Preparation process of multi-cavity high-barrier bag for multi-layer co-extrusion infusion

Abstract

The invention provides a preparation process of a multi-cavity high-barrier bag for multi-layer co-extrusion infusion. The preparation process comprises the following steps: S1, preparing a multi-layer co-extrusion film; s2, the multi-layer co-extrusion film is fixed to a bag making machine, bag making parameters are set, the film welding temperature of the periphery of a bag is 120160 DEG C, the welding pressure is 4.06.0 bar, the welding time is 0.52.0 s, the film weak welding temperature among multiple cavities is 110-130 DEG C, the weak welding pressure is 3.0-5.0 bar, the weak welding time is 0.8-3.0 s, and the bag making machine is operated; s3, a label printing module of the bag making machine automatically prints a label on the multi-layer co-extrusion film; s4, after the multiple layers of co-extrusion films are welded through the bag making machine, the multiple layers of co-extrusion films are integrally cut into a bag shape; and S5, a manipulator of the bag making machine removes flashes of the formed multi-cavity high-barrier bag. Each chamber of the infusion bag prepared by the invention has good high-temperature resistance and barrier property, and can adapt to a wide-temperature use environment.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical supplies, in particular to a preparation process of a multi-layer co-extrusion multi-chamber high-barrier bag for infusion. BACKGROUND

[0002] With the improvement of domestic medical level, the multi-layer co-extrusion multi-chamber bag for infusion is widely used, and the peritoneal dialysis and hemofiltration replacement multi-chamber bag is increasingly widely used in China. The enterprises producing and selling the multi-chamber bag are also increasing. Since the multi-chamber bag entered China in 2004, it has been developed for more than ten years, and is widely used in China. The annual sales volume exceeds 5 million bags. In the clinical application of major countries in Europe such as France, Sweden and Finland, the proportion of the use of the multi-chamber bag has exceeded 80%.

[0003] The multi-layer co-extrusion multi-chamber bag for infusion is mainly used for packaging of pre-filled peritoneal dialysis, hemofiltration replacement and nutrient agent, and is applied to (1) for continuous ambulatory peritoneal dialysis of patients with acute and chronic renal failure who need continuous ambulatory peritoneal dialysis due to non-dialysis treatment invalid, (2) for treatment of acute kidney injury during continuous renal replacement therapy (CRRT), and (3) for adult patients who cannot normally take nutrients orally / enterally due to various external conditions.

[0004] The multi-chamber bag of the prior art has the problems of low heat sealing strength, poor drop resistance and poor temperature adaptability, and it is necessary to improve the process to improve various performances. SUMMARY

[0005] In order to make up for the deficiencies in the prior art, the present application provides a preparation process of a multi-layer co-extrusion multi-chamber high-barrier bag for infusion. The chambers of the infusion bag prepared by the process have good high-temperature resistance and barrier performance, and can adapt to a wide temperature use environment.

[0006] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0007] A preparation process of a multi-layer co-extrusion multi-chamber high-barrier bag for infusion, comprising the following steps:

[0008] S1. preparing a multi-layer co-extrusion film;

[0009] S2. fixing the multi-layer co-extrusion film on a bag making machine, setting bag making parameters, the film welding temperature of the bag periphery is 120-160℃, the welding pressure is 4.0-6.0 bar, the welding time is 0.5-2.0 s, the film weak welding temperature between the multi-chambers is 110-130℃, the weak welding pressure is 3.0-5.0 bar, and the weak welding time is 0.8-3.0 s, and the bag making machine is operated;

[0010] S3. the label printing module of the bag making machine automatically prints a label on the multi-layer co-extrusion film;

[0011] S4. The bag-making machine welds the multi-layer co-extrusion film into bags.

[0012] S5. The mechanical hand of the bag-making machine removes the flash of the formed multi-chamber high-barrier bag.

[0013] Further, in step S2, the ratio of the film welding temperature to the welding pressure of the bag periphery is 30:1, and the ratio of the film welding temperature to the welding time of the bag periphery is 110:1; the ratio of the film weak welding temperature to the weak welding pressure between the multi-chambers is 30:1, and the ratio of the film weak welding temperature to the weak welding time between the multi-chambers is 85:1.

