Investigation of insoluble particles test method of porous microsphere lyophilized powder

< Zimeng Technology> porous microsphere dry powder is a material with a special structure, which can use its own large specific surface area and porous structure as a carrier of active substances, which can simultaneously load a variety of active substances, such as growth factors, proteins, peptides, etc.
, change the way of adding and releasing active substances, can increase its stability, prolong the release time, prolong the effective action time, maintain the release concentration, and reduce the irritating substances to the skin, reduce toxic side effects
。 Porous microsphere dry powder is widely used in the pharmaceutical field and cosmetics industry, so it is very important for the detection of porous microspheres
.
The technicians of Zimeng Technology have done a lot of experiments on the detection of particles in porous microfluids, and finally found a suitable method
.
The biggest feature of porous microsphere dry powder is large particle size, easy to stick to the wall, and easy to precipitate
.
Section CP0903 of the Chinese Pharmacopoeia explains that the photoresist method is not suitable for preparation products that are prone to bubbles, easy to crystallize and high viscosity, and microscopic counting is required to detect
insoluble particles in such products.
The disadvantages of photoresist testing of insoluble particles of porous microspheres dry powder are: 1) The large particle size makes it easy to block the channel during detection and cause damage
to the equipment.
2) The particle size is large and numerous, and the particles are easy to block each other during the test, resulting in false results
.
The technicians of Zimeng Technology have done a lot of experiments and found that the microscopic counting insoluble particle meter ZMP930 is suitable
for detecting porous microsphere dry powder.
Specific operation steps: 1.
First check the blank membrane, place the blank filter on the test platform, scan the entire filter membrane and analyze it to ensure that the filter itself is clean, if the number of particles on the filter membrane exceeds the value specified in the pharmacopoeia, it is necessary to clean the filter membrane or replace the new filter membrane, and repeat this step
again.
Ensure that the number of particles in the membrane itself is within the limits specified by
the pharmacopeia.
2.
After wetting the membrane, place it on the filter device, dilute the porous microsphere dry powder with absolute ethanol, and the diluent passes through the filter membrane in the filter device to collect particles
.
3.
Use a metal bath to dry the filter membrane, the drying temperature is set at about 25 °C-30 °C, because absolute ethanol is volatile, so as to avoid the drying speed is too fast The filter membrane is curled and uneven, the drying time is about 10 minutes, and there is no watermark or waterline on the surface of the filter membrane
.
4.
Use special flat-tipped tweezers to put the dried filter membrane into the microcounting insoluble particle meter ZMP930 for whole image scanning
.
5.
Analyze the experimental data, export the standard report, and obtain the test report
of the porous microsphere dry powder.
Technical advantages of microcounting insoluble particle meter ZMP930: 1) Automatic scanning of the full filter membrane, simple operation, saving time; 2) Automatic counting of particles, protect eyes, reduce human operation errors; 3) Comply with national pharmacopoeia/national standard regulations, and automatically issue pharmacopoeia reports with one click; 4) Meet the 21CFR Part 11 regulations and GMP requirements for data integrity; 5) Super depth of field autofocus function to ensure that every picture is clear and not miss every grain
.