Method and system for automatically testing performance parameters of drug delivery system

Abstract

The invention relates to the technical field of automatic testing of drug delivery system performance parameters, in particular to a method and system for automatically testing the drug delivery system performance parameters, and the method comprises the steps: S1, setting test parameters; s2, drying and weighing the empty collection bottle to obtain the weight of the empty collection bottle, and recording the weight as m1; s3, preparing an injector, injection, a pipeline and a collecting bottle; s4, based on the test parameters, pushing and injecting the injection, and collecting the injection into the collection bottle; s5, recycling the injector and the pipeline, and heating the collection bottle for collecting the injection; s6, drying and weighing the heated collection bottle, and recording the obtained weight as m2; and S7, calculating the administration efficiency by using m1 and m2. The drug administration efficiency obtained through calculation is more accurate, the test time of testers is shortened, and the test difficulty is lowered.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of automatic testing of performance parameters of a drug delivery system, and in particular to a method and system for automatically testing performance parameters of a drug delivery system. BACKGROUND

[0002] For a drug delivery system, especially for radioactive drug-loaded microspheres, intravenous drug delivery, etc., the drug needs to be mixed with physiological saline, glucose solution, etc., and then injected through a push injection pipeline. During the research and development process, different specifications and materials of drug delivery system components need to be combined, and the performance parameters of the product injection pipeline need to be iteratively tested repeatedly, such as the test of drug delivery efficiency, so as to obtain the best product design. During the product stability test and change test, the drug delivery efficiency performance parameter also needs to be verified repeatedly.

[0003] The existing method for measuring drug delivery efficiency is to weigh the injected drug before and after injection, and calculate the summary efficiency by using the weight difference of the injected drug before and after injection. However, the injected drug contains the drug and the mixed solvent, so the performance parameter measured by this method is actually the drug delivery efficiency of the injected drug liquid composed of the drug and the mixed solvent, which has an error compared with the actual drug delivery efficiency. In addition, there are a lot of air dust and debris in the final collected liquid during the test, which greatly affects the accuracy of the test results.

[0004] Moreover, during the repeated tests, the replacement of components and data recording need to be repeated constantly, which consumes a lot of manpower and resources. SUMMARY

[0005] In order to solve at least one of the above technical problems in the prior art, the present application provides a method and system for automatically testing performance parameters of a drug delivery system, which aims to more accurately obtain data such as drug delivery efficiency in the performance parameters of the drug delivery system, automatically generate a data record table, and analyze the best combination of drug delivery system components to replace human labor for repetitive and tedious work.

[0006] To achieve the above-mentioned purpose, the technical scheme of the present application is as follows:

[0007] In a first aspect, the present application provides a method for automatically testing performance parameters of a drug delivery system, which is suitable for single drug delivery efficiency test, comprising:

[0008] S1, setting test parameters;

[0009] S2, drying and weighing the empty collection bottle to obtain the weight of the empty collection bottle, denoted as m1;

[0010] S3, configuring the syringe, injection liquid, pipeline and collection bottle;

[0011] S4, based on the test parameters, a bolus injection is performed, and the injection is collected into the collection bottle;

[0012] S5, the syringe and the pipeline are recovered, and the collection bottle for collecting the injection is heated;

[0013] S6, the heated collection bottle is dried and weighed, and the weight is recorded as m2;

[0014] S7, the drug delivery efficiency is calculated using m1 and m2.

[0015] Further, the test parameters include: drug syringe number, pipeline number, drug injection speed, solvent injection speed, drug injection time, solvent injection time, flushing pipeline solvent injection speed, flushing pipeline solvent injection time, weighing difference, and drug delivery efficiency criterion.

[0016] Further, step S2 specifically includes:

[0017] S201, the empty collection bottle is first dried, and then weighed, and the weighing result m 11 is recorded;

[0018] S202, the empty collection bottle that has been first dried and weighed is secondly dried, and then weighed, and the weighing result m 12 is recorded;

[0019] S203, the difference between m 12 and m 11 is calculated, and whether the weighing difference is met is determined, if yes, m 12 is taken as m1;

[0020] If not, the drying and weighing operations are repeated until the difference between the last weighing result and the last weighing result meets the weighing difference, and then the last weighing result is taken as the final empty collection bottle weight m1.

[0021] Further, the drying condition each time is: drying temperature 110℃, drying time 2h, and normal temperature standing for 1h after drying.

[0022] Further, step S3 specifically includes:

[0023] S301, the empty collection bottle that has been last dried and weighed is placed at the injection collection position;

[0024] S302, according to the test parameters, the pipeline with the specified number is placed on the pipeline positioning groove;

[0025] S303, according to the test parameters, placing the liquid medicine syringe with the specified number under the downstream of the push injection structure, and connecting the outlet of the liquid medicine syringe and the inlet of the pipeline and the outlet of the solvent syringe and the inlet of the pipeline.

[0026] Further, step S4 specifically comprises:

[0027] S401, empty pushing the push injection motor corresponding to the liquid medicine syringe, so that the push plate at the output end of the push injection motor contacts the push rod of the liquid medicine syringe;

[0028] S402, based on the test parameters, simultaneously injecting the liquid medicine and the solvent;

[0029] S403, based on the test parameters, separately injecting the solvent to flush the pipeline.

[0030] Further, step S5 specifically comprises:

[0031] S501, placing the collection bottle collecting the injection liquid on the heating device for heating;

[0032] S502, disassembling the pipeline and the liquid medicine syringe, and placing the pipeline and the liquid medicine syringe in the corresponding tested area.

