Method and device for optimizing the formulation of oxytetracycline injection

Abstract

The present invention discloses a method and device for optimizing the formula of oxytetracycline injection, which specifically relates to the technical field of biological preparations, including: step 1: obtaining the formula evaluation coefficients of N oxytetracycline samples, and placing the corresponding oxytetracycline samples in I test environments in turn according to the formula evaluation coefficients; step 2: obtaining the maximum formula evaluation coefficient, determining the target test environment according to the maximum formula evaluation coefficient and obtaining the corresponding degradation characteristic data; calculating the formula change coefficient of the oxytetracycline sample based on the degradation characteristic data; the present invention can systematically improve the stability and effectiveness of oxytetracycline injection, reduce the risk of degradation and failure, optimize production and storage efficiency, ensure drug quality and patient safety, improve supervision and response capabilities, and ultimately achieve efficient, stable and safe use of drugs.

Description

Technical Field

[0001] The present invention relates to the technical field of biological preparations, and more specifically, to a method and device for optimizing the formulation of oxytetracycline injection. Background Art

[0002] Oxytetracycline is a broad-spectrum antibiotic belonging to the tetracycline class of antibiotics, and is widely used to treat infections caused by a variety of bacteria, such as respiratory tract infections, urinary tract infections, skin infections, etc. Oxytetracycline exerts its antibacterial effect by inhibiting bacterial protein synthesis, and has a good antibacterial spectrum and efficacy; currently, oxytetracycline injection, as a commonly used antibiotic injection, has been widely used clinically. Existing methods make oxytetracycline injection release drugs stably and efficiently by optimizing the components of the liquid medicine and finely controlling the preparation process. For example, a Chinese patent application with publication number CN116492296A discloses a formula and preparation process of oxytetracycline injection. Although the above method can achieve the stability of oxytetracycline injection, the inventor has studied and applied the above method and the prior art and found that the above method and the prior art have at least the following partial defects:

[0003] High-concentration drugs are more easily degraded during storage, especially in high-temperature or high-humidity environments. If high-concentration solutions are easily precipitated in low-temperature environments, the uniformity and effectiveness of the drugs will be affected. For this reason, the present invention provides a method and device for optimizing the formulation of oxytetracycline injection. Summary of the invention

[0004] In order to overcome the above-mentioned defects of the prior art, the present invention provides a method and device for optimizing the formulation of oxytetracycline injection to solve the problems raised in the above-mentioned background technology.

[0005] To achieve the above-mentioned purpose, in a first aspect, the present invention provides the following technical solution: a method for optimizing the formulation of oxytetracycline injection, comprising:

[0006] Step 1: Obtain the formula evaluation coefficients of N oxytetracycline samples, and place the corresponding oxytetracycline samples into I test environments in sequence according to the formula evaluation coefficients;

[0007] Step 2: Obtain the maximum formula evaluation coefficient, determine the target test environment according to the maximum formula evaluation coefficient and obtain the corresponding degradation characteristic data; calculate the formula change coefficient of the oxytetracycline sample based on the degradation characteristic data;

[0008] Step 3: preset a formula change threshold, compare the formula change coefficient with the preset formula change threshold, and determine whether the corresponding Oxytetracycline sample is abnormal. If there is an abnormality, mark the corresponding Oxytetracycline sample as an abnormal Oxytetracycline sample;

[0009] Step 4: Obtain environmental data of the abnormal oxytetracycline sample, and perform analysis based on the environmental data and the corresponding formula change coefficient to obtain the corresponding optimized adjustment value; after adjusting the environmental data of the abnormal oxytetracycline sample, obtain the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline sample;

[0010] Step 5: Determine the adjustment evaluation coefficient of the abnormal oxytetracycline sample to determine whether to generate an optimization exception instruction; if an optimization exception instruction is generated, send the generated optimization exception instruction to the regulatory user end.

[0011] Furthermore, the method for obtaining the formula evaluation coefficients of N oxytetracycline samples includes:

[0012] Obtain the oxytetracycline concentration, solvent concentration, and buffer concentration of the nth oxytetracycline sample, and mark the oxytetracycline concentration, solvent concentration, and buffer concentration as Tm, respectively. n 、Ym n and Hj n ; n∈N;

[0013] The concentration of oxytetracycline Tm n , solvent concentration Ym n and buffer concentration Hj n Perform a formula calculation to obtain the formula evaluation coefficient Yp for the nth oxytetracycline sample n .

[0014] Further, the method of placing the corresponding oxytetracycline samples into I test environments in sequence according to the formula evaluation coefficient includes:

[0015] Step a1. Obtaining the formula evaluation coefficients of N oxytetracycline samples;

[0016] Step a2. Setting I recipe coefficient threshold intervals, and setting I test environments corresponding to the I recipe coefficient threshold intervals;

[0017] Each recipe coefficient threshold interval is divided according to the same gradient if and only if there is a test environment associated and bound to it;

[0018] Step a3. Compare the formula evaluation coefficient of the nth oxytetracycline sample with each formula coefficient threshold interval to obtain the formula coefficient threshold interval into which the formula evaluation coefficient of the nth oxytetracycline sample falls;

[0019] Step a4. According to the formula coefficient threshold interval into which the formula evaluation coefficient of the nth oxytetracycline sample falls, the nth oxytetracycline sample is placed in the corresponding test environment; and n=n+1 is set, and the process is returned to step a1;

[0020] Step a5. Repeat the above steps a1 to a4 until the loop ends when n = N, and place each of the oxytetracycline samples into I test environments in sequence.