[0014] Preferably, in step S2, the film welding temperature of the bag periphery is 132-144℃, the welding pressure is 4.4-4.8 bar, the welding time is 1.2-1.3 s, the film weak welding temperature between the multi-chambers is 118-124℃, the weak welding pressure is 3.9-4.2 bar, and the weak welding time is 1.4-1.5 s.

[0015] Further, the multi-layer co-extrusion film comprises an outer layer film, a middle layer film, and an inner layer film, the outer layer film has a thickness of 10-100 μm and is made of any one of poly-ester copolymer, ethylene-vinyl alcohol copolymer, polyvinylidene chloride, polyethylene naphthalate, m-xylylene adipic acid, and modified polymethyl methacrylate; the middle layer film has a thickness of 100-280 μm and is made of any one of polypropylene, adhesive resin, ethylene methacrylate polymer, high-density polyethylene, metallocene polyethylene, and polyolefin elastomer; and the inner layer film has a thickness of 10-80 μm and is made of any one of polyester, ester copolymer, propylene copolymer, modified ethylene, and styrene-ethylene-butylene copolymer.

[0016] Further, the thickness ratio of the outer layer film to the middle layer film is 5:1, and the thickness ratio of the outer layer film to the inner layer film is 1:2.

[0017] Preferably, the outer layer film has a thickness of 30-50 μm and is made of polyvinylidene chloride; the middle layer film has a thickness of 150-250 μm and is made of high-density polyethylene; and the inner layer film has a thickness of 15-25 μm and is made of modified ethylene.

[0018] Further, in step S1, the preparation process of the multi-layer co-extrusion film is as follows:

[0019] S101. Set the melting point of each layer of material, set each extruder to independently control the temperature curve at 180-250℃ and the screw rotation speed at 20-150 rpm, ensure that the difference in melt viscosity of each layer is ≤10%, use a high-precision melt pump to deliver the melt at a constant pressure to the co-extrusion die, and ensure that the layer thickness deviation is ≤±1%;

[0020] S102. The melt is layered and converged in the spiral mandrel annular die;

[0021] S103. The film material is rapidly cooled and shaped at 15-45℃, and the full width is scanned by an infrared thickness gauge, the detection data are fed back to the die bolt thermal expansion adjustment system, the thickness is automatically corrected within 1 second, and finally a multilayer co-extruded film is obtained.

[0022] Compared with the prior art, the present application has the following beneficial technical effects:

[0023] (1) The product prepared by the present application has a wide heat sealing range, high heat sealing strength, impact resistance, puncture resistance, and good barrier properties to water vapor, oxygen and nitrogen. In addition, the film material is prepared by a multilayer co-extrusion process, does not use adhesive and plasticizer, and does not pollute the environment after treatment.

[0024] (2) The product prepared by the present application has excellent barrier properties, can effectively block the penetration of oxygen, moisture and carbon dioxide, and can reduce the loss of volatile components in the drug solution. This can significantly prolong the shelf life of the drug solution, especially for drugs sensitive to oxidation and moisture, to ensure the stability of the drug effect. In addition, the synergistic effect of the multilayer material makes it more compatible with different properties of the drug solution (including acid, alkali, fat-soluble, etc.), and it is not easy to adsorb effective components (such as some protein and fat-soluble drugs) in the drug solution, which can ensure the stability of the drug solution concentration, and the application range is wider than traditional packaging. DETAILED DESCRIPTION

[0025] In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in many different ways beyond the specific embodiments disclosed herein, and it is understood that one of ordinary skill in the art can make similar modifications without departing from the scope of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0026] A multilayer co-extrusion multi-chamber high-barrier bag preparation process for infusion solution, comprising the following steps:

[0027] S1. Prepare a multilayer co-extruded film; the multilayer co-extruded film comprises an outer layer film, a middle layer film and an inner layer film, the outer layer film has a thickness of 10-100 μm and is made of any one of polyesters, ethylene-vinyl alcohol copolymer, polyvinylidene chloride, polyethylene naphthalate, m-xylylene adipic acid, and modified polymethyl methacrylate; the middle layer film has a thickness of 100-280 μm and is made of any one of polypropylene, adhesive resin, ethylene methacrylate polymer, high-density polyethylene, metallocene polyethylene, and polyolefin elastomer; and the inner layer film has a thickness of 10-80 μm and is made of any one of polyester, ester copolymer, propylene copolymer, modified ethylene, and styrene-ethylene-butylene copolymer.

