Zimeng - Particle size detection method for topical ointment preparations

<Zimeng Technology>Topical preparations are mostly applied to the surface of the skin, used to protect the skin, treat various skin diseases, or treat certain systemic diseases. In ancient China, preparations used for the skin included powders, ointments, wines, and pastes. Modern external preparations include powder, lotion, tincture, liniment, paint, cream, ointment, gel, paste, transdermal paste, spray, etc. External preparations have diverse dosage forms and complex excipient components. Small differences in prescription composition and preparation process parameters may lead to different quality characteristics of the product, thereby affecting the safety and effectiveness of the medication. Therefore, in the development of such formulations, scientific and reasonable detection is necessary, and particle size distribution is the most basic detection indicator to achieve consistency with the quality and efficacy of reference formulations.

In the testing of topical preparations, the detection of particle size and particle type is also of utmost importance. We take ointment as an example to analyze how to perform particle size detection. The main methods for determining the droplet size and API particle size distribution of ointment are laser particle size determination and microscopic analysis. Laser particle size determination is controversial due to its high requirements for sample preparation methods and the presence of large molecular substances in cream formulations, which may affect the specificity of the determination. Microscopic analysis is more intuitive and suitable for analyzing the droplet size of emulsions and creams.

The ZML310 external preparation particle size analyzer from Zimeng Technology provides a good detection method for ointment preparations.

Firstly, prepare the sample. One of the characteristics of this external preparation particle size analyzer ZML310 is that the sample preparation method is simple and does not require dilution of the sample. Apply the cream sample onto a microscope slide, gently press the cover with a cover slip, and place it under the microscope.

2. Focus, select the appropriate microscope objective, adjust to the field of view, use software to capture images, and then move to another field of view to capture images. Continuously capture several fields of view to ensure there are enough particles.

3. Analyze the particle size distribution and shape of the particles.