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The basic concept of a pack of chips
Package chip (as shown in Figure 1): the outer layer of the chip is coated by means of tableting, the general chip is released slowly, and the outer layer is released (or controlled release), which is also a kind of preparation of two-component drug multiple times. Controlled-release tablets are compressed into tablets which are not mixed with each other. The middle inner layer is called a chip, and the chip is a kind of relief tablet, which can protect against light and control oxidation, and can also control the release rate of each component drug separately.
Structure and principle of 2 rotary tablet press (rotary core tablet press)
2.1 The composition of the rotary core-spinning press consists of a casing, an upper pressing wheel, upper and lower rails, a turntable, a feeding, a lower pressing wheel, a transmission, a lubrication, and a core-adding component or device.
2.2 Principle When the machine is driven by the motor, the turntable rotates, and when the turntable drives 20 pairs of punches to rotate, the turntable with gears also rotates the cored disk, and the up and down punching moves with the curved guide rail to complete the filling and pressing action. The core is completed by the action of the core device, where the outer layer is initially filled, cored, and refilled to complete the compression of the packaged chip. Among them, the upper pressing wheel can adjust the depth of the upper punching die by moving up and down to achieve the control of the thickness of the pressing process; the upper and lower rails are equivalent to the cylindrical cam, which determines the orbit of lifting up and down on the circumference.
2.3 Several special loading and core loading systems are the key to the core-loading machine. It involves the precise positioning and detection of the chip position. This requires the core position of the chip to be accurate and avoid when the core disk is running. The chip is misplaced.
2.3.1 Powder suction device The device consists of a powder suction nozzle, a damping pin, a spring and an adjusting screw. The powder suction nozzle is fixed on the frame, the powder suction port is aligned with the core circle, and the suction port position is not adjustable to meet the requirements of the suction chip; the damping pin is adjusted by the spring in the front through hole of the suction nozzle. The screw is placed on the spring, and the adjusting screw is used to adjust the spring tension so that the end face of the damping pin is tightly attached to the core disk, which can eliminate the gear backlash generated when the three sets of gears drive the core disk, so that the core disk operates. Smooth, correspondingly improve the pass rate of the core. When the machine is running, the powder suction device can use negative pressure to suck the stuck chip and powder, which can avoid the powder on the surface of the chip is easy to be adsorbed on the card chip in the core hole, and the phenomenon of "card core" will cause the tablet to be missing. The core rate rises, and when it is severe, the chip will be broken and the core process cannot be performed.
2.3.2 Core-adding device The device consists of a turntable, a cored disk, a lower punch, a lower punched core rail and a gear. Wherein, the center of the turntable is connected with a central axis, and the punch circle is uniformly provided with a die hole; and the center of the cored disk is connected with a cored shaft, and the core circle is uniformly provided with a core hole; the lower punch is added to the core rail The lower punching core is connected to the lower rail, and the lower punch slides on the track of the lower punching core and the lower rail, and the lower punching core rail has an angle with the horizontal, so that the pitch circle of the turntable intersects with the core circle of the core. . In this way, the special device changes the position of the chip from tangent to two points, so that the position of the core is accurate, and the chip is synchronized with the running of the middle mold, which ensures the accuracy of the core and improves the stability of the operation.
(3) The core nozzle device is a split structure. The core tube can adjust the radial direction and the upper and lower positions by adjusting the bracket. The adjusted core nozzle position can make the chip neither turn nor jam.
3 rotary core film tableting machine features
3.1 Structure (1) The fully enclosed structure is used, and the working chamber is isolated from the outside to ensure the cleaning of the core and the pressing area, and will not cause cross-contamination with the outside world.
(2) The core drop and tableting chamber are made of stainless steel, which is easy to clean and maintain, ensuring clean and non-polluting parts in contact with the drug.
(3) Since the turntable is in direct contact with the powder, the surface of the stainless steel surface of the turntable adopts an innovative surface treatment process, and the surface has a high hardness to ensure that these surfaces are resistant to corrosion and wear, thereby inhibiting the precipitation of insoluble particles.
(4) With the split type turntable, the direct contact part with the medicine can be disassembled to ensure the reliable cleaning and disinfection of the surface of the part.
(5) For the quality control of the affected package chips, the “double multiple†automatic detection and rejection process is adopted, so that the core rate of the package chip reaches 100%, and the process requirements are met.