[0028] The thickness ratio of the outer layer film to the middle layer film is 5:1, and the thickness ratio of the outer layer film to the inner layer film is 1:2. The outer layer film has a thickness of 30-50 μm and is made of polyvinylidene dichloride; the middle layer film has a thickness of 150-250 μm and is made of high-density polyethylene; and the inner layer film has a thickness of 15-25 μm and is made of modified ethylene.

[0029] The preparation process of the multi-layer co-extrusion film is as follows:

[0030] S101. The melting points of the materials of the layers are set, and the temperature curve of each extruder is independently controlled at 180-250 ℃ and the screw rotation speed is 20-150 rpm, so as to ensure that the difference in the melt viscosity of the layers is ≤10%, and the melt is delivered to the co-extrusion die at a constant pressure by using a high-precision melt pump, so as to ensure that the thickness deviation is ≤±1%;

[0031] S102. The melt is layered and converged in the spiral mandrel annular die.

[0032] S103. The film material is quickly cooled and shaped at 15-45 ℃, and the full width is scanned by using an infrared thickness gauge, and the detection data are fed back to the die bolt thermal expansion adjustment system to realize automatic correction of the thickness within 1 second, and finally the multi-layer co-extrusion film is obtained.

[0033] S2. The multi-layer co-extrusion film is fixed on a bag making machine, and the bag making parameters are set, the film welding temperature of the bag periphery is 120-160 ℃, the welding pressure is 4.0-6.0 bar, the welding time is 0.5-2.0 s, the film weak welding temperature between the multi-chambers is 110-130 ℃, the weak welding pressure is 3.0-5.0 bar, the weak welding time is 0.8-3.0 s, and the bag making machine is operated.

[0034] The ratio of the film welding temperature of the bag periphery to the welding pressure is 30:1, and the ratio of the film welding temperature of the bag periphery to the welding time is 110:1; the ratio of the film weak welding temperature between the multi-chambers to the weak welding pressure is 30:1, and the ratio of the film weak welding temperature between the multi-chambers to the weak welding time is 85:1.

[0035] Preferably, the film welding temperature of the bag periphery is 132-144 ℃, the welding pressure is 4.4-4.8 bar, the welding time is 1.2-1.3 s, the film weak welding temperature between the multi-chambers is 118-124 ℃, the weak welding pressure is 3.9-4.2 bar, and the weak welding time is 1.4-1.5 s.

[0036] S3. The label printing module of the bag making machine automatically prints a label on the multi-layer co-extrusion film.

[0037] S4. After the multi-layer co-extrusion film is welded by the bag making machine, the multi-layer co-extrusion film is integrally cut into a bag shape.

[0038] S5. The robot of the bag making machine removes the flash of the formed multi-chamber high-barrier bag.

[0039] Proof of efficacy test

[0040] The three-layer co-extruded film (outer layer: polyvinylidene chloride, film thickness: 40 μm; middle layer: density polyethylene, film thickness: 200 μm; inner layer: modified ethylene, film thickness: 20 μm) of the present application was subjected to process parameter screening for the preparation of a multi-layer co-extruded multi-chamber bag for infusion, and was compared with products (Competitor 1 and Competitor 2) that are well received in the market in terms of bag performance, in order to confirm the excellent effects of the multi-layer co-extruded multi-chamber high-barrier bag for infusion of the present application.

[0041] I. Multi-layer co-extruded multi-chamber high-barrier bag for infusion - weak welding process parameter screening

[0042] 1.1 Effect of temperature on weak welding strength

[0043] (1) Bag-making parameters

[0044] Samples were prepared at a temperature of 115°C to 135°C, a pressure of 4.0 bar, and a weak welding time of 1.5 s. The bags were filled with water for injection according to the indicated amount and sterilized at 121°C for 30 min. The bag-making parameters are shown in Table 1 below.