[0021] Further, the degradation characteristic data includes the degradation rate, pH value, and solution clarity of the oxytetracycline sample;

[0022] The acquisition logic of the maximum formulation evaluation coefficient is as follows:

[0023] Sort the formulation evaluation coefficients of each oxytetracycline sample in descending order of value;

[0024] Take the formulation evaluation coefficient ranked first as the maximum formulation evaluation coefficient of the oxytetracycline sample;

[0025] Transmit the oxytetracycline sample with the maximum formulation evaluation coefficient to the i-th test environment, and mark the i-th test environment as the target test environment.

[0026] Further, the method for calculating the formulation change coefficient of the target test environment based on the degradation characteristic data includes:

[0027] Perform a formula-based calculation on the degradation rate, pH value, and solution clarity of the oxytetracycline sample to obtain the formulation change coefficient Np of the target test environment.

[0028] Further, the method for determining whether the corresponding oxytetracycline sample is abnormal includes:

[0029] Extract the preset formulation change thresholds Pz1 and Pz2 of the oxytetracycline sample, where Pz1 > Pz2, and compare the formulation evaluation coefficient with the formulation change threshold;

[0030] If Np > Pz1 or Np < Pz2, it is determined that the corresponding oxytetracycline sample is abnormal and marked as an abnormal oxytetracycline sample;

[0031] If Pz1 ≥ Np ≥ Pz2, it is determined that the corresponding oxytetracycline sample is not abnormal.

[0032] Further, the environmental data is the temperature value and humidity value of the target test environment; the optimization adjustment value is the temperature adjustment value and the pH value difference;

[0033] The method for analyzing based on the temperature value and the corresponding formulation change coefficient to obtain the corresponding optimization adjustment value includes:

[0034] Step b1: Obtain the formulation change coefficient of the test oxytetracycline sample corresponding to the r unit temperature value, and obtain the formulation change coefficient of the test oxytetracycline sample corresponding to the r - v unit temperature value; r is a positive integer, the initial value of r is the initial temperature value, and v is a positive constant;

[0035] Step b2: taking the formula change coefficient of the test oxytetracycline sample corresponding to the r unit temperature value as the first optimization coefficient, and taking the formula change coefficient of the test oxytetracycline sample corresponding to the rv unit temperature value as the second optimization coefficient;

[0036] Step b3: Compare the first optimization coefficient with the second optimization coefficient to determine whether the first optimization coefficient is less than or equal to the second optimization coefficient; if the first optimization coefficient is greater than the second optimization coefficient, set r=rv and return to step b1; if the first optimization coefficient is less than or equal to the second optimization coefficient, obtain the temperature value r corresponding to the first optimization coefficient;

[0037] Step b4: Calculate the difference between the temperature value r and the temperature value to obtain a second adjustment difference, and use the second adjustment difference as the temperature adjustment value of the abnormal oxytetracycline sample;

[0038] Step b5: Repeat the above steps b1 to b3 until the first optimization coefficient is greater than or equal to the second optimization coefficient, and then end the loop;

[0039] The method of analyzing the humidity value and the corresponding formula variation coefficient to obtain the corresponding optimized adjustment value also includes:

[0040] Step c1: obtaining the formula variation coefficient of the oxytetracycline sample tested under the unit humidity value of f, and obtaining the formula variation coefficient of the oxytetracycline sample tested under the unit humidity value of fu; f is an integer greater than zero, the initial value of f is the initial humidity value, and u is a constant greater than zero;

[0041] Step c2: taking the formula change coefficient of the test oxytetracycline sample corresponding to the unit humidity value of f as the third optimization coefficient, and taking the formula change coefficient of the test oxytetracycline sample corresponding to the unit humidity value of fu as the fourth optimization coefficient;

[0042] Step c3: compare the third optimization coefficient with the fourth optimization coefficient to determine whether the third optimization coefficient is less than or equal to the fourth optimization coefficient; if the third optimization coefficient is greater than the fourth optimization coefficient, set f=fu and return to step c1; if the third optimization coefficient is less than or equal to the fourth optimization coefficient, obtain the humidity value f corresponding to the third optimization coefficient;

[0043] Step c4: Calculate the difference between the humidity value f and the humidity value to obtain a second adjustment difference, and use the second adjustment difference as the humidity adjustment value of the abnormal oxytetracycline sample;

[0044] Step c5: Repeat the above steps c1 to c3 until the third optimization coefficient is greater than or equal to the fourth optimization coefficient, and then end the loop.

[0045] Furthermore, the generation logic of obtaining the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline sample is as follows:

[0046] Obtain the degradation rate difference and pH value difference of abnormal oxytetracycline samples and mark them as Jc and P respectively. c ,

[0047] The degradation rate difference Jc and pH value difference Pc of abnormal oxytetracycline samples were dimensionlessly processed and then calculated to obtain the adjustment evaluation coefficient Tp.

[0048] Further, the method of judging the adjustment evaluation coefficient of the abnormal oxytetracycline sample and whether to generate an optimization abnormal instruction includes:

[0049] Preset an adjustment evaluation coefficient threshold, and compare the adjustment evaluation coefficient with the adjustment evaluation coefficient threshold;

[0050] If the adjustment evaluation coefficient is less than the adjustment evaluation coefficient threshold, an optimization exception instruction is generated;

[0051] If the adjustment evaluation coefficient is greater than or equal to the adjustment evaluation coefficient threshold, no optimization exception instruction is generated.

