A hydrolysis-resistant lysine aspirin composition for injection and preparation method thereof

Abstract

The present invention relates to a hydrolysis-resistant lysine aspirin composition for injection and a preparation method thereof, and belongs to the technical field of drug preparation. The preparation method comprises: step 1, preparing solution 1; step 2, preparing powder 1; step 3, preparing solution 2; step 4-step 5, preparing product 1; step 6, preparing a final product. The lysine aspirin composition prepared by the above method has the advantages of high temperature resistance and moisture resistance, and can improve the stability of the lysine aspirin composition.

Description

Technical Field

[0001] The invention relates to the preparation of lysine aspirin, in particular to a hydrolysis-resistant lysine aspirin composition for injection and a preparation method thereof, belonging to the technical field of drug preparation. Background Art

[0002] Lysine aspirin is a complex salt of aspirin and lysine. Lysine aspirin can be hydrolyzed into aspirin and lysine, and aspirin can be further hydrolyzed into salicylic acid. Lysine aspirin is unstable to moisture and heat. If lysine aspirin decomposes into salicylic acid during storage, the efficacy of lysine aspirin will be reduced.

[0003] CN1739530A discloses a lysine aspirin for injection, which is composed of lysine aspirin and glycine, wherein the preferred ratio of lysine aspirin to glycine is 85-92%:8-15%. When the ratio of lysine aspirin to glycine is 85%:15%, the drug can play a certain role in enhancing stability under dry conditions at 40°C. However, under high temperature and harsh conditions, it cannot play a good role in inhibiting the decomposition of lysine aspirin. In addition, the existing lysine aspirin cannot achieve good stability under certain relative humidity conditions. Summary of the invention

[0004] In view of the above problems, the present invention provides a hydrolysis-resistant lysine aspirin combination for injection and a preparation method thereof, so as to improve the storage stability of lysine aspirin in a high temperature and high humidity environment.

[0005] To achieve the above object, the technical solution of the present invention is: a method for preparing a hydrolysis-resistant lysine aspirin composition for injection, comprising the following steps:

[0006] Step S1: add 1000 parts by weight of deionized water and 6 parts by weight of glacial acetic acid to container 1, stir evenly, then add 8-12 parts by weight of chitosan and 6-10 parts by weight of calcium chloride, stir evenly, and adjust the pH to 5 with disodium hydrogen phosphate to obtain solution 1;

[0007] Step S2: taking 14 parts by weight of lysine aspirin and 1 part by weight of glycine, mixing them thoroughly and uniformly to obtain powder 1;

[0008] Step S3: adding 1000 parts by weight of deionized water and 18-22 parts by weight of sodium alginate into container 2, stirring evenly, and adjusting the pH to 10 with sodium hydroxide to obtain solution 2;

[0009] Step S4: immersing the ring for producing the film into the solution 1 and then placing it above the liquid surface of the solution 2, slowly and evenly sprinkling the powder 1 on the film, and letting it stand to obtain an intermediate product solution;

[0010] Step S5: filtering the intermediate product solution using a microporous filtration membrane to obtain product 1, and washing product 1 with distilled water;

[0011] Step S6: The washed product 1 is freeze-dried to obtain the final product.

[0012] Furthermore, the amount of chitosan added in step S1 is 10 parts by weight.

[0013] Furthermore, the amount of calcium chloride added in step S1 is 8 parts by weight.

[0014] Furthermore, the amount of sodium alginate used in step S3 is 20 parts by weight.

[0015] Furthermore, in step S4, the ring immersed in solution 1 is placed 0.5 cm above the liquid surface of solution 2, and the ratio of the mass of powder 1 to the diameter of the ring is 1 mg:1 cm.

[0016] Furthermore, in step S4, the standing time is 30-40 minutes, starting from the time when the powder 1 falls into the solution 2.

[0017] Furthermore, the standing time is 35 min.

[0018] Furthermore, the microporous filtration membrane in step S5 is a microporous filtration membrane of 3-10 microns.

[0019] Further, the freeze drying in step S6 is performed according to the following steps:

[0020] Step 1: pre-freeze the washed product 1 at a temperature of -40°C for 4 hours;

[0021] Step 2: Maintain the temperature at 0°C and the pressure at 0.15 mbar for 4 hours.

[0022] Step 3: Maintain the temperature at 30°C and the pressure at 0.05 mbar for 4 hours of analytical drying.

