Application of an integrated method for digital capability evaluation of comprehensive quality of intelligent manufacturing of traditional Chinese medicine in pediatric Xiaoji Zhike oral liquid

Abstract

The present invention provides an application of an integrated method for evaluating the comprehensive quality digitalization capability of intelligent manufacturing of traditional Chinese medicine in pediatric Xiaoji Zhike oral liquid. The specific steps are as follows: Step 1: Collecting the chemical, physical and other quality attributes of multiple batches of alcohol-precipitated intermediates, corresponding batches of water-precipitated intermediates and corresponding batches of oral liquid finished products in the real world of pediatric Xiaoji Zhike oral liquid production; Step 2: Fuzzy upper and lower limits are set for the specifications of various quality attributes of the three samples in Step 1; Step 3: Weights are assigned to various quality attributes obtained in Step 1; Step 4: Based on the quality attribute specifications in Step 2 and the assignment results in Step 3, a fuzzy point estimation of the comprehensive quality digitalization capability level of intelligent manufacturing of each manufacturing unit in the production process of pediatric Xiaoji Zhike oral liquid is established, thereby realizing an objective evaluation of the digitalization capabilities of the three units in the production process of pediatric Xiaoji Zhike oral liquid.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine and relates to the scope of intelligent manufacturing and quality management of traditional Chinese medicine. It specifically includes the application of an integrated method for evaluating the digitalization capability of the comprehensive quality of intelligent manufacturing of traditional Chinese medicine preparations in the evaluation of the digitalization capability and manufacturing process capability of the intelligent manufacturing of pediatric Xiaoji Zhike oral liquid. Technical Background

[0002] Currently, quality control methods oriented towards the production process, characterized by diversified quality attributes, supported by big data, and using artificial intelligence as the mainstream technology have become an inevitable trend in the development of TCM quality control. The digitalization of TCM production processes is a key parameter for evaluating the degree of intelligent manufacturing in TCM. It reflects the ability of factors such as people, machines, materials, methods, and the environment in the production process to ensure that the produced TCM products meet quality standards. It is an indispensable part of TCM process quality management.

[0003] Pediatric Xiaoji Zhike Oral Liquid, a representative traditional Chinese medicine oral liquid preparation, suffers from complex production processes and unclear digitalization levels. During the evaluation of the comprehensive digitalization capabilities of Pediatric Xiaoji Zhike Oral Liquid's intelligent manufacturing, unclear quality attributes and unclear upper and lower product specification limits significantly reduced the accuracy of objective evaluations of whether the Pediatric Xiaoji Zhike Oral Liquid intelligent manufacturing production unit could meet product quality requirements during the production process. Summary of the Invention

[0004] In order to solve the above-mentioned problem of objective evaluation of the digitalization capability of intelligent manufacturing of pediatric Xiaoji Zhike oral liquid, the purpose of the present invention is to provide an integrated method for evaluating the comprehensive quality digitalization capability of intelligent manufacturing of traditional Chinese medicine preparations and its application in pediatric Xiaoji Zhike oral liquid.

[0005] The present invention provides an integrated method for evaluating the digital capability of intelligent manufacturing of comprehensive quality of traditional Chinese medicine preparations, and its application in the evaluation of the digital capability of intelligent manufacturing of pediatric Xiaoji Zhike oral liquid. The method is characterized by the following specific steps:

[0006] (1) Digital characterization of the quality attributes of multiple batches of samples of alcohol precipitation unit, water precipitation unit, and inclusion unit in the production process of Pediatric Xiaoji Zhike Oral Liquid;

[0007] (2) Based on the digital representation data of quality attributes in (1), fuzzy set theory is introduced to define the fuzzy specifications of product quality attributes;

[0008] (3) Based on the comprehensive weight assignment method of subjective and objective integration, the multi-quality attributes obtained in (1) are assigned comprehensive weights;

[0009] (4) Based on the fuzzy specifications in (2) and the weight assignment results in (3), the fuzzy point estimation of the comprehensive quality digitalization capability of the three units in the production process of the pediatric Xiaoji Zhike oral liquid is constructed.

[0010] According to some specific embodiments of the present invention, the quality attributes in (1) include: the contents of four chemical quality attributes, namely, forsythiaside E, neoerythrin, hesperidin, and neohesperidin; pH value; and physical quality attributes of electronic sensory signals such as electronic tongue and electronic eye.

[0011] According to some specific embodiments of the present invention, the fuzzy specifications in (2) are to introduce fuzzy set theory into the sample quality attribute specifications of the three units, including the fuzzy upper limit and fuzzy lower limit of the quality attribute specifications.

