CN-121994875-A - Drug encapsulation production monitoring device and use method

CN121994875ACN 121994875 ACN121994875 ACN 121994875ACN-121994875-A

Abstract

The application discloses a medicine encapsulation production monitoring device and a use method thereof, and relates to the technical field of biological medicines, wherein the medicine encapsulation production monitoring device comprises a waste liquid collecting part, a sample collecting part and a monitoring component, wherein output pipelines capable of switching on states are respectively arranged between the monitoring component and the waste liquid collecting part and between the monitoring component and the sample collecting part, and the monitoring component is used for receiving target medicines and detecting the component proportion of the target medicines; the monitoring component is used for switching the conducting state of the two output pipelines according to the detection result of the component proportion of the target medicine, can be adapted to the traditional large-scale medicine encapsulation production line, can be flexibly embedded into miniaturized and integrated preparation scenes such as microfluidic chips, ensures timely diversion of unqualified products, and effectively ensures the quality and yield of final products.

Inventors

ZHANG XIAO
CHEN XUEPING
YANG HANLIN
DONG JIANHUA
LI SHUYOU
LU JUN
WEN XIAOHUI
YE QINGQING
WANG YUANHUA

Assignees

中国科学院广州生物医药与健康研究院

Dates

Publication Date: 20260508
Application Date: 20260128

Claims (10)

1. A pharmaceutical encapsulation production monitoring device, comprising: A delivery assembly for delivering components of a target drug independently of each other; The mixing unit is connected with the conveying assembly and is used for mixing the components conveyed by the conveying assembly into the target medicine; the monitoring component is connected to the mixing unit and used for detecting the target medicine, and comprises two mutually independent output pipelines which are respectively used for outputting unqualified waste liquid and qualified samples, and the monitoring component is used for switching the conduction states of the two output pipelines according to the detection result of the component proportion of the target medicine.
2. The apparatus of claim 1, wherein the monitoring module comprises an input end for inputting a target drug, a first output end for outputting a waste liquid, a second output end for outputting a sample, and a third output end connected to an inlet end of the detection structure, and an outlet end of the detection structure connected to an outlet end of the first output end.
3. The pharmaceutical encapsulation manufacturing monitor of claim 2, wherein the third output is disposed between the input end of the first output and the input end of the second output.
4. The pharmaceutical encapsulation production monitoring device of claim 3, wherein the detection structure is a microfluidic chip comprising an electrical impedance detection structure.
5. The pharmaceutical encapsulation manufacturing monitor of claim 1, wherein the delivery assembly comprises at least two sets of fluid pumps, each of the fluid pumps being coupled to the mixing unit for delivering a material, the mixing unit having an output coupled to the monitoring assembly.
6. The pharmaceutical encapsulation manufacturing monitor of claim 5, wherein a flow meter is disposed between each of the fluid pumps and the mixing unit.
7. The pharmaceutical encapsulation manufacturing monitoring device of claim 5, wherein the delivery assembly comprises two sets of the fluid pumps.
8. A method of using a pharmaceutical encapsulation production monitoring device according to any one of claims 1 to 7, comprising the steps of: inputting raw materials according to a preset component proportion; the output pipeline between the monitoring component and the unqualified waste liquid is conducted; the monitoring component performs sampling inspection on the target medicine according to preset interval time; When the deviation of the proportion of the detection components exceeds a preset error range, closing the output pipeline between the monitoring assembly and the sample with qualified output, and conducting the output pipeline between the monitoring assembly and the waste liquid with unqualified output; Correcting the proportion of the input components, repeating the steps until the deviation of the proportion of the detected components is within a preset error range, closing the output pipeline between the monitoring assembly and the unqualified waste liquid, and conducting the pipeline between the monitoring assembly and the qualified sample.
9. The method of claim 8, wherein the error is in the range of-5% to 5% of the error of the actual duty cycle of each component compared to the target duty cycle.
10. The method of claim 8, wherein the predetermined time interval is 500ms.

Description

Drug encapsulation production monitoring device and use method Technical Field The application relates to the technical field of biological medicines, in particular to a monitoring device for drug encapsulation production and a using method thereof. Background The nucleic acid nano-drug is focused as a brand-new biological therapeutic means, and the problems of nucleic acid nano-drug preparation efficiency and real-time quality monitoring are key to solving the problem of early development to clinical-grade application of the nucleic acid nano-drug. The technology of drug encapsulation is one of the core processes in the field of biological medicine, and the component proportion of the encapsulated product directly determines the activity, stability and administration safety of the drug. Traditional medicine encapsulation production links rely on multi-unit systems to finish, generally contain a plurality of functional units such as material bear, proportion detection, material reposition of redundant personnel, and the whole design of traditional monitoring relevant device is difficult to match miniaturized, integrated production scene such as micro-fluidic chip, and traditional technique has efficiency bottleneck in monitoring with follow-up product management and control's linking, easily leads to disqualified product accumulation because of management and control hysteresis, and simultaneously complicated material circulation route has also increased cross contamination's risk, and then influences the reliability of monitoring result and the quality stability of final product. Disclosure of Invention In order to solve at least one of the above technical problems, the present application provides a device for monitoring production of pharmaceutical encapsulation and a method for using the same, and the technical scheme adopted is as follows. The application provides a drug encapsulation production monitoring device, comprising: A delivery assembly for delivering components of a target drug independently of each other; The mixing unit is connected with the conveying assembly and is used for mixing the components conveyed by the conveying assembly into the target medicine; the monitoring component is connected to the mixing unit and used for detecting the target medicine, and comprises two mutually independent output pipelines which are respectively used for outputting unqualified waste liquid and qualified samples, and the monitoring component is used for switching the conduction states of the two output pipelines according to the detection result of the component proportion of the target medicine. In some embodiments of the present application, the monitoring assembly has an input for inputting a target drug, a first output for outputting a waste liquid, a second output for outputting a sample, and a detection structure for detecting a component ratio of the target drug, the third output being connected to an inlet of the detection structure, and an outlet of the detection structure being connected to an outlet of the first output. In some embodiments of the application, the third output end is disposed between the input end of the first output end and the input end of the second output end. In certain embodiments of the application, the detection structure is a microfluidic chip comprising an electrical impedance detection structure. In some embodiments of the application, the conveying assembly comprises at least two groups of fluid pumps, each fluid pump is connected with the mixing unit, the fluid pumps are used for conveying raw materials, and the mixing unit is provided with a combined output end, and the combined output end is connected with the monitoring assembly. In some embodiments of the present application, a flow meter is disposed between each of the fluid pumps and the mixing units. In certain embodiments of the application, the delivery assembly comprises two sets of the fluid pumps. The application also provides a use method of the drug encapsulation production monitoring device, which comprises the following steps: inputting raw materials according to a preset component proportion; the output pipeline between the monitoring component and the unqualified waste liquid is conducted; the monitoring component performs sampling inspection on the target medicine according to preset interval time; When the deviation of the proportion of the detection components exceeds a preset error range, closing the output pipeline between the monitoring assembly and the sample with qualified output, and conducting the output pipeline between the monitoring assembly and the waste liquid with unqualified output; Correcting the proportion of the input components, repeating the steps until the deviation of the proportion of the detected components is within a preset error range, closing the output pipeline between the monitoring assembly and the unqualified waste liquid, and conducting the pipeline between the