Development Of A Portable NIR Instrument For The Detection Of Pharmaceutical Raw Materials And Excipients

The significance of pharmaceutical products’ effectiveness and safety as treatments for human ailments cannot be emphasized.Testing and quality evaluation of raw and auxiliary materials in pharmaceutical production is the starting point of pharmaceutical production and the source of controlling the quality of medicines.Quality control of the production process is an indispensable step in producing safe and effective medicines.The State Drug Administration is also aggressively promoting this aspect of the adoption of real-time drug testing.At the same time,the real-time monitoring of drug manufacture before feeding is also a component of the international drug organization’s efforts to promote testing.Testing of pharmaceutical raw materials and auxiliary components has always been a contentious issue.Although there are many different testing techniques,each has its own benefits and drawbacks and cannot satisfy the demands of non-destructive,real-time,speedy,simple,and inexpensive testing.Near Infrared Spectroscopy(NIRS)can fill this demand,however the NIRS equipment now used in laboratories is bulky,nonportable,expensive to operate,and difficult to utilize for real-time on-site inspection.It also requires a lot of storage space.These issues have been effectively resolved by the development of portable NIR spectrometers in recent years.Handheld NIR spectrometers are more practical and comfortable and are essential in addressing the issue of real-time monitoring of raw materials and auxiliary materials in factory mass production.This work develops a portable NIR detection system using a Nirone sensor that can efficiently detect pharmaceutical raw ingredients and auxiliary components.The specific research is as follows:(1)On the basis of the pertinent technical specifications and features of the NIRONE-Sensor detector,the general design of a compact,portable NIR spectrometer is suggested.The design of a grippable gun shape combined with the ESP-NOW communication protocol and the CH340G USB to serial communication method improves the portability of the NIR instrument.This is done in accordance with the unique application scenarios of the measured samples.(2)The top computer control software was created during the software development process utilising the Pycharm programming environment in accordance with the actual application requirements.The higher computer software’s features were all incorporated.The data transmission module,spectrum collection module,data processing module,data storage module,sample prediction module,and user interface module are the primary components of the software.The host computer for the instrument includes a user-friendly interface and may be utilised with Windows or Mac systems.The system is more feasible for use in production sites than professional NIR instruments because it is developed for general workers in pharmaceutical plants and is simple and easy to use overall.(3)It is suggested to use a hierarchical multi-model identification system.The top computer software for hierarchical identification contains numerous identification models embedded in it to lessen the probability of identification errors with a single model.By doing this,the possibility of misidentifying raw and auxiliary materials can be significantly reduced.The recognition system also has functions for data pre-processing and model optimisation to automatically finish model development without the need for user parameter adjustment.To increase the model quality,a new NIR band selection technique is lastly suggested.(4)Hardware performance tests and system application tests were performed once the instrument had been developed overall.Even though the performance indicators are insufficient,the test results demonstrate that the instrument can satisfy the qualitative analysis.Several raw and auxiliary materials were utilised as the research object in order to assess the viability of the NIRONE spectrometer testing system,and model evaluation was carried out after using the system to create a discriminative model for raw and auxiliary pharmaceutical materials.The outcomes demonstrated that the system’s discriminative model could effectively distinguish between various raw and auxiliary materials and had good prediction results.