[0033] Further, the heating condition is that the power of the heating device is 50w, and the heating time is 8h.

[0034] Further, in the heating process, a dust cloth is used to cover the bottle mouth of the collection bottle.

[0035] Further, step S6 specifically comprises:

[0036] S601, first drying the collection bottle after heating, weighing after drying, and recording the weighing result m 21 ;

[0037] S602, second drying the collection bottle after the first drying and weighing, weighing after drying, and recording the weighing result m 22 ;

[0038] S603, calculating the difference between m 22 and m 21 , whether it meets the weighing difference, if it meets, taking m 22 as m2;

[0039] If it does not meet, repeat the drying and weighing operation until the difference between the last weighing result and the last time weighing result meets the weighing difference, then taking the last weighing result as the final empty collection bottle weight m2.

[0040] Further, the drying condition is as follows: drying temperature 110 degrees Celsius, drying time 1 hour, and normal temperature standing for 30 minutes after drying.

[0041] Further, the method for calculating the drug delivery efficiency is as follows:

[0042]

[0043] wherein μ represents the drug delivery efficiency, and m represents the drug content (weight) in the total amount of the drug solution injection.

[0044] In a second aspect, the present application provides a method for automatically testing the performance parameters of a drug delivery system, which is suitable for multiple drug delivery efficiency tests, and comprises the following steps:

[0045] Step 1: setting k groups of test parameters, repeating n times of testing for each group of test parameters, n≥2, k≥2;

[0046] Step 2: setting the intra-group judgment condition and the inter-group judgment condition;

[0047] Step 3: for the k groups of test parameters, obtaining k groups of drug delivery efficiency respectively according to the method for automatically testing the performance parameters of a drug delivery system suitable for single drug delivery efficiency test;

[0048] Step 4: judging the abnormal data based on the intra-group judgment condition;

[0049] Step 5: judging whether the tests can be combined based on the inter-group judgment condition.

[0050] Further, the test parameters include the following: drug solution injector number, pipeline number, drug solution injection speed, solvent injection speed, drug solution injection time, solvent injection time, flushing pipeline solvent injection speed, flushing pipeline solvent injection time, weighing difference, and drug delivery efficiency criterion.

[0051] Further, the intra-group judgment condition is the intra-group difference, and the specific method for judging the abnormal data is as follows: the maximum value of the intra-group drug delivery efficiency minus the minimum value of the intra-group drug delivery efficiency to obtain a difference value, and if the difference value is greater than the intra-group difference, the data is abnormal.

[0052] Further, the inter-group judgment condition is the inter-group difference, and the specific method for judging whether the tests can be combined is as follows: calculating the average drug delivery efficiency of each group of drug delivery efficiency, and if the difference of the average drug delivery efficiency of each group is less than the inter-group difference, the tests can be combined, otherwise the tests cannot be combined.

[0053] Further, the method for automatically testing the performance parameters of a drug delivery system further comprises the following steps:

[0054] Step 6: drawing a line graph to display the abnormal data and the drug delivery efficiency of each group.

[0055] In a third aspect, the present application provides a system for automatically testing performance parameters of a drug delivery system, for performing the method for automatically testing performance parameters of a drug delivery system described above, the system comprising:

[0056] A drug solution injection device, comprising a drug solution injector, a solvent injector, and a pipeline, the drug solution injector being used for injecting a drug solution, the solvent injector being used for injecting a solvent, and the pipeline being used for mixing the drug solution and the solvent;

[0057] A drug solution collecting device, comprising a collecting bottle, and being used for collecting an injection solution containing the drug solution;

[0058] A drying and weighing device, being used for drying the injection solution and weighing the collecting bottle;

[0059] A positioning fixture, comprising a clamping system, and being used for transferring the drug solution injector, the pipeline, and the collecting bottle;

[0060] A control device, being used for controlling the clamping system, collecting the weight collected by the drying and weighing device, and calculating and displaying a test result.

[0061] Further, the drug solution injection device further comprises:

[0062] A drug solution storage, comprising an untested area for placing an unused drug solution injector and a tested area for placing a used drug solution injector;

[0063] A bolus injection structure, comprising a drug solution bolus injection motor and a solvent bolus injection motor, the drug solution bolus injection motor corresponding to the drug solution injector and being used for injecting the drug solution, and the solvent bolus injection motor corresponding to the solvent injector and being used for injecting the solvent.

[0064] Further, the drug solution injection device further comprises:

[0065] A replaceable pipeline rack, comprising an untested area for placing an unused pipeline and a tested area for placing a used pipeline.

[0066] Further, the drug solution collecting device further comprises:

[0067] A collecting bottle storage, comprising an untested area for placing an unused collecting bottle and a tested area for placing a used collecting bottle.

[0068] Further, the drying and weighing device comprises:

[0069] A drying box, being used for drying the collecting bottle;

[0070] An electronic scale, being used for weighing the weight of an empty collecting bottle and the weight of a collecting bottle containing the injection solution.

[0071] A heating furnace is used to heat the collection bottle filled with injection liquid.

[0072] Further, the drying and weighing device further comprises:

[0073] An asbestos net is placed above the heating furnace.

[0074] A dust cloth is used to cover the bottle opening of the collection bottle filled with injection liquid when the collection bottle is heated.

[0075] A straight variable slide rail is used to control the lifting of the dust cloth.

[0076] Further, the system for automatically testing the performance parameters of the drug delivery system further comprises:

[0077] A glass cover is used to accommodate the liquid medicine injection device, the liquid medicine collection device, the drying and weighing device, and the positioning clamp.