[0045] Table 1 Bag-making parameters

[0046]

[0047] (2) Test results

[0048] Three bags were sampled from each batch before and after sterilization, and the weak welding strength was tested and the average value of the three bags was calculated. The test results are shown in Table 2 below.

[0049] Table 2 Weak welding strength test results

[0050]

[0051] Conclusion: The above test results show that the welding temperature has a greater effect on the weak welding strength, especially when the temperature is between 125°C and 135°C, the weak welding strength changes significantly with the welding temperature.

[0052] 1.2 Effect of time on weak welding strength

[0053] (1) Bag-making parameters

[0054] Samples were prepared at a temperature of 122°C, a pressure of 4.0 bar, and a weak welding time of 1.0 s to 2.5 s. The bags were filled with water for injection according to the indicated amount and sterilized at 121°C for 30 min. The bag-making parameters are shown in Table 3 below.

[0055] Table 3 Weak welding bag-making parameters

[0056]

[0057] (2) Test results

[0058] Three bags of samples before and after sterilization were taken for weak welding strength test and the average of three bags was calculated. The test results are shown in Table 4 below.

[0059] Table 4 Weak welding strength test results

[0060]

[0061] Conclusion: The above test results show that when the weak welding temperature and pressure are fixed, within the range of 1.0s~2.5s, the weak welding strength does not change significantly with the extension of welding time, indicating that the welding time has little effect on the weak welding strength.

[0062] 1.3 Effect of pressure on weak welding strength

[0063] (1) Bag-making parameters

[0064] The weak welding temperature was fixed at 122℃ and the time was 1.5s. Samples with welding pressures of 3.5bar~4.5bar were prepared, filled with water for injection according to the indicated amount and sterilized, with sterilization parameters of 121℃ / 30min. The bag-making parameters are shown in Table 5 below.

[0065] Table 5 Weak welding bag-making parameters

[0066]

[0067] (2) Test results

[0068] Three bags of samples before and after sterilization were taken for weak welding strength test and the average of three bags was calculated. The test results are shown in Table 6 below.

[0069] Table 6 Weak welding strength test results

[0070]

[0071] Conclusion: The above test results show that when the weak welding temperature and time are fixed, the weak welding strength does not change significantly with the change of welding pressure, indicating that the welding pressure has little effect on the weak welding strength. After sterilization, the weak welding strength increases by 1~2N compared with that before sterilization.

[0072] 1.4 Confirmation of weak welding process parameters

[0073] The weak welding parameters were confirmed and compared with the performance of the better-known products on the market (Competitor 1, Competitor 2) to screen suitable weak welding process parameters.

[0074] (1) Bag-making parameters

[0075] According to the above test results, different weak welding parameters are set, mainly changing the weak welding temperature, and samples with different weak welding strength ranges are prepared, and the injection water is filled according to the indicated amount and sterilized, and the sterilization parameters are 121℃ / 30min. The bag making parameters are shown in Table 7 below.

[0076] Table 7 Weak welding bag making parameters

[0077]

[0078] (2) Test results

[0079] Weak welding strength: 3 bags of samples before and after sterilization are taken for weak welding strength test and calculation of 3 bag average. The test results are shown in Table 8 below.

[0080] Table 8 Weak welding strength test results

[0081]

[0082] Conclusion: The test results show that the weak welding strength of the product of the application and the competitive products 1 and 2 after sterilization is increased by 1-4N compared with that before sterilization, and the weak welding strength is relatively stable.

[0083] Drop resistance test: 5 bags of samples before and after sterilization are taken, dropped horizontally at a height of 1.0m until the weak welding is opened or the periphery is opened, and the number of drops per batch is counted, and the maximum number of drops is 10. The test results are shown in Table 9.

[0084] Table 9 Drop resistance test results

[0085]

[0086] Conclusion: The test results show that the weak welding temperature of the product of the application is 119℃-124℃, and the samples before and after sterilization of each batch can withstand at least 2 drops, which meets the requirements; with the increase of weak welding strength, the weak welding is less likely to be opened in the drop test. The competitive products 1 and 2 can only withstand 1 drop after sterilization, so they are prone to cracking during actual transportation.