[0052] In a second aspect, the present invention provides a formulation optimization device for oxytetracycline injection, which is used to implement the above-mentioned formulation optimization method for oxytetracycline injection, comprising:

[0053] The oxytetracycline distribution module is used to obtain the formula evaluation coefficients of N oxytetracycline samples, and place the corresponding oxytetracycline samples in I test environment in turn according to the formula evaluation coefficients;

[0054] An analysis module is used to obtain a maximum formula evaluation coefficient, determine a target test environment according to the maximum formula evaluation coefficient, and obtain corresponding degradation characteristic data; and calculate a formula variation coefficient of the oxytetracycline sample based on the degradation characteristic data;

[0055] The first judgment module presets a formula change threshold, compares the formula change coefficient with the preset formula change threshold, and judges whether the corresponding soil mold sample is abnormal. If there is an abnormality, the corresponding soil mold sample is marked as an abnormal oxytetracycline sample;

[0056] An optimization module is used to obtain environmental data of abnormal oxytetracycline samples, analyze the environmental data and the corresponding formula change coefficient to obtain the corresponding optimization adjustment value; after adjusting the environmental data of the abnormal oxytetracycline samples, obtain the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline samples;

[0057] The second judgment module is used to judge the adjustment evaluation coefficient of the abnormal oxytetracycline sample and whether to generate an optimization exception instruction; if an optimization exception instruction is generated, the generated optimization exception instruction is sent to the supervision user end.

[0058] Technical effects and advantages of the present invention:

[0059] The present invention, by obtaining the formula evaluation coefficient of N oxytetracycline samples, puts the corresponding oxytetracycline samples into 1 test environment in sequence according to the formula evaluation coefficient; obtain the maximum formula evaluation coefficient, determine the target test environment according to the maximum formula evaluation coefficient and obtain the corresponding degradation characteristic data; calculate the formula variation coefficient of oxytetracycline samples based on the degradation characteristic data; preset the formula variation threshold, compare the formula variation coefficient with the preset formula variation threshold, judge whether the corresponding soil mold sample is abnormal, if there is abnormality, the corresponding soil mold sample is marked as abnormal oxytetracycline sample; obtain the environmental data of abnormal oxytetracycline sample, analyze based on environmental data and corresponding formula variation coefficient, to obtain the corresponding optimization adjustment value; after adjusting the environmental data of abnormal oxytetracycline sample, obtain the adjustment evaluation coefficient corresponding to abnormal oxytetracycline sample; judge the adjustment evaluation coefficient of abnormal oxytetracycline sample, whether to generate optimization abnormal instruction; if generate optimization abnormal instruction, send the generated optimization abnormal instruction to the supervision user end. The present invention can systematically improve the stability and effectiveness of oxytetracycline injection by the above method, reduce degradation and failure risk, optimize production and storage efficiency, ensure drug quality and patient safety, improve supervision and response capability, and finally realize the efficient, stable and safe use of medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 The flowchart of the method for optimizing the formulation of oxytetracycline injection of Example 1 is as follows;

[0061] Figure 2 It is a schematic diagram of the structure of the formulation optimization device of oxytetracycline injection in Example 2;

[0062] Figure 3 This is a schematic diagram of an electronic device according to Embodiment 3;

[0063] Figure 4 A schematic diagram of a computer-readable storage medium of Example 4. DETAILED DESCRIPTION

[0064] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0065] In addition, the accompanying drawings are only schematic illustrations of the present invention and are not necessarily drawn to scale. The same reference numerals in the figures represent the same or similar parts, and their repeated description will be omitted. Some of the block diagrams shown in the accompanying drawings are functional entities and do not necessarily correspond to physically or logically independent entities. The functional entities can be implemented in software form, or implemented in one or more hardware modules or integrated circuits, or implemented in different networks and / or processor methods and / or microcontroller methods.

[0066] It should be understood that, although the terms "first", "second", etc. may be used herein to describe various units, these units should not be limited by these terms. These terms are used only to distinguish one unit from another unit. For example, without departing from the scope of the exemplary embodiments, a first unit may be referred to as a second unit, and a similar second unit may be referred to as a first unit. The term "and / or" used herein includes any and all combinations of one or more of the listed associated items.

[0067] Example 1

[0068] See also Figure 1 As shown, this embodiment discloses a method for optimizing the formulation of oxytetracycline injection, comprising:

[0069] Step 1: Obtain the formula evaluation coefficients of N oxytetracycline samples, and place the corresponding oxytetracycline samples into I test environments in sequence according to the formula evaluation coefficients;

[0070] It should be noted that N oxytetracycline samples are prepared in the oxytetracycline pharmaceutical factory, each of which is an oxytetracycline injection prepared by mixing different oxytetracycline concentrations, solvent concentrations and buffer concentrations, and each of the oxytetracycline samples corresponds to a formula evaluation coefficient; the solvent is water for injection or purified water as a solvent, and the buffer includes but is not limited to citrate buffer or phosphate buffer; it should be further noted that since oxytetracycline injections of different concentrations require different storage environments to ensure their stability and effectiveness, the storage environment of the oxytetracycline pharmaceutical factory is optimized to ensure the quality and efficacy of the drug. The oxytetracycline pharmaceutical factory is equipped with multiple sensors, including but not limited to infrared temperature sensors, concentration sensors and humidity sensors, etc.;

