As a multifunctional testing equipment specialized for the pharmaceutical industry, the tablet four use instrument strictly follows the technical requirements of the Chinese Pharmacopoeia and international standards, aiming to quantify the quality of tablets through physical or chemical methods, and ensure the stability and effectiveness of drugs during production, storage, and use. The following are the core technical requirements of the tablet four use instrument:
1、 Core functions and technical parameters
Hardness testing:
Measurement range: usually 2-199N (some models can reach 2-200N), ensuring coverage of the hardness requirements of different tablets.
Accuracy error: ≤± 1.5% (some models have higher accuracy, such as ± 1N), ensuring the accuracy of measurement results.
Supporting tablet diameter: The maximum diameter can reach 16mm to 40mm, suitable for detecting tablets of different sizes.
Detection principle: The pressure plate is driven by a motor, and pressure is applied along the diameter direction of the tablet. The instantaneous force value during the crushing of the tablet is recorded by a pressure sensor, and the particle binding force is evaluated based on the tablet diameter, thickness, and crushing force.
Fragility testing:
Standard drum: equipped with a standard drum with an inner diameter of approximately 286mm and a depth of 39mm, simulating collisions and friction during vehicle and vessel transportation.
Adjustable speed: The maximum speed can reach 560 revolutions per minute (some models default to 25 revolutions per minute and can be set to 1-999 revolutions per minute), and different transportation conditions can be simulated by adjusting the speed.
Weight loss rate calculation: Weigh before and after testing, calculate the ratio of wear loss to initial tablet weight, and the pharmacopoeia requires ≤ 1%.
Dissolution test:
Testing method: Supports basket or paddle rotation to simulate the human digestive environment.
Temperature control: accuracy ± 0.5 ℃, ensuring the stability of the testing environment.
Speed range: 50-150rpm (some models extend to 25-250rpm), suitable for the dissolution needs of different drugs.
Dynamic release monitoring: The drug dissolution rate is detected by timed sampling using a UV spectrophotometer or HPLC, and the dissolution curves of the reference formulation and the test formulation are compared using the similarity factor method.
Determination of disintegration time limit:
Guide rod lifting frequency: 30-32 times/minute, simulating gastrointestinal peristalsis.
Disintegration time record: The time required for the recording agent to completely disintegrate is evaluated for its rapid release performance. The classification criteria include ordinary tablets ≤ 15 minutes, enteric coated tablets ≤ 60 minutes, and sustained-release tablets that meet the dissolution requirements.
2、 Intelligence and operational convenience
Touch screen interface: supports parameter preset, real-time data display, and wireless data transmission, simplifying the operation process.
Automatic control function: including automatic timed shutdown, automatic display, automatic locking, automatic reset, and automatic cyclic testing, to improve detection efficiency.
Security protection: Equipped with overload protection, real-time fault diagnosis, and dual over temperature protection functions to prevent equipment damage and data loss.
Transparent observation window: The hardness testing chamber is equipped with a transparent observation window for real-time monitoring of the testing process.
3、 Scalability and Structural Design
Batch testing capability: Some models support the installation of 6 sets of testing components simultaneously, which can batch test different batches of tablets and improve laboratory throughput.
Compact body design: reduces laboratory space occupation and adapts to laboratory needs of different scales.
Dissolution cup specifications: A dissolution cup with a height of 185mm and a volume of 1000ml, meeting the needs of large-scale testing.
4、 Compliance with standards and after-sales service
Adhere to standards: Technical indicators strictly comply with the Chinese Pharmacopoeia and international standards.
After sales service: Provides a complete machine warranty period (usually 1 year), which can be extended, and also offers on-site technical consultation and training services.