Comprehensive medicine stability experiment box sterilization control method and system

Abstract

The invention relates to the technical field of ultraviolet irradiation sterilization, in particular to a comprehensive medicine stability experiment box sterilization control method and system. According to the method, the historical ultraviolet sterilization record is analyzed, the reference irradiation intensity and the basic sterilization duration are determined, and then the microbial metabolism condition is analyzed in the sterilization process of the sterilization control conditions corresponding to the reference irradiation intensity and the basic sterilization duration, so that the sterilization effect is evaluated, and the sterilization control conditions are dynamically adjusted according to the real-time sterilization effect; the sterilization effect of the comprehensive medicine stability experiment box is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of ultraviolet irradiation sterilization, and particularly relates to a sterilization control method and system for a comprehensive drug stability test chamber. Background Art

[0002] A comprehensive drug stability test chamber is mainly used to simulate the storage states of different drugs under different environmental conditions to evaluate the long-term stability of drugs. In order to ensure the accuracy and reliability of experimental results, sterilization operations need to be carried out before drug stability experiments to prevent microorganisms in the test chamber from contaminating drugs and affecting experimental results. Ultraviolet sterilization is one of the sterilization means for comprehensive drug stability test chambers. It destroys the microbial cell structure to achieve the sterilization effect and effectively reduces the risk of drug contamination.

[0003] In the prior art, sterilization is carried out by setting standard ultraviolet irradiation intensity, irradiation time and other conditions. However, due to factors such as the structure of the comprehensive drug stability test chamber, different degrees of microbial contamination may exist in different regions, and the standard ultraviolet irradiation conditions may lead to incomplete sterilization. However, blindly prolonging the ultraviolet irradiation time or increasing the irradiation intensity may lead to over-irradiation, which in turn may cause the performance of the comprehensive drug stability test chamber to decline or affect the properties of drugs. Therefore, it is an urgent technical problem to determine appropriate ultraviolet irradiation intensity and irradiation time for sterilization. Summary of the Invention

[0004] In order to solve the technical problem that the prior art cannot accurately determine the ultraviolet irradiation intensity and irradiation time for a comprehensive drug stability test chamber, resulting in poor sterilization control effect, the purpose of the present invention is to provide a sterilization control method and system for a comprehensive drug stability test chamber. The specific technical solutions adopted are as follows: The present invention provides a sterilization control method for a comprehensive drug stability test chamber, the method comprising: Obtaining all ultraviolet sterilization records of the comprehensive drug stability test chamber, each of the ultraviolet sterilization records including at least the irradiation intensity, irradiation duration and drug to be tested corresponding to the historical sterilization process; According to the occurrence frequency of each irradiation intensity in all historical sterilization processes corresponding to each drug to be tested, and the types of drugs to be tested corresponding to each irradiation intensity in all historical sterilization processes, obtaining the sterilization selectivity of each irradiation intensity for each drug to be tested; determining the reference irradiation intensity of each drug to be tested according to the sterilization selectivity; and determining the basic sterilization duration according to the irradiation duration in all ultraviolet sterilization records; Based on the reference irradiation intensity and the basic sterilization duration, combined with the types of drugs to be experimented currently, perform ultraviolet sterilization on the comprehensive drug stability test chamber, and during the current sterilization process, obtain the monitoring curves of each measuring point in the comprehensive drug stability test chamber under each microbial metabolic index; according to the fluctuation differences of the monitoring curves of different measuring points under the same microbial metabolic index, obtain the sterilization defect coefficient of the current sterilization process; According to the sterilization defect coefficient of the current sterilization process, combined with the reference irradiation intensity and the basic sterilization duration, perform ultraviolet sterilization control on the comprehensive drug stability test chamber.

[0005] Furthermore, the method for obtaining the sterilization selectability includes: In all ultraviolet sterilization records, regard each irradiation intensity in each sterilization process corresponding to each drug to be experimented as a candidate irradiation intensity; Take the normalization result of the product of the occurrence frequency of each candidate irradiation intensity corresponding to each drug to be experimented in all sterilization processes and the total number of types of drugs to be experimented corresponding to each candidate irradiation intensity in all sterilization processes as the usage popularity of each candidate irradiation intensity for each drug to be experimented; Weight the occurrence frequency of each candidate irradiation intensity of each drug to be experimented by the corresponding usage popularity, and take the weighted result as the sterilization selectability of each candidate irradiation intensity for each drug to be experimented.

[0006] Furthermore, the method for obtaining the reference irradiation intensity includes: Among all candidate irradiation intensities of each drug to be experimented, regard the candidate irradiation intensity corresponding to the maximum sterilization selectability as the reference irradiation intensity of the drug to be experimented.

[0007] Furthermore, the method for obtaining the basic sterilization duration includes: In all ultraviolet sterilization records, regard the minimum irradiation duration among all irradiation durations as the basic sterilization duration.

