What are the traditional pharmaceutical process accessories?

In the Drug Administration Law, pharmaceutical excipients refer to excipients and additives.

As follows:

Pharmaceutical excipients refer to excipients and additives used in drug production and formulation; It is a substance that has been reasonably evaluated in terms of safety except active ingredients, and has been included in pharmaceutical preparations. In addition to shaping, acting as a carrier and improving stability, pharmaceutical excipients also have important functions such as solubilization, solubilization and sustained and controlled release.

It is an important component that may affect the quality, safety and effectiveness of drugs. In the process of prescription design, in order to solve the formability, effectiveness, stability and safety of the preparation, all medicinal materials except the main medicine are added to the prescription. The essence of prescription design of pharmaceutical preparations is the process of screening and applying pharmaceutical excipients according to the characteristics of drugs and the requirements of dosage forms.

Pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations, the material basis for ensuring the production and development of pharmaceutical preparations, and play a key role in the formulation and production of pharmaceutical preparations. It not only endows drugs with specific dosage forms. But also has a great relationship with improving the curative effect of drugs and reducing adverse reactions. The reliability and diversity of its quality are the basis to ensure the advanced dosage forms and preparations.

It can be divided into solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, correctants, preservatives, suspending agents, coating materials, spices, anti-adhesives, integrators, penetration enhancers, pH regulators, buffers, plasticizers, surfactants and foaming agents.

Defoamer, thickener, inclusion agent, humectant, absorbent, diluent, flocculant and anti-flocculant, filter aid, slow release agent, etc. Research data and documents of production technology. Including preparation process and chemical reaction formula, starting materials and organic solvents, reaction conditions (temperature, pressure, time, catalyst, etc. ) and operation steps.

Refining methods, main physical and chemical constants, cumulative results of phased data, etc. , and indicate the amount and output, impurities or other intermediate products that may be produced or introduced in the process, provide the specifications and standards of chemical raw materials used, and the sources and scientific names of animal, plant and mineral raw materials. Where the compilation process is different from the main references, the basis for revision shall be put forward.