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1： Using diatomite as super disintegrating agent to prepare drug dosage form, in which diatomite mixed with drug active ingredients or natural mineral mixture containing diatomite is used as filler in solid drug dosage form, which is a function of drug excipient used in drug formulation. The most important function of using other additives to adjust the action mode, stability, release of active ingredients and sensory characteristics of drug formulations is to provide a consistent mass proportion and dose of active ingredients.
II. In addition to active ingredients, diatomite or natural mineral mixture containing diatomite is used as filler. Diatomite or mineral mixture containing diatomite is used as filler in diatomite, which is more advantageous to prepare the preparation by compression. Compared with the raw materials used for filling purposes in the operation of pharmaceutical preparations, diatomite shows several favorable characteristics, which makes it very suitable for filling in pharmaceutical preparations. Diatomite can be compressed even in the absence of any other tablet pressing AIDS. The special advantage of using diatomite as filler lies in the fact that diatomite is easy to wet, which supports the appropriate distribution of solvents (such as water, alcohols and diols) in the process of pharmaceutical technical operation (tablet preparation, granulation and coating).
III. It is easily soaked by water, aqueous granulation liquid, diols, alcohols, organic solvent oils and waxes. Wetting is an adsorption process managed by capillary force without forming chemical bonds. The wetting solvent can be removed quickly and easily by drying from the surface of diatomite. Diatomite is resistant to water and solvents, and it may adsorb 140% by weight of the liquid without changing the consistency. Another advantage of diatomite is that it is biologically inert, almost does not react with the human body, and even if there is a reaction, it is beneficial to organisms. Diatomite is not adsorbed in the body and it is excreted in an unchanged form. It is assumed that a very small amount of silicone is adsorbed from an amorphous silicate (a salt of silicate), which improves the body's defense} ability and nourishes the skin.
[main use in pharmaceutical industry]:
① Diatomite is the preferred diatomite in glucose filling
② brine
③ eye drops
④ oral solution
⑤ antibiotics and vitamins
⑥ extract of Chinese herbal medicine
Senda diatomite - Functional filler - Physical and chemical indexes | ||
Item | Index | |
Model | SD-3001# |
|
Grade | Roasted product | Flux roasted product |
Appearance | Fine articles | white |
Form | Pink | powder |
Drying reduction w/% | ≤3.0 | ≤3.0 |
Loss on ignition w/% | ≤0.50 | ≤0.50 |
Bulk density（g/cm3） | ≤0.50 | ≤0.65 |
PH（100g/L） | 5-10 | 8-11 |
Whiteness | - | 83 |
SiO2 w/% | ≥90 | ≥90 |
As （mg/kg） | ≤5 | ≤5 |
Pb （mg/kg） | ≤4 | ≤4 |
150 mesh sieve residue wt/% | - | 11.00 |
300 mesh sieve residue wt/% | 1 | - |
Median mesh | 600 | 200 |
Diatomite safety instructions
Hazard overview
Hazard category: diatomite is not applicable;
Invasion route: inhalation or dust contact with eyes.
Environmental hazards: diatomite is not applicable;
Fire and explosion hazard: diatomite is not applicable;
Health hazards: prolonged and frequent exposure to excessive concentrations of dust from this product (or any other dust hazard) may lead to chronic lung disease. Dust entering the eyes may cause temporary tingling or red eyes. This product has not been listed as a carcinogen by NTP or IARC.
First aid measures
Skin contact: not applicable
Eye contact: flush eyes with plenty of water. If the inflammation persists, consult your doctor.
Rain shall be prevented during transportation. It shall not be transported with contaminated, corrosive or sharp metal objects. It shall be handled with care during loading and unloading. It is not allowed to throw it directly from a high place or lift it with hard objects such as iron hooks, so as to ensure that the outer packaging is intact.
Precautions for diatomite storage
Storage conditions
During storage, the products shall be protected from rain, moisture, sun and corrosion. When stacking, the products shall not directly contact the ground. They shall be stacked on pallets or moisture-proof felt plates, and the stacking layer height shall not exceed 30 layers.
Product specification: 20kg / bag, 25kg / bag, ton bag
Product validity: 36 months
Precautions for transportation: prevent rain during transportation and do not transport with polluting, corrosive or sharp metal objects. Handle with care during loading and unloading. Do not throw it directly from height or lift it with hard objects such as iron hooks, so as to ensure that the outer packaging is intact.
CDMO