[0008] Furthermore, the method for obtaining the sterilization defect coefficient includes: Under each microbial metabolic index, according to the differences in the corresponding times of the extreme points in the monitoring curves at different measuring points, obtain the first metabolic difference coefficient of the microorganisms at different measuring points; Under each microbial metabolic index, according to the differences in the change characteristics of the data points in the monitoring curves at different measuring points, obtain the second metabolic difference coefficient of the microorganisms at different measuring points; Fuse the first metabolic difference coefficient and the second metabolic difference coefficient of the microorganisms at different measuring points under all microbial metabolic indexes to obtain the sterilization defect coefficient.

[0009] Further, the method for obtaining the first metabolic difference coefficient includes: Taking the moments corresponding to the extreme points in the monitoring curves at each measurement point as sequence elements to construct an extreme moment sequence; Taking the variance of the moments corresponding to the sequence elements with the same serial number in the extreme moment sequences at all measurement points under each microbial metabolic index as the fluctuation difference parameter, and taking the mean of the fluctuation difference parameters under all the same serial numbers as the first metabolic difference coefficient.

[0010] Further, the method for obtaining the second metabolic difference coefficient includes: Taking the normalization result of the cumulative sum of the index differences at all adjacent moments in the monitoring curves at each measurement point as the fluctuation trend parameter of the monitoring curve; Under each microbial metabolic index, obtaining the second metabolic difference coefficient according to the differences in the fluctuation trend parameters of the monitoring curves at all different measurement points.

[0011] Further, the method for performing ultraviolet sterilization on the comprehensive drug stability test chamber includes: When the sterilization defect coefficient is less than the preset threshold, terminate the ultraviolet sterilization; when the sterilization defect coefficient is greater than or equal to the preset threshold, continue to perform a new round of ultraviolet sterilization on the comprehensive drug stability test chamber based on the reference irradiation intensity and the basic sterilization duration, and obtain the sterilization defect coefficient of the new round of sterilization process; Iterate continuously until the sterilization defect coefficient of the latest round of sterilization process is less than the preset threshold.

[0012] Further, the microbial metabolic index at least includes temperature and humidity.

[0013] The present invention also provides a sterilization control system for a comprehensive drug stability test chamber, including a memory, a processor, and a computer program stored in the memory and executable on the processor. When the processor executes the computer program, the steps of the sterilization control method for a comprehensive drug stability test chamber are implemented.

[0014] The present invention has the following beneficial effects: The present invention first obtains all the ultraviolet sterilization records of the comprehensive drug stability test chamber. Each ultraviolet sterilization record includes at least the irradiation intensity, irradiation duration, and the drug to be tested corresponding to the historical sterilization process, preparing for determining the ultraviolet irradiation conditions in the sterilization control plan. According to the occurrence frequency of each irradiation intensity in all historical sterilization processes corresponding to each drug to be tested, and the types of drugs to be tested corresponding to each irradiation intensity in all historical sterilization processes, the sterilization selectability of each irradiation intensity for each drug to be tested is obtained. The sterilization selectability reflects the suitability of each irradiation intensity for sterilizing the drug to be tested. Then, based on the sterilization selectability, the reference irradiation intensity of each drug to be tested is determined. According to the irradiation duration in all ultraviolet sterilization records, the basic sterilization duration is determined. Based on the reference irradiation intensity and the basic sterilization duration, combined with the type of the current drug to be tested, the comprehensive drug stability test chamber is sterilized by ultraviolet rays. During the current sterilization process, the monitoring curves of each measurement point in the comprehensive drug stability test chamber under each microbial metabolic index are obtained, providing data preparation for subsequent analysis of the microbial metabolic conditions at different measurement points. According to the fluctuation differences of the monitoring curves of different measurement points under the same microbial metabolic index, the microbial metabolic differences at different measurement points are evaluated. The greater the difference, the more uneven the sterilization. Thus, the sterilization defect coefficient of the current sterilization process can be obtained. Then, based on the sterilization defect coefficient of the current sterilization process, combined with the reference irradiation intensity and the basic sterilization duration, the ultraviolet sterilization control of the comprehensive drug stability test chamber is carried out. By analyzing the historical ultraviolet sterilization records, the present invention determines the reference irradiation intensity and the basic sterilization duration. Then, during the sterilization process corresponding to the sterilization control conditions of the reference irradiation intensity and the basic sterilization duration, the microbial metabolic conditions are analyzed to evaluate the sterilization effect. Furthermore, according to the real-time sterilization effect, the sterilization control conditions are dynamically adjusted to improve the sterilization control effect. Description of the Drawings

[0015] In order to more clearly illustrate the technical solutions and advantages in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0016] Figure 1 It is a flowchart of a method for controlling the sterilization of a comprehensive drug stability test chamber provided by an embodiment of the present invention; Figure 2 It is a flowchart of a method for obtaining the sterilization selectability provided by an embodiment of the present invention; Figure 3 It is a flowchart of a method for obtaining the sterilization defect coefficient provided by an embodiment of the present invention. Detailed Embodiments

[0017] In order to further elaborate on the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the following combines the accompanying drawings and preferred embodiments to detail the specific implementation manner, structure, features and effects of a sterilization control method and system for a comprehensive drug stability test chamber according to the present invention. In the following description, different "one embodiment" or "another embodiment" do not necessarily refer to the same embodiment. In addition, the specific features, structures or characteristics in one or more embodiments can be combined in any suitable form.

