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CN-121972002-A - Sterilization device for producing lactulose bulk drug and use method thereof

CN121972002ACN 121972002 ACN121972002 ACN 121972002ACN-121972002-A

Abstract

The application relates to a sterilization device for producing lactulose bulk drug and a use method thereof, which relate to the technical field of biological pharmacy, and the sterilization device comprises a filter cavity and a filter module, wherein the upper end of the filter cavity is provided with a feed inlet, the lower end of the filter cavity is provided with a discharge outlet, the filter module is arranged in the filter cavity, and the filter module is used for filtering microorganisms in the liquid flowing from the feed inlet and can ensure that thick liquid passes through the filter module at a normal flow rate. The application can actively and intelligently resist the problem of membrane blockage caused by high viscosity, thereby ensuring the filtration flux of the filtration membrane and the production efficiency of products.

Inventors

  • CHEN SHAOYAN
  • CAO YANLAI
  • XU CHENGWU

Assignees

  • 湖北广辰药业有限公司

Dates

Publication Date
20260505
Application Date
20260109

Claims (8)

  1. 1. A sterilization apparatus for producing a lactulose drug substance, comprising: The filter comprises a filter cavity (1), wherein a feed inlet (11) is formed in the upper end of the filter cavity (1), and a discharge outlet (12) is formed in the lower end of the filter cavity (1); the filtering module (2) is arranged in the filtering cavity (1), and the filtering module (2) is used for filtering microorganisms in liquid flowing from the feeding hole (11) and can ensure that thick liquid passes through the filtering module (2) at a normal flow rate.
  2. 2. A sterilization apparatus for producing a lactulose drug substance as claimed in claim 1, wherein said filter module (2) comprises: The mounting frame (21) is arranged in the filter cavity (1), and a filter membrane (23) for filtering microorganisms in liquid is arranged on the mounting frame (21); the shape memory alloy grid (24) is arranged on the mounting frame (21), and the shape memory alloy grid (24) is positioned at the upper end of the filtering membrane (23) and keeps a preset tiny gap with the surface of the filtering membrane (23); a heating and vibrating assembly (3) for instantaneously heating the shape memory alloy mesh (24) and vibrating the shape memory alloy to enhance the fluidity of the liquid.
  3. 3. A sterilization apparatus for lactulose drug substance production as claimed in claim 2, wherein said shape memory alloy mesh (24) is composed of a plurality of shape memory alloy wires which are fixed in tension in a low temperature martensitic state and have a tendency to recover a nonlinear shape when heated to a high temperature austenitic state, thereby generating mechanical micro-vibration in a restrained state.
  4. 4. A sterilization apparatus for lactulose drug substance production as claimed in claim 3, wherein said heat-supplying vibration unit (3) is a pulse power controller electrically connected to said shape memory alloy grid (24), said pulse power controller being adapted to apply a pulse current to said shape memory alloy grid (24) to drive said shape memory alloy grid (24) to generate heat and mechanical micro-vibration to locally heat and dynamically disturb the feed liquid in the vicinity of the surface of said filtering membrane (23).
  5. 5. The sterilization device for producing lactulose bulk drug according to claim 4, wherein a monitoring component (4) for monitoring the pressure difference between the upstream and downstream of the filtering membrane (23) is arranged in the filtering cavity (1), the monitoring component (4) is electrically connected with the pulse power controller, and the pulse power controller adaptively adjusts the frequency or amplitude of the pulse current according to the pressure difference change monitored by the monitoring component (4).
  6. 6. A sterilization apparatus for lactulose bulk drug production as claimed in claim 3, wherein said filter membrane (23) is provided as an elastic filter membrane (23), a protrusion (231) is provided at each focal point of shape memory alloy wires in said shape memory alloy mesh (24), said protrusion (231) being in contact with an upper end surface of said filter membrane (23).
  7. 7. A sterilization apparatus for lactulose bulk drug production as claimed in claim 2, wherein said mounting frame (21) is provided with a detachable connection member (5) for facilitating replacement of the filter membrane (23).
  8. 8. A method of using a sterilization apparatus according to any one of claims 1-7, comprising the steps of: s1, injecting lactulose raw material medicine solution to be sterilized from a feed inlet (11) of the filter cavity (1); S2, starting the heat supply vibration component (3), applying electric energy to the shape memory alloy grid (24) to enable the shape memory alloy grid to generate mechanical micro-vibration by utilizing a phase change effect in a constrained state, and simultaneously, locally heating the lactulose raw material solution near the surface of the filtering membrane (23); S3, regulating and controlling the electric energy application parameters of the heat supply vibration assembly (3) to actively manage the fluid boundary layer state on the surface of the filtering membrane (23) by cooperatively utilizing the dynamic turbulence and viscosity reduction effect generated by the mechanical micro-vibration and the local heating, so that the aseptic filtration of the lactulose raw material solution is realized while the filtration flux is ensured; And S4, when the filtering membrane (23) needs to be replaced, the filtering membrane (23) is replaced independently by operating the detachable connecting piece (5) on the mounting frame (21).

