Moisture absorption composite film and preparation method and application thereof

Abstract

The invention discloses a moisture absorption composite film as well as a preparation method and application thereof, and relates to the technical field of medicine packaging. The moisture absorption composite film comprises a substrate layer, an aluminum foil and an adsorption layer which are sequentially stacked from top to bottom, the adsorption layer comprises a moisture absorption layer and an interlayer which are arranged up and down, the moisture absorption layer is located between the aluminum foil and the interlayer, the material of the moisture absorption layer comprises resin containing an adsorption material, and the adsorption material comprises calcium oxide and a molecular sieve or zeolite and a molecular sieve. And the material of the interlayer comprises resin. The packaging moisture absorption requirement of the faropenem sodium particles can be met, and the quality of packaged products is guaranteed.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical packaging technology, and in particular to a moisture-absorbing composite film, its preparation method, and its application. Background Technology

[0002] Penicillin antibiotics are effective but unstable, sensitive to moisture, and easily degraded in water, leading to a significant increase in related substances and polymers. Instability in product quality poses safety risks, especially for children, and is increasingly attracting attention. For example, pediatric faropenem sodium granules hydrolyze in water at room temperature, significantly increasing degradation products. This results in noticeable changes in product properties and odor, and related substances and polymers exceeding acceptable limits within a short period.

[0003] Research has found a correlation between the stability of granular products and the packaging materials used. Specifically, the packaging materials should possess a certain degree of hygroscopicity; for example, a moisture-absorbing film (packaging material) can be used to absorb free water from the product granules. However, the moisture absorption capacity of the moisture-absorbing film should be appropriate. Too low a capacity will have no effect, while too high a capacity will absorb the water of crystallization from faropenem sodium (leading to changes in the water of crystallization and decreased stability).

[0004] Therefore, how to provide a moisture-absorbing film material that can ensure the moisture absorption requirements of ferropene sodium granule packaging has become an urgent problem to be solved. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a moisture-absorbing composite film, its preparation method, and its application, which can ensure that the moisture absorption requirements of faropenem sodium granules are met and guarantee the quality of the packaged product.

[0006] This invention is achieved through the following technical solution: In a first aspect, the present invention provides a moisture-absorbing composite film comprising a matrix layer, a spacer layer, and an adsorption layer stacked sequentially from top to bottom, wherein the adsorption layer comprises a moisture-absorbing layer and a spacer layer disposed vertically, and the moisture-absorbing layer is located between the aluminum foil and the spacer layer. The moisture-absorbing layer is made of resin containing adsorbent material, which includes calcium oxide and molecular sieve, or zeolite and molecular sieve. The separator is made of resin and has a thickness of 20-30 μm. The matrix layer is made of one of polyethylene terephthalate, polyethylene, polyvinyl chloride, polyvinylidene chloride, or polypropylene.

[0007] Optionally, the thickness of the matrix layer is 10~20μm.

[0008] Optionally, the thickness of the aluminum foil is 9~12μm.

[0009] Optionally, the particle size of the calcium oxide, the molecular sieve, and the zeolite is all D. 90 <30μm, D 50 <15μm, D 10 <5μm.

[0010] Optionally, the calcium oxide or zeolite accounts for 40% to 60% of the mass of the molecular sieve.

[0011] Optionally, the density of the adsorbent material in the resin of the moisture-absorbing layer is 0.05~1.5 mg / cm³. 2 .

[0012] Secondly, the present invention provides a method for preparing a moisture-absorbing composite film, comprising the following steps: S1, Prepare an adsorption layer, the adsorption layer comprising an upper and lower moisture-absorbing layer and a separator, wherein the moisture-absorbing layer is made of a resin containing an adsorbent material, the adsorbent material comprising a combination of calcium oxide or zeolite and molecular sieve, the separator is made of a resin, and the thickness of the separator is 20~30μm; S2, Select a matrix layer and aluminum foil, wherein the material of the matrix layer includes one of polyethylene terephthalate, polyethylene, polyvinyl chloride, polyvinylidene chloride or polypropylene; S3, the matrix layer, the aluminum foil, and the adsorption layer are placed and laminated in a top-to-bottom order to obtain the moisture-absorbing composite film. The moisture-absorbing layer is located between the aluminum foil and the spacer, and the moisture absorption capacity of the moisture-absorbing composite film is 0.1 g / m³. 2 ~1.1g / m 2 .