[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this invention belongs.

[0019] The following specifically describes the specific solution of a sterilization control method and system for a comprehensive drug stability test chamber provided by the present invention with reference to the accompanying drawings.

[0020] Please refer to Figure 1 , which shows a flowchart of a sterilization control method for a comprehensive drug stability test chamber provided by an embodiment of the present invention, specifically including: Step S1, obtain all ultraviolet sterilization records of the comprehensive drug stability test chamber. Each ultraviolet sterilization record includes at least the irradiation intensity, irradiation duration of the corresponding historical sterilization process, and the drug to be tested.

[0021] In an embodiment of the present invention, first, all ultraviolet sterilization records of the comprehensive drug stability test chamber are obtained, that is, historical sterilization plan records. Each ultraviolet sterilization record includes at least the set irradiation intensity and irradiation duration of ultraviolet rays in each historical sterilization process, and the drug to be tested for the upcoming stability test, so as to evaluate a suitable sterilization control plan in combination with the historical ultraviolet sterilization records of each drug to be tested.

[0022] It should be noted that the ultraviolet sterilization control of the comprehensive drug stability test chamber in the embodiment of the present invention is determined by analyzing and evaluating a large number of historical ultraviolet sterilization records. The set ultraviolet irradiation intensity and irradiation duration in the historical ultraviolet sterilization records are both reasonable parameters determined by professional experimental personnel through biochemical calculations and empirical analyses, and are ideal sterilization plans that can ensure the performance of the test chamber and the properties of the drug without affecting them; the acquisition of ultraviolet sterilization records is already a well-known prior art to those skilled in the art and will not be elaborated here.

[0023] Step S2: Obtain the sterilization selectability of each irradiation intensity for each drug to be tested based on the occurrence frequency of each irradiation intensity in all historical sterilization processes corresponding to each drug to be tested, and the types of drugs to be tested corresponding to each irradiation intensity in all historical sterilization processes; determine the reference irradiation intensity for each drug to be tested according to the sterilization selectability; and determine the basic sterilization duration according to the irradiation duration in all ultraviolet sterilization records.

[0024] Considering that in all historical ultraviolet sterilization records, if a certain irradiation intensity is applied to a certain drug to be tested more times, it indicates that the possibility of the influence of this irradiation intensity on the properties of the drug to be tested and the performance of the experimental chamber is lower, and it is more suitable for sterilizing the drug to be tested; and considering that the more types of drugs to be tested that a certain irradiation intensity can be applied to for sterilization, it indicates that its application range is wider, the influence on the properties of most drugs to be tested is smaller, and it is more suitable to be applied to sterilization; Based on this, in the embodiments of the present invention, the sterilization selectability of each irradiation intensity for each drug to be tested will be obtained according to the occurrence frequency of each irradiation intensity in all historical sterilization processes corresponding to each drug to be tested, and the types of drugs to be tested corresponding to each irradiation intensity in all historical sterilization processes; the sterilization selectability reflects the suitability of each irradiation intensity for sterilizing the drug to be tested, and prepares for subsequent screening of the reference irradiation intensity for ultraviolet sterilization of the drug to be tested.

[0025] Preferably, in an embodiment of the present invention, the method for obtaining the sterilization selectability includes: Please refer to Figure 2 , which shows a flowchart of a method for obtaining sterilization selectability provided by an embodiment of the present invention, specifically including: Step S201: In all ultraviolet sterilization records, regard each irradiation intensity in all sterilization processes corresponding to each drug to be tested as a candidate irradiation intensity.

[0026] As an example, considering that the irradiation intensity used for the drug to be tested in the historical sterilization process should be preferentially selected for sterilization to ensure the reliability of sterilization; therefore, first regard each irradiation intensity in all sterilization processes corresponding to each drug to be tested as a candidate irradiation intensity, so as to facilitate subsequent analysis and screening of the best reference irradiation intensity.

[0027] Step S202: Take the normalization result of the product of the occurrence frequency of each candidate irradiation intensity in all sterilization processes corresponding to each drug to be tested and the total number of types of drugs to be tested corresponding to each candidate irradiation intensity in all sterilization processes as the usage breadth of each candidate irradiation intensity for each drug to be tested.