[0087] Human squeeze test: 12 bags of samples after sterilization are taken, and two groups of test personnel, 2 men and 2 women, are found to experience the difficulty of opening the samples. The difficulty of opening is divided into five degrees: A: very easy to open; B: easy to open; C: slightly difficult to open; D: difficult to open; E: unable to open. The samples in different weak welding ranges are numbered and registered in advance, and each person takes three bags per batch, squeezes to open, and fills in the opening experience. The test results are shown in Table 10.

[0088] Table 10 Human squeeze test results

[0089]

[0090] Conclusion: The above test results show that the product of the application cannot be opened when the weak welding temperature is 124℃; when the weak welding temperature is 119℃-123℃ and the weak welding strength is 6-14N / 15mm, all test personnel can open it, which meets the design requirements of the product and is convenient for clinical use. The products of the competitive products 1 and 2 cannot be opened.

[0091] Opening force test: Take 5 bags of sterilized samples, respectively, and place the large cavity between two parallel plates (the small cavity is suspended), apply pressure until the weak welding part is opened, and measure the opening pressure. The test results are shown in Table 11 below.

[0092] Table 11 Opening force test results

[0093]

[0094] Conclusion: The above test results show that the weak welding strength of the product of the application and the competitive products 1 and 2 is 119-124℃, and the opening force of the corresponding samples after sterilization is in the range of 700N-1500N.

[0095] Insoluble particle test: Take 6 bags of sterilized samples, of which 3 bags are used to measure the number of insoluble particles in the large chamber and small chamber before mixing, and the other 3 bags are used to measure the number of insoluble particles after mixing. The number of particles of 5μm and above in each 1ml should not exceed 100; the number of particles of 10μm and above in each 1ml should not exceed 20; the number of particles of 25μm and above in each 1ml should not exceed 2. The test results are shown in Table 12 below.

[0096] Table 12 Insoluble particle test results

[0097]

[0098] Conclusion: The above results show that the insoluble particles in the small chamber, large chamber before mixing and the bag after mixing of the product of the application and the competitive products 1 and 2 meet the requirements, and the welding part after opening has no effect on the insoluble particles of the product.

[0099] Weak welding width and flatness: Take 5 bags of sterilized samples, open the weak welding, and measure the width and flatness of the opened weak welding part. The test results are shown in Table 13.

[0100] Table 13 Weak welding width measurement results

[0101]

[0102] Conclusion: The above results show that the narrow part of the bag weak welding width made by different bag making parameters of the invention is 9.19mm~9.48mm, and the wide part is 28.08mm~28.81mm, the welding width is uniform, and the welding part is flat after the weak welding is opened, without visible adhesion, burr and the like. The width difference of the narrow part and the wide part of the bag weak welding width of the competitive product 1 and the competitive product 2 is large, which affects the flatness of the welding part after the weak welding is opened.

[0103] According to the above test results: the bags made by different bag making parameters meet the requirements in all tests except that the weak welding cannot be opened when the weak welding temperature is 124℃ in the human body squeezing test, according to the test results, the weak welding temperature of 124℃ is discarded, and the weak welding temperature is determined to be 119℃~123℃; the average value range of the intermediate weak welding strength is 4.0N / 15mm~10.0N / 15mm, and the single point value is not less than 3N / 15mm; the average value range of the finished product weak welding strength is 6.0N / 15mm~14.0N / 15mm, and the single point value is not less than 5N / 15mm; the opening force range is 700N~1500N. Combined with the actual production experience in the workshop, the weak welding bag making parameters are determined in Table 14.

[0104] Table 14 Weak welding bag making parameters

[0105]

[0106] II. Multi-layer co-extrusion multi-chamber high-barrier infusion bag - periphery welding process parameter screening

[0107] 2.1 Bag making parameters

[0108] According to the parameters in the following Table 15, 50 bags are prepared for each batch, of which 30 bags are filled with water for injection according to the indicated filling amount, and 25 bags are sterilized, and the sterilization parameters are 121℃ / 30min. The appearance, heat sealing strength, and anti-falling test are carried out on the samples before and after sterilization, and the temperature adaptability and sealing test are carried out on the samples after sterilization.