Description

Sterilization device for producing lactulose bulk drug and use method thereof Technical Field The application relates to the technical field of biological pharmacy, in particular to a sterilization device for producing lactulose bulk drugs and a use method thereof. Background In the production process of the lactulose bulk drug, the sterilization treatment of the terminal is a key step for ensuring the sterility of the product and ensuring the medication safety, but the traditional sterilization treatment mode is usually high-temperature steam, and the lactulose bulk drug can be sterilized by adopting a sterile filtration mode because the lactulose can be degraded and isomerized at high temperature for a long time. The sterile filter in the prior art generally comprises a stainless steel shell and a built-in filter element, wherein a filter membrane capable of filtering microorganisms in solution is arranged on the built-in filter element, the solution enters the shell from a feed inlet at the upper end of the shell, and then flows out from a discharge outlet at the lower end of the shell after being filtered by the filter membrane, so that the sterilization treatment of the solution is completed. However, since the viscosity of lactulose bulk drug is relatively high, a high driving pressure is required when fluid passes through a micron-pore filtration membrane, under high pressure, the concentration of solute molecules on the membrane surface is rapidly increased, so-called concentration polarization phenomenon is formed, and the concentration polarization phenomenon rapidly develops into a dense gel layer, which is a main source of filtration resistance, and rapidly blocks the membrane pores, so that the filtration flux is rapidly reduced, the production batch time is prolonged, and even filtration cannot be completed. Disclosure of Invention The application aims to provide a sterilization device for producing lactulose bulk drug and a use method thereof, which can actively and intelligently resist the problem of membrane blockage caused by high viscosity, thereby ensuring the filtration flux of a filtration membrane and the production efficiency of products. In a first aspect, the application provides a sterilization device for producing lactulose bulk drugs, which adopts the following technical scheme: the filter comprises a filter cavity, wherein the upper end of the filter cavity is provided with a feed inlet, and the lower end of the filter cavity is provided with a discharge outlet; the filtering module is arranged in the filtering cavity and is used for filtering microorganisms in the liquid flowing from the feeding hole, and thick liquid can be ensured to pass through the filtering module at a normal flow rate. Optionally, the filtering module includes: The mounting frame is arranged in the filter cavity, and a filter membrane for filtering microorganisms in liquid is arranged on the mounting frame; the shape memory alloy grid is arranged on the mounting frame, is positioned at the upper end of the filtering membrane and keeps a preset micro gap with the surface of the filtering membrane; And the heat supply vibration assembly is used for instantaneously heating the shape memory alloy grid and vibrating the shape memory alloy so as to strengthen the fluidity of the liquid. Optionally, the shape memory alloy mesh is composed of a plurality of shape memory alloy wires that are tensioned and fixed in a low temperature martensitic state and have a tendency to recover a nonlinear shape when heated to a high temperature austenitic state, thereby generating mechanical micro-vibrations in a constrained state. Optionally, the heat supply vibration component is a pulse power supply controller, the pulse power supply controller is electrically connected with the shape memory alloy grid, and the pulse power supply controller is used for applying pulse current to the shape memory alloy grid so as to drive the shape memory alloy grid to generate heat and mechanical micro-vibration, thereby carrying out local heating and dynamic turbulence on the feed liquid near the surface of the filtering membrane. Optionally, a monitoring component for monitoring the upstream and downstream pressure differences of the filtering membrane is arranged in the filtering cavity, the monitoring component is electrically connected with the pulse power supply controller, and the pulse power supply controller adaptively adjusts the frequency or the amplitude of the pulse current according to the pressure difference change monitored by the monitoring component. Optionally, the filtering membrane is an elastic filtering membrane, each focus of the shape memory alloy wires in the shape memory alloy grid is provided with a protrusion, and the protrusions are in contact with the upper end face of the filtering membrane. Optionally, the mounting frame is provided with a detachable connecting piece which is convenient for replacing the filt