[0028] As an example, the calculation formula for the usage breadth is: where m is the serial number of the drug to be experimented; n is the serial number of the optional irradiation intensity for each drug to be experimented; is the popularity of the nth optional irradiation intensity of the mth drug to be experimented; is the frequency of occurrence of the nth optional irradiation intensity in all sterilization processes corresponding to the mth drug to be experimented; is the total number of types of drugs to be experimented in all sterilization processes corresponding to the nth optional irradiation intensity of the mth drug to be experimented; is a linear normalization function.

[0029] In the calculation formula of the popularity, the higher the frequency of occurrence of each optional irradiation intensity in all sterilization processes corresponding to each drug to be experimented, the lower the possibility that the irradiation intensity affects the properties of the drug to be experimented; the larger the total number of types of drugs to be experimented corresponding to each irradiation intensity in all historical sterilization processes, the wider the application range of the irradiation intensity; multiplying the two and integrating them, comprehensively evaluate the popularity of each optional irradiation intensity of each drug to be experimented. The larger the popularity of the optional irradiation intensity, the more likely it is to be used as the reference irradiation intensity.

[0030] Step S203: Weight the frequency of occurrence of each optional irradiation intensity of each drug to be experimented by the corresponding popularity, and use the weighted result as the sterilization selectability of each optional irradiation intensity for each drug to be experimented.

[0031] As an example, use the ratio of the frequency of occurrence of each optional irradiation intensity of each drug to be experimented to the total number of ultraviolet sterilization records as its frequency of occurrence; the frequency of occurrence reflects the relative application frequency of the optional irradiation intensity among all irradiation intensities in the ultraviolet sterilization records. The more frequently it is applied, the lower the impact of the optional irradiation intensity on the properties of the drug and the performance of the experimental chamber when it is used as the reference irradiation intensity; Then multiply the frequency of occurrence of each optional irradiation intensity of each drug to be experimented by the corresponding popularity, and use the product as the sterilization selectability of each optional irradiation intensity for each drug to be experimented; the sterilization selectability comprehensively evaluates the possibility of using it as the reference irradiation intensity from two aspects: the application range and the relative frequency of use of the optional irradiation intensity.

[0032] After obtaining the sterilization selectability of each irradiation intensity for each drug to be experimented, the irradiation intensity most suitable for the corresponding drug to be experimented can be selected from all irradiation intensities according to the sterilization selectability, that is, the reference irradiation intensity of the drug to be experimented.

[0033] Preferably, in an embodiment of the present invention, among all the optional irradiation intensities of each drug to be experimented, the optional irradiation intensity corresponding to the maximum sterilization selectability is used as the reference irradiation intensity of the drug to be experimented.

[0034] Considering that the irradiation duration is also an important parameter in the sterilization control plan, a reasonable sterilization duration can achieve an ideal sterilization effect, thereby ensuring the accuracy of the results of the drug stability experiment. Also considering that the irradiation durations in all historical ultraviolet sterilization records can provide a certain basis for analysis and reference, the embodiments of the present invention will determine the basic sterilization duration according to the irradiation durations in all ultraviolet sterilization records. The basic sterilization duration is the initial sterilization operation duration, so as to analyze and evaluate the sterilization effect in real time during the corresponding sterilization operation process, and thus reasonably determine the sterilization control plan according to the real-time sterilization effect to determine whether it is necessary to perform the next round of sterilization operation until the ideal sterilization effect is achieved.

[0035] Preferably, in an embodiment of the present invention, considering that in the historical ultraviolet sterilization records, the shortest irradiation duration can also ensure the ultraviolet sterilization effect, the minimum irradiation duration among all the irradiation durations in all ultraviolet sterilization records is used as the basic sterilization duration.

[0036] In other embodiments of the present invention, the implementer can also use the irradiation duration corresponding to the mode among all the irradiation durations in all ultraviolet sterilization records as the basic sterilization duration.

[0037] Step S3: Based on the reference irradiation intensity and the basic sterilization duration, combined with the type of the current drug to be experimented, perform ultraviolet sterilization on the comprehensive drug stability test chamber, and during the current sterilization process, obtain the monitoring curves of each measuring point in the comprehensive drug stability test chamber under each microbial metabolic index; according to the fluctuation differences of the monitoring curves of different measuring points under the same microbial metabolic index, obtain the sterilization defect coefficient of the current sterilization process.

[0038] After obtaining the reference irradiation intensity and the basic sterilization duration, it is possible to start performing ultraviolet sterilization on the comprehensive drug stability test chamber in combination with the type of the current drug to be experimented, and obtain the monitoring curves of each measuring point in the test chamber under each microbial metabolic index during the current sterilization process, so as to analyze the monitoring curves later and evaluate the sterilization effect of the current sterilization process.

[0039] It should be noted that the current drug to be experimented in the embodiments of the present invention should be a drug that has undergone sterilization experiments during the historical ultraviolet sterilization process.

