Medicinal grade sodium alginate use properties

Medicinal grade sodium alginate use properties Sodium alginate is a by-product of iodine and mannitol extracted from the kelp or sargasso of brown algae, and its molecules are composed of β-D-mannuronic acid (β-D-mannuronic, M) and α-L-guluronic acid (α-L-guluronic, G) by (1→4) bond connection, is a natural polysaccharide, with the stability, solubility, viscosity and safety
required for pharmaceutical preparation excipients.

Sodium alginate has been widely used in the food industry and medicine the process of sodium alginate is as follows: dry or wet seaweed (algae) is crushed, washed away, strong alkaline water extraction, clarified to obtain crude alginate solution, precipitated by calcium chloride to colored calcium alginate, after decolorization, deodorization with acid treatment, remove soluble impurities to obtain alginate precipitation, and sodium carbonate to obtain sodium alginate, and then by drying, crushing, sieving sodium alginate powder (4) take the residue under the burning residue, Add 5 ml of water to dissolve, showing the identification reaction of sodium salts (General Principle 0301
).

【Inspection】 The clarity and color of the solution Take 0.
10g of this product, add water to an appropriate amount of continuous stirring to dissolve, dilute with water to 30ml, shake well, place for 1 hour, take 1ml precision, put in a 10ml measuring bottle, dilute with water to the scale, shake well, check according to law (General 0901 and General 0902), the solution should be clear and colorless; If it appears turbid, it must not be more concentrated compared with the No.
2 turbidity standard liquid (General Principle 0902 First Law); If the color is developed, it must not be deeper
than the yellow No.
2 standard colorimetric solution (General Principle 0901 First Law).

Chloride Take 2.
5g of this product, precision weighing, placed in a 100ml measuring bottle, dilute 50ml of nitric acid, shake for 1 hour, dilute with dilute nitric acid to scale, shake well, filter, precise amount of 50ml of filtrate, precision add silver nitrate titration solution (0.
1mol/ L) 10ml, add toluene 5ml and ferric ammonium sulfate indicator solution 2ml, titrate with ammonium thiocyanate titration solution (0.
1mol / L), drop to the near end point, shake vigorously
.

Each lml of silver nitrate titrant (0.
1 mol/L) corresponds to 3.
545 mg of Cl
.

Not more than 1.
0%
with Cl.

Loss on drying Take 0.
5g of this product, dry at 105 ° C for 4 hours, the weight loss shall not exceed 15.
0% (General 0831).
Blazing residue Take 0.
5g of this product, check according to law (General Principle 0841), according to the calculation of dry products, the residual residue should be 30.
0% ~ 36.
0%.
Calcium salt Take two parts of this product 0.
1g, placed in an Erlenmeyer flask, one part added 5ml of nitric acid digestion, quantitatively transferred to a 100ml measuring bottle, diluted with water to the scale, shaken well, precision amount taken 10ml, placed in a 100ml measuring bottle, diluted with water to the scale, shaken well, as a test solution; the other part of the precision added standard calcium solution (1000 μg of calcium per lml) 1.
5ml, the same method, as a
。
According to the atomic absorption spectrophotometry (general rule 0406 second method), measured separately at a wavelength of 422.
7 nm, should comply with the regulations (1.
5%)
.

Lead Take two parts of this product 1.
0g, placed in an Erlenmeyer flask, one part is added to 10ml nitric acid digestion, quantitatively transferred to a 10ml measuring bottle, diluted with water to the scale, shaken well, as a test solution; the other part is precisely added to the standard lead solution (precision amount of lead single element standard solution appropriate amount, quantitative dilution with water to make a solution containing 10μg of lead per lml) lml, the same method, as a control solution
.

According to the atomic absorption spectrophotometry (general principle 0406 second method), measured separately at a wavelength of 283.
3 nm, should comply with the regulations (0.
001%)
.

Heavy metals Take the residue left under the burning residue and inspect it according to law (General Principle 0821 Second Law, if necessary, filtered), and the heavy metal shall not exceed 20 parts
per million.

Arsenic salt Take 1.
33g of this product, add 1.
3g of calcium hydroxide, mix, add water to moisten, dry, first heat it with a low fire to make it react completely, gradually increase the fire to make it carbonized, and then at 500 ~ 600 ° C to make it completely ashed, let it cool, add 8ml of hydrochloric acid and 23ml of water to dissolve, check according to law (general 0822 second law), should meet the regulations (0.
000 15%)
.

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; Salmonella
must not be detected in every 10 g of the sample.