[0023] The lysine aspirin composition manufactured according to the preparation method of the anti-hydrolysis lysine aspirin composition for injection comprises the following components in percentage by mass: lysine aspirin content is 70%-85%, glycine content is 5%-5.68%, and auxiliary material content is 9.32%-25%.

[0024] The anti-hydrolysis lysine aspirin composition for injection and the preparation method thereof of the present invention have the following beneficial effects:

[0025] The invention uses chitosan and sodium alginate as wall materials to wrap lysine aspirin, thereby preventing direct contact between water and lysine aspirin and increasing the stability of lysine aspirin in a humid environment.

[0026] The lysine aspirin prepared by the present invention is stored in a microcapsule, which limits the diffusion of the hydrolysis products of the lysine aspirin to other areas, thereby inhibiting the generation of the hydrolysis products. The microencapsulation structure can not only increase the stability of the lysine aspirin under high temperature conditions, but also improve the stability of the lysine aspirin to humidity, thereby preventing the hydrolysis of the lysine aspirin. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present invention are described clearly and completely below. In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention can also be implemented in other ways different from those described herein, and those skilled in the art can make similar generalizations without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0028] A method for preparing a hydrolysis-resistant lysine aspirin composition for injection comprises the following steps:

[0029] Step S1: add 1000 parts by weight of deionized water and 6 parts by weight of glacial acetic acid to container 1, stir evenly, then add 8-12 parts by weight of chitosan and 6-10 parts by weight of calcium chloride, stir evenly, and adjust the pH to 5 with disodium hydrogen phosphate to obtain solution 1; preferably, the amount of chitosan added is 10 parts by weight, and the amount of calcium chloride added is 8 parts by weight;

[0030] Step S2: taking 14 parts by weight of lysine aspirin and 1 part by weight of glycine, mixing them thoroughly and uniformly to obtain powder 1;

[0031] Step S3: adding 1000 parts by weight of deionized water and 18-22 parts by weight of sodium alginate into container 2, stirring evenly, and adjusting the pH to 10 with sodium hydroxide to obtain solution 2; preferably, the amount of sodium alginate is 20 parts by weight;

[0032] Step S4: immersing the ring for producing the film into the solution 1 and then placing it above the liquid surface of the solution 2, slowly and evenly sprinkling the powder 1 on the film, and letting it stand to obtain an intermediate product solution; preferably, the ring immersed in the solution 1 is placed 0.5 cm above the liquid surface of the solution 2, and the ratio of the mass of the powder 1 to the diameter of the ring is 1 mg: 1 cm; the standing time is 30-40 min from the time when the powder 1 falls into the solution 2; more preferably, the standing time is 35 min;

[0033] Step S5: filtering the intermediate product solution using a microporous filtration membrane to obtain product 1, and washing product 1 with distilled water; preferably, the microporous filtration membrane is a microporous filtration membrane of 3-10 microns;

[0034] Step S6: The washed product 1 is freeze-dried to obtain a final product; preferably, freeze-drying is performed according to the following steps:

[0035] Step 1: pre-freeze the washed product 1 at a temperature of -40°C for 4 hours;

[0036] Step 2: Maintain the temperature at 0°C and the pressure at 0.15 mbar for 4 hours.

[0037] Step 3: Maintain the temperature at 30°C and the pressure at 0.05 mbar for 4 hours of analytical drying.

[0038] The lysine aspirin composition manufactured according to the above-mentioned method for preparing the hydrolysis-resistant lysine aspirin composition for injection includes the following components in percentage by mass: a lysine aspirin content of 70%-85%, a glycine content of 5%-5.68%, and an auxiliary material content of 9.32%-25% (the auxiliary material types are mainly wall material components used to form microcapsules).

[0039] Example 1

[0040] A method for preparing a hydrolysis-resistant lysine aspirin composition for injection comprises the following steps:

[0041] Step S1: add 1000 g of deionized water and 6 g of glacial acetic acid to container 1, stir evenly, then add 10 g of chitosan and 8 g of calcium chloride, stir evenly, and adjust the pH to 5 with disodium hydrogen phosphate to obtain solution 1;

[0042] Step S2: Take 14 g of lysine aspirin and 1 g of glycine, mix them thoroughly and evenly to obtain powder 1;

[0043] Step S3: Add 1000 g of deionized water and 20 g of sodium alginate into container 2, stir evenly, and adjust the pH to 10 with sodium hydroxide to obtain solution 2;