[0012] According to some specific embodiments of the present invention, the weight assignment method in (3) is the AHP-CRITIC method, which performs comprehensive weight assignment on the multi-source quality attributes of the three unit samples of the alcohol precipitation intermediate, water precipitation intermediate and finished product in the production process of the children's Xiaoji Zhike oral liquid, solving the weight problem of the multi-source quality attributes.

[0013] According to some specific implementation schemes of the present invention, fuzzy mathematics theory is introduced into the calculation process of the comprehensive quality digital capability of intelligent manufacturing in (4), and the digital capability is improved to a certain value, which is generalized from the fuzzy specifications of the quality attributes, so that the accuracy of the digital capability is significantly improved.

[0014] The present invention provides an integrated method for evaluating the comprehensive quality digitalization capability of intelligent manufacturing of traditional Chinese medicine preparations for use in Pediatric Xiaoji Zhike Oral Liquid. A multivariate quality attribute characterization method for Pediatric Xiaoji Zhike Oral Liquid is constructed, combining fuzzy set theory with upper and lower limits of product quality attribute specifications, integrating a comprehensive weight assignment method combining subjective and objective factors, and establishing a fuzzy point estimate of the comprehensive quality digitalization capability level of intelligent manufacturing for each manufacturing unit in the production process of Pediatric Xiaoji Zhike Oral Liquid. This overcomes the problem of low accuracy of digitalization capability due to unclear quality specifications. The evaluation of the comprehensive quality digitalization capability of intelligent manufacturing for Pediatric Xiaoji Zhike Oral Liquid is completed, achieving an objective evaluation of the capability level of the intelligent manufacturing unit of Pediatric Xiaoji Zhike Oral Liquid to meet the product quality requirements of the production process. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 Diagram of the membership functions for the fuzzy upper and lower specification limits of a quality attribute specification. DETAILED DESCRIPTION

[0016] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0017] This example uses multiple quality attribute data of alcohol-precipitated intermediates, water-precipitated intermediates and finished products in the real world of the production of Pediatric Xiaoji Zhike Oral Liquid as the research object, and realizes the objective evaluation of the ability level of the Pediatric Xiaoji Zhike Oral Liquid intelligent manufacturing unit to meet the product quality requirements of the production process. In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below, but it should not be understood as limiting the scope of implementation of the present invention.

[0018] The present invention provides an application of an integrated method for evaluating the digital capability of intelligent manufacturing of comprehensive quality of traditional Chinese medicine preparations in the evaluation of the digital capability of intelligent manufacturing of pediatric Xiaoji Zhike oral liquid. The specific steps are as follows:

[0019] (1) Digital characterization of the quality attributes of 30 batches of samples of alcohol-precipitated intermediates, water-precipitated intermediates and finished products in the production process of Pediatric Xiaoji Zhike Oral Liquid; including the determination of the contents of four chemical quality attributes, forsythiaside E, neoerythrin, hesperidin and neohesperidin; as well as the characterization of physical quality attributes such as pH value, six sensor signals of the electronic tongue, namely P1, P2, P3, P4, P5 and P6, and three sensor signals of the electronic eye, namely L, a and b.

[0020] (2) Based on the digital representation data of quality attributes in (1), fuzzy set theory is introduced to define fuzzy specifications of product quality attributes; first, each quality attribute is tested for normal distribution; after satisfying the normal distribution, the corresponding α-cut set, membership function, and indicator function are defined, and the upper and lower limits of each quality attribute are introduced into fuzzy set theory to make the upper and lower limits fuzzy. The detailed steps are as follows:

[0021] Let R be the set of all real numbers, F(R) be the set of all fuzzy sets on R, F(R) = {A|A:R→[0,1]}, and A is a continuous function.

[0022] Regulation 1: It is a non-increasing function, there exists u1∈R that satisfies x≤u1. Then Defined as the upper limit of the fuzzy specification, called the upper fuzzy specification, F U (R) represents the set of all upper fuzzy specifications.

[0023] Regulation 2: It is a non-decreasing function, there exists l1∈R, satisfying x>l1. Then Defined as the lower limit of the fuzzy specification, called the lower fuzzy specification, F L (R) represents the set of all lower fuzzy specifications.

