ตำรายาของประเทศไทย
Thai Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public HealthCoconut Butter
Thai name น้ำมันมะพร้าว (NAM MAN MAPHRAO)
Category Pharmaceutic aid.
Coconut Oil is the refined fixed oil of the seeds of Cocos nucifera L. (Family Arecaceae).
Origin of plant Coconut Oil-yielding plant is native to the tropical coast of the Pacific Ocean.
Constituents Coconut Oil, contains fatty acids predominantly lauric, myristic, palmitic, and caprylic acids. It also contains phospholipids (phosphatidylcholine, phosphatidylethanolamine, and phosphatidylinositol), triacylglycerols (CCLa, CLaLa, LaLaLa, and LaLaLaM, where C stands for capric acid, La represents lauric acid, and M refers to myristic acid), and tocopherols (as vitamin E).
Description White to light yellow mass or colourless to light yellow, clear oil; odour, faint and characteristic; taste, mild. At a temperature below 15º, it congeals to a hard and brittle solid.
Solubility Soluble, at 60º, in 2 parts of ethanol, less soluble at lower temperatures; freely soluble in carbon disulfide, in chloroform, in ether, and in petroleum ether (boiling range, 40º to 60º).
Stability On exposure to the air, the oil readily becomes rancid, acquiring an unpleasant odour and a strong acrid taste.
Packaging and storage Coconut Oil shall be kept in well-filled, tightly closed containers, protected from light, and stored at a temperature not exceeding 25.
Identification of fixed oils by thin-layer chromatography Carry out the test as described in Appendix==.
Results The chromatogram obtained is similar to the corresponding chromatogram shown in the figure.
Melting range 23° to 26° (Class II, Appendix 4.3).
Loss on drying Not more than 0.05 per cent w/w after drying at 105° to constant weight (Appendix 4.15).
Acid value Not more than 0.2 (Appendix 5.4); use 20 g.
Peroxide value Not more than 5.0 (Appendix 5.12).
Unsaponifiable matter Not more than 1.0 per cent w/w (Appendix 5.8).
Test for alkaline impurities Mix 10 mL of freshly distilled acetone and 0.3 mL of water, and add 50 µL of bromophenol blue TS. Neutralize the solution to a green colour, if necessary, with 0.01 M hydrochloric acid or 0.01 M sodium hydroxide. Add 10 mL of Coconut Oil, shake, and allow to stand. Titrate with 0.01 M hydrochloric acid VS. Not more than 0.1 mL of 0.01 M hydrochloric acid is required to change the colour of the upper layer to yellow.
Arsenic Not more than 0.5 ppm (Appendix 5.2); use 6.0 g.
Composition of fatty acids Carry out the test as described in the “Gas Chromatography” (Appendix 3.4).
Standard solution Prepare an ester mixture of known composition containing the esters required in the Coconut oil. (Nu-Chek mixture 17A® or equivalent is suitable.)
0.5 M Methanolic sodium hydroxide solution Dissolve 2 g of sodium hydroxide in 100 mL of methanol.
Test solution (Note If fatty acids containing more than 2 double bonds are present in the sample, remove air from the flask by purging it with nitrogen for a few minutes.) Transfer about 100 mg of the sample, accurately weighed, to a 50-mL conical flask fitted with a suitable water-cooled reflux condenser and a magnetic stir bar. Add 4 mL of 0.5 M Methanolic sodium hydroxide solution, and reflux until fat globules disappear (usually 5 to 10 minutes). Add 5.0 mL of a solution prepared by dissolving 14 g of boron trifluoride in methanol to make 100 mL, swirl to mix, and reflux for 2 minutes. Add 4 mL of n-heptane for chromatography through the condenser, and reflux for 1 minute. Cool, remove the condenser, add about 15 mL of a saturated solution of sodium chloride, shake, and allow the layers to separate. Pass the n-heptane layer through 100 mg of anhydrous sodium sulfate (previously washed with n-heptane for chromatography) into a suitable flask. Transfer 1.0 mL of this solution to a 10-mL volumetric flask, dilute with n-heptane for chromatography to volume, and mix.
System suitability solution Transfer about 20 mg each of stearic acid, palmitic acid, and oleic acid to a 25-mL conical flask fitted with a suitable water-cooled reflux condenser and a magnetic stir bar, and prepare as directed for Test solution beginning with “Add 5.0 mL of a solution prepared by dissolving . . . .”
Chromatographic system
Detector Flame ionization.
Column A fused-silica capillary column (30 m × 0.53 mm) bonded with a 1.0-µm layer of polyethylene glycol compound (Polyethylene Glycol Compound 20M®, also known as Carbowax 20M®, or equivalent).
Temperature
Column The temperature programme is as follows:
Time (Minutes) | Temperature (°) |
0 - 2 | 70 |
2 - 36 | 70 → 240 (5° per minute) |
36 - 41 | 240 |
Injection port 220.
Detector 260.
Carrier gas Helium.
Flow rate About 50 cm per second (6.6 mL per minute).
(Note The relative retention times are about 0.87, 0.99, and 1.0 for methyl palmitate, methyl stearate, and methyl oleate, respectively.)
System suitability
Sample System suitability solution.
Suitability requirements
Resolution Not less than 1.5 between methyl stearate and methyl oleate peaks.
Relative standard deviation The relative standard deviation of the peak area responses for the palmitate and stearate peaks for replicate injections is not more than 6.0 per cent. The relative standard deviation of the peak area response ratio of the palmitate to stearate peaks from these replicate injections is not more than 1.0 per cent.
Procedure Separately inject equal volumes (about 1 µL) of Standard solution and Test solution into the chromatograph, and record the chromatograms. Identify the peak due to the fatty acid ester peaks in the chromatogram of the Test solution by comparing the retention times of these peaks with those in the chromatogram of the Standard solution, and measure the peak areas for all of the fatty acid ester peaks in the chromatogram from the Test solution.
Calculation Calculate the percentage content of the components of Coconut Oil taken by normalization procedure.
Limits Coconut Oil exhibits the composition profiles of fatty acids in Table 1 below.
Table 1
Carbon-Chain Length | Number of Double Bonds | Percentage |
6 | 0 | ≤1.5 |
8 | 0 | 5.0-11.0 |
10 | 0 | 4.0-9.0 |
12 | 0 | 40.0-50.0 |
14 | 0 | 15.0-20.0 |
16 | 0 | 7.0-12.0 |
18 | 0 | 1.5-5.0 |
20 | 0 | ≤0.2 |
16 | 1 | ≤1.0 |
18 | 1 | 4.0-10.0 |
18 | 2 | 1.0-3.0 |
18 | 3 | ≤0.2 |
20 | 1 | ≤0.2 |