[0044] Step S4: immersing the ring for producing the film into the solution 1 and then placing it above the liquid surface of the solution 2, slowly and evenly sprinkling the powder 1 on the film, and letting it stand to obtain an intermediate product solution; specifically, the ring immersed in the solution 1 is placed 0.5 cm above the liquid surface of the solution 2, and the ratio of the mass of the powder 1 to the diameter of the ring is 1 mg: 1 cm; the standing time is 35 min, starting from the time when the powder 1 falls into the solution 2;

[0045] Step S5: filtering the intermediate product solution using a microporous filtration membrane to obtain product 1, and washing product 1 with distilled water; the microporous filtration membrane is a 6-micron microporous filtration membrane;

[0046] Step S6: The washed product 1 is freeze-dried to obtain a final product; the freeze-drying is performed according to the following steps:

[0047] Step 1: pre-freeze the washed product 1 at a temperature of -40°C for 4 hours;

[0048] Step 2: Maintain the temperature at 0°C and the pressure at 0.15 mbar for 4 hours.

[0049] Step 3: Maintain the temperature at 30°C and the pressure at 0.05 mbar for 4 hours of analytical drying.

[0050] The final product was quality tested, and its physicochemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) all met the requirements of the Appendix II of the 1990 edition of the Chinese Pharmacopoeia; the aspirin content was 45.63% (aspirin content = aspirin mass / final product mass x 100%), and the final product mass included the mass of lysine, the mass of aspirin, the mass of glycine, and the mass of auxiliary materials; the lysine content was 37.45% (lysine content = lysine mass / final product mass x 100%), and the final product mass included the mass of lysine, the mass of aspirin, the mass of glycine, and the mass of auxiliary materials; the content of lysine aspirin in the present embodiment was 83.08% (lysine aspirin content = lysine aspirin mass / final product mass x 100%); the lysine aspirin in the final product was 98.96% of the initial raw material lysine aspirin, and the loss rate was extremely low.

[0051] The content was determined by the following method (the following examples and comparative examples have the same detection method):

[0052] Aspirin content was determined according to the high performance liquid chromatography method (General Rule 0512).

[0053] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; methanol-water-glacial acetic acid (40:60:1) was used as mobile phase; the detection wavelength was 276nm. The theoretical plate number was calculated based on the aspirin peak and was not less than 2000.

[0054] Determination method: Prepare fresh product for clinical use. Take 10 mg of this product, weigh accurately, place in a 25 ml volumetric flask, add 2 ml of glacial acetic acid to dissolve, dilute to scale with acetonitrile, shake well, use as test solution, accurately measure 10 μl, inject into liquid chromatograph, record chromatogram; take appropriate amount of aspirin reference substance, and determine in the same way. Calculate by peak area according to external standard method to obtain.

[0055] Determination of lysine content Take about 0.13g of this product, weigh accurately, add 20ml of glacial acetic acid and 1ml of formic acid to dissolve, add 5 drops of glacial acetic acid solution (0.2→100) of α-naphthol benzyl alcohol, titrate with perchloric acid titrant (0.1mol / L) until the solution turns yellow-green, and correct the titration result with a blank test. Each 1ml of perchloric acid titrant (0.1mol / L) is equivalent to 7.310mg of C6H 14 N2O2.

[0056] Example 2

[0057] A method for preparing a hydrolysis-resistant lysine aspirin composition for injection comprises the following steps:

[0058] Step S1: add 1000 g of deionized water and 6 g of glacial acetic acid to container 1, stir evenly, then add 12 g of chitosan and 6 g of calcium chloride, stir evenly, and adjust the pH to 5 with disodium hydrogen phosphate to obtain solution 1;

[0059] Step S2: Take 14 g of lysine aspirin and 1 g of glycine, mix them thoroughly and evenly to obtain powder 1;

[0060] Step S3: Add 1000 g of deionized water and 18 g of sodium alginate into container 2, stir evenly, and adjust the pH to 10 with sodium hydroxide to obtain solution 2;

[0061] Step S4: immersing the ring for producing the film into the solution 1 and then placing it above the liquid surface of the solution 2, slowly and evenly sprinkling the powder 1 on the film, and letting it stand to obtain an intermediate product solution; specifically, the ring immersed in the solution 1 is placed 0.5 cm above the liquid surface of the solution 2, and the ratio of the mass of the powder 1 to the diameter of the ring is 1 mg: 1 cm; the standing time is 30 minutes starting from the time when the powder 1 falls into the solution 2;

[0062] Step S5: filtering the intermediate product solution using a microporous filtration membrane to obtain product 1, and washing product 1 with distilled water; the microporous filtration membrane is a 6-micron microporous filtration membrane;

[0063] Step S6: The washed product 1 is freeze-dried to obtain a final product; the freeze-drying is performed according to the following steps:

[0064] Step 1: pre-freeze the washed product 1 at a temperature of -40°C for 4 hours;

[0065] Step 2: Maintain the temperature at 0°C and the pressure at 0.15 mbar for 4 hours.