[0078] The glass cover is provided with a drying oven vent, a heating furnace vent, and an air inlet, the drying oven vent is arranged at the rear side of the drying oven, the heating furnace vent is arranged above the heating furnace, and the air inlet is provided with a filter.

[0079] Further, the glass cover is further provided with an electric exhaust fan.

[0080] Compared with the prior art, the present application has the following beneficial effects:

[0081] The method and system for automatically testing the performance parameters of the drug delivery system provided by the present application utilize the automatic cooperation between multiple devices and the positioning clamp to realize the automatic testing of the performance parameters of the drug delivery system, reduce the testing time of the testing personnel, reduce the testing difficulty, and have good repeatability.

[0082] Furthermore, the present application utilizes the drying device to obtain the weight of the empty collection bottle, and after the collection of the injection liquid, the moisture in the injection liquid is dried to obtain the weight of the collection bottle and the medicine, and thus the weight of the injected medicine is more accurate, and the calculated drug delivery efficiency is more accurate.

[0083] In addition, after injection, the present application also utilizes the flushing pipeline to flush the residual medicine in the pipeline into the collection bottle, thereby further improving the testing accuracy.

[0084] The present application utilizes the control device to automatically record and calculate the testing data, reduces the tedious testing work of the testing personnel, has high testing accuracy, and has high testing efficiency.

[0085] The application can not only test the efficiency of single administration, but also test the efficiency of multiple administrations under different test parameters, and automatically give comparison results, thereby helping the test personnel to quickly screen suitable design combinations and identify abnormalities, and facilitating the optimization design of the administration system. BRIEF DESCRIPTION OF DRAWINGS

[0086] Figure 1 The method flow chart of the embodiment one of the application.

[0087] Figure 2 The method flow chart of the embodiment two of the application.

[0088] Figure 3 The line chart in the embodiment two of the application.

[0089] Figure 4 The system block diagram of the embodiment three of the application.

[0090] Figure 5 The top view structural schematic diagram of the medicine liquid injection device in the embodiment three of the application.

[0091] Figure 6 The three-dimensional structural schematic diagram of the medicine liquid injection device in the embodiment three of the application.

[0092] Figure 7 The structural schematic diagram of the replaceable pipeline frame in the embodiment three of the application.

[0093] Figure 8 The structural schematic diagram of the drying and weighing device in the embodiment three of the application.

[0094] Figure 9 The structural schematic diagram of the glass cover in the embodiment three of the application.

[0095] BRIEF DESCRIPTION OF DRAWINGS

[0096] 1, medicine liquid injection motor, 2, solvent injection motor, 3, medicine liquid injector, 4, solvent injector, 5, pipeline, 6, collection bottle, 7, drying box, 8, electronic scale, 9, heating furnace, 10, asbestos net, 11, dust cloth, 12, linear variable guide rail, 13, glass cover, 14, positioning clamp, 15, medicine liquid warehouse, 16, replaceable pipeline frame, 17, collection bottle warehouse, 18, drying box air vent, 19, heating furnace air vent, 20, filter piece, 21, electric exhaust fan, 22, display screen, 23, processor. DETAILED DESCRIPTION

[0097] The technical solutions of the present application will be clearly described below with reference to the drawings. Obviously, the described embodiments are not all the embodiments of the present application, and all other embodiments obtained by those of ordinary skill in the art without creative efforts based on the described embodiments are within the protection scope of the present application.

[0098] It should be noted that, unless otherwise specified, the relative arrangement of components and steps, numerical expressions set forth in these embodiments should not be understood as limiting the scope of the present application.

[0099] The following description of the exemplary embodiments is merely illustrative in nature and is in no way intended to limit the application or its application or use in any way. Techniques, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail herein, but should be considered part of the present specification when applicable.

[0100] Embodiment one

[0101] The present embodiment provides a method for automatically testing performance parameters of a drug delivery system, which is suitable for single-dose efficiency testing, such as Figure 1 As shown, the specific method comprises:

[0102] S1, setting test parameters; wherein the test parameters include: number of drug liquid syringes, number of pipelines, drug liquid injection speed, solvent injection speed, drug liquid injection time, solvent injection time, flushing pipeline solvent injection speed, flushing pipeline solvent injection time, weighing difference, and drug delivery efficiency criterion.

[0103] S2, drying and weighing the empty collection bottle to obtain the weight of the empty collection bottle, denoted as m1; specifically comprising:

[0104] S201, first drying the empty collection bottle, weighing after drying, and recording the weighing result m 11 .

[0105] S202, second drying the empty collection bottle after the first drying and weighing, weighing after drying, and recording the weighing result m 12 .

[0106] S203, calculating the difference between m 12 and m 11 , whether it meets the weighing difference, if it meets, taking m 12 as m1;

[0107] If it does not meet, repeat the drying and weighing operation until the difference between the last weighing result and the last weighing result meets the weighing difference, then take the last weighing result as the final empty collection bottle weight m1.

[0108] The conditions of each drying are as follows: drying temperature 110℃, drying time 2h, and normal temperature standing for 1h after drying.

[0109] S3, configuring a syringe, injection liquid, pipeline and collection bottle; specifically comprising:

[0110] S301, placing the empty collection bottle that is dried and weighed for the last time at the injection liquid collection position;

[0111] S302, placing the pipeline with a specified number on the pipeline positioning groove according to the test parameters;

[0112] S303, placing the liquid injection syringe with a specified number downstream of the push injection structure, and connecting the outlet of the liquid injection syringe and the inlet of the pipeline, and the outlet of the solvent injection syringe and the inlet of the pipeline.

