Pharmaceutical grade silica is a new excipient used as a pharmaceutical preparation, with a variety of characteristics and wide application, the following is a specific introduction:
peculiarity
- Physical properties: It is a white powder with high purity and good fluidity, with small particle size, large specific surface area and many pores.
- Chemical properties: chemical properties are stable, do not react with the main ingredients in the drug preparation, in the drug body metabolism process in the original form of excretion, not absorbed by metabolism.
Apply
- Flow aid: can reduce the interaction between drug particles, improve the flow of particles or powder, suitable for oil, extractum drug granulation, so that the produced particles flow and pressureability.
- Anti-adhesion agent: When applied to gel paste, it can make the paste carry a large amount of medicine and have a good transdermal effect; It can also prevent the material from sticking to the surface of the punch when pressing the tablet to ensure the smooth process of pressing the tablet.
- Adsorbent: can absorb water, improve drug properties, improve the uniformity and fluidity of drug ingredients, can be used to deal with oily or high water main drugs and insoluble drugs.
- Antistatic agent: it can obviously eliminate powder static electricity, reduce electrostatic charge and surface resistivity, and prevent powder electrostatic adsorption in the process of preparing particles in the fluidized bed.
- Grinding aid: As a grinding aid to promote the grinding and refining of the raw material, to provide high porosity structure of the cogulation for rapid water penetration, enhance the disintegration effect of the dispersion tablets.
- Slow-release preparation: as a drug carrier, it uses its adsorption capacity to wrap drugs, achieve slow release, prolong efficacy, and improve treatment effect and reduce side effects through targeted drug delivery.
Pharmaceutical grade silica has no specific national standard number, and its quality standards are mainly based on the "Chinese Pharmacopoeia". For example, the 2020 edition of the Chinese Pharmacopoeia stipulates that according to the incandescene calculation, the SiO₂ shall not be less than 99.0%, and the characteristics, identification, inspection items (particle size, pH, chloride, sulfate, drying weight loss, incandescene weight loss, iron salt, heavy metals, arsenic salt, etc.) and content determination methods are clearly required.