[0071] During implementation, the method for obtaining the formula evaluation coefficients of N oxytetracycline samples includes:

[0072] Obtain the oxytetracycline concentration, solvent concentration, and buffer concentration of the nth oxytetracycline sample, and mark the oxytetracycline concentration, solvent concentration, and buffer concentration as Tm, respectively. n 、Ym n and Hjn ; n∈N;

[0073] The concentration of oxytetracycline Tm n , solvent concentration Ym n and buffer concentration Hj n Perform a formula calculation to obtain the formula evaluation coefficient Yp for the nth oxytetracycline sample n ; The calculation formula is:

[0074]

[0075] Where: Yp n represents the formula evaluation coefficient of the nth oxytetracycline sample, α1 represents the oxytetracycline concentration weight factor of the nth oxytetracycline sample; α2 represents the solvent concentration weight factor of the nth oxytetracycline sample; α3 represents the buffer concentration weight factor of the nth oxytetracycline sample, and α1, α2 and α3 are all greater than zero; the weight factors are all set by those skilled in the art based on experience;

[0076] It should be noted that the oxytetracycline concentration, solvent concentration and buffer concentration are collected by concentration sensors and obtained after preprocessing, and the preprocessing includes but is not limited to data cleaning, noise removal, missing value processing or error data repair.

[0077] It should be noted that: the test environment is to store oxytetracycline samples under different temperature and humidity conditions to test their stability; illustratively, the one test environment includes a normal temperature dark environment, a high temperature and high humidity environment, and a low temperature dark environment, as shown in Table 1 below:

[0078] Table 1 Test environment

[0079]

[0080] In implementation, the method of placing the corresponding oxytetracycline samples into I test environments in sequence according to the formula evaluation coefficient includes:

[0081] Step a1. Obtaining the formula evaluation coefficients of N oxytetracycline samples;

[0082] Step a2. Setting I recipe coefficient threshold intervals, and setting I test environments corresponding to the I recipe coefficient threshold intervals;

[0083] It should be understood that each formula coefficient threshold interval is divided according to the same gradient if and only if there is a test environment associated with it. The gradient division can be used to evaluate the stability of oxytetracycline samples under different environmental conditions, providing a scientific basis for optimizing the formula and storage conditions.

[0084] Step a3. Compare the formula evaluation coefficient of the nth oxytetracycline sample with each formula coefficient threshold interval to obtain the formula coefficient threshold interval into which the formula evaluation coefficient of the nth oxytetracycline sample falls;

[0085] Step a4. According to the formula coefficient threshold interval into which the formula evaluation coefficient of the nth oxytetracycline sample falls, the nth oxytetracycline sample is placed in the corresponding test environment; and n=n+1 is set, and the process is returned to step a1;

[0086] Step a5. Repeat the above steps a1 to a4 until the cycle ends when n=N, so that each oxytetracycline sample is placed in I test environments in turn.

[0087] This step improves the accuracy and credibility of the test results through reasonable matching to ensure that each oxytetracycline sample is tested under appropriate conditions to obtain the best test data and improve the efficiency, accuracy and reliability of the experimental process.

[0088] Step 2: Obtain the maximum formula evaluation coefficient, determine the target test environment based on the maximum formula evaluation coefficient and obtain the corresponding degradation characteristic data; calculate the formula variation coefficient of the oxytetracycline sample based on the degradation characteristic data.

[0089] It should be noted that the degradation characteristic data include the degradation rate, pH value and solution clarity of the oxytetracycline sample;

[0090] In implementation, the logic for obtaining the maximum formula evaluation coefficient is as follows:

[0091] The formulation evaluation coefficient of each oxytetracycline sample was sorted from large to small according to the value;

[0092] The formula evaluation coefficient ranked first is used as the maximum formula evaluation coefficient of the oxytetracycline sample;

[0093] The oxytetracycline sample with the maximum formulation evaluation coefficient is transmitted to the i-th test environment, and the i-th test environment is marked as the target test environment, i∈I.

[0094] In implementation, the method for calculating the formula variation coefficient of the target test environment based on the degradation characteristic data includes:

[0095] The degradation rate, pH value and solution clarity of the oxytetracycline sample were calculated by formula to obtain the formula variation coefficient Np of the target test environment, and the calculation formula is:

[0096]

[0097] Wherein, Np is the formulation change coefficient, Js is the degradation rate, β1 is the weight factor of the degradation rate, pH is the pH value, β2 is the weight factor of the pH value, Cl is the solution clarity, β3 is the weight factor of the solution clarity, and β1, β2, and β3 are all greater than zero; the weight factors are all set by those skilled in the art according to experience;

[0098] It should be noted that: the degradation rate, pH value, and solution clarity are respectively obtained by measuring with a spectroanalyzer, a pH meter, and a turbidimeter.

[0099] This step can scientifically evaluate the performance of oxytetracycline formulations under different environmental conditions by determining the target test environment according to the maximum formulation evaluation coefficient, ensuring the stability and effectiveness of the drug, improving experimental efficiency, saving resources, and predicting and managing risks in advance.