[0024] Rule 3: α-cut is a definite set, for any α∈[0,1],

[0025] Rule 4: When l1≤u1, then:

[0026] in:

[0027] u0, l0 are arbitrary real numbers, g∈[0,1] is a non-increasing function, satisfying g(0)=0, For example: g(α)=(n+1)α n ,n=1,2,3,…

[0028] When the fuzzy specification is the indicator function I {x|x≥LSL} , I {x|x≤USL} ; and l α =LSL,u α = USL, for any α∈(0,1]: It is stipulated that the membership functions of upper fuzzy and lower fuzzy are:

[0029]

[0030]

[0031] make For the above fuzzy, For lower blur, when g(α)=(n+1)α n , when n=1,2,3…, we have

[0032]

[0033] The process capability index can be extended to a fuzzy process capability index as follows:

[0034]

[0035] (3) Comprehensive weight assignment is performed on the multivariate quality attributes obtained in (1); the weight assignment method is the AHP-CRITIC method, and comprehensive weight assignment is performed on the multivariate quality attributes of the three unit samples of the production process of Xiaoer Xiaoji Zhike Oral Liquid: alcohol precipitation intermediate, water precipitation intermediate, and finished product. The detailed steps are as follows:

[0036] a. Subjective assignment method based on hierarchical analysis

[0037] By analyzing the influencing factors and correlations contained in the three units of the Pediatric Xiaoji Zhike Oral Liquid, the problems were organized and hierarchical, and a hierarchical analysis structure model was constructed. The elements of each level were compared pairwise, and a 1-9 level scaling method was adopted (see Table 1). The electronic tongue, electronic eye, pH and chemical composition were divided into four major categories, and the importance was compared with each other to assign scoring values ​​to establish a judgment matrix (see Table 2).

[0038] Table 1 Scale coefficients and meanings of levels 1 to 9 of the AHP

[0039]

[0040]

[0041] Table 2 Quality attribute judgment matrix of pediatric Xiaoji Zhike oral liquid

[0042]

[0043] Calculate the maximum characteristic root λ of the judgment matrix in Table 2 according to Formula 7 max The obtained quality attribute judgment matrix of Xiaoer Xiaoji Zhike Oral Liquid was normalized, and the weight vectors W of the four categories of electronic tongue, electronic eye, pH, and chemical composition were calculated according to formula 8. The weight vectors were standardized and the weight coefficients W of each quality attribute were calculated according to formula (9). i The relative importance of each element at this level relative to the quality attribute at the previous level can be calculated by calculating the maximum eigenvalue and eigenvector of the judgment matrix, and the importance order of each element at each level to a certain element at the previous level can be obtained, thereby establishing the weight vector of the quality attribute of Pediatric Xiaoji Zhike Oral Liquid. Finally, the consistency of the indicator layer is calculated according to formulas 10-11, and the indicator CR is tested.

[0044]

[0045]

[0046]

[0047] CI=(λ max -n) / (n-1) (10)

[0048] CR=CI / RI (11)

[0049] In formula 10-11, CI is the consistency index, λ max is the maximum eigenvalue of the pairwise comparison matrix, and RI is the random consistency index, which is only related to the n-order of the matrix.

[0050] The results of subjective assignment calculation based on hierarchical analysis are shown in Table 3, and the consistency test results are: max=4.072, CI=0.02401, CR=0.02668<0.10, indicating that random factors do not lead to unreasonable weight vectors and meet the consistency requirements.

[0051] Table 3 Results of subjective evaluation by hierarchical analysis

[0052]

[0053] b. Objective weight assignment method based on CRITIC method

[0054] The quality attributes of the three units of the Xiaoji Zhike oral liquid for children have been assigned weights of the four categories of electronic tongue, electronic eye, pH, and chemical composition as the factor layer weights in the hierarchical analysis. The CRITIC method objectively assigns multiple evaluation indicators under the four categories as control layer weights; including six indicators such as P1-P6 of the electronic tongue, three indicators such as L, a, and b of the electronic eye, four chemical components: forsythiaside E, neoeriocitrin, hesperidin, neohesperidin, and pH value. The indicator set of the factor layer composed of n evaluation indicators and m control layer indicators forms the original matrix Y=(y ij ) m×n ,According to formula (12), the matrix data is averaged and normalized to eliminate the dimensional differences of different quality parameters and obtain the normalized matrix.

[0055] x ij '=(xx mean ) / (x max -x min ) (12)

[0056] In formula 12, x ij is the value of the jth quality parameter of the i-th sample, x is the measured value, x mean 、x max 、x min are the mean, maximum and minimum values ​​of each quality parameter respectively.