[0013] Optionally, step S1 specifically includes: S11, the adsorbent material is micronized, mixed, and then sealed. The adsorbent material includes calcium oxide and molecular sieves, or zeolite and molecular sieves, wherein the particle size of the calcium oxide, the molecular sieves, and the zeolite is all D. 90 <30μm, D 50 <15μm, D 10 <5μm; S12, prepare moisture-absorbing masterbatch from the sealed adsorbent material; S13, the moisture-absorbing masterbatch is blown into an adsorption layer by a blown film process. The adsorption layer includes an upper and lower moisture-absorbing layer and a spacer layer. The moisture-absorbing layer is made of resin containing the moisture-absorbing masterbatch, and the spacer layer is made of resin.

[0014] Optionally, the calcium oxide or zeolite accounts for 40% to 60% of the mass of the molecular sieve; and the density of the adsorbent material in the resin of the hygroscopic layer is 0.05 to 1.5 mg / cm³. 2 .

[0015] Thirdly, the present invention provides an application of a moisture-absorbing composite film in the field of pharmaceutical packaging.

[0016] Compared with the prior art, the advantages of this invention are: 1. The moisture-absorbing composite film of the present invention includes a matrix layer, an aluminum foil and an adsorption layer stacked from top to bottom. The adsorption layer set in the bottommost layer (i.e. the bottom layer) is used to adsorb moisture in the internal environment of the packaging, thereby adsorbing moisture in the internal environment of the packaging or free water in the sample, meeting the moisture absorption requirements of pharmaceutical packaging and ensuring the quality of the packaged product.

[0017] 2. The absorbent layer of the moisture-absorbing composite film of the present invention includes an upper and lower absorbent layer and a separator. The absorbent layer is located between the aluminum foil and the separator. Since the absorbent material is selected from materials such as calcium oxide or zeolite, these materials will generate alkaline substances, such as calcium hydroxide, after absorbing moisture. The separator isolates the absorbent layer from the packaged medicine, avoiding direct contact between the absorbent layer and the medicine, thereby avoiding affecting the stability of the medicine and further ensuring the quality of the packaged product. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of the moisture-absorbing composite membrane according to a first aspect embodiment of the present invention; Figure 2 The graph shows the trend of impurity B content in existing formulations and the formulation of the present invention during accelerated testing of the application of the moisture-absorbing composite film of the third aspect of the present invention in the field of pharmaceutical packaging. Figure 3 The graph shows the trend of related substance II content in an accelerated test of the application of the moisture-absorbing composite film of the third aspect of the present invention in the field of pharmaceutical packaging. Figure 4 This is a graph showing the trend of impurity B content in existing formulations and the formulation of the present invention during a long-term test of the application of the moisture-absorbing composite film of the third aspect of the present invention in the field of pharmaceutical packaging. Figure 5 This is a graph showing the trend of related substance II content in existing formulations and the formulation of the present invention during a long-term test of the application of the moisture-absorbing composite film of the third aspect of the present invention in the field of pharmaceutical packaging.

[0019] Reference numerals: 10, substrate layer; 20, aluminum foil; 30, absorbent layer; 31, moisture-absorbing layer; 32, separator. Detailed Implementation

[0020] The following detailed, non-limiting description of the invention's technical solutions, in conjunction with preferred embodiments and accompanying drawings, is provided. In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the invention, and should not be construed as limiting the invention.

[0021] The moisture-absorbing composite membrane of the present invention will now be described in detail with reference to the accompanying drawings.

[0022] like Figure 1 As shown, the present invention provides a moisture-absorbing composite membrane, which may include a matrix layer 10, an aluminum foil 20, and an adsorption layer 30 stacked sequentially from top to bottom. The adsorption layer 30 may include a moisture-absorbing layer 31 and a spacer layer 32 disposed vertically, with the moisture-absorbing layer 31 located between the aluminum foil 20 and the spacer layer 32. The material of the moisture-absorbing layer 31 may include a resin containing an adsorbent material, which may include calcium oxide and molecular sieves, or zeolite and molecular sieves. The material of the spacer layer may include resin.