[0100] Step 3: Preset a formulation change threshold, compare the formulation change coefficient with the preset formulation change threshold, and determine whether the corresponding oxytetracycline sample is abnormal. If it is abnormal, mark the corresponding oxytetracycline sample as an abnormal oxytetracycline sample;

[0101] During implementation, the method for determining whether the corresponding oxytetracycline sample is abnormal includes:

[0102] Extract the preset formulation change thresholds Pz1 and Pz2 of the oxytetracycline sample, where Pz1 > Pz2, and compare the formulation evaluation coefficient with the formulation change threshold;

[0103] It should be noted that: the calculation process of the preset formulation change threshold is the same as the generation process of the formulation evaluation coefficient. For details, refer to the above text, and the preset formulation change thresholds Pz1 and Pz2 are determined by the staff, and will not be elaborated here;

[0104] If Np > Pz1 or Np < Pz2, it is determined that the corresponding oxytetracycline sample is abnormal and marked as an abnormal oxytetracycline sample;

[0105] If Pz1 ≥ Np ≥ Pz2, it is determined that the corresponding oxytetracycline sample is not abnormal.

[0106] Step 4: Obtain the environmental data of the abnormal oxytetracycline sample, analyze based on the environmental data and the corresponding formulation change coefficient to obtain the corresponding optimization adjustment value; after adjusting the environmental data of the abnormal oxytetracycline sample, obtain the adjusted evaluation coefficient corresponding to the abnormal oxytetracycline sample;

[0107] It should be noted that: the environmental data is the temperature value and humidity value of the target test environment; the optimization adjustment value is the temperature adjustment value and humidity adjustment value;

[0108] Specifically, the method of analyzing the temperature value and the corresponding formula variation coefficient to obtain the corresponding optimization adjustment value includes:

[0109] Step b1: obtaining the formula variation coefficient of the oxytetracycline sample under the unit temperature value r, and obtaining the formula variation coefficient of the oxytetracycline sample under the unit temperature value rv; r is an integer greater than zero, the initial value of r is the initial temperature value, and v is a constant greater than zero;

[0110] Step b2: taking the formula change coefficient of the test oxytetracycline sample corresponding to the r unit temperature value as the first optimization coefficient, and taking the formula change coefficient of the test oxytetracycline sample corresponding to the rv unit temperature value as the second optimization coefficient;

[0111] Step b3: Compare the first optimization coefficient with the second optimization coefficient to determine whether the first optimization coefficient is less than or equal to the second optimization coefficient; if the first optimization coefficient is greater than the second optimization coefficient, set r=rv and return to step b1; if the first optimization coefficient is less than or equal to the second optimization coefficient, obtain the temperature value r corresponding to the first optimization coefficient;

[0112] Step b4: Calculate the difference between the temperature value r and the temperature value to obtain a second adjustment difference, and use the second adjustment difference as the temperature adjustment value of the abnormal oxytetracycline sample;

[0113] Step b5: Repeat the above steps b1 to b3 until the first optimization coefficient is greater than or equal to the second optimization coefficient, and then end the loop.

[0114] In another specific embodiment, the method for analyzing the humidity value and the corresponding formula variation coefficient to obtain the corresponding optimized adjustment value further includes:

[0115] Step c1: obtaining the formula variation coefficient of the oxytetracycline sample tested under the unit humidity value of f, and obtaining the formula variation coefficient of the oxytetracycline sample tested under the unit humidity value of fu; f is an integer greater than zero, the initial value of f is the initial humidity value, and u is a constant greater than zero;

[0116] Step c2: taking the formula change coefficient of the test oxytetracycline sample corresponding to the unit humidity value of f as the third optimization coefficient, and taking the formula change coefficient of the test oxytetracycline sample corresponding to the unit humidity value of fu as the fourth optimization coefficient;

[0117] Step c3: compare the third optimization coefficient with the fourth optimization coefficient to determine whether the third optimization coefficient is less than or equal to the fourth optimization coefficient; if the third optimization coefficient is greater than the fourth optimization coefficient, set f=fu and return to step c1; if the third optimization coefficient is less than or equal to the fourth optimization coefficient, obtain the humidity value f corresponding to the third optimization coefficient;

[0118] Step c4: Calculate the difference between the humidity value f and the humidity value to obtain a second adjustment difference, and use the second adjustment difference as the humidity adjustment value of the abnormal oxytetracycline sample;

[0119] Step c5: repeat the above steps c1 to c3 until the third optimization coefficient is greater than or equal to the fourth optimization coefficient, and then end the loop;

[0120] Furthermore, the generation logic of obtaining the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline sample is as follows:

[0121] Obtain the degradation rate difference and pH value difference of abnormal oxytetracycline samples and mark them as Jc and P respectively. c ,

[0122] The degradation rate difference Jc and pH value difference Pc of abnormal oxytetracycline samples are dimensionlessly processed and calculated to obtain the adjustment evaluation coefficient Tp, and the calculation formula is as follows:

[0123] Tp = γ1 × Jc + γ2 × Pc;

[0124] Wherein, Tp represents the adjustment evaluation coefficient of the abnormal oxytetracycline sample, γ1 represents the weight factor of the degradation rate difference, and Y2 represents the weight factor of the pH value difference of the abnormal oxytetracycline sample; γ1 and γ2 are both greater than zero; and the weight factors are set by those skilled in the art based on experience;

[0125] It should be understood that: the smaller the degradation rate difference and pH value difference of the abnormal oxytetracycline sample, the smaller the value of the adjustment evaluation coefficient. On the contrary, the larger the degradation rate difference and pH value difference of the abnormal oxytetracycline sample, the larger the value of the adjustment evaluation coefficient.

