Production and storage of sprays

① Sprays should be prepared in an environment that meets the requirements of the relevant varieties, such as a certain degree of cleanliness, sterilization conditions, and low-temperature environment.
② Additives such as solvents, cosolvents, antioxidants, antibacterial agents, and surfactants can be added as needed. When determining the formulation, the antibacterial efficacy of the antibacterial agent should comply with the provisions of the antibacterial efficacy test method (General Principle 1121 of the Chinese Pharmacopoeia). The added additives should be non-irritating to the skin or mucous membranes.
③ All components in the spray device should be made of non-toxic, non-irritating, stable materials that do not react with the drug.
④ The drug solution of the solution-type spray should be clear; the droplets of the emulsion-type spray should be evenly dispersed in the liquid medium; the suspension-type spray should fully mix and grind the drug powder and additives to make a stable suspension. The size of the droplets (particles) for inhalation after atomization by the nebulizer should be controlled below 10μm, and most of them should be below 5μm.
⑤ Unless otherwise specified, the spray should be stored in a sealed manner away from light.
⑥ Inhalation sprays and metered-dose inhalation sprays for nebulizers should be sterile preparations.