[0057] Perform correlation analysis on each quality parameter and construct a correlation coefficient matrix between each parameter. Then use contrast intensity and conflict to calculate the weight coefficient of the quality parameter. The contrast intensity is expressed in the form of standard deviation. The larger the standard deviation, the greater the degree of variation of the quality parameter and the higher the weight. The conflict is the correlation between the quality parameters. A strong positive correlation between two parameters indicates that the conflict is smaller and the weight is lower. The formula is as follows:

[0058]

[0059]

[0060]

[0061] In formula 13-15, C j is the influence of the jth quality parameter on the system, σ j is the standard deviation of the jth quality parameter, indicating the contrast strength s of the quality parameter j , r ij is the correlation coefficient between the i-th and j-th quality parameters, δ j Indicates the conflict between quality parameters, ω j is the objective weight of the jth quality parameter. The results of the objective assignment of the quality attributes of the alcohol precipitation unit, water precipitation unit and finished product unit in the production process of the Children's Xiaoji Zhike Oral Liquid by the CRITIC method are shown in Table 4. CRITIC .

[0062] Table 4 Comprehensive weight assignment of multiple quality attributes based on the AHP-CRITIC method

[0063]

[0064]

[0065] c. Determine the comprehensive weight based on the AHP-CRITIC method

[0066] The comprehensive weights of the quality attributes of the three production units of Xiaoji Zhike Oral Liquid for Children were calculated according to formula (15). That is, the indicator weights obtained by the hierarchical analysis method were multiplied by the indicator weights obtained by the CRITIC method to calculate the comprehensive weights of each indicator. The results are shown in W in Table 4. 综 .

[0067]

[0068] (4) Assuming that all products meet quality requirements and that all quality attribute specifications are within their specification ranges, the maximum and minimum values ​​of the quality attribute characterization range measured in (1) are used as the upper and lower specification limits. Combined with the comprehensive weight assignment results in (3), the intelligent manufacturing comprehensive quality digitalization capabilities of the three units in the production process of Pediatric Xiaoji Zhike Oral Liquid are constructed. The minimum possible intelligent manufacturing comprehensive quality digitalization capabilities of the three units are calculated by the sum of the product of the process capability index of each quality attribute and its comprehensive weight. The results are shown in Table 5.

[0069] Table 5 Comprehensive quality digitalization capabilities of intelligent manufacturing in the production process of Pediatric Xiaoji Zhike Oral Liquid based on the scope of quality attribute characterization

[0070]

[0071] (5) Based on the fuzzy specifications in (2) and the comprehensive weight assignment results in (3), the fuzzy point estimation of the comprehensive quality digitalization capability of intelligent manufacturing of the three units in the production process of the pediatric Xiaoji Zhike oral liquid is constructed. The fuzzy point estimation of the comprehensive quality digitalization capability of intelligent manufacturing is a definite value, which is generalized from the fuzzy specifications of the quality attributes. The specific implementation process includes calculating the fuzzy process capability index under multiple quality attributes of the three units in the production process of the pediatric Xiaoji Zhike oral liquid according to formula (6), and stipulating that n in the formula is 1; l1 and u1 are the minimum and maximum values ​​of the data representing each quality attribute, respectively. The fuzzy lower limit interval is l0 to l1, and the fuzzy upper limit interval is u1 to u0. Finally, the fuzzy point estimate of the comprehensive quality digital capability of intelligent manufacturing for the three units is calculated by multiplying the fuzzy process capability index of each quality attribute by its comprehensive weight. The results are shown in Table 6. The introduction of fuzzy set theory expands the upper and lower limits of product specifications from two points to two intervals, improving the accuracy and confidence of the objective evaluation of the digital capability of the intelligent manufacturing production unit for Pediatric Xiaoji Zhike Oral Liquid.

[0072] Table 6 Comprehensive quality digitalization capabilities of intelligent manufacturing in the production process of Pediatric Xiaoji Zhike Oral Liquid based on fuzzy specifications of quality attributes

[0073]

[0074] According to the point estimation results of the comprehensive quality digitalization capabilities of intelligent manufacturing in the three units of the production process of the Pediatric Xiaoji Zhike Oral Liquid, the quality standard level of the Pediatric Xiaoji Zhike Oral Liquid is at Level III, which is at the 2-3 sigma level, indicating that improvement measures are needed for the production process.