[0113] S4, pushing the injection liquid based on the test parameters, and the injection liquid is collected into the collection bottle; specifically comprising:

[0114] S401, empty pushing the push injection motor corresponding to the liquid injection syringe, so that the push plate at the output end of the push injection motor contacts the push rod of the liquid injection syringe;

[0115] S402, simultaneously pushing the liquid and the solvent based on the test parameters;

[0116] S403, separately pushing the solvent based on the test parameters to flush the pipeline.

[0117] S5, recovering the syringe, pipeline, and heating the collection bottle for collecting the injection liquid; specifically comprising:

[0118] S501, placing the collection bottle for collecting the injection liquid on the heating device for heating; the heating conditions are as follows: heating device power 50w, heating time 8h; and in the heating process, preferably covering the bottle opening of the collection bottle with a dust cloth to avoid foreign matter falling into the collection bottle.

[0119] S502, disassembling the pipeline and the liquid injection syringe, and placing the pipeline and the liquid injection syringe in the corresponding tested area.

[0120] S6, drying and weighing the heated collection bottle to obtain the weight m2; specifically comprising:

[0121] S601, first drying the heated collection bottle, and weighing after drying to record the weighing result m 21 ;

[0122] S602, second drying the collection bottle that is dried and weighed for the first time, and weighing after drying to record the weighing result m 22 ;

[0123] S603, Calculate m 22 and m 21 The difference between the values ​​satisfies the weighing difference condition; if so, m... 22 As m2;

[0124] If the condition is not met, the drying and weighing operations are repeated until the difference between the last weighing result and the previous weighing result meets the weighing difference requirement. Then, the last weighing result is taken as the final weight m2 of the empty collection bottle.

[0125] The drying conditions for each drying were as follows: drying temperature 110 degrees Celsius, drying time 1 hour, and resting at room temperature for 30 minutes after drying.

[0126] S7. Using m1 and m2, calculate the drug administration efficiency using the following formula:

[0127]

[0128] Where μ represents the dosing efficiency and m represents the drug content (by weight) in the total amount of drug injected.

[0129] Example: Set up a type A1 drug solution (5ml total, containing 0.1g of drug) and a type B1 tubing. Use water for injection as the solvent. Inject the drug solution at a rate of 5ml / min, followed by the solvent at a rate of 20ml / min, until all the drug solution is injected. Then, flush the tubing with the solvent at a rate of 20ml / min for 1 minute. Collect the mixture of drug solution and solvent at the tubing outlet using a pre-dried and weighed beaker. After evaporating the moisture and drying the beaker, weigh it again. Subtract the weight of the beaker before testing from the weight of the beaker after testing to obtain the mass of solids in the collected drug solution. Divide the mass of solids in the collected drug solution by the original mass of solids in the drug solution to obtain the dosing efficiency data for that administration.

[0130] The specific testing steps include:

[0131] A1. Set parameters for a single test:

[0132] Interactive operation via the display screen allows setting component combination parameters as follows: A1 type drug solution, B1 type tubing; injection parameters as follows: 5ml / min injection of drug solution, 20ml / min injection of solvent, 1min solvent flushing of tubing, 20ml / min injection of solvent, weighing difference ≤0.3mg, and single-dose efficacy criterion ≥98%.

[0133] A2. Dry and weigh the empty collection bottle:

[0134] Use the positioning clamp to clamp a collection bottle from the untested area of the collection bottle warehouse. Open the electric hatch of the drying box, and use the positioning clamp to place the collection bottle into the drying box, and close the electric hatch.

[0135] Set the drying temperature to 110°C, and the drying time to 2h. Wait for 1h.

[0136] Open the electric hatch, and use the positioning clamp to take out the collection bottle from the drying box, and close the electric hatch. Place the collection bottle on the high-precision electronic scale. Wait for 5s for the weighing data to stabilize, and record the weighing weight of 38.47182g.

[0137] Use the positioning clamp to clamp the collection bottle from the high-precision electronic scale. Open the electric hatch of the drying box, and place the collection bottle into the drying box, and close the electric hatch.

[0138] Set the drying temperature to 110°C, and the drying time to 2h. Wait for 1h.

[0139] Open the electric hatch, and use the positioning clamp to take out the collection bottle from the drying box, and close the electric hatch. Place the collection bottle on the high-precision electronic scale. Wait for 5s for the weighing data to stabilize, and record the weighing weight of 38.47178g.

[0140] Calculate the difference between the second weighing and the first weighing data, 38.47178g-38.47182g=-0.00004g, which meets the requirements. Record the collection bottle weight m1=38.47178g.

[0141] A3, place the liquid medicine, pipeline, and collection bottle:

[0142] Use the positioning clamp to clamp the collection bottle from the high-precision electronic scale, and place it on the elevator at the outlet end of the right pipeline of the replaceable pipeline positioning slot. Raise the elevator to make the bottle mouth of the collection bottle close to the height of the pipeline outlet.

[0143] Use the positioning clamp to clamp a B1 type pipeline from the untested area of the replaceable pipeline rack, and place it on the replaceable pipeline positioning slot, so that the outlet end of the solvent packaging syringe contacts the luer joint.

[0144] Use the positioning clamp to clamp an A1 type liquid medicine from the untested area of the liquid medicine warehouse, and place it below the push injection structure, so that the outlet end of the liquid medicine packaging syringe contacts the inlet end of the pipeline.

[0145] Rotate the solvent packaging syringe and the liquid medicine packaging syringe clockwise respectively, so that the two groups of contacted luer joints are locked.