[0040] In an embodiment of the present invention, specifically, after placing the current drug to be experimented in the comprehensive drug stability test chamber, set the ultraviolet irradiation conditions to the corresponding reference irradiation intensity and basic sterilization duration, and then start sterilization; several measuring points are usually arranged in the comprehensive drug stability test chamber, and corresponding microbial metabolic index monitoring sensors are installed at each measuring point to monitor the microbial metabolic situation in real time during the sterilization process; Among them, considering that if sterilization is not thorough, the residual microbial metabolism may release additional heat, causing temperature changes. At the same time, microbial metabolism is also accompanied by the generation of moisture, so humidity will also change. Therefore, the microbial metabolism indicators at least include temperature and humidity. Temperature sensors and humidity sensors need to be arranged at each measurement point respectively to obtain the temperature change curve and humidity change curve at each measurement point during the current sterilization process. As an example, the measurement points are at least set at the inner wall corners of the comprehensive drug stability test chamber and at positions such as near the test chamber door where bacteria and other microorganisms are likely to breed. The acquisition frequency of all sensors is set to 50HZ. After setting the ultraviolet irradiation conditions of the comprehensive drug stability test chamber, each sensor starts to collect temperature data and humidity data from the start time of irradiation, and constructs a monitoring curve according to the time sequence of the collected data, that is, obtains the temperature change curve and humidity change curve at each measurement point during the current sterilization process.

[0041] In other embodiments of the present invention, the implementer can also define the layout scheme of the measurement points in the comprehensive drug stability test chamber by himself, such as uniform layout, etc. The implementer can also evaluate and set other types or quantities of microbial metabolism indicators, such as setting other products of microbial metabolism reactions such as carbon dioxide concentration as microbial metabolism indicators, which will not be elaborated here.

[0042] Considering that if there are differences in the same microbial metabolism indicators at the same moment at different measurement points in the comprehensive drug stability test chamber, it means that there may be different degrees of microbial metabolism reactions at different measurement points in the comprehensive drug stability test chamber, further indicating that the sterilization effect in the comprehensive drug stability test chamber is not good. Therefore, in the embodiment of the present invention, the sterilization defect coefficient of the current sterilization process is obtained according to the fluctuation difference of the monitoring curves under the same microbial metabolism indicators at different measurement points. The sterilization defect coefficient determines whether further sterilization is required for precise sterilization control.

[0043] Preferably, in an embodiment of the present invention, the method for obtaining the sterilization defect coefficient includes: Please refer to Figure 3 , which shows a flowchart of a method for obtaining a sterilization defect coefficient provided by an embodiment of the present invention, specifically including: Step S301, under each microbial metabolism indicator, according to the difference in the corresponding moments of the extreme points in the monitoring curves at different measurement points, obtain the first metabolic difference coefficient of the microorganisms at different measurement points.

[0044] Considering that extreme points can usually help evaluate the fluctuation characteristics of a curve, when there are differences in the occurrence times of extreme points in different monitoring curves, it indicates that there are differences in fluctuations. Therefore, an embodiment of the present invention is based on this to evaluate the first metabolic difference coefficient of microorganisms at different measurement points. The first metabolic difference coefficient evaluates the fluctuation difference with the help of extreme points, reflects the differences in microbial metabolic reactions at different measurement points, and prepares for subsequent evaluation of the sterilization effect.

[0045] In a preferred embodiment of the present invention, the method for obtaining the first metabolic difference coefficient includes: Taking the corresponding times of extreme points in the monitoring curves at each measurement point as sequence elements, constructing an extreme time sequence; Taking the variance of the corresponding times of sequence elements with the same serial number in the extreme time sequences at all measurement points under each microbial metabolic index as the fluctuation difference parameter, and taking the mean of the fluctuation difference parameters under all the same serial numbers as the first metabolic difference coefficient.

[0046] It should be noted that the acquisition of extreme points is already well-known prior art to those skilled in the art and will not be elaborated here. The total number of extreme points in different monitoring curves may not be the same. When comparing the corresponding times of sequence elements with the same serial number, the extreme time sequence with the least total number of extreme points is used as the benchmark. For example, there are three extreme time sequences, namely {10, 21, 56, 78, 101}, {8, 11, 25, 36, 49, 66, 77, 98, 50, 19}, {10, 25, 65, 78}, and the sequence length of the shortest extreme time sequence is 4. Then, it is only necessary to compare the variances of the corresponding times of the first 4 sequence elements with the same serial number in all extreme time sequences.

[0047] As an example, the calculation formula for the first metabolic difference coefficient is: ; where x is the serial number of the type of microbial metabolic index; is the first metabolic difference coefficient of microorganisms at different measurement points under the x-th type of microbial metabolic index; c is the serial number of the sequence element in the extreme time sequence; is the corresponding sequence length of the shortest sequence in all extreme time sequences under the x-th type of microbial metabolic index; z is the measurement point serial number; Z is the total number of measurement points; is the corresponding time of the c-th sequence element in the extreme time sequence at the z-th measurement point under the x-th type of microbial metabolic index; is the variance of the corresponding times of the c-th sequence element in all extreme time sequences under the x-th type of microbial metabolic index, and is also the fluctuation difference parameter.