3.2 Control (1) The whole machine electrical control adopts PLC controller and variable program control, with various automatic control functions such as tablet overload stop, chip hopper shortage and shutdown.
(2) Double detection of photoelectric switch and pressure sensor ensures automatic chipping of missing chips. First, the use of photoelectric sensing, when the chip or chip position is inaccurate, it will immediately send an abnormal signal; secondly, the pressure sensor will also send an abnormal signal when it encounters undervoltage. When any unit of this double detection generates an abnormal signal, the PLC controller will start the chipping process to complete the chipping action. In order to ensure that the photoelectric sensor can still complete the test when it fails, a second set of photoelectric sensors is added, so that the core rate of the package chip reaches 100%.
(3) Based on the core tablet press, when the tablet is pressed, there are many movements and many detection points, so the speed adjustment and the control are required to be accurate. The machine enables the speed control through the advanced variable frequency motor and the frequency converter.
3.3 Operation (1) The operation of the handwheel and electrical control of the whole machine are concentrated in the positive direction, which is convenient to operate. The thickness of the tablet, the filling amount, the pressure, the speed and the speed are adjusted by the hand wheel and the button control. The adjustment range is controlled by a special device. The adjustment size is displayed by the scale. The pressure 9 adjustment and speed adjustment only need to press the function key on the touch screen. The value can be reached and read directly from the reading tachometer and pressure gauge for easy operation and control.
(2) The electrical control system of the whole machine has the characteristics of safety, reliability, convenient operation and maintenance. The control system has multiple protection measures. The operation panel has visual symbols, and the operation instructions are extremely intuitive, which is conducive to the operation and maintenance personnel to troubleshoot.
(3) The machine can be used as a general ordinary tablet press or used to press double-layer sheets with a slight change.
3.4 indicators (1) higher tablet pressure, can ensure the mechanical properties of the package chip, especially the performance verification of the hardness and friability of the packaged chip. At the same time, these indicators have a decisive influence on film coating.
(2) The coaxiality between the chip and the package chip is ≤ Ф 0.3.
4. Application prospects of rotary core- pressing machine
Based on the fact that there is a big gap between the research and development of dosage forms in China and the developed countries in the West. In a sense, creating a new dosage form is equivalent to creating a new drug, and slow release is one of the new dosage forms. This new dosage form at home and abroad is also enjoying the same conditions of patent protection. The development of new drugs similar to slow-release drugs is a fast and good development method, especially in the reality that China's preparations are relatively backward. Particularly important.
However, the packaged chips are part of the controlled release drug, and most of the controlled release drugs are mostly micropellets. The large effect of the packaged tablet tablet is slow and controlled release, which can release the drug slowly (sustained release) or constant rate (controlled release) according to a certain regularity, and the drug maintains the effective drug concentration for a long time in the body, thereby achieving a reduction. Drug dosage, improve the efficacy and safety, prolong the effect of the drug and reduce the frequency of drug use, and reduce the phenomenon of blood concentration peaks and valleys. The development and research of such dosage forms has received extensive attention abroad, but has just begun in China.
The reason why the package chip is favored by people is because it has many features that are unmatched by ordinary tablets:
(1) When the drug is administered, the outer component of the packaged chip is distributed on the surface of the intestinal mucosa during administration, and the components of the chip are concentrated on the surface of the gastric mucosa to completely absorb the drug, thereby improving bioavailability.
(2) Through the combination of different release rates of the two layers, a better release rate can be obtained, the expected blood concentration can be achieved, and a stable, long-term effective concentration can be maintained, the toxicity of the drug can be reduced, and the stomach can be avoided. Adverse reactions such as mucosal irritation.
(3) Tablets which are not mixed with each other by two different components can increase the stability of the drug.
(4) The process of slowly controlling the release of the packaged chip by the tableting method to achieve the outer coating is more reliable than the direct coating on the surface of the tablet, and the problem of drug leakage caused by uneven coating of the tablet directly can be avoided.
(5) Package chip technology and then adding components with slow release pellets and outer layer recoating technology, can prepare more combinations of slow and controlled release requirements, which overcomes the limitation of the effect of compressing tablets with a single controlled release pellet. Sexuality can also extend the requirements for more controlled release of the drug delivery process.
Rotary cored tablet press structure principle and prospect
One of the trends in the development of tablets in China is to create new dosage forms. One of the new tablets is a controlled release drug, and some of the controlled release tablets need to be coated. The core preparation of the tablet will depend on the core. The tablet press was implemented.