[0146] A4, push the medicine:

[0147] The lower push motor (corresponding to the drug liquid injector) pushes forward for a distance until it contacts the push rod of the drug liquid injector. The upper (solvent) and lower (drug liquid) push motors continuously push at a speed of 20 ml / min and 5 ml / min respectively for 1 min. The upper (solvent) push motor continuously pushes at a speed of 20 ml / min for 1 min to flush the residual drug liquid in the pipeline.

[0148] A5, recover the drug liquid, the pipeline, and transfer the collection bottle to the heating furnace:

[0149] The elevator is lowered, the collection bottle is clamped from the elevator using the positioning clamp, and the collection bottle is placed on the asbestos net of the heating furnace.

[0150] The solvent injector and the drug liquid injector are rotated counterclockwise respectively, and the two sets of locked luer connectors are rotated to loosen.

[0151] The drug liquid injector is clamped from the push structure using the positioning clamp, and the drug liquid injector is placed in the tested area of the drug liquid warehouse.

[0152] The pipeline is clamped from the replaceable pipeline positioning groove using the positioning clamp, and the pipeline is placed in the tested area of the replaceable pipeline rack.

[0153] A6, heat the collection bottle to evaporate moisture:

[0154] The height of the dust cloth is lowered by controlling the linear variable slide rail to approach the opening of the collection bottle. The power of the heating furnace is set to 50W, and the heating is continued for 8h to evaporate most of the moisture in the collection bottle.

[0155] A7, dry and weigh the collection bottle:

[0156] The height of the dust cloth is raised, and the collection bottle is clamped from the asbestos net using the positioning clamp. The electric hatch of the drying box is opened, the collection bottle is placed in the drying box, and the electric hatch is closed. The drying temperature is set to 110°C, and the drying time is 1h. Wait for 30min. Open the electric hatch, use the positioning clamp to take out the collection bottle from the drying box, and close the electric hatch. Place the collection bottle on the high-precision electronic scale. Wait for 5s to stabilize the weighing data, and record the weighing weight of 38.57201g.

[0157] The collection bottle is clamped from the high-precision electronic scale using the positioning clamp. The electric hatch of the drying box is opened, the collection bottle is placed in the drying box, and the electric hatch is closed. The drying temperature is set to 110°C, and the drying time is 1h. Wait for 30min. Open the electric hatch, use the positioning clamp to take out the collection bottle from the drying box, and close the electric hatch. Place the collection bottle on the high-precision electronic scale. Wait for 5s to stabilize the weighing data, and record the weighing weight of 38.57158g.

[0158] The difference between the two weighing data is calculated as 38.57158g-38.57201g=-0.00043g, which does not meet the requirement, and the drying is continued.

[0159] The drying and weighing are repeated, and the weighing weight is recorded as 38.57146g. The difference between this weighing data and the second weighing data is calculated as 38.57146g-38.57158g=-0.00012g, which meets the requirement. The collection bottle weight m2 is recorded as 38.57146g.

[0160] A8, calculate the drug delivery efficiency

[0161] According to the formula:

[0162] (m2-m1)÷0.1g×100%=(38.57146-38.47182)÷0.1g×100%=99.6%

[0163] which meets the requirement. The drug delivery efficiency is recorded as 99.6%.

[0164] Example Two

[0165] The present embodiment provides a method for automatically testing performance parameters of a drug delivery system, which is suitable for multiple drug delivery efficiency tests, such as Figure 2 as shown, comprising:

[0166] Step 1, set k groups of test parameters, each group of test parameters is repeated n times of testing, n≥2, k≥2; wherein the test parameters include: number of drug liquid syringes, number of pipelines, drug liquid injection speed, solvent injection speed, drug liquid injection time, solvent injection time, flushing pipeline solvent injection speed, flushing pipeline solvent injection time, weighing difference, drug delivery efficiency criterion.

[0167] Step 2, set intra-group judgment conditions and inter-group judgment conditions; the intra-group judgment condition is the intra-group difference, and the inter-group judgment condition is the inter-group difference.

[0168] Step 3, for the k groups of test parameters, respectively according to the above-mentioned method for automatically testing performance parameters of a drug delivery system suitable for single drug delivery efficiency test, k groups of drug delivery efficiencies are obtained, each group of drug delivery efficiency includes n data;

[0169] Step 4, based on the intra-group judgment condition, judge the abnormal data; the specific method is: the maximum value of the intra-group drug delivery efficiency is subtracted from the minimum value of the intra-group drug delivery efficiency, to obtain a difference, if the difference is greater than the intra-group difference, it is an abnormal data.

[0170] Step 5, judging whether the test can be combined based on the inter-group judgment condition; the specific method is: calculating the average drug efficiency of the drug efficiency of each group, if the difference of the average drug efficiency of each group is less than the inter-group difference, the test can be combined, otherwise the test cannot be combined, thereby reducing the number of test groups and relaxing the process control range.

[0171] Step 6, drawing a line graph to show abnormal data and the drug efficiency of each group.

[0172] Example: Set two groups of configurations, calculate the data difference between different test times of the same configuration, the data difference between different configurations, draw a line graph, prompt abnormal data points, and assist in decision-making whether the two groups of configurations can be combined into one group. For data between different test times of the same configuration, if the difference between any two times is greater than 1%, it is considered abnormal. For the data difference between different configurations, if the difference between the average numbers of the two groups is less than 0.4%, it is considered that they can be combined into one group.

[0173] Configuration 1: A1 type of drug solution (total drug solution 5ml, drug content 0.1g), B1 type of pipeline, with water for injection as solvent. Push the drug solution at a speed of 5ml / min, push the solvent at a speed of 20ml / min, until the drug solution is completely pushed, then push the solvent at a speed of 20ml / min to flush the pipeline for 1min, test 5 times.