[0048] In the calculation formula of the first metabolic difference coefficient, specifically, in the extreme value time series at different measurement points, the greater the variance of the sequence elements with the same serial number, that is, the variance of the corresponding moments of the extreme value points, the more inconsistent the fluctuation changes. At this serial number angle, the fluctuation difference parameter is larger. Furthermore, the mean value of the fluctuation difference parameters at all serial number angles is analyzed to comprehensively evaluate the first metabolic difference coefficient at different measurement points. The larger the first metabolic difference coefficient, the more uneven the sterilization effect, and there may be residues.

[0049] In other embodiments of the present invention, the implementer can also directly normalize the sum of the absolute values of the differences between the corresponding moments of the extreme value points with the same serial number in the monitoring curves at different measurement points, and use the normalized result as the first metabolic difference coefficient.

[0050] Step S302, under each microbial metabolic index, according to the differences in the change characteristics of the data points in the monitoring curves at different measurement points, obtain the second metabolic difference coefficient of the microorganisms at different measurement points.

[0051] Considering that the change characteristics of the data points can usually help evaluate the fluctuation change trend of the curve. When there are significant differences in the fluctuation change trends in different monitoring curves, it indicates that the microbial metabolic reaction degrees at different measurement points are inconsistent, such as caused by inconsistent colony sizes or incomplete sterilization due to factors such as ultraviolet irradiation angles. Therefore, in an embodiment of the present invention, based on the differences in the change characteristics of the data points in the monitoring curves at different measurement points, the second metabolic difference coefficient of the microorganisms at different measurement points is evaluated. The second metabolic difference coefficient also reflects the differences in the microbial metabolic reactions at different measurement points, preparing for subsequent evaluation of the sterilization effect.

[0052] In a preferred embodiment of the present invention, the method for obtaining the second metabolic difference coefficient includes: Take the normalized result of the sum of the index differences at all adjacent moments in the monitoring curve at each measurement point as the fluctuation trend parameter of the monitoring curve; Under each microbial metabolic index, according to the differences in the fluctuation trend parameters of the monitoring curves at all different measurement points, obtain the second metabolic difference coefficient.

[0053] As an example, the calculation formula of the second metabolic difference coefficient is: ; where x is the type serial number of the microbial metabolic index; is the second metabolic difference coefficient of the microorganisms at different measurement points under the x-th microbial metabolic index; is the linear normalization function; z is the measurement point serial number; r is the serial number of the remaining measurement points except the z-th measurement point; Z is the total number of measurement points; is the fluctuation trend parameter of the monitoring curve at the z-th measurement point under the x-th microbial metabolic index; is the fluctuation trend parameter of the monitoring curve at the rth measuring point except the zth measuring point under the xth microbial metabolism index; is the absolute value symbol; Among them, the method for obtaining the fluctuation trend parameter includes: ; s is the serial number of the indicator data point in the monitoring curve; is the total number of indicator data points in the monitoring curve; is the sth indicator data point in the monitoring curve at the zth measuring point under the xth microbial metabolism indicator; It is the s+1th indicator data point in the monitoring curve at the zth measuring point under the xth microbial metabolism indicator.

[0054] In the method for obtaining the second metabolic difference coefficient, the fluctuation trend parameter is first evaluated by the absolute value of the difference between the indicator data points at adjacent moments. The larger the absolute value of the difference, the more drastic the fluctuation. Then, by comparing the fluctuation trend parameters between all different measuring points, the change differences in the monitoring curves between different measuring points are evaluated. The larger the change difference, the larger the second metabolic difference parameter, which means that the sterilization effect is more uneven and there may be residues.

[0055] In other embodiments of the present invention, the implementer may also directly use the two-point formula to calculate the slope of each monitoring curve, and use the slope as the fluctuation trend parameter; the implementer may also use discrete parameters such as the variance of the fluctuation trend parameters at different measuring points to evaluate the second metabolic difference coefficient, the larger the variance, the larger the second metabolic difference coefficient; these are all commonly used technical means and will not be elaborated here.

[0056] Step S303, combining the first metabolic difference coefficient and the second metabolic difference coefficient of the microorganisms at different measuring points under all microbial metabolic indicators to obtain the sterilization failure coefficient.

[0057] As an example, the first metabolic difference coefficient and the second metabolic difference coefficient of the microorganisms at different measuring points under each microbial metabolic index are multiplied and combined, and then the cumulative sum of the corresponding products under all microbial metabolic indicators is linearly normalized, and the normalized result is used as the sterilization poor coefficient.