[0126] Step 5: Determine the adjustment evaluation coefficient of the abnormal oxytetracycline sample to determine whether to generate an optimization abnormality instruction; if an optimization abnormality instruction is generated, send the generated optimization abnormality instruction to the supervisory user end so that the staff can further optimize the abnormal oxytetracycline sample;

[0127] Specifically, the method for judging the adjustment evaluation coefficient of the abnormal oxytetracycline sample and whether to generate an optimization abnormal instruction includes:

[0128] Preset an adjustment evaluation coefficient threshold, and compare the adjustment evaluation coefficient with the adjustment evaluation coefficient threshold;

[0129] If the adjustment evaluation coefficient is less than the adjustment evaluation coefficient threshold, an optimization abnormality instruction is generated; this indicates that the environmental data adjustment of the abnormal oxytetracycline sample is inappropriate, and the staff is required to further monitor the abnormal oxytetracycline sample;

[0130] If the adjustment evaluation coefficient is greater than or equal to the adjustment evaluation coefficient threshold, no optimization exception instruction is generated; this indicates that the environmental data adjustment of the abnormal oxytetracycline sample is appropriate and no further optimization of the abnormal oxytetracycline sample is required.

[0131] The present embodiment, by obtaining the formula evaluation coefficient of N oxytetracycline samples, puts the corresponding oxytetracycline samples into 1 test environment in turn according to the formula evaluation coefficient; obtain the maximum formula evaluation coefficient, determine the target test environment according to the maximum formula evaluation coefficient and obtain the corresponding degradation characteristic data; calculate the formula variation coefficient of oxytetracycline sample based on the degradation characteristic data; preset the formula variation threshold, compare the formula variation coefficient with the preset formula variation threshold, judge whether the corresponding soil mold sample is abnormal, if there is abnormality, the corresponding soil mold sample is marked as abnormal oxytetracycline sample; obtain the environmental data of abnormal oxytetracycline sample, analyze based on environmental data and corresponding formula variation coefficient, to obtain the corresponding optimization adjustment value; after adjusting the environmental data of abnormal oxytetracycline sample, obtain the adjustment evaluation coefficient corresponding to abnormal oxytetracycline sample; judge the adjustment evaluation coefficient of abnormal oxytetracycline sample, whether to generate optimization abnormal instruction; if generate optimization abnormal instruction, send the generated optimization abnormal instruction to the supervision user end. The stability and effectiveness of oxytetracycline injection can be systematically improved by the above method, degradation and failure risk can be reduced, production and storage efficiency can be optimized, drug quality and patient safety can be ensured, supervision and response capabilities can be improved, and efficient, stable and safe use of medicine can be finally achieved.

[0132] Example 2

[0133] See also Figure 2 As shown, this embodiment provides a formulation optimization device for oxytetracycline injection, comprising:

[0134] The oxytetracycline distribution module is used to obtain the formula evaluation coefficients of N oxytetracycline samples, and place the corresponding oxytetracycline samples in I test environment in turn according to the formula evaluation coefficients;

[0135] An analysis module is used to obtain a maximum formula evaluation coefficient, determine a target test environment according to the maximum formula evaluation coefficient, and obtain corresponding degradation characteristic data; and calculate a formula variation coefficient of the oxytetracycline sample based on the degradation characteristic data;

[0136] The first judgment module presets a formula change threshold, compares the formula change coefficient with the preset formula change threshold, and judges whether the corresponding soil mold sample is abnormal. If there is an abnormality, the corresponding soil mold sample is marked as an abnormal oxytetracycline sample;

[0137] An optimization module is used to obtain environmental data of abnormal oxytetracycline samples, analyze the environmental data and the corresponding formula change coefficient to obtain the corresponding optimization adjustment value; after adjusting the environmental data of the abnormal oxytetracycline samples, obtain the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline samples;

[0138] The second judgment module is used to judge the adjustment evaluation coefficient of the abnormal oxytetracycline sample and whether to generate an optimization exception instruction; if an optimization exception instruction is generated, the generated optimization exception instruction is sent to the supervision user end.

[0139] Example 3

[0140] See also Figure 3 As shown, this embodiment provides an electronic device 500. The electronic device 500 may include one or more processors and one or more memories. The memories store computer readable codes, and when the computer readable codes are run by one or more processors, the formula optimization method of oxytetracycline injection as described above may be executed.

[0141] The system according to the embodiment of the present application can also be used Figure 3 The electronic device architecture shown in FIG. Figure 3 As shown, the electronic device 500 may include a bus 501, one or more CPUs 502, a read-only memory (ROM) 503, a random access memory (RAM) 504, a communication port 505 connected to a network, an input / output 506, a hard disk 507, etc. The storage device in the electronic device 500, such as the ROM 503 or the hard disk 507, may store the formulation optimization method of oxytetracycline injection provided in the present application. Further, the electronic device 500 may also include a user interface 508. Of course, Figure 3 The architecture shown is only exemplary and can be omitted according to actual needs when implementing different devices. Figure 3 One or more components of an electronic device are shown.

[0142] Example 4

[0143] See also Figure 4 As shown, this embodiment provides a computer-readable storage medium storing instructions, which, when executed on a computer, enable the computer to execute the formula optimization method of oxytetracycline injection of Example 1.

