Study on the Physical Properties of Chinese Medicine Pellet Soft Material by Texture Analyzer

Pellets are spherical bodies of less than 2.5 mm in diameter composed of pharmaceutical powders and excipients. They are multi-unit drug delivery systems and have many advantages over single-dose delivery systems. Each dose usually contains tens or Hundreds of pellets, the release behavior is the sum of the individual pellets; the distribution area in the body is large, the bioavailability is high, and the intestinal tract is small; the retention time in the stomach is long, the particle size is small, and the transport is transported by food. The influence of rhythm is small. With the development of modern pellet manufacturing technology, the application of pellets in immediate release and controlled release formulations is increasing.

For a long time, traditional Chinese medicine pellets have been mainly prepared by coating pan and panning method. The operation is complicated, the yield is low, and the drug loss is large, which seriously affects the industrial production efficiency. In recent years, continuous improvement of technologies and equipment such as extrusion spheronization, centrifugal granulation, and fluidized bed granulation have greatly promoted the development of traditional Chinese medicine pellets. Extrusion rolling round is to mix the drug and the auxiliary material evenly, adding the adhesive to make the soft material, and extruding the wet material through a hole or sieve with a certain pore diameter to form a cylindrical particle or a strip extrudate, and then rolling into a pellet The method for preparing the pellets is stable, reliable, simple in operation, large in production volume and high in production efficiency. The pellets prepared by the method have smooth surface, narrow particle size distribution, high roundness, good fluidity and brittleness. The low degree of fragmentation is especially suitable for the mass production of Chinese medicine pellets, and it is especially suitable for the preparation of pellets of Chinese medicine water extracting powder.

The formability of the pellets prepared by the extrusion spheronization method largely determines the physical properties of the soft materials, and the soft materials must satisfy the requirements of extrusion and spheronization. The main process of the extrusion process is the softness of the soft material, the fluidity through the mesh and the ability to cohesive into a rod-like extrudate, and it is required to remain homogenous throughout the extrusion process; Whether the output can be interrupted into a pellet. The ideal extrudate should be capable of being cut into short rods of the appropriate size and also be sufficiently flexible to form a sphere under the action of the turntable. In order for the particles to be separated and kept discrete throughout the process, there should be no adhesion between the extrudates, between the extrudate and the turntable, and the extrudate should have sufficient cohesion to ensure that the extrudate does not It will be broken into fine powder. Therefore, the physical properties such as hardness, adhesion, elasticity and cohesiveness of soft materials are important factors affecting the rounding process of the airport.

1 Preparation of soft materials

Weigh 6 parts of the appropriate amount, add a certain proportion of wetting agent (distilled water), respectively, and put it into the extruder for extrusion, the mesh aperture is 0.6mm, the extrusion speed is 60rpm, that is.

2 Experimental methods

Instrument: Universal TA Texture Analyzer

Probe: P/BE reverse extrusion probe

( 1) Preloading

Since the state of the soft material in the sample cup, that is, the initial state of the test, has a great influence on the experimental result, in order to ensure the consistency of the state before the test, the soft material in the sample cup is pre-pressed in advance.

Test mode: single compression

Speed ​​before test: 2mm/s

Test speed: 5mm/s

Speed ​​after test: 5mm/s

Trigger force: 5g

Target mode: force 1500g

(2 ) Full texture analysis ( TPA)

Full-texture analysis (TPA) typically involves two compressions of a sample to determine the physical properties of the sample.

Test mode: TPA

Speed ​​before test: 2mm/s

Test speed: 5mm/s

Speed ​​after test: 5mm/s

Trigger force: 1500g

Target mode: deformation 40%

Add 30g soft material to the anti-extrusion cup, pre-press the sample by pre-pressing method, and then pass the TPA test after pre-pressing to test the hardness, recovery, adhesion, cohesion, elasticity of the soft material. Chewing and other indicators.

3 Experimental results

Hardness indicates the local resistance of the solid to the invasion of external objects. The greater the value, the stronger the ability of the soft material to resist deformation, which may result in the disintegration degree of the tablet not meeting the requirements, and the preparation of the pellets by the extrusion spheronization method. It will cause more pellets to be short rods, affecting the roundness; excessive or too little adhesion or cohesiveness may affect the quality of tablets, pills and granules, such as the adhesion of tablets or Problems with the yield of tablets, pills and granules. Elasticity indicates the energy retained by the soft material when it is sheared. The greater the value, the stronger the ability of the soft material to return to its original shape after the shear force is removed, which may affect the formulation of the formulation.