The main effects and effects of pharmaceutical grade xanthope gum

The main effects and effects of pharmaceutical grade west yellow yarrow xihuangshijiao Tragacanth [9000-65-1] The mucus extracted from this line of legume Astragalus gummifer Labill
.

【Properties】This product is a white or off-white translucent flat and curved band of thin sheets; Parallel pinstripes on the surface; Hard flat and smooth; or as a white or off-white powder; In case of water, it swells into colloidal mucus
.

【Identification】 (1) Take an appropriate amount of this product, use 50% glycerol solution to pack tablets (General 2001), add 1 drop of zinc chloride iodine test solution dropwise, place it under the microscope for observation, you can see round or oval starch granules, diameter of 4 ~ 10 μm, occasionally 20 μm, mostly single grains, occasional polymerization particles
.

(2) Take about 0.
1g of this product, put it in a centrifuge tube, add trifluoroacetic acid solution (6.
7→100) 2ml, strong shaking to form a gel, plugged, placed in a 120 °C oven for 1 hour, centrifuge, take the supernatant and transfer it to a 50ml round-bottom flask, add 10ml of water, 60 °C rotation and steam drying; The residue is dissolved by adding 1ml of 90% methanol solution, filtered, and the filtrate is taken as the test solution; Take another 10 mg of arabinose, rhamnose, xylose and galactose, add 5 ml of 90% methanol solution to dissolve, shake well, and use as a control solution
.

According to the thin layer chromatography (general 0502) test, aspirate 5 μl of the test solution and the control solution, respectively, on the same silica gel G thin layer plate, with 1.
6% sodium dihydrogen phosphate solution - butanol - acetone (10: 40: 50) as the unfolding agent, the second unfolding distance is about 10 cm, the second unfolding distance is about 15 cm, take out, dry, spray with anisaldehyde solution (take anisaldehyde 0.
5ml, glacial acetate 10ml, Methanol 85ml mixed with 5ml sulfuric acid, i.
e.
, heated at 110 °C to spot is clearly displayed, immediately examined
.

The test solution shows spots of the same color in the corresponding position of galactose, arabinose and xylose in the control solution, and the spots of the same color shall not appear in the corresponding position of rhamnosose
.

(3) Take about 0.
5g of this product, add 1ml of ethanol to soak, add 50ml of water in parts, shake while adding, and form a uniform mucus
.

Take 5ml of mucus, add 5ml of water and 2ml of 4.
5% barium hydroxide solution, shake well, form a white flocculent precipitate, heat, the solution and precipitate gradually appear yellow, dilute 2 drops of hydrochloric acid, shake well, the precipitate dissolves, the solution fades
.

【Inspection】Viscosity Take this product 9.
0g, add 3.
0g, add 300ml of water, stir at a speed of 800r/min for about 2 hours until it is completely uniformly dispersed and wet, measured according to law (general 0633 third method), with BrookfieldRV-DV type rotary viscometer, No.
5 rotor, 60 revolutions per minute, at 20 °C± 0.
1 °C The viscosity should be 80% to 120%
of the viscosity indicated.

Foreign substances Take 2.
0g of this product, place it in a 250ml round-bottom flask, add 95ml of methanol vortex to moisten the sample, add hydrochloric acid solution (25→100) 60ml, add a few glass beads, heat the water bath for 3 hours, remove the glass beads, decompress the sample solution while hot with the G4 vertical molten funnel of constant weight, rinse the round bottom flask with a small amount of water, filter, and then wash the residue with methanol 40ml in parts, dry to constant weight at 110 ° C, and the residual residue shall not exceed 1.
0%.
Ash take 1.
0g of this product, check according to law (General Principle 2302), and the residual residue shall not exceed 4.
0%.
Heavy metals Take the residue left under the ash sub-item and inspect it according to law (General Principle 0821 Second Law), and the heavy metal shall not exceed 20 parts per million
.

Microbial limits Take this product, check according to law (General Principle 1105 and General Principle 1106), the total number of aerobic bacteria in each 1g of the test product shall not exceed 103cfu, the total number of mold and yeast shall not exceed 102cfu, and Escherichia coli
shall not be detected.

【Category】Pharmaceutical excipients, adhesives, suspensions and emulsifiers, etc
.

【Storage】Airtight and store
in a dry place.

【Labeling】The marking value
of the viscosity of this product should be indicated.