcomes of 5-HMF limit in the 5% glucose infusion (n = 19). Results Absortion X ± SD Samples 1 2 3 4 5 Solution A 0.0409 0.0373 0.0378 0.0424 0.0393 0.0390 ± 0.0020 1 0.1118 0.0991 0.0988 0.1120 0.1131 0.1070 ± 0.0070 2 0.0795 0.0892 0.0867 0.0786 0.0911 0.0850 ± 0.0060 3 0.0548 0.0637 0.0599 0.0612 0.0631 0.0605 ± 0.0030 4 0.0558 0.0551 0.0592 0.0602 0.0614 0.0583 ± 0.0020 156
5. Journal of military pharmaco-medicine n 08-2017 5 0.0498 0.0528 0.0571 0.0512 0.0489 0.0520 ± 0.0030 6 0.0925 0.1012 0.0966 0.0934 0.0951 0.0958 ± 0.0030 7 0.2141 0.2130 0.2126 0.2097 0.2092 0.2117 ± 0.0020 8 0.1137 0.1098 0.1140 0.1121 0.1130 0.1125 ± 0.0020 9 0.1832 0.1824 0.1836 0.1839 0.1811 0.1828 ± 0.0010 10 0.1981 0.1972 0.1899 0.1965 0.1978 0.1959 ± 0.0030 11 0.0922 0.0892 0.0930 0.0919 0.0931 0.0912 ± 0.0010 12 0.1446 0.1429 0.1431 0.1466 0.1454 0.1445 ± 0.0010 13 0.1324 0.1341 0.1349 0.1340 0.1314 0.1334 ± 0.0010 14 0.0721 0.0764 0.0739 0.0761 0.0752 0.0747 ± 0.0020 15 0.1899 0.1892 0.1911 0.1943 0.1903 0.1910 ± 0.0020 16 0.0486 0.0502 0.0521 0.0410 0.0497 0.0483 ± 0.0040 17 0.1099 0.1065 0.1048 0.0994 0.1092 0.1060 ± 0.0040 18 0.0827 0.0928 0.0866 0.0892 0.0917 0.0886 ± 0.0040 19 0.1643 0.1598 0.1654 0.1631 0.1599 0.1625 ± 0.0020 The 5-HMF limit in the 5% glucose infusion of the 19 samples met requirements in the Vietnamese Pharmacopoeia IV [1], but it was 1.22 to 5.35 times (0.0483 - 0.2117) higher than glucose material (0.0395) and closed up to max limit (0.25) [1], two factors which destroyed glucose to 5-HMF were temperature and pressure [5]. To keep at the 5-HMF limit, whose material have met standard, steamed procedure must be mastered (time, temperature, pressure) [1, 4, 5]. * Bacterial endotoxin: Table 4: Results of identifying bacterial endotoxin in 5% glucose infusion (n = 5). Samples 1 2 3 4 5 Parameters No No No No No Observation precipitation, precipitation, precipitation, precipitation, precipitation, turbidity turbidity turbidity turbidity Turbidity Conclusion Passed Passed Passed Passed Passed All of 5 samples of 5% glucose infusion in 5 different preparing times were not turbid or precipitated in contact with reagent Lysat and achieved the endotoxin limit under the regulation of Vietnamese Pharmacopoeia IV [1]. It is the most important parameter when evaluating the infusion. To keep at endotoxin limit, these conditions must be satisfied: pre-packaged materials, non - bacterial distilled water, the instruments have met sterilization, the infusion has been steamed after preparation immediately [2, 5, 6]. 157
6. Journal of military pharmaco-medicine n 08-2017 CONCLUSION biopharmacy of all kind of medications, episode 1. Medical Publisher. Hanoi. 2013. Evaluating the quality of 5% glucose 3. Nguyen Vi Ninh . Appearance of infusion. infusion prepared in the field condition Military medical review. Department of Military was based on method 1 and method 2, Medicine. 1986, 1 (128), pp.47-49. it showed that four parameters: description, 4. Nguyen Minh Tuan . Research on appearance, pH and concentration were developing and evaluating the applicability of not different. However, the 5-HMF and the document Guideline of preparing infusions bacterial endotoxin limits were impossible in field condition. Scientific Research at to be tested by method 1, but when Military Medical University level. 2014. having enough conditions for preparation 5. Phan Cong Thuan. Check out impurities (instruments, material, sterillation), they of 5 hydroxy methyl furfural (5-HMF) and quality will satisfy in the Vietnamese Pharmacopoeia assurance of preparing glucose infusion in the stipulate. treatment facility. Military Medical Research. The Guideline for preparation of Military Medical University. 1992, No 4, pp.52-54. intravenous fluids in field condition can be used to control the quality of 5% 6. Phan Cong Thuan. The situation of glucose infusion. bacterial infection of infusion which preparation in field condition. Military Medical Research. Military Medical University. 1991, No 4, p.25. REFERENCES 7. Phan Cong Thuan. Test the appearance 1. Ministry of Health . Vietnamese Pharmacopoeia. of infusion which preparation in field condition Fourth edition. Medical Publisher. Hanoi. 2009. by the battery light source. Military Medical 2. Ministry of Health . Hanoi Pharmaticeutical Research. Military Medical University. 1990, University. Technique of dosage and the episode 1, pp.23-26. 158