[0109] Table 15 Periphery welding bag making parameters

[0110]

[0111] 2.2 Test results

[0112] (1) Appearance

[0113] Take 10 bags of samples before and after sterilization in a bright place under natural light, and visually observe. The bag body should be transparent, smooth, without visible foreign matter, the weak welding seal should be uniform without burr, the periphery heat sealing part should be flat and uniform, the hose should not have a stringing phenomenon after preheating, the tube film welding should be good, and the film material and the hose cannot be obviously peeled off. The test results are shown in Table 16

[0114] Table 16 Appearance test results

[0115]

[0116] Conclusion: The results show that the bag prepared under the prepared process parameters of the application and the competitive products 1 and 2 are transparent, smooth, and free of visible foreign matter before and after sterilization, the weak welding is uniform and free of burrs, the appearance of the periphery heat sealing is flat and uniform, the hose is free of stringing phenomenon after preheating, the tube film is welded well, and the film material and the hose are free of obvious peeling, and the appearance of the bag can meet the control requirements.

[0117] (2) Heat sealing strength

[0118] Take 3 groups of samples before and after sterilization per batch, and test the periphery welding heat sealing strength according to the method of the heat sealing strength determination method (YBB00122003-2015) for composite bags, and calculate the average value of the 3 groups, and the average value of the heat sealing part shall not be less than 30N / 15mm. The test results are shown in Table 17.

[0119] Table 17 Heat sealing strength test results

[0120]

[0121] Conclusion: The above test results show that the heat sealing strength of the samples of the competitive products 1 and 2 before and after sterilization has individual points lower than 30N / 15mm, and the heat sealing strength of the batch samples of the application before and after sterilization is greater than 30N / 15mm, which meets the standard requirements.

[0122] (3) Drop resistance

[0123] Take 5 bags of samples before and after sterilization, open the weak welding, and drop horizontally at a height of 1.0m until the periphery is welded and leaked, count the drop times per batch, and drop at most 10 times. The test results are shown in Table 18.

[0124] Table 18 Drop resistance test results

[0125]

[0126] Conclusion: The above test results show that the samples of the application before sterilization can withstand at least 10 drops, and the samples after sterilization can withstand at least 8 drops, and the drop resistance meets the requirements. The samples of the competitive products 1 and 2 after sterilization can withstand less than 8 drops, and the drop resistance performance is poor.

[0127] (4) Temperature adaptability

[0128] Take 5 bags of sterilized sample, according to the three-layer co-extrusion infusion film (I), bag (YBB00102005-2015) "temperature adaptability" method test. Take the sample, at-25℃±2℃, for 24 hours, then at 50℃±2℃, continue to place for 24 hours, then at 23℃±2℃, for 24 hours, place the sample between two parallel plates, withstand 67KPa internal pressure, maintain 10 minutes, should be no liquid leakage. Test results are shown in Table 19.

[0129] Table 19 Temperature adaptability test results

[0130]

[0131] Conclusion: The results show that the bags of each batch of the product prepared under the proposed parameters, after sterilization and treatment under the specified conditions, withstand 67KPa internal pressure on the pressure tester for 10 minutes, and no liquid leakage, the temperature adaptability meets the control requirements. The liquid leakage of the competitive products 1 and 2 after sterilization test, the temperature adaptability is not good.

[0132] (5) Sealing property

[0133] Take 5 bags of sterilized sample per batch, use high-voltage discharge method for sealing property test (test voltage 6.0kv, threshold 14.0mA), should be no leakage. Test results are shown in Table 20.

[0134] Table 20 Sealing property test results

[0135]

[0136] Conclusion: The results show that the bags of each batch prepared under the proposed parameters, after sterilization, use high-voltage discharge method for sealing property test, and no leakage.

[0137] Based on the above test results: the detection of each batch of the product prepared under different bagging parameters meets the requirements, the final determination of the peripheral welding parameters of the packaging system is shown in Table 21.