[0023] Specifically, the moisture-absorbing composite membrane of the present invention has a matrix layer 10 on its uppermost (i.e., outermost) layer to provide excellent airtightness, moisture resistance, and mechanical strength. Preferably, the matrix layer 10 can be any one of polyethylene terephthalate, polyethylene, polyvinyl chloride, polyvinylidene chloride, or polypropylene. As an example, the matrix layer 10 can be made of PET (polyethylene terephthalate) film. On the one hand, this material has moderate moisture resistance, and its moisture permeability decreases at low temperatures, effectively isolating moisture and preventing the internal materials from becoming damp. On the other hand, this material has high tensile strength and impact resistance, and good toughness, allowing it to withstand large tensile deformations (such as 500% elongation), ensuring the structural stability of the moisture-absorbing membrane. Finally, PET film has good airtightness, effectively isolating gas exchange, preventing moisture evaporation or external gas infiltration, and maintaining a dry environment for the moisture-absorbing membrane. In addition, PET material is non-toxic, recyclable, and does not release harmful gases when burned, meeting environmental protection requirements. Preferably, the thickness of the matrix layer is 10~20μm. A thickness less than 10μm results in low mechanical strength, which is not conducive to the formation of composite films. A thickness greater than 20μm leads to increased costs while ensuring sufficient mechanical strength.

[0024] Specifically, the moisture-absorbing composite film of the present invention, with aluminum foil 20 in the middle, mainly serves to prevent moisture, ensure airtightness, and isolate moisture. The shielding properties of the aluminum foil protect the contents of the packaging from external moisture. Preferably, the thickness of the aluminum foil is 9-12 μm. Within this thickness range, moisture and gas can be effectively blocked, suitable for packaging requirements in high-humidity environments. Too thin a foil can easily lead to wrinkling, which is detrimental to the formation of the composite film; too thick a foil increases production costs.

[0025] The moisture-absorbing composite film of the present invention has an adsorption layer 30 at its bottommost layer (i.e., the lowest layer) to adsorb moisture from the internal environment of the packaging. This adsorption layer meets the moisture absorption requirements of pharmaceutical packaging and ensures the quality of the packaged product. Furthermore, the adsorption layer 30 of the moisture-absorbing composite film of the present invention includes an upper and lower adsorption layer 31 and a separator 32. The adsorption layer 31 is located between the separator 32 and the aluminum foil 20. Since the adsorption materials are calcium oxide, zeolite, etc., these materials generate alkaline substances, such as calcium hydroxide, after absorbing moisture. The separator 32 isolates the adsorption layer 31 from the packaged pharmaceutical product, preventing direct contact between the adsorption layer 31 and the pharmaceutical product and thus avoiding affecting the stability of the pharmaceutical product, further ensuring the quality of the packaged product.

[0026] It should be noted that the resins in the moisture-absorbing layer 31 and the separator 32 can be polyolefin resins, polyvinyl alcohol (PVA) resins, polyether ether ketone (PEEK) resins, etc. The separator 32 is made of resin material, which serves two purposes: firstly, it acts as a barrier; secondly, it utilizes the inherent gas permeability of its polymer material (the presence of numerous gaps between molecular chains allows gas molecules to pass through more easily), enabling water vapor molecules in the packaged medicine to permeate into the moisture-absorbing layer 31 and meet normal moisture absorption requirements. Preferably, the thickness of the separator is 20~30μm.

[0027] Preferably, the particle size of calcium oxide, molecular sieve, and zeolite is all D. 90 <30μm, D 50 <15μm, D 10 <5μm. When the particle size of the above-mentioned adsorbent material is within this range, the moisture absorption per unit area is consistent throughout the moisture-absorbing layer 3, effectively ensuring the uniformity of moisture absorption on the surface of the moisture-absorbing layer 3, thereby enabling the precise preparation of a moisture-absorbing membrane that meets the predetermined moisture absorption requirements.

[0028] In some embodiments, the adsorbent material may include calcium oxide and molecular sieves, or a combination of zeolite and molecular sieves, wherein the mass of calcium oxide or zeolite accounts for 40% to 60% of the mass of the molecular sieves. Furthermore, the density of the adsorbent material in the resin of the moisture-absorbing layer 31 is 0.05 to 1.5 mg / cm³. 2 Therefore, the resin within the moisture-absorbing layer, when at a predetermined thickness, can prevent localized overload (i.e., uneven distribution of the adsorbent material, or excessive adsorbent material, leading to ineffective distribution of the adsorbent material on the membrane, or excessive localized moisture-absorbing material affecting the membrane's hygroscopicity, sealing, and permeability), ensuring that the moisture-absorbing composite membrane of this invention achieves the predetermined moisture absorption capacity, i.e., 0.1 g / m³. 2 ~1.0g / m 2 It meets the moisture-absorbing requirements for packaging faropenem sodium granules.

