|
Grade/Item |
CP |
PH-101 |
PH-102 |
|
Particle Size % |
/ |
>250um(60 mesh)
≤1.0 |
>250um(60 mesh ≤8.0 |
|
/ |
>75um(200 mesh)
≤30.0 |
>75um(200 mesh) ≤45.0 |
|
Loss on drying % |
≤5.0 |
≤5.0 |
≤5.0 |
|
Bulk Density, g/ml |
/ |
0.26-0.31 |
0.28-0.33 |
|
PH |
5.0-7.5 |
5.0-7.0 |
5.0-7.0 |
|
Ether-soluble substances % |
/ |
≤0.05 |
≤0.05 |
|
Water-soluble substances % |
≤0.2 |
≤0.24 |
≤0.24 |
|
Heavy metals ppm |
≤10 |
≤10 |
≤10 |
|
Total aerobic microbial count CFU/g |
/ |
≤100 |
≤100 |
|
Fungi / molds and yeasts CFU/g |
/ |
≤20 |
≤20 |
|
E coli, Pseudomonas aeruginosa |
/ |
Absent in 10g |
Absent in 10g |
|
Staph aureus, Salmonella spec. |
/ |
Absent in 10g |
Absent in 10g |
|
Enterobacteriaceae |
/ |
Absent in 1g |
Absent in 1g |
Microcrystalline cellulose (MCC, Microcrystalline cellulose), the main component is a linear polysaccharide substance bound by β-1,4-glucoside bonds [1], which is natural cellulose hydrolyzed by dilute acid to the limit degree of polymerization ( LOOP) is a white, odorless, tasteless crystalline powder composed of free-flowing extremely fine short rod-like or powder-like porous particles.
In general plant fibers, microcrystalline cellulose accounts for about 70%, and the other 30% is amorphous. Microcrystalline cellulose is widely used in pharmacy, cosmetics, food and other industries. Different particle size and water content have different characteristics and application ranges.
1. The pharmaceutical industry
Microcrystalline cellulose is commonly used as an adsorbent, suspending agent, diluent, and disintegrant. Microcrystalline cellulose is widely used in pharmaceutical preparations. It is mainly used as a diluent and binder in oral tablets and capsules. It can be used not only for wet granulation but also for dry direct compression. It also has a certain degree of lubrication and disintegration, which is very useful in tablet preparation. [4]
Because there are hydrogen bonds between the molecules of microcrystalline cellulose, the hydrogen bonds are associated when pressed, so it has a high degree of compressibility and is often used as a binder; when the compressed tablet encounters liquid, water quickly enters the content of microcrystalline cellulose. In the crystalline cellulose tablet, the hydrogen bond breaks instantly, so it can be used as a disintegrant. Therefore, it is a widely used excipient in tablet production, which can increase the hardness of the tablet. For example, in the preparation of rifampicin tablets, microcrystalline cellulose and starch (with a mass ratio of 6.25:1) and various raw materials can be mixed uniformly and then directly pressed into tablets. The product disintegrates into a mist within 1 minute. Moreover, the content remains unchanged during the validity period, and can well improve the stability of the drug. There is no need to go through the traditional granulation process when microcrystalline cellulose is used as an auxiliary material for tablet compression. For example, because microcrystalline cellulose is added to the preparation of Kebiqing tablets, it solves the serious stickiness that occurs when the Kebiqing wet granulation and compression method is easy to absorb moisture. Rush phenomenon, and disintegrate quickly. [6]
Microcrystalline cellulose can also be used as a slow release agent for medicines. The slow-release process involves the active substance entering the porous structure of the carrier. The active material is contained by intermolecular hydrogen bonds, and the active material is fixed after drying. When the active substance is released, because water diffuses in the capillary system of the polymer carrier and causes swelling, the bond between the carrier and the immobilized active substance is destroyed, and the active substance is slowly released. [6]
Microcrystalline cellulose powder can form a stable dispersion system in water. It can be combined with medicine to make a cream or suspension liquid medicine, and it can also be used as a capsule. Microcrystalline cellulose is vigorously stirred in water to form a gel, which can also be used to make paste and suspension type pharmaceutical preparations. [4]
2. Food Industry
In the food industry, microcrystalline cellulose, as a kind of edible fiber and an ideal health food additive, can maintain the stability of emulsification and foam, maintain the stability of high temperatures, and improve the stability of liquids. It has been awarded by the Food and Agriculture Organization of the United Nations and the World Health Organization. With the certification and approval of the Food Additives Joint Appraisal Committee to which the organization belongs, the corresponding fiber products have also appeared, and they have been widely used in dairy products, frozen foods, and meat products. [7]
Microcrystalline cellulose can be used as an anticaking agent, emulsifier, dispersant, and binder. my country's "Sanitary Standards for the Use of Food Additives" (GB2760-2011) stipulates that it can be used for non-dairy powder and cream, with a maximum use amount of 20g/kg; for ice cream, 40g/kg; high-fiber foods and bread, 20g/kg. Other reference for use: Use in ice cream can improve the overall emulsification effect, prevent the formation of ice slag, and improve the taste. Combined with carboxymethyl cellulose can increase the suspension of cocoa powder in milk beverages.
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