Zimeng-Multi functional particle size analyzerSuspension budesonide nasal sprayinapplication

In the treatment of allergic rhinitis, nasal polyps and other common nasal diseases, the suspension budesonide nasal spray relies on“Strong local anti-inflammatory effect and low systemic side effects”Our core advantages make us the trusted choice for clinical doctors and patients. Behind this' trust 'lies a key quality control point - the particle size of the active ingredient budesonide. The particle size directly determines the deposition rate, bioavailability, and therapeutic effect of drugs on the nasal mucosa, and its precise detection has become a "must test" for quality control in pharmaceutical companies.

1 Testing pain points, bottlenecks that traditional devices find difficult to overcome

For the suspension budesonide nasal spray, "particle size" is not a simple numerical index, but a core parameter directly related to clinical value. If the particles are too large (over 10 μ m), they are prone to form sediment blocks in the nasal cavity, which not only cannot effectively penetrate the mucosa to exert anti-inflammatory effects, but may also cause local irritation; If the particles are too small (less than 1 μ m), they are prone to enter the deep respiratory tract with the airflow, increasing the risk of systemic absorption and violating the original design intention of "local medication".

Suspension agent“Solid particles dispersed in liquid medium”As a feature, budesonide nasal spray also contains complex excipients such as surfactants and suspension aids, which make the traditional particle size analyzer frequently "fail". The main pain points focus on three aspects:

1. Particles are prone to agglomeration, and the true particle size cannot be hidden

Budesonide particles have a large specific surface area and high surface energy, making them highly susceptible to degradation in liquid mediamolecular forceReunion occurs, formingFake large particlesThe dispersion system of traditional equipment is mostly fixed power ultrasound or simple stirring, or the dispersion is insufficient to disperse the aggregates, resulting in false high particle size measurement; Either excessive dispersion can damage the particles themselves, resulting in distorted results and making it difficult to capture the true particle size distribution of the particles.

2. The particle size distribution is wide, but the testing accuracy cannot keep up

To achieve balanceSedimentation efficiencyand'Security'，The particle size of budesonide nasal spray must have a certain distribution range, while the traditional single technology equipment has obvious shortcomings: the laser method has low sensitivity to identify large particles, and it is easy to miss particles that exceed the standard;Ordinary microscopeWeak ability to capture small particles, unable to accurately calculate the proportion of fine particles, resulting in one-sided test results that cannot fully reflect the overall particle size distribution.

3. Strong matrix interference makes signal recognition difficult to distinguish

The auxiliary materials such as propylene glycol and stabilizer in budesonide nasal spray will produce optical interference with the test system - or reflect the laser signal, or react with the test reagent, causing the equipment to misjudge the auxiliary material interference as "particle signal"; At the same time, the viscosity characteristics of the formulation can also affect the injection stability, further exacerbating testing errors. The anti-interference ability and adaptability of traditional equipment are difficult to meet the requirements.

II ZML320 core advantage, precise solution to suspension testing difficulties

There are various suspension systems (such as external suspension, sustained-release gel, medicated cream, etc.), and the samples often have problems such as uneven color, large particle size span, easy agglomeration, etc. It is difficult for traditional equipment to achieve full type adaptation. ZML320 precisely overcomes this pain point through multi-dimensional design:

a. Synchronous analysis of particle size and shape:Equipped with a 20 megapixel high-definition color camera and a professional image analysis system, it can synchronously measure equivalent diameter, roundness, aspect ratio, etcmanyThe morphology parameters are used to characterize the microstructure of suspension particles from both particle size and shape dimensions, filling the technical gap in traditional equipment that can only characterize particle size alone. For example, in pharmaceutical suspension testing, particle shape parameters can predict the transdermal absorption efficiency and irritation risk of particles, providing more comprehensive data support for formulation process optimization.

b. Wide range detection with full coverage:The analysis range covers 0.2 μ m~3000 μ m, which can accurately capture the full particle size distribution range from submicron level ultrafine particles to micron level conventional particles in the suspension, and adapt to the testing needs of different dosage forms of suspensions. Multiple types of sample detection can be completed without changing equipment.

c. Intelligent anti-interference adaptation:Supporting flexible switching of multiple background modes, the detection conditions can be adjusted according to the color and transparency characteristics of the suspension. For example, white background mode can be used for colored suspensions to effectively avoid the interference of sample color on particle recognition and accurately distinguish particles from impurities, aggregates from single particles.

d. Simplify operations to improve efficiency:The sample pre-treatment process is greatly simplified, without the need for complex mixing, and the testing cycle for a single sample is shortened to a few minutes; The testing process supports automatic photography, automatic particle recognition, and automatic statistical analysis. The particle count can reach thousands, ensuring the representativeness and efficiency of the statistical results

In addition to budesonide nasal spray, the strong adaptability of ZML320 can also coverSemi solid preparationMicrospheresSolid preparations, solid powdersParticle size analysis of various pharmaceutical preparations, as well as raw materials and pharmaceutical excipients. Zimeng Technology has always been committed to“Drive R&D and quality control upgrade”To fulfill our mission, we will work together with pharmaceutical companies to safeguard public medication safety and build a high-quality development path for the pharmaceutical industry with more accurate, stable, and intelligent detection equipment.