Study on physical properties of soft material of Chinese medicine pellets by texture analyzer

Pellets are spherical bodies with a diameter of less than 2.5mm composed of drug powder and excipients, which belong to multi unit drug delivery system Compared with single dose drug delivery system, they have many advantages Each dose usually contains dozens or hundreds of pellets, and the release behavior is the total sum of each pellet; the distribution area in the body is large, the bioavailability is high, and the intestinal irritation is small; in the stomach The retention time is long, the particle size is small, and the transport is little affected by the rhythm of food transport With the development of modern pelletizing technology, more and more pellets are used in rapid release, slow release and controlled release preparations For a long time, traditional Chinese medicine pellets were mainly prepared by the method of over coating pan pill The operation was complex, the output was low, and the drug consumption was large, which seriously affected the industrial production efficiency In recent years, the continuous improvement of extrusion spheronization, centrifugal granulation, fluidized bed granulation and other technologies and equipment has greatly promoted the development of Chinese medicine pellets The method of extruding round hair is to mix medicine and excipients evenly, add adhesive to make soft material, extrude wet material through a hole or sieve with a certain aperture to make cylindrical particles or strip extrudates, and then roll them into pellets The method is stable, reliable, easy to operate, large production volume and high production efficiency The surface of pellets prepared by this method is smooth and granularity is high Because of its narrow distribution, high roundness, good fluidity and low brittleness, it is especially suitable for the mass production of Chinese medicine pellets, especially for the preparation of Chinese medicine water extract powder To a large extent, the formability of the pellets prepared by extrusion and spheronization is determined by the physical properties of the soft material, which must meet the requirements of extrusion and spheronization In the extrusion process, Zui is mainly characterized by the compressibility of the soft material, the fluidity through the sieve hole and the ability to cohere into rod-shaped extrudates, and it is required to maintain homogeneity in the whole extrusion process; the success or failure of the rolling depends on whether the extrudates can be broken into pellets The ideal extrudate should be able to cut into a short rod of suitable size, and it should have enough elasticity to form a sphere under the action of a turntable In order to keep the particles separate and discrete in the whole process, there should be no adhesion between the extrudates, between the extrudates and the turntable, and the extrudates should have enough cohesion to ensure that the extrudates will not break into fine powder Therefore, the hardness, adhesion, elasticity, cohesion and other physical properties of the soft material are important factors affecting the rolling process of the airport 1 Preparation of soft materials: weigh 6 parts of materials, add a certain proportion of wetting agent (distilled water) respectively, and put them into the extruder for extrusion The mesh diameter is 0.6mm, and the extrusion speed is 60rpm 2 experiment method instrument: Universal TA texture instrument probe: P / be back extrusion probe (1) preloading Because the state of the soft material in the sample cup, i.e the initial state of the test, has a great influence on the experiment results, in order to ensure the consistency of the state before the test, the soft material in the sample cup is preloaded in advance Test mode: speed before single compression test: 2mm/s test speed: 5mm/s after test speed: 5mm/s trigger force: 5g target mode: 1500g force (2) total texture analysis (TPA) total texture analysis (TPA) generally, the sample is compressed for two times to determine the physical properties of the sample Test mode: TPA speed before test: 2mm / s test speed: 5mm / s test speed after test: 5mm / s trigger force: 1500g target mode: deformation 40% 30g soft material is added into the back extrusion cup, and the sample is pre pressed by pre pressing method, and then tested by TPA after pre pressing to test the hardness, recovery, adhesion, cohesion, elasticity, mastication and other indexes of the soft material 3 experimental results Hardness refers to the local resistance of the solid to the invasion of external objects The larger the value is, the stronger the ability of the soft material to resist deformation is, which may cause the disintegration of the tablet not to meet the requirements For the preparation of pellets by extrusion and spheronization method, more pellets will be in the shape of short rods, which will affect the roundness Too large or too small adhesion and cohesion may affect the tablets, pills and granules Quality has an impact, such as tablet viscosity or powder, pill and granule yield Elasticity refers to the energy retained by the soft material when it receives shear The larger the value is, the stronger the ability of the soft material to return to its original shape after the shear force is removed, which may affect the formation of the preparation.