[0058] In other examples, implementers may also use basic mathematical operations such as addition or weighted summation or related mapping methods to combine the two, and then normalize the cumulative sum of the fusion results under all microbial metabolic indicators through other normalization methods to obtain the sterilization defect coefficient. These are all existing technical methods and will not be repeated here.

[0059] Step S4, based on the sterilization failure coefficient of the current sterilization process, combined with the benchmark irradiation intensity and the basic sterilization time, ultraviolet sterilization control is performed on the comprehensive drug stability test box.

[0060] After obtaining the sterilization failure coefficient of the current sterilization process, it is possible to evaluate whether further sterilization operations are required based on the sterilization failure coefficient of the current sterilization process. Then, in combination with the reference irradiation intensity and the basic sterilization duration, ultraviolet sterilization control is performed on the comprehensive drug stability test chamber.

[0061] Preferably, in an embodiment of the present invention, the method for performing ultraviolet sterilization on the comprehensive drug stability test chamber includes: When the sterilization failure coefficient is less than the preset threshold, terminate the ultraviolet sterilization; when the sterilization failure coefficient is greater than or equal to the preset threshold, continue to perform a new round of ultraviolet sterilization on the comprehensive drug stability test chamber based on the reference irradiation intensity and the basic sterilization duration, and obtain the sterilization failure coefficient of the new round of sterilization process; continuously iterate until the sterilization failure coefficient of the latest round of sterilization process is less than the preset threshold.

[0062] As an example, the preset threshold is set to 0.88, and the implementer can also set it to any value within 0.88 - 1; when the sterilization failure coefficient of the current sterilization process is higher than 0.88, it indicates that the sterilization effect of the current drug to be tested in the first sterilization process is not good, and a new round of sterilization operation is required; then keep the reference irradiation intensity unchanged, and then extend the basic sterilization duration, that is, after the current sterilization process ends, continue to perform ultraviolet irradiation for the basic sterilization duration, and simultaneously obtain the monitoring curves of each measurement point in the comprehensive drug stability test chamber under each microbial metabolic index during the new round of basic sterilization period, and obtain the sterilization failure coefficient of the new round of sterilization process according to the method described in step S3, and then calculate and judge whether it is greater than the preset threshold and whether a new round of ultraviolet sterilization is required, continuously iterate, and dynamically adjust the ultraviolet irradiation duration, that is, extend the basic irradiation duration, until the sterilization failure coefficient of the latest round of ultraviolet sterilization process is less than 0.88 to terminate the sterilization, so as to set the relevant parameters of the stability test for the current drug to be tested for the stability test.

[0063] The present invention also proposes a sterilization control system for a comprehensive drug stability test chamber, including a memory, a processor, and a computer program stored in the memory and executable on the processor. When the processor executes the computer program, it implements the steps of a sterilization control method for a comprehensive drug stability test chamber described in steps S1 - S4.

[0064] In summary, the present invention first obtains all the ultraviolet sterilization records of the comprehensive drug stability test chamber, then analyzes all the ultraviolet sterilization records to obtain the sterilization selectivity of each irradiation intensity for each drug to be tested, and further determines the reference irradiation intensity for each drug to be tested and the basic sterilization duration; then, based on the reference irradiation intensity and the basic sterilization duration, combined with the type of the current drug to be tested, the comprehensive drug stability test chamber is sterilized by ultraviolet rays. During the current sterilization process, the monitoring curves of each measuring point in the comprehensive drug stability test chamber under each microbial metabolic index are analyzed to evaluate the sterilization defect coefficient of the current sterilization process, and further, according to the sterilization defect coefficient of the current sterilization process, the ultraviolet sterilization control of the comprehensive drug stability test chamber is carried out. By analyzing the historical ultraviolet sterilization records, the present invention determines the reference irradiation intensity and the basic sterilization duration, and then during the sterilization control process corresponding to the reference irradiation intensity and the basic sterilization duration, analyzes the microbial metabolism situation, so as to evaluate the sterilization effect, and further dynamically adjusts the sterilization control conditions according to the real-time sterilization effect, thereby improving the sterilization control effect.

[0065] It should be noted that the above sequence of the embodiments of the present invention is only for description and does not represent the superiority or inferiority of the embodiments. The processes depicted in the drawings do not necessarily require the specific order or continuous order shown to achieve the desired result. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0066] Each embodiment in this specification is described in a progressive manner, and the same or similar parts among the embodiments can be referred to each other. The key point of each embodiment is to illustrate the differences from other embodiments.