[0066] Step 3: Maintain the temperature at 30°C and the pressure at 0.05 mbar for 4 hours of analytical drying.

[0067] The final product was quality tested, and its physical and chemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) all met the requirements of the Appendix II of the Chinese Pharmacopoeia 1990 Edition; the aspirin content was 44.98%, the lysine content was 37.26%, and the lysine content of the present embodiment was 82.24%; the lysine content of the final product was 98.94% of the lysine content of the initial raw material, and the loss rate was extremely low.

[0068] Example 3

[0069] A method for preparing a hydrolysis-resistant lysine aspirin composition for injection comprises the following steps:

[0070] Step S1: add 1000 g of deionized water and 6 g of glacial acetic acid to container 1, stir evenly, then add 8 g of chitosan and 10 g of calcium chloride, stir evenly, and adjust the pH to 5 with disodium hydrogen phosphate to obtain solution 1;

[0071] Step S2: Take 14 g of lysine aspirin and 1 g of glycine, mix them thoroughly and evenly to obtain powder 1;

[0072] Step S3: add 1000 g of deionized water and 22 g of sodium alginate into container 2, stir evenly, and adjust the pH to 10 with sodium hydroxide to obtain solution 2;

[0073] Step S4: immersing the ring for producing the film into the solution 1 and then placing it above the liquid surface of the solution 2, slowly and evenly sprinkling the powder 1 on the film, and letting it stand to obtain an intermediate product solution; specifically, the ring immersed in the solution 1 is placed 0.5 cm above the liquid surface of the solution 2, and the ratio of the mass of the powder 1 to the diameter of the ring is 1 mg: 1 cm; the standing time is 40 minutes starting from the time when the powder 1 falls into the solution 2;

[0074] Step S5: filtering the intermediate product solution using a microporous filtration membrane to obtain product 1, and washing product 1 with distilled water; the microporous filtration membrane is a 6-micron microporous filtration membrane;

[0075] Step S6: The washed product 1 is freeze-dried to obtain a final product; the freeze-drying is performed according to the following steps:

[0076] Step 1: pre-freeze the washed product 1 at a temperature of -40°C for 4 hours;

[0077] Step 2: Maintain the temperature at 0°C and the pressure at 0.15 mbar for 4 hours.

[0078] Step 3: Maintain the temperature at 30°C and the pressure at 0.05 mbar for 4 hours of analytical drying.

[0079] The final product was quality tested, and its physical and chemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) all met the requirements of the Appendix II of the Chinese Pharmacopoeia 1990 Edition; the aspirin content was 45.12%, the lysine content was 36.93%, and the lysine content of the present embodiment was 82.05%; the lysine content of the final product was 99.13% of the lysine content of the initial raw material, and the loss rate was extremely low.

[0080] Comparative Examples 1 and 2

[0081] Comparative Examples 1 and 2 are comparative experiments of Example 1, except that the amount of chitosan added in step S1 is 6g, and the amount of chitosan added in step S1 of Comparative Example 2 is 15g, and the others are the same as Example 1. Results The final product was subjected to quality inspection, and the final physical and chemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) of Comparative Examples 1 and 2 all met the provisions in the Appendix of Part II of the 1990 edition of the Chinese Pharmacopoeia; in Comparative Example 1, the aspirin content was 39.24%, the lysine content was 33.38%, and the content of lysine aspirin was 72.60%, and the lysine aspirin in the final product was 92.37% of the initial raw material lysine aspirin, and the loss rate was relatively high; in Comparative Example 2, the aspirin content was 44.78%, the lysine content was 37.12%, and the content of lysine aspirin was 81.90%, and the lysine aspirin in the final product was 95.36% of the initial raw material lysine aspirin, and the loss rate was also relatively high.