[0029] The preparation method of the moisture-absorbing composite membrane of the present invention will be described in detail below.

[0030] This invention provides a method for preparing a moisture-absorbing composite film, which may include the following steps: S1, Prepare an adsorption layer. The adsorption layer includes an upper and lower moisture-absorbing layer and a spacer layer. The moisture-absorbing layer is made of a resin containing an adsorbent material, which includes one or more of calcium oxide, molecular sieves, and zeolite. The spacer layer is made of a resin. S2, Select the substrate layer and aluminum foil; S3, the matrix layer, aluminum foil, and adsorption layer are placed and laminated in a top-to-bottom order to obtain a moisture-absorbing composite film. The moisture-absorbing layer is located between the aluminum foil and the separator, and the moisture absorption capacity of the moisture-absorbing composite film is 0.1 g / m³. 2~1.1g / m 2 .

[0031] Specifically, the method for preparing the moisture-absorbing composite film of the present invention involves first preparing an adsorption layer containing adsorption material, and then placing the matrix layer, aluminum foil, and adsorption layer in a top-to-bottom (i.e., outside-to-inside) order to composite the film, ultimately obtaining the moisture-absorbing composite film. It should be noted that the preparation method of the present invention must be carried out in a humidity environment below 40% to ensure that the prepared moisture-absorbing composite film meets packaging requirements. In step S3, when the matrix layer, aluminum foil, and adsorption layer are composited, a segmented (staged temperature or time control) curing process is adopted to ensure that the moisture-absorbing layer in the adsorption layer is not the innermost layer. The curing process is a single curing step, with processing conditions of 48-52°C and a processing time of 46-50 hours.

[0032] In some embodiments, step S1 may specifically include: S11, after micronizing and mixing the adsorbent material, it is sealed. The adsorbent material includes calcium oxide and molecular sieve, or zeolite and molecular sieve, and the particle size of calcium oxide, molecular sieve, and zeolite is D. 90 <30μm, D 50 <15μm, D 10 <5μm; S12, prepare moisture-absorbing masterbatch from the sealed adsorbent material; S13, the moisture-absorbing masterbatch is blown into an adsorption layer by a blown film process. The adsorption layer includes an upper and lower moisture-absorbing layer and a spacer layer. The moisture-absorbing layer is made of resin containing the moisture-absorbing masterbatch, and the spacer layer is made of resin.

[0033] Specifically, in step S11, since there is a certain humidity in the production environment, in order to prevent the adsorbent materials from absorbing moisture from the air after mixing, which would reduce the moisture absorption capacity of the subsequently produced composite membrane, the mixed adsorbent materials are encapsulated, for example, using aluminum foil bags, to prevent moisture absorption and thus maintain the moisture absorption capacity of the adsorbent materials. In step S12, when preparing the moisture-absorbing masterbatch, a moisture-absorbing substrate (such as polyethylene particles) is first selected and ground into powder. Then, the ground moisture-absorbing substrate is mixed with the adsorbent materials in a certain proportion, and finally, the mixed powder is granulated to prepare the moisture-absorbing masterbatch.

[0034] In some embodiments, the mass of calcium oxide or zeolite accounts for 40% to 60% of the mass of the molecular sieve; and the density of the adsorbent material in the resin of the hygroscopic layer is 0.05 to 1.5 mg / cm³. 2 This ensures that the resulting moisture-absorbing composite film meets the moisture absorption requirements of pharmaceutical packaging, thus guaranteeing the quality of the packaged products.

[0035] Furthermore, in the preparation method of the moisture-absorbing composite membrane of the present invention, the length of the prepared membrane is controlled not to exceed 600m during the composite preparation process. The resulting moisture-absorbing composite membrane is then wrapped with 15μm thick aluminum foil for 7 turns, followed by another 7 turns of the membrane itself (this is a moisture-absorbing operation and is not fixed). It is then packaged in two layers of aluminum foil bags, vacuum-sealed, and the vacuum level should be greater than or equal to 0.8MPa. To avoid damage during transportation due to collisions, the outermost layer is packaged with at least two layers of foam.