Claims

1. A sterilization control method for a comprehensive drug stability test chamber, characterized in that The method includes: Obtaining all ultraviolet sterilization records of the comprehensive drug stability test chamber, where each ultraviolet sterilization record includes at least the irradiation intensity, irradiation duration, and the drug to be tested corresponding to the historical sterilization process; Based on the occurrence frequency of each irradiation intensity in all historical sterilization processes corresponding to each drug to be tested, and the types of drugs to be tested corresponding to each irradiation intensity in all historical sterilization processes, obtaining the sterilization selectivity of each irradiation intensity for each drug to be tested; determining the reference irradiation intensity for each drug to be tested according to the sterilization selectivity; determining the basic sterilization duration according to the irradiation duration in all ultraviolet sterilization records; Based on the reference irradiation intensity and the basic sterilization duration, combined with the type of the current drug to be tested, performing ultraviolet sterilization on the comprehensive drug stability test chamber, and during the current sterilization process, obtaining the monitoring curves of each measurement point in the comprehensive drug stability test chamber under each microbial metabolic index; obtaining the sterilization defect coefficient of the current sterilization process according to the fluctuation difference of the monitoring curves of different measurement points under the same microbial metabolic index; According to the sterilization defect coefficient of the current sterilization process, combined with the reference irradiation intensity and the basic sterilization duration, performing ultraviolet sterilization control on the comprehensive drug stability test chamber.

2. A sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that, The method for obtaining the sterilization selectivity includes: In all ultraviolet sterilization records, taking each irradiation intensity in all sterilization processes corresponding to each drug to be tested as the candidate irradiation intensity; Taking the normalization result of the product of the occurrence frequency of each candidate irradiation intensity in all sterilization processes corresponding to each drug to be tested and the total number of types of drugs to be tested corresponding to each candidate irradiation intensity in all sterilization processes as the usage breadth of each candidate irradiation intensity for each drug to be tested; Weighting the occurrence frequency of each candidate irradiation intensity of each drug to be tested by the corresponding usage breadth, and taking the weighted result as the sterilization selectivity of each candidate irradiation intensity for each drug to be tested.

3. A sterilization control method for a comprehensive pharmaceutical stability test chamber according to claim 2, characterized in that, The method for obtaining the reference irradiation intensity includes: Among all candidate irradiation intensities of each drug to be tested, taking the candidate irradiation intensity corresponding to the maximum sterilization selectivity as the reference irradiation intensity of the drug to be tested.

4. A sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that, The method for obtaining the basic sterilization duration includes: In all ultraviolet sterilization records, taking the minimum irradiation duration among all irradiation durations as the basic sterilization duration.

5. A sterilization control method for a comprehensive pharmaceutical stability test chamber according to claim 1, characterized in that, The method for obtaining the sterilization defect coefficient includes: Under each microbial metabolic index, obtaining the first metabolic difference coefficient of microorganisms at different measurement points according to the difference in the corresponding times of the extreme value points in the monitoring curves at different measurement points; Under each microbial metabolic index, obtaining the second metabolic difference coefficient of microorganisms at different measurement points according to the difference in the change characteristics of the data points in the monitoring curves at different measurement points; Fusing the first metabolic difference coefficient and the second metabolic difference coefficient of microorganisms at different measurement points under all microbial metabolic indexes to obtain the sterilization defect coefficient.

6. The sterilization control method for a comprehensive drug stability test chamber according to claim 5, wherein, The method for obtaining the first metabolic difference coefficient includes: Taking the corresponding times of the extreme value points in the monitoring curve at each measurement point as sequence elements to construct an extreme value time sequence; For each microbial metabolic index, the variance of the corresponding moments of the sequence elements with the same serial number in all the extreme value moment sequences at all measurement points is used as the fluctuation difference parameter, and the mean value of the fluctuation difference parameters under all the same serial numbers is used as the first metabolic difference coefficient.

7. A sterilization control method for a comprehensive drug stability test chamber according to claim 5, characterized in that The method for obtaining the second metabolic difference coefficient includes: The normalization result of the cumulative sum of the index differences at all adjacent moments in the monitoring curve at each measurement point is used as the fluctuation trend parameter of the monitoring curve; Under each microbial metabolic index, the second metabolic difference coefficient is obtained according to the differences in the fluctuation trend parameters of the monitoring curves at all different measurement points.

8. A sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that, The method for performing ultraviolet sterilization on the comprehensive drug stability test chamber includes: When the sterilization failure coefficient is less than the preset threshold, terminate the ultraviolet sterilization; when the sterilization failure coefficient is greater than or equal to the preset threshold, continue to perform a new round of ultraviolet sterilization on the comprehensive drug stability test chamber based on the reference irradiation intensity and the basic sterilization duration, and obtain the sterilization failure coefficient of the new round of sterilization process; Iterate continuously until the sterilization failure coefficient of the latest round of sterilization process is less than the preset threshold.

9. A sterilization control method for a comprehensive pharmaceutical stability test chamber according to claim 1, characterized in that The microbial metabolic index at least includes temperature and humidity.

10. A sterilization control system for a comprehensive pharmaceutical stability test chamber, characterized in that, It includes a memory, a processor, and a computer program stored in the memory and executable on the processor. When the processor executes the computer program, it implements the steps of a method for controlling the sterilization of a comprehensive drug stability test chamber as described in any one of claims 1-9.

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