[0144] The formulas involved in the above are all calculated by removing dimensions and taking their numerical values. They are a formula that is closest to the actual situation obtained by collecting a large amount of data and performing software simulation. The weight factors in the formula and the preset thresholds in the analysis process are set by technicians in this field according to actual conditions or obtained by simulating a large amount of data; the size of the weight factor is to quantify each parameter to obtain a specific value for subsequent comparison. The size of the weight factor depends on the amount of sample data and the corresponding processing coefficient initially set by technicians in this field for each group of sample data; as long as it does not affect the proportional relationship between the parameter and the quantized value.

[0145] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art who is familiar with the present technical field can easily think of changes or substitutions within the technical scope disclosed in the present application, which should be included in the protection scope of the present application. Therefore, the protection scope of the present application should be based on the protection scope of the claims.

[0146] Finally: The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for optimizing the formulation of oxytetracycline injection, characterized in that: include: Step 1: Obtain the formula evaluation coefficients of N oxytetracycline samples, and place the corresponding oxytetracycline samples into I test environments in sequence according to the formula evaluation coefficients; Step 2: Obtain the maximum formulation evaluation coefficient, determine the target test environment according to the maximum formulation evaluation coefficient, and obtain the corresponding degradation characteristic data; The coefficient of variation of the formulation of oxytetracycline samples was calculated based on the degradation characteristic data; Step 3: preset a formula change threshold, compare the formula change coefficient with the preset formula change threshold, and determine whether the corresponding Oxytetracycline sample is abnormal. If there is an abnormality, mark the corresponding Oxytetracycline sample as an abnormal Oxytetracycline sample; Step 4: Obtain environmental data of abnormal oxytetracycline samples, and analyze based on the environmental data and the corresponding formula variation coefficient to obtain the corresponding optimized adjustment value; After adjusting the environmental data of the abnormal oxytetracycline sample, the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline sample is obtained; Step 5: Determine the adjustment evaluation coefficient of the abnormal oxytetracycline sample to determine whether to generate an optimization exception instruction; if an optimization exception instruction is generated, send the generated optimization exception instruction to the regulatory user end.

2. The method for optimizing the formulation of oxytetracycline injection according to claim 1, characterized in that: Methods for obtaining formulation evaluation coefficients of N oxytetracycline samples include: Obtain the oxytetracycline concentration, solvent concentration, and buffer concentration of the nth oxytetracycline sample, and mark the oxytetracycline concentration, solvent concentration, and buffer concentration as Tm, respectively. n 、Ym n and Hj n ; n∈N; The concentration of oxytetracycline Tm n , solvent concentration Ym n and buffer concentration Hj n Perform a formula calculation to obtain the formula evaluation coefficient Yp for the nth oxytetracycline sample n .

3. The method for optimizing the formulation of oxytetracycline injection according to claim 2, characterized in that: The method of placing the corresponding oxytetracycline samples into I test environments in sequence according to the formula evaluation coefficients includes: Step a1. Obtaining the formula evaluation coefficients of N oxytetracycline samples; Step a2. Setting I recipe coefficient threshold intervals, and setting I test environments corresponding to the I recipe coefficient threshold intervals; Each recipe coefficient threshold interval is divided according to the same gradient if and only if there is a test environment associated and bound to it; Step a3. Compare the formula evaluation coefficient of the nth oxytetracycline sample with each formula coefficient threshold interval to obtain the formula coefficient threshold interval into which the formula evaluation coefficient of the nth oxytetracycline sample falls; Step a4. According to the formula coefficient threshold interval into which the formula evaluation coefficient of the nth oxytetracycline sample falls, the nth oxytetracycline sample is placed in the corresponding test environment; and n=n+1 is set, and the process is returned to step a1; Step a5. Repeat the above steps a1 to a4 until the cycle ends when n=N, so that each oxytetracycline sample is placed in I test environments in turn.

4. The method for optimizing the formulation of oxytetracycline injection according to claim 3, characterized in that: The degradation characteristic data include the degradation rate, pH value and solution clarity of the oxytetracycline sample; The logic for obtaining the maximum formula evaluation coefficient is as follows: The formulation evaluation coefficient of each oxytetracycline sample was sorted from large to small according to the value; The formula evaluation coefficient ranked first is used as the maximum formula evaluation coefficient of the oxytetracycline sample; The oxytetracycline sample with the maximum formulation evaluation coefficient is transmitted to the i-th test environment, and the i-th test environment is marked as the target test environment.

5. The method for optimizing the formulation of oxytetracycline injection according to claim 4, characterized in that: Methods for calculating the coefficient of variation of the formulation for the target test environment based on the degradation characteristic data include: The degradation rate, pH value and solution clarity of oxytetracycline samples were calculated by formula to obtain the formula variation coefficient Np of the target test environment.

6. The method for optimizing the formulation of oxytetracycline injection according to claim 5, characterized in that: Methods for determining whether the corresponding soil mold sample is abnormal include: Extract the preset formula change thresholds Pz1 and Pz2 of the oxytetracycline sample, where Pz1 > Pz2, and compare the formula evaluation coefficient with the formula change threshold; If Np > Pz1 or Np < Pz2, it is determined that the corresponding oxytetracycline sample is abnormal and marked as an abnormal oxytetracycline sample; If Pz1 ≥ Np ≥ Pz2, it is determined that the corresponding oxytetracycline sample is not abnormal.