[0036] In addition, to ensure consistent hygroscopicity of the membrane, the width of the prepared hygroscopic composite membrane is increased by 10% compared to the theoretical width (the predetermined required width), and 5% is cut off from each end during the final product cutting process. Therefore, the hygroscopic capacity of the membrane at both ends can be avoided due to placement, thus ensuring the quality of the final membrane product.

[0037] In addition, before production, the required amount of absorbent material to be added under the planned production volume is calculated based on the intended absorbency of the absorbent membrane and the absorbency of the mixture. The calculation formula is as follows: The formula is as follows: Moisture-absorbing material feed rate (g) = (Planned production rate (m³)) 2 ) × Proposed moisture absorption (g / m 2 Moisture absorption of the mixture (%) The moisture-absorbing composite membrane prepared by the method of the present invention will be described in detail below with reference to specific embodiments. Example 1

[0038] 1. Preparation of the adsorption layer: Based on the moisture absorption capacity of the proposed absorbent layer, the feed amount of the calcium oxide and molecular sieve mixture is calculated. This mixture is then mixed in resin to form the absorbent layer. The mass of calcium oxide accounts for 40% of the mass of the molecular sieve. The particle size D of both calcium oxide and the molecular sieve is... 90 29.1μm, D 50 14.8μm, D 10 The thickness of the absorbent layer is 4.4 μm, and the thickness of the moisture-absorbing layer is 35.8 μm; a separator made of polyolefin resin with a thickness of 29.6 μm is made, and the absorbent layer and the separator are combined to form the adsorption layer. 2. Polyethylene terephthalate was selected as the matrix layer with a thickness of 20.3 μm, and aluminum foil with a thickness of 9.4 μm was selected; 3. Place the matrix layer, aluminum foil and adsorption layer in order from top to bottom and laminate them. The lamination process is carried out in one curing step. The processing conditions are 48℃ ambient temperature and 46h processing time to obtain a moisture-absorbing composite film. Example 2

[0039] 1. Preparation of the adsorption layer: Based on the moisture absorption capacity of the proposed absorbent layer, the feed amount of the calcium oxide and molecular sieve mixture is calculated. This mixture is then mixed in resin to form the absorbent layer. In this process, the zeolite accounts for 50% of the molecular sieve mass, and the particle size D of both the zeolite and molecular sieve is... 90 23.7μm, D 50 12.6μm, D 10 The thickness of the absorbent layer is 4.0 μm, and the thickness of the moisture-absorbing layer is 29.7 μm; a separator made of polyvinyl alcohol (PVA) resin with a thickness of 20.4 μm is made, and the absorbent layer and the separator are combined to form the adsorption layer; 2. Polyethylene was selected as the matrix layer with a thickness of 16.1 μm, and aluminum foil with a thickness of 10.2 μm was selected; 3. Place the matrix layer, aluminum foil and adsorption layer in order from top to bottom and laminate them. The lamination process is carried out in one curing step. The processing conditions are 50℃ ambient temperature and 48h processing time to obtain a moisture-absorbing composite film. Example 3

[0040] 1. Preparation of the adsorption layer: Based on the moisture absorption capacity of the proposed absorbent layer, the feed amount of the calcium oxide and molecular sieve mixture is calculated. This mixture is then mixed with resin to form the absorbent layer. In this process, the zeolite accounts for 60% of the molecular sieve mass, and the particle size D of both the zeolite and molecular sieve is... 90 2.4μm, D 50 11.0μm, D 10 The thickness of the absorbent layer is 3.5 μm, and the thickness of the moisture-absorbing layer is 29.7 μm; a separator made of polyvinyl alcohol (PVA) resin with a thickness of 20.4 μm is made, and the absorbent layer and the separator are combined to form the adsorption layer. 2. Polyvinyl chloride was selected as the matrix layer with a thickness of 10.6 μm, and aluminum foil with a thickness of 12.0 μm was selected; 3. Place the matrix layer, aluminum foil and adsorption layer in order from top to bottom and laminate them. The lamination process is carried out in one curing step. The processing conditions are 52℃ ambient temperature and 50h processing time to obtain a moisture-absorbing composite film. Comparative Example 1

[0041] 1. Preparation of the adsorption layer: A moisture-absorbing layer with a thickness of 26.2 μm is prepared by mixing calcium oxide or molecular sieve without pulverization; a separator with a thickness of 20.3 μm is prepared by using polyvinyl alcohol (PVA) resin; and an adsorption layer is prepared by combining the moisture-absorbing layer and the separator. 2. Polyvinyl chloride was selected as the matrix layer with a thickness of 10.2 μm, and aluminum foil with a thickness of 11.0 μm was selected; 3. Place the matrix layer, aluminum foil and adsorption layer in order from top to bottom and laminate them. The lamination process is carried out in one curing step. The processing conditions are 45℃ ambient temperature and 60h processing time to obtain a moisture-absorbing composite film.