[0174] Configuration 2: change the pipeline from B1 type to B2 type, keep the rest of the parameters unchanged, test 5 times.

[0175] The specific test method includes:

[0176] B1, set the test requirements of the first group of configurations:

[0177] Through the display screen interactive operation, set the component combination parameters to A1 type of drug solution and B1 type of pipeline. Set the push parameters to 5ml / min for pushing the drug solution, 20ml / min for pushing the solvent, 1min for flushing the pipeline with the solvent, and 20ml / min for pushing the solvent. Set the weighing difference to be less than or equal to 0.3mg, and the single drug efficiency criterion to be greater than or equal to 98%. Set the test times of the first group to be 5 times.

[0178] B2, set the test requirements of the second group of configurations:

[0179] Through the display screen interactive operation, set the component combination parameters to A1 type of drug solution and B2 type of pipeline. Set the push parameters to 5ml / min for pushing the drug solution, 20ml / min for pushing the solvent, 1min for flushing the pipeline with the solvent, and 20ml / min for pushing the solvent. Set the weighing difference to be less than or equal to 5mg, and the single drug efficiency criterion to be greater than or equal to 98%. Set the test times of the first group to be 5 times, and the data difference between different times within the group to be less than or equal to 1%.

[0180] B3, set the group within the judgment condition and inter-group judgment condition:

[0181] By the display screen interaction operation, set the data difference between different times in the first group ≤1%. Set the data difference between different times in the second group ≤1%. Set the inter-group difference ≥0.4%.

[0182] B4, obtain all the drug delivery efficiency data:

[0183] Under the first group configuration condition, sequentially execute the single drug delivery efficiency test in embodiment one for 5 times, obtain 5 test data, respectively a1=98.1%, a2=98.5%, a3=98.4%, a4=98.6%, a5=98.5%.

[0184] Under the second group configuration condition, sequentially execute the single drug delivery efficiency test in embodiment one for 5 times, obtain 5 test data, respectively b1=98.6%, b2=98.8%, b3=98.7%, b4=99.0%, b5=99.2%.

[0185] B5, calculate abnormal data:

[0186] The minimum of the first group data is a1=98.1%, the maximum is a4=98.6%, the intra-group difference value is 98.6%-98.1%=0.5%, which meets the requirement of ≤1%, and there is no abnormal data.

[0187] The minimum of the second group data is b1=98.6%, the maximum is b5=99.2%, the intra-group difference value is 99.2%-98.6%=0.6%, which meets the requirement of ≤1%, and there is no abnormal data.

[0188] B6, calculate whether it can be merged into a group:

[0189] The average of the first group data is (98.1%+98.5%+98.4%+98.6%+98.5%) ÷5=98.42%.

[0190] The average of the second group data is (98.6%+98.8%+98.7%+99.0%+99.2%) ÷5=98.86%.

[0191] The difference between the average of the first group and the average of the second group is 98.86%-98.42%=0.44%, which does not meet the requirement of <0.4%, and cannot be merged into the same group.

[0192] B7, draw a line graph and mark abnormal points:

[0193] Draw a line graph as shown in Figure 3 There is no abnormal point, so it does not need to be marked.

[0194] Example 3

[0195] This invention provides a system for automatically testing the performance parameters of a drug delivery system, and a method for performing the aforementioned automated testing of drug delivery system performance parameters, such as... Figure 4 As shown, the system includes:

[0196] The drug injection device includes a drug injector 3, a solvent injector 4, and a tubing 5. The drug injector 3 is used to inject the drug solution, and the solvent injector 4 is used to inject the solvent, thereby realizing the drug solution preparation and injection.

[0197] A drug collection device, including a collection bottle 6, for collecting injection solutions containing drug solutions;

[0198] A drying and weighing device is used to dry the injection solution and weigh the collection bottle.

[0199] Positioning clamp 14, including a clamping system, is used to transfer a drug syringe, tubing, and collection bottle;

[0200] The control device is used to control the clamping system, collect the weight collected by the drying and weighing device, and calculate and display the test results.

[0201] Among them, such as Figure 4 , Figure 5 and Figure 6 As shown, the drug injection device also includes:

[0202] The drug reservoir 15 includes an untested area for placing unused drug syringes and a tested area for placing used drug syringes.

[0203] The injection mechanism includes a drug injection motor 1 and a solvent injection motor 2. The drug injection motor 1 corresponds to the drug injector 3 and is used to inject the drug solution, while the solvent injection motor 2 corresponds to the solvent injector 4 and is used to inject the solvent. The drug injector 3 and the solvent injector 4 are connected to the same pipeline 5 via a three-way valve to achieve drug solution mixing. A collection bottle 6 is installed at the outlet of the pipeline 5, and a lift is installed below the collection bottle 6 for raising and lowering the collection bottle 6.

[0204] Replaceable pipe rack 16, such as Figure 7 As shown, the replaceable pipe rack 16 includes an untested area for placing unused pipes and a tested area for using pipes.

[0205] like Figure 4 As shown, the liquid medicine collection device also includes:

[0206] The bottle collection compartment 17 includes an untested area for placing unused collection bottles and a tested area for placing used collection bottles.

[0207] As shown in Figure 4 and Figure 8 The drying and weighing device comprises:

[0208] A drying oven 7 for drying the collection bottle;

[0209] An electronic scale 8 for weighing the weight of the empty collection bottle 6 and the weight of the collection bottle 6 filled with injection solution;

[0210] A heating furnace 9 for heating the collection bottle 6 filled with injection solution, which evaporates most of the water in the collection bottle by heating principle.