7. The method for optimizing the formulation of oxytetracycline injection according to claim 6, characterized in that: The environmental data are the temperature value and humidity value of the target test environment; the optimization adjustment value is the temperature adjustment value and the pH value difference; The method for analyzing based on the temperature value and the corresponding formula change coefficient to obtain the corresponding optimization adjustment value includes: Step b1: Obtain the formula change coefficient of the test oxytetracycline sample corresponding to the r unit temperature value, and obtain the formula change coefficient of the test oxytetracycline sample corresponding to the r - v unit temperature value; r is an integer greater than zero, the initial value of r is the initial temperature value, and v is a constant greater than zero; Step b2: Take the formula change coefficient of the test oxytetracycline sample corresponding to the r unit temperature value as the first optimization coefficient, and take the formula change coefficient of the test oxytetracycline sample corresponding to the r - v unit temperature value as the second optimization coefficient; Step b3: Compare the first optimization coefficient and the second optimization coefficient to determine whether the first optimization coefficient is less than or equal to the second optimization coefficient; if the first optimization coefficient is greater than the second optimization coefficient, let r = r - v and return to step b1; if the first optimization coefficient is less than or equal to the second optimization coefficient, obtain the temperature value r corresponding to the first optimization coefficient; Step b4: Calculate the difference between the temperature value r and the temperature value to obtain the second adjustment difference, and take the second adjustment difference as the temperature adjustment value of the abnormal oxytetracycline sample; Step b5: Repeat the above steps b1 - b3 until the first optimization coefficient is greater than or equal to the second optimization coefficient, and then end the loop; The method for analyzing based on the humidity value and the corresponding formula change coefficient to obtain the corresponding optimization adjustment value further includes: Step c1: Obtain the formula change coefficient of the test oxytetracycline sample corresponding to the f unit humidity value, and obtain the formula change coefficient of the test oxytetracycline sample corresponding to the f - u unit humidity value; f is an integer greater than zero, the initial value of f is the initial humidity value, and u is a constant greater than zero; Step c2: Take the formula change coefficient of the test oxytetracycline sample corresponding to the f unit humidity value as the third optimization coefficient, and take the formula change coefficient of the test oxytetracycline sample corresponding to the f - u unit humidity value as the fourth optimization coefficient; Step c3: Compare the third optimization coefficient and the fourth optimization coefficient to determine whether the third optimization coefficient is less than or equal to the fourth optimization coefficient; if the third optimization coefficient is greater than the fourth optimization coefficient, let f = f - u and return to step c1; if the third optimization coefficient is less than or equal to the fourth optimization coefficient, obtain the humidity value f corresponding to the third optimization coefficient; Step c4: Calculate the difference between the humidity value f and the humidity value to obtain the second adjustment difference, and take the second adjustment difference as the humidity adjustment value of the abnormal oxytetracycline sample; Step c5: Repeat the above steps c1 - c3 until the third optimization coefficient is greater than or equal to the fourth optimization coefficient, and then end the loop.

8. The method for optimizing the formulation of oxytetracycline injection according to claim 7, characterized in that: The logic for obtaining the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline sample is as follows: Obtain the degradation rate difference and pH value difference of abnormal oxytetracycline samples and mark them as Jc and Pc respectively. The degradation rate difference Jc and pH value difference Pc of abnormal oxytetracycline samples were dimensionlessly processed and then calculated to obtain the adjustment evaluation coefficient Tp.

9. The method for optimizing the formulation of oxytetracycline injection according to claim 8, characterized in that: The method for judging the adjustment evaluation coefficient of the abnormal oxytetracycline sample and whether to generate an optimization abnormal instruction includes: Preset an adjustment evaluation coefficient threshold, and compare the adjustment evaluation coefficient with the adjustment evaluation coefficient threshold; If the adjustment evaluation coefficient is less than the adjustment evaluation coefficient threshold, an optimization exception instruction is generated; If the adjustment evaluation coefficient is greater than or equal to the adjustment evaluation coefficient threshold, no optimization exception instruction is generated.

10. A formulation optimization device for oxytetracycline injection, used for implementing the formulation optimization method for oxytetracycline injection according to any one of claims 1 to 9, characterized in that: include: The oxytetracycline distribution module is used to obtain the formula evaluation coefficients of N oxytetracycline samples, and place the corresponding oxytetracycline samples in I test environment in turn according to the formula evaluation coefficients; An analysis module, used to obtain a maximum formulation evaluation coefficient, determine a target test environment according to the maximum formulation evaluation coefficient, and obtain corresponding degradation characteristic data; The formulation variation coefficient of oxytetracycline samples was calculated based on the degradation characteristic data; The first judgment module presets a formula change threshold, compares the formula change coefficient with the preset formula change threshold, and judges whether the corresponding soil mold sample is abnormal. If there is an abnormality, the corresponding soil mold sample is marked as an abnormal oxytetracycline sample; An optimization module, used to obtain environmental data of abnormal oxytetracycline samples, and to analyze the environmental data and corresponding formula variation coefficients to obtain corresponding optimization adjustment values; After adjusting the environmental data of the abnormal oxytetracycline sample, the adjustment evaluation coefficient corresponding to the abnormal oxytetracycline sample is obtained; The second judgment module is used to judge the adjustment evaluation coefficient of the abnormal oxytetracycline sample and whether to generate an optimization exception instruction; if an optimization exception instruction is generated, the generated optimization exception instruction is sent to the supervision user end.

Images