[0082] Comparative Examples 3 and 4

[0083] Comparative Examples 3 and 4 are comparative experiments of the embodiments, except that the amount of calcium chloride added in step S1 of Comparative Example 3 is 4g, and the amount of calcium chloride added in step S1 of Comparative Example 4 is 12g, and the rest is the same as Example 1. Results The final product was subjected to quality inspection, and the final physical and chemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) of Comparative Examples 3 and 4 all met the provisions in the Appendix of Part II of the 1990 edition of the Chinese Pharmacopoeia; in Comparative Example 3, the aspirin content was 40.32%, the lysine content was 35.74%, and the content of lysine aspirin was 76.06%, and the lysine aspirin in the final product was 94.25% of the initial raw material lysine aspirin, and the loss rate was relatively high; in Comparative Example 4, the aspirin content was 44.17%, the lysine content was 36.93%, and the content of lysine aspirin was 81.10%, and the lysine aspirin in the final product was 94.29% of the initial raw material lysine aspirin, and the loss rate was also relatively high.

[0084] Comparative Examples 5 and 6

[0085] Comparative Examples 5 and 6 are comparative experiments of Example 1, except that the amount of sodium alginate added in step S3 of Comparative Example 5 is 15 g, and the amount of sodium alginate added in step S3 of Comparative Example 6 is 25 g, and the rest is the same as Example 1. Results The final product was subjected to quality inspection, and the final physical and chemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) of Comparative Examples 5 and 6 all met the provisions in the Appendix of Part II of the 1990 edition of the Chinese Pharmacopoeia; in Comparative Example 5, the aspirin content was 41.23%, the lysine content was 34.89%, and the content of lysine aspirin was 76.12%, and the lysine aspirin in the final product was 95.63% of the initial raw material lysine aspirin, and the loss rate was relatively high; in Comparative Example 6, the aspirin content was 44.57%, the lysine content was 36.84%, and the content of lysine aspirin was 81.41%, and the lysine aspirin in the final product was 96.13% of the initial raw material lysine aspirin, and the loss rate was also relatively high.

[0086] Comparative Examples 7 and 8

[0087] Comparative Examples 7 and 8 are comparative experiments of Example 1, except that the standing time in step S4 of Comparative Example 7 is 25 min, and the standing time in step S4 of Comparative Example 8 is 45 min, and the rest is the same as Example 1. The final product is subjected to quality inspection, and the final physical and chemical properties (clarity, abnormal toxicity, pyrogen, sterility, etc.) of Comparative Examples 7 and 8 are in accordance with the provisions in the Appendix of Part II of the 1990 edition of the Chinese Pharmacopoeia; in Comparative Example 7, the aspirin content is 31.63%, the lysine content is 29.57%, and the content of lysine aspirin is 61.20%. The lysine aspirin in the final product is 84.57% of the initial raw material lysine aspirin, and the loss rate is relatively high; in Comparative Example 8, the aspirin content is 44.66%, the lysine content is 36.83%, and the content of lysine aspirin is 81.49%. The lysine aspirin in the final product is 91.43% of the initial raw material lysine aspirin, and the loss rate is also relatively high.

[0088] High temperature and high humidity stability test verification

[0089] In order to test the stability of the lysine aspirin composition prepared by the present invention under high temperature environment, the experiment is designed as follows:

[0090] The drugs used in the experimental group are 10g of each of the lysine aspirin compositions of Examples 1-3 and Comparative Examples 1-8, and the pH value of the drugs is controlled to be 5; the preparation method of the control group is to take 8.3g of lysine aspirin and 1.7g of glycine, and adjust the pH to 5 after sufficient mixing, and the initial content of lysine aspirin is measured to be 83.07%. The pH adjusting agent used in the experimental group and the control group is the same.

[0091] Take 4 samples from each experimental group and 4 samples from the control group and label them as control group 1, control group 2, control group 3 and control group 4. The experimental operation is as follows:

[0092] The first experimental group and control group 1 were placed in the same incubator at 60°C for 24 h;

[0093] The second experimental group and control group 2 were placed in the same incubator at 70°C for 16 h;

[0094] The third batch of experimental groups 3-1 to 3-11 and control group 3 were placed in the same incubator at 80°C for 7 h;

[0095] The fourth experimental groups 4-1 to 4-11 and control group 4 were placed in the same incubator at 90°C for 3 h;

[0096] The experimental results are shown in Table 1.

[0097] Table 1 Stability test under high temperature environment

[0098]

[0099]

[0100] By analyzing the lysine aspirin content of the experimental group and the control group in Table 1, it can be seen that the stability of lysine aspirin in the compositions