[0211] An asbestos net 10 placed above the heating furnace 9; the heat of the heating furnace 9 is evenly distributed and conducted to the collection bottle 6 above.

[0212] A dust cloth 11 covering the bottle opening of the collection bottle 6 filled with injection solution when heating.

[0213] A linear variable slide rail 12 for controlling the lifting and lowering of the dust cloth 11; when the collection bottle 6 needs to be transferred to the asbestos net 10, the dust cloth 11 is lifted by the linear variable slide rail 12 to provide enough space for the positioning clamp 14 holding the collection bottle 6. After the transfer operation is completed, the dust cloth 11 is lowered by the linear variable slide rail 12 to cover the collection bottle 6 to prevent dust from falling in the space.

[0214] The drying oven 7 and the electronic scale 8 each have an electrically controllable electric hatch.

[0215] In addition, as shown in Figure 9 The system for automatically testing the performance parameters of the drug delivery system further comprises:

[0216] A glass cover 13 in which the liquid medicine injection device, the liquid medicine collection device, the drying and weighing device, and the positioning clamp 14 are arranged; the control device is arranged on the outer wall of the glass cover 13. The positioning clamp 14 is basically arranged at the center position inside the glass cover 13, the liquid medicine injection device and the liquid medicine collection device are arranged on one side of the positioning clamp 14, and the drying and weighing device is arranged on the other side. The positioning clamp 14 is a movable and positionable clamping system, which can be used to transfer the unused collection bottle 6 from the collection bottle warehouse 17 to the drying oven 7 for drying, and to transfer the dried and weighed collection bottle 6 from the high-precision electronic scale 8 to the pipeline outlet end on the right side of the pipeline 5 for collecting the outflowing liquid medicine and solvent. It can also be used to transfer the collection bottle 6 that has completed the collection from the pipeline 5 outlet end to the asbestos net 10 to evaporate most of the water, and to transfer the collection bottle 6 between the drying oven 7 and the electronic scale 8 for further drying and weighing.

[0217] The glass cover 13 is provided with a drying oven vent 18, a heating furnace vent 19, and an air inlet. The drying oven vent 18 is provided at the rear side of the drying oven 7 to provide heat dissipation when the drying oven 7 is working. The heating furnace vent 19 is provided above the heating furnace 9 to provide an external passage for collecting moisture evaporation in the bottle 6 when the heating furnace 9 is working, so as to prevent water vapor and heat from concentrating in the glass cover 13. The air inlet is provided with a filter 20 to filter dust and provide a passage for external air to enter the glass cover 13 after filtration, so that the air pressure in the glass cover 13 is stable and there is no large particle dust. The glass cover 13 is also provided with an electric exhaust fan 21.

[0218] In addition, the control device includes a display screen 22 and a processor 23. The display screen 22 is used to display the software graphical interface of the control system, and can control the operation of all powered components, the start, pause, and termination of the system, display the state of the test system, and show all data for final analysis. The processor 23 is used to read and execute the preset program, accept operation data of the display screen 22 and send it to each system component that needs to be operated, read the data obtained by the system components (drying oven data, electronic scale data, heating furnace data, push injection structure motor data, positioning data), and process the electronic scale data and draw and analyze the drug delivery efficiency under different component and push injection speed combinations.

[0219] The above specific embodiments are only used to illustrate the technical solutions of the present application and not to limit it. Although the present application has been described in detail with reference to the examples, it should be understood by those skilled in the art that the technical solutions of the present application can be modified or replaced equivalently without departing from the scope of the technical solutions of the present application, and all should be covered in the scope of the claims of the present application.

Claims

1. A method for automatically testing performance parameters of a drug delivery system, characterized in that, include: S1. Set test parameters; S2. Dry and weigh the empty collection bottle to obtain the weight of the empty collection bottle, which is recorded as m1. S3. Prepare syringes, injection solutions, tubing, and collection bottles; S4. Based on the test parameters, inject the injection solution, and the injection solution is collected in the collection bottle; S5. Recover the syringe and tubing, and heat the collection bottle for collecting the injection solution; S6. Dry and weigh the heated collection bottle, and record the weight as m2. S7. Calculate the drug administration efficiency using m1 and m2.

2. The method according to claim 1, characterized in that, Test parameters include: syringe number, tubing number, drug injection rate, solvent injection rate, drug injection time, solvent injection time, solvent injection rate of flushing tubing, solvent injection time of flushing tubing, weighing difference, and drug administration efficiency criteria.

3. The method according to claim 1, characterized in that, Step S2 specifically includes: S201. Dry the empty collection bottle for the first time, weigh it after drying, and record the weighing result m. 11 ; S202. The empty collection bottle, after the first drying and weighing, is dried a second time, and then weighed again. The weighing result m is recorded. 12 ; S203, Calculate m 12 and m 11 The difference between the values ​​satisfies the weighing difference condition; if so, m... 12 As m1; If the condition is not met, the drying and weighing operations are repeated until the difference between the last weighing result and the previous weighing result meets the weighing difference requirement. Then, the last weighing result is taken as the final weight m1 of the empty collection bottle.

4. The method according to claim 3, characterized in that, Step S3 specifically includes: S301. Place the empty collection bottle, which has been dried and weighed for the last time, at the injection collection position; S302. According to the test parameters, place the pipe with the specified number on the pipe positioning groove; S303. According to the test parameters, place the specified numbered drug injector downstream of the injection structure and connect the outlet of the drug injector to the inlet of the tubing, as well as the outlet of the solvent injector to the inlet of the tubing.