[0042] Table 1: Results of moisture absorption measurement for each example and comparative sample

[0043] As shown in Tables 1 and 2, the results indicate that the moisture absorption capacity of the three batches of samples differs little from the theoretical value (i.e., the intended moisture absorption capacity), with errors all within ±5%. In other words, the moisture-absorbing composite film prepared by the method of this invention can effectively meet the moisture absorption requirements of pharmaceutical packaging, with a small error range compared to the theoretical moisture absorption capacity (i.e., the intended moisture absorption capacity).

[0044] Finally, the present invention also provides an application of a moisture-absorbing composite film in the field of pharmaceutical packaging.

[0045] The application of the moisture-absorbing composite film of the present invention in the field of pharmaceutical packaging will be described in detail below with reference to specific embodiments.

[0046] Two types of application samples were prepared by repackaging a batch of pediatric faropenem sodium granules using a moisture-absorbing membrane from Comparative Example 1 and a moisture-absorbing composite membrane from Example 1. Influence factor tests were then conducted on these two application samples. Specifically, all three samples were placed at 50°C for 30 days to investigate the properties, moisture content, related substances I, related substances II, and their contents of the faropenem sodium granules. Additionally, ten moisture content results for each of the two samples after 30 days at 50°C were measured, and the corresponding RSD values ​​for these ten results were calculated. The specific results are shown in Table 4.

[0047] Table 2: Performance evaluation table of two application samples after being placed at 50℃ for 30 days.

[0048] As shown in Table 2, after placing the two application samples at 50°C for 30 days, the content of related substances I and II in the sample packaged with the moisture-absorbing composite film of the present invention was significantly lower than that in the sample packaged with commercially available moisture-absorbing film, and the moisture content of the sample packaged with commercially available moisture-absorbing film was also lower. Furthermore, the relative standard deviation (RSD) of the moisture content measurement results of the 10 bags of samples packaged with the moisture-absorbing composite film of the present invention (i.e., the packaging material of the present invention) was smaller, indicating that the film can effectively ensure the quality of the packaged product and provide more uniform moisture absorption. Therefore, the moisture-absorbing composite film of this application has significant advantages as a packaging material for pediatric faropenem granules (i.e., ensuring product quality and providing more uniform moisture absorption).

[0049] A feasibility study for large-scale production of the moisture-absorbing composite film of the present invention was conducted. A batch of moisture-absorbing composite film was produced according to the preparation method of the present invention. Simultaneously, three batches of pediatric faropenem sodium granules were produced according to the preparation process of faropenem sodium granules, each with a batch size of 100,000 bags. The three batches were tested under the following conditions: 30 days at 50°C, 6 months at 40°C ± 2°C (accelerated test), and 6 months at 25°C ± 2°C (long-term test), respectively. The moisture-absorbing composite film of the present invention was used as packaging material (moisture absorption capacity of 0.2~0.8 g / m³). 2 The faropenem sodium granules were packaged into a formulation, wherein the horizontal sealing temperature during granule filling was 90℃~120℃, the side sealing temperature was 110℃~130℃, and the filling speed was 240 bags / minute~320 bags / minute. Stability tests were conducted on the prepared samples, and the relevant test results are shown in Tables 5, 6, and 7.

[0050] Table 3: Evaluation of the test results of the influencing factors of the packaging formulation of Comparative Example 1 and the packaging formulation of Example 1 (50℃, 30 days)

[0051] Table 4: Evaluation of accelerated test results of factors affecting the packaging formulations of Comparative Example 1 and Example 1 (40℃±2℃, 6 months)

[0052] Table 5: Evaluation of long-term test results (25℃±2℃, 6 months) of factors affecting the packaging formulations of Comparative Example 1 and Example 1.