[0138] Table 21 Peripheral welding bagging parameters

[0139]

[0140] The above is only a preferred embodiment of the present application and is not intended to limit the present application, although the present application has been described in detail with reference to the embodiments, those skilled in the art can still modify the technical solutions described in the above embodiments, or make equivalent replacement for some technical features, but any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A process for the preparation of a multilayer co-extruded multi-chamber high barrier bag for infusion solutions, characterized by, The method comprises the following steps: S1. Preparing a multi-layer co-extrusion film; S2. Fixing the multi-layer co-extrusion film on a bag making machine, setting bag making parameters, the film welding temperature of the bag periphery is 120-160℃, the welding pressure is 4.0-6.0 bar, the welding time is 0.5-2.0 s, the film weak welding temperature between multi-chambers is 110-130℃, the weak welding pressure is 3.0-5.0 bar, the weak welding time is 0.8-3.0 s, and the bag making machine is operated; S3. The label printing module of the bag making machine automatically prints labels on the multi-layer co-extrusion film; S4. After the multi-layer co-extrusion film is welded by the bag making machine, the multi-layer co-extrusion film is integrally cut into a bag shape; S5. The robot of the bag making machine removes the flash of the formed multi-chamber high barrier bag.

2. The multilayer co-extrusion multi-chamber high barrier bag for infusion preparation process according to claim 1, characterized in that: In step S2, the ratio of the film welding temperature of the bag periphery to the welding pressure is 30:1, and the ratio of the film welding temperature of the bag periphery to the welding time is 110:1; the ratio of the film weak welding temperature between multi-chambers to the weak welding pressure is 30:1, and the ratio of the film weak welding temperature between multi-chambers to the weak welding time is 85:

1.

3. The multilayer co-extrusion multi-chamber high barrier bag for infusion preparation process according to claim 2, characterized by the fact that: In step S2, the film welding temperature of the bag periphery is 132-144℃, the welding pressure is 4.4-4.8 bar, the welding time is 1.2-1.3 s, the film weak welding temperature between multi-chambers is 118-124℃, the weak welding pressure is 3.9-4.2 bar, and the weak welding time is 1.4-1.5 s.

4. Process for the preparation of a multilayer co-extruded multichamber high barrier bag for infusion solutions according to any one of claims 1-3, characterized by: The multi-layer co-extrusion film comprises an outer layer film, a middle layer film and an inner layer film, the outer layer film has a thickness of 10-100 μm and is made of any one of polyesters, ethylene-vinyl alcohol copolymer, polyvinylidene chloride, polyethylene naphthalate, m-xylylenediamine-adipic acid and modified polymethyl methacrylate; the middle layer film has a thickness of 100-280 μm and is made of any one of polypropylene, adhesive resin, ethylene-methacrylic acid ester polymer, high-density polyethylene, metallocene polyethylene and polyolefin elastomer; and the inner layer film has a thickness of 10-80 μm and is made of any one of polyester, ester copolymer, propylene copolymer, modified ethylene and styrene-ethylene-butylene copolymer.

5. The multilayer co-extrusion multi-chamber high barrier bag for infusion preparation process according to claim 4, characterized by the fact that: The thickness ratio of the outer layer film to the middle layer film is 5:1, and the thickness ratio of the outer layer film to the inner layer film is 1:

2.

6. The multilayer co-extrusion multi-chamber high barrier bag for infusion preparation process according to claim 5, characterized by the fact that: The outer layer film has a thickness of 30-50 μm and is made of polyvinylidene chloride; the middle layer film has a thickness of 150-250 μm and is made of high-density polyethylene; and the inner layer film has a thickness of 15-25 μm and is made of modified ethylene.

7. The multilayer co-extrusion multi-chamber high barrier bag for infusion preparation process according to claim 6, characterized in that, In step S1, the preparation process of the multi-layer co-extrusion film is as follows: S101. Setting the melting point of each layer material, setting the temperature curve of each extruder to be independently controlled at 180-250℃ and the screw rotation speed to be 20-150 rpm, ensuring that the difference between the melt viscosities of the layers is ≤10%, using a high-precision melt pump to constantly deliver the melt to the co-extrusion die head, and ensuring that the layer thickness deviation is ≤±1%; S102. The melt is layered and converged in the spiral mandrel ring die head; S103. The film material is quickly cooled and shaped at 15-45℃, the full width is scanned by an infrared thickness gauge, the detection data are fed back to the die head bolt thermal expansion adjustment system, the thickness is automatically corrected within 1 s, and finally the multi-layer co-extrusion film is obtained.

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