5. The method according to claim 2, characterized in that, Step S4 specifically includes: S401, The push motor of the corresponding drug injector is pushed without load, so that the push plate at the output end of the push motor contacts the push rod of the drug injector. S402. Based on test parameters, simultaneously inject the drug solution and solvent; S403. Based on the test parameters, inject solvent separately to flush the tubing.

6. The method according to claim 1, characterized in that, Step S5 specifically includes: S501. Place the collection bottle containing the injection solution on a heating device for heating; the heating conditions are: heating device power 50w, heating time 8h; during the heating process, cover the mouth of the collection bottle with a dustproof cloth; S502. Disassemble the tubing and syringe, and place the tubing and syringe in the corresponding tested area.

7. The method according to claim 6, characterized in that, Step S6 specifically includes: S601. Dry the heated collection bottle for the first time, weigh it after drying, and record the weighing result m. 21 ; S602. After the collection bottle has undergone the first drying and weighing, it is dried a second time, and then weighed again. The weighing result m is recorded. 22 ; S603, Calculate m 22 and m 21 The difference between the values ​​satisfies the weighing difference condition; if so, m... 22 As m2; If the condition is not met, the drying and weighing operations are repeated until the difference between the last weighing result and the previous weighing result meets the weighing difference requirement. Then, the last weighing result is taken as the final weight m2 of the empty collection bottle.

8. The method according to claim 1, characterized in that, The method for calculating dosing efficiency is as follows: Where μ represents the dosing efficiency and m represents the weight of the drug in the total amount of drug injected.

9. A method for automatically testing performance parameters of a drug delivery system, characterized in that, include: Step 1: Set up k sets of test parameters, and repeat the test n times for each set of test parameters, where n≥2 and k≥2; Step 2: Set the conditions for judgment within a group and the conditions for judgment between groups; Step 3: For k sets of test parameters, obtain k sets of drug delivery efficiency according to the method for automatically testing the performance parameters of the drug delivery system as described in any one of claims 1-8, where each set of drug delivery efficiency includes n data points; Step 4: Identify abnormal data based on the group's internal judgment criteria; Step 5: Based on the inter-group judgment criteria, determine whether the tests can be combined.

10. The method according to claim 9, characterized in that, Test parameters include: syringe number, tubing number, drug injection rate, solvent injection rate, drug injection time, solvent injection time, solvent injection rate of the flushing tubing, solvent injection time of the flushing tubing, and weighing difference.

11. The method according to claim 9, characterized in that, The condition for judging within a group is the difference within the group. The specific method for judging outlier data is as follows: subtract the minimum value of the dosing efficiency within the group from the maximum value of the dosing efficiency within the group to get the difference. If the difference is greater than the difference within the group, then it is outlier data.

12. The method according to claim 9, characterized in that, The condition for determining whether a test can be combined is the difference between groups. The specific method for determining whether a test can be combined is as follows: calculate the average dosing efficiency of each group. If the difference in the average dosing efficiency of each group is less than the difference between groups, the test can be combined; otherwise, the test cannot be combined.

13. The method according to claim 9, characterized in that, Also includes: Step 6: Draw a line graph to display abnormal data and the drug administration efficiency of each group.

14. A system for automatically testing performance parameters of a drug delivery system, used to perform the method for automatically testing performance parameters of a drug delivery system according to any one of claims 1-13, characterized in that the system... include: A drug injection device includes a drug injector, a solvent injector, and tubing. The drug injector is used to inject the drug solution, and the solvent injector is used to inject the solvent, thereby achieving the drug solution preparation and injection. A drug collection device, including a collection bottle, for collecting injection solutions containing drug solutions; A drying and weighing device is used to dry the injection solution and weigh the collection bottle. Positioning clamps, including clamping systems, are used to transfer drug syringes, tubing, and collection bottles; The control device is used to control the clamping system, collect the weight collected by the drying and weighing device, and calculate and display the test results.

15. The system according to claim 14, characterized in that, The drug injection device also includes: The drug reservoir includes an untested area for placing unused drug syringes and a tested area for placing used drug syringes. The injection structure includes a drug injection motor and a solvent injection motor. The drug injection motor corresponds to the drug syringe and is used to inject the drug, and the solvent injection motor corresponds to the solvent syringe and is used to inject the solvent. A replaceable piping rack, the replaceable piping rack including an untested area for storing unused piping and a tested area for storing used piping.

16. The system according to claim 14, characterized in that, The liquid medicine collection device also includes: The collection bottle compartment includes an untested area for placing unused collection bottles and a tested area for placing used collection bottles.

17. The system according to claim 14, characterized in that, The drying and weighing device includes: A drying oven, used for drying the collection bottles; An electronic scale, used to weigh empty collection bottles and collection bottles containing injection solutions; A heating furnace for heating a collection bottle containing an injection solution; An asbestos mesh is placed above the heating furnace; A dustproof cloth is used to cover the mouth of a collection bottle containing an injection solution when heating it. Linear sliding rails are used to control the raising and lowering of the dustproof cloth.

18. The system according to claim 14, characterized in that, Also includes: The glass cover, the drug injection device, the drug collection device, the drying and weighing device, and the positioning clamp are all housed inside the glass cover; The glass cover is equipped with a drying oven vent, a heating furnace vent, an air inlet, and an electric exhaust fan. The drying oven vent is located on the rear side of the drying oven; the heating furnace vent is located above the heating furnace; and a filter is installed on the air inlet.

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