[0053] From the experimental results in Tables 3-5 and Figures 2-5 (The reference formulation in the figure is the packaged formulation of Comparative Example 1, and the self-made formulation is the packaged formulation of Example 1.) This shows that the moisture-absorbing membrane of the present invention uses a combination of physical adsorption (molecular sieve) and chemical adsorption (calcium oxide or zeolite) materials, exhibiting significant moisture absorption advantages and effectively ensuring product quality. Specifically, in the product, free water combines with the chemical adsorption material and undergoes a chemical reaction, while the physical adsorption material maintains a dynamic equilibrium. This synergistic effect effectively avoids the adsorption of the water of crystallization of faropenem sodium, which is closely related to product quality. Therefore, the formulation of the present invention using this material combination exhibits a significant advantage in stability.

[0054] In summary, the results show that the quality of the formulation of the present invention is significantly better than that of the reference formulation, indicating that the packaging material prepared by the present invention can effectively guarantee the quality of the packaged products.

[0055] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A moisture-absorbing composite membrane, characterized in that, The structure comprises a matrix layer, an aluminum foil, and an adsorption layer stacked sequentially from top to bottom. The adsorption layer includes a moisture-absorbing layer and a spacer layer disposed vertically, with the moisture-absorbing layer located between the aluminum foil and the spacer layer. The moisture-absorbing layer is made of resin containing adsorbent material, which includes calcium oxide and molecular sieve, or zeolite and molecular sieve. The separator is made of resin and has a thickness of 20-30 μm. The matrix layer is made of one of polyethylene terephthalate, polyethylene, polyvinyl chloride, polyvinylidene chloride, or polypropylene.

2. The moisture-absorbing composite membrane according to claim 1, characterized in that, The thickness of the matrix layer is 10~20μm.

3. The moisture-absorbing composite membrane according to claim 1, characterized in that, The thickness of the aluminum foil is 9~12μm.

4. The moisture-absorbing composite film according to claim 1, characterized in that, The particle size of the calcium oxide, the molecular sieve, and the zeolite is all D. 90 <30μm, D 50 <15μm, D 10 <5μm.

5. The moisture-absorbing composite film according to claim 1 or 4, characterized in that, The mass of the calcium oxide or zeolite accounts for 40% to 60% of the mass of the molecular sieve.

6. The moisture-absorbing composite film according to claim 1 or 4, characterized in that, The density of the adsorbent material in the resin of the moisture-absorbing layer is 0.05~1.5 mg / cm³. 2 .

7. A method for preparing a moisture-absorbing composite membrane, characterized in that, Includes the following steps: S1, Prepare an adsorption layer, the adsorption layer comprising an upper and lower moisture-absorbing layer and a separator, wherein the moisture-absorbing layer is made of a resin containing an adsorbent material, the adsorbent material comprising calcium oxide and molecular sieve, or zeolite and molecular sieve, the separator is made of a resin, and the thickness of the separator is 20~30μm; S2, Select a matrix layer and aluminum foil, wherein the material of the matrix layer includes one of polyethylene terephthalate, polyethylene, polyvinyl chloride, polyvinylidene chloride or polypropylene; S3, the matrix layer, the aluminum foil, and the adsorption layer are placed and laminated in a top-to-bottom order to obtain the moisture-absorbing composite film. The moisture-absorbing layer is located between the aluminum foil and the spacer, and the moisture absorption capacity of the moisture-absorbing composite film is 0.1 g / m³. 2 ~1.1g / m 2 .

8. The preparation method according to claim 7, characterized in that, Step S1 specifically includes: S11, the adsorbent material is micronized, mixed, and then sealed. The adsorbent material includes calcium oxide and molecular sieves, or zeolite and molecular sieves, wherein the particle size of the calcium oxide, molecular sieves, and zeolite is all D. 90 <30μm, D 50 <15μm, D 10 <5μm; S12, prepare moisture-absorbing masterbatch from the sealed adsorbent material; S13, the moisture-absorbing masterbatch is blown into an adsorption layer by a blown film process. The adsorption layer includes an upper and lower moisture-absorbing layer and a spacer layer. The moisture-absorbing layer is made of resin containing the moisture-absorbing masterbatch, and the spacer layer is made of resin.

9. The method for preparing the moisture-absorbing composite membrane according to claim 7, characterized in that, The calcium oxide or zeolite accounts for 40% to 60% of the mass of the molecular sieve; and The density of the adsorbent material in the resin of the moisture-absorbing layer is 0.05~1.5 mg / cm³. 2 .

10. The application of the moisture-absorbing composite film according to any one of claims 1 to 6 in the field of pharmaceutical packaging.

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