Pharmaceutical excipients refer to all ingredients except the main drug, which have been properly evaluated in terms of safety and have been included in the drug release system. They can help to deal with the drug release system in the production process, protect, support and strengthen the stability, bioavailability or patient compliance of drugs, help to identify drugs, and improve the overall safety and effectiveness of drugs during storage or use.
In addition to shaping, acting as a carrier and improving stability, pharmaceutical excipients also have important functions such as solubilization, solubilization, sustained and controlled release, and are important components that may affect the quality, safety and effectiveness of preparations. Therefore, pharmaceutical excipients must meet the medical requirements in production, storage and application, have no toxic effect on human body after safety evaluation, have stable chemical properties, and are not easily affected by temperature, PH value and storage time. There is no incompatibility with the main drug and auxiliary materials, which does not affect the inspection of the preparation, and plays a greater role with a smaller dose as much as possible.
The development path of drugs in China has always been based on the concept of "emphasizing raw materials, grasping preparations and neglecting excipients". With the large-scale development of raw materials and preparations, the attention of pharmaceutical excipients industry is still insufficient. China's pharmaceutical excipients started late, accounting for 3-5% of the total output value of pharmaceutical preparations, and it is predicted that it will reach 654.38+040.6 billion yuan in 2025.
Foreign pharmaceutical excipients account for 10-20% of the total output value of pharmaceutical preparations, and it is estimated that the global pharmaceutical excipients market will reach $85.3 billion in 2023. China pharmaceutical excipients market has a broad development space. Under the background of drug consistency evaluation, national centralized procurement and policy encouragement to develop high-end preparations, it is imperative for APIs to advocate green development and high-quality development of pharmaceutical excipients.