Medical grade gum arabic experiment application research and development test

Medical grade gum arabic experiment declared research and development of small test gum arabic albecajiao Acacia [9000-01-5] This product is a dried gelatinous exudate obtained from the branches of Acacia Senegal (Linne) Willdenow of the genus Acacia genus of the legume family Acaigu
.

【Properties】This product is white to brownish yellow translucent or opaque spherical or irregular particles, fragments or powder
.

【Identification】(1) Take 1.
0g of this product, add 2ml of water, leave for 2 hours and stir to dissolve, add 2ml of ethanol, shake, generate a white gel-like precipitate, add 10ml of water, and dissolve
the precipitate.

(2) The 20% aqueous solution of this product shows weak acidic reaction
in the blue litmus test strip.

(3) Take 1.
0g of this product, add 100ml of water to dissolve, take 1ml of the above solution, add 10% lead acetate solution 1.
0ml, and add 4% sodium hydroxide solution 1.
0ml, that is, generate a white precipitation
.

(4) In the chromatography recorded under the glucose and fructose examination, the location and color of the spots shown in the test solution should be the same as
the spots of the galactose, arabinose and rhamnosin control solutions.

(5) Take the appropriate amount of this product, after researching and filling the film with liquid paraffin (General Principles 2001), place it under the microscope for observation, and visible angular or irregular colorless transparent fragments; Or occasionally small amounts of starch and plant tissue
.

【Check】Insoluble substances Take 5.
0g of this product, add 100ml of water to dissolve, add 3mol/L hydrochloric acid solution 10ml, slowly boil for 15 minutes, filter with No.
4 vertical melting crucible dried at 105 °C to constant weight, repeatedly wash the filter with hot water, dry at 105 °C to constant weight, and the residual residue shall not exceed 0.
5%.


Starch or dextrin Take this product aqueous solution (1→50) boiled, put cold, drop iodine test liquid a few drops, the solution must not appear blue or red
.

Tannic acid-containing gum Take 10ml of this product's aqueous solution (l→50), add 0.
1ml of iron trichloride test solution, the solution must not appear black or do not produce black precipitation
.

Sycamore gum take 0.
2g of this product, put it in a flat-bottomed glass measuring cylinder with a resolution value of 0.
1ml, add 60% ethanol 10ml, the dense plug shakes, and the colloid produced shall not exceed 1.
5ml
.

Glucose and fructose Take 0.
1g of this product, place in a centrifuge tube, add 1% tri-solution 2ml, vigorously shake to dissolve, dense plug, 120 °C for 1 hour, centrifuge, take the supernatant and transfer to a 50ml round-bottom flask, add water 10ml, 60 °C rotation under reduced pressure and evacuation (or blow dry with a nitrogen blower), The residue is added with water 0.
1ml and methanol 0.
9ml to dissolve, if necessary, add 1ml of methanol, filter, take the filtrate as the test solution; take 10mg of arabinose, galactose, glucose, rhamnose and xylose controls, add 1ml of water and appropriate amount of methanol to dissolve, and dilute with methanol to 10ml, shake well, as a control solution
.

According to the thin layer chromatography (general rule 0502) test, aspirate 2 ~ 10 μl of the test solution, 10 ~ 30 μl of the control solution (the amount of spotting is clear and not overloaded as appropriate), respectively, on the same silica gel G thin layer plate (recommended MERCK plate), with 1.
6% sodium dihydrogen phosphate solution - n-butanol - acetone (10:40:50) as the unfolding agent, secondary unfolding, the first unfolding distance is about 10cm, removal, drying or blow-drying, The second unfolding distance is about 15cm (no need to change the unfolding agent), take out, dry, spray with p-methoxy solution (take p-methoxy 0.
5ml, add glacial acetic acid 10ml, methanol 85ml, sulfuric acid 5ml, shake well, that is) to just wet, immediately heated at 110 ° C for 10 minutes, cool, immediately examine, the control solution should show 5 clearly separated spots, from bottom to top order is galactose (gray-green or green), glucose (gray), arabinose (yellow-green), Xylose (greenish gray or yellow-gray), rhamnose (yellow-green
).

In the chromatography of the test product, gray or gray-green spots
should not be shown between the corresponding positions of the galactose and arabinose control chromatography.

In the chromatography recorded under glucose and fructose examination, the test solution must not show greenish-gray or yellow-gray spots
in the corresponding position with the xylose control chromatography.

Loss on drying Take this product, dry at 105 °C for 5 hours, and the weight loss shall not exceed 15.
0% (General 0831).


The total ash content must not exceed 4.
0% (General Rule 2302
).

Acid insoluble ash content shall not exceed 0.
5% (General Rule 2302).


Heavy metals Take 1.
0g of this product, inspect according to law (General 0821 Second Law), containing heavy metals shall not exceed 20
parts per million.

Arsenic salt take this product 0.
67g, add calcium hydroxide 1.
0g, add water 2ml, mix well, dry at 100 ° C, slowly burn to carbonize over low heat, and then burn at 480 ° C to completely ash, put it cold, add 5ml of hydrochloric acid and 21ml of water, check according to law (general rule 0822 first law), should comply with the provisions (0.
0003%)
.

Microbial limit Take this product, check according to law (General Rule 1105 and General Rule 1106), the total number of aerobic bacteria per 1g of test product shall not exceed 103cfu, the total number of molds and yeasts shall not exceed 102cfu, and Escherichia coli shall not be detected; Salmonella
should not be detected in every 10 g of the sample.

【Category】Pharmaceutical excipients, suspension aids, thickeners and emulsifiers
.

【Storage】Sealed and stored
in a dry place.

【Indication】The indicated value
of viscosity should be indicated.