[0075] The present invention provides an integrated method for evaluating the comprehensive digitalization capability of intelligent manufacturing of traditional Chinese medicine preparations and its application in pediatric Xiaoji Zhike oral liquid, constructs a multivariate quality attribute characterization method for pediatric Xiaoji Zhike oral liquid, adopts a combination of fuzzy set theory and upper and lower limits of product quality attribute specifications, integrates a comprehensive weight assignment method combining subjective and objective factors, establishes a fuzzy point estimation of the comprehensive digitalization capability level of intelligent manufacturing of each manufacturing unit in the production process of pediatric Xiaoji Zhike oral liquid, solves the problems of unclear quality attribute weights and unclear upper and lower limits of product specifications in digital capability evaluation, improves the accuracy of objective evaluation of whether the intelligent manufacturing production unit of pediatric Xiaoji Zhike oral liquid can meet the product quality requirements of the production process; completes the comprehensive digitalization capability evaluation of intelligent manufacturing of pediatric Xiaoji Zhike oral liquid, and realizes the objective evaluation of the capability level of whether the intelligent manufacturing unit of pediatric Xiaoji Zhike oral liquid can meet the product quality requirements of the production process.

Claims

1. An integrated method for evaluating the digital capability of comprehensive quality of intelligent manufacturing of traditional Chinese medicine is used in children's antitussive and cough-relieving oral liquid, characterized in that: The specific steps are as follows: Step 1: Digital characterization of the quality attributes of multiple batches of samples manufactured in each process unit of the Xiaoer Xiaoji Zhike Oral Liquid production process; Step 2: Define fuzzy specifications for the product quality attributes obtained in step 1. First, perform a normal distribution test on each quality attribute. Once the normal distribution is satisfied, define the corresponding α-cut set, membership function, and indicator function. Introduce the upper and lower limits of each quality attribute into fuzzy set theory to make the upper and lower limits fuzzy. Step 3: Assign weights to the various quality attributes of the multi-unit samples obtained in step 1; Step 4: Based on the fuzzy specifications in step 2 and the weight assignment results in step 3, construct the fuzzy point estimation of the comprehensive quality digital capability of multiple batches of samples manufactured by each process unit in the production process of Pediatric Xiaoji Zhike Oral Liquid. The fuzzy point estimation of the comprehensive quality digital capability of intelligent manufacturing is a definite value, which is generalized from the fuzzy specifications of quality attributes. The specific implementation process includes according to the formula Calculate the fuzzy process capability index of the production process of Xiaoji Zhike oral liquid for three units under multiple quality attributes, and specify that n is 1 in the formula. l1 and u1 are the minimum and maximum values ​​of the data representing each quality attribute, respectively. The fuzzy lower limit interval is composed of l0~l1, and the fuzzy upper limit interval is composed of u1~u0. Finally, the fuzzy point estimate of the comprehensive quality digitalization capability of intelligent manufacturing of the three units is calculated by the sum of the products of the fuzzy process capability index of each quality attribute and the comprehensive weight.

2. The application of the integrated method for evaluating the comprehensive quality digital capability of intelligent manufacturing of traditional Chinese medicine according to claim 1 in the pediatric Xiaoji Zhike oral liquid is characterized in that: The various process units of the production process of the pediatric Xiaoji Zhike oral liquid in step 1 include no less than any two consecutive units of the extraction, concentration, alcohol precipitation, water precipitation, inclusion, flavoring, and sterilization units in the manufacturing process.

3. The application of the integrated method for evaluating the digital capability of comprehensive quality of intelligent manufacturing of traditional Chinese medicine according to claim 1 in the pediatric Xiaoji Zhike oral liquid is characterized in that: The quality attributes in step 1 include quality attributes of two or more dimensions among the four aspects of physical, chemical, biological and microbiological quality attributes.

4. The application of the integrated method for evaluating the digital capability of comprehensive quality of intelligent manufacturing of traditional Chinese medicine according to claim 1 in the pediatric Xiaoji Zhike oral liquid is characterized in that: The weight assignment method in step 3 is an integrated assignment of the hierarchical analysis method based on subjective assignment and the CRITIC method based on objective assignment, which assigns weights to multi-source quality attributes.

5. The application of the integrated method for evaluating the digital capability of comprehensive quality of intelligent manufacturing of traditional Chinese medicine according to claim 1 in the pediatric Xiaoji Zhike oral liquid is characterized in that: The comprehensive quality digitalization capability of intelligent manufacturing in step 4 is the comprehensive quality obtained by weighting multiple quality attributes by their respective digitalization levels. It can evaluate the digitalization capability of the pediatric detoxification and cough-relieving oral liquid and whether it can meet the production capacity level of product quality requirements.

Images