What are the hazards of microcrystalline cellulose to humans?

People often hear about the nutrient cellulose. In fact, there are many types of cellulose, including microcrystalline cellulose, which is also called wood powder. It is a white particle with no obvious odor. Microcrystalline cellulose has a wide range of uses. For example, it is often used as a diluent. It also has many functions such as lubrication and disintegration. So what harm may this cellulose have?

The harm of microcrystalline cellulose to humans:

This product is widely used in oral preparations and foods and is a relatively non-toxic and non-irritating substance. It is not absorbed orally and has almost no potential toxicity. Large-scale use may cause mild diarrhea, and it has no difficulty being used as an excipient in pharmaceutical preparations.

Abuse of cellulose-containing preparations, such as inhalation or injection, can lead to cellulose granulomas.

Microcrystalline cellulose is incompatible with strong oxidants.

Fineness: Take 20.0g of this product and put it in a medicine sieve. The powder that cannot pass through the No. 7 sieve shall not exceed 5.0%, and the powder that can pass through the No. 9 sieve shall not be less than 50.0%.

Acidity and alkalinity: Take 2.0 g of this product, add 100 ml of water, shake for 5 minutes, filter, take the filtrate, and determine the pH value according to the method (Appendix ⅥH). The pH value should be 5.0-7.5. Take 5.0 g of the product dissolved in water, add 80 ml of water, shake for 10 minutes, filter, place the filtrate in a constant weight evaporating dish, evaporate to dryness on a water bath, and dry at 105°C for 1 hour. The remaining residue shall not exceed 0.2%.

Chloride: Take 0.10 g of this product, add 35 ml of water, shake, filter, take the filtrate, and check it according to the law (Appendix VIII A). Compare it with the control solution made from 3.0 ml of standard sodium chloride solution. It must not be more concentrated (0.03%).

Take 0.1g of starch, add 5ml of water, shake, add 0.2ml of iodine test solution, and no blue color should appear.

Loss on drying: Take this product and dry it at 105℃ to constant weight. The loss in weight shall not exceed 5.0% (Appendix VIII L).

Take 1.0g of the product as residue on ignition and determine it according to the law (Appendix VIIIN). The residue left shall not exceed 0.2%.

Heavy metals shall be taken from the residues left over from the item of ignition residues. According to the law, the inspection (Appendix VIIIH, Method 2) shall show that the content of heavy metals shall not exceed 10 parts per million.

Arsenic salt: Take 1.0g of this product and add 1.0g of calcium hydroxide, mix, add water and stir evenly. After drying, first burn it with a low fire to carbonize it, and then burn it at 600℃ to completely ash it. Cool it, add 5ml of hydrochloric acid and 23ml of water to dissolve it, and check it according to Appendix VIII J, Method 1). It should meet the requirements (0.0002%).

【Content determination】

Take about 0.125g of this product, weigh it accurately, put it in a conical flask, add 25ml of water, accurately add 50ml of potassium dichromate solution (take 4.903g of standard potassium dichromate, add appropriate amount of water to dissolve and dilute to 200ml), mix well, carefully add 100ml of sulfuric acid, quickly heat to boiling, cool to room temperature, transfer to a 250ml volumetric flask, dilute to the scale with water, shake well, accurately measure 50ml, add 3 drops of o-phenanthroline indicator solution, titrate with ammonium ferrous sulfate titration solution (0.1mol/L), and correct the titration result with a blank test. Each 1 ml of ammonium ferrous sulfate titration solution (0.1 mol/L) is equivalent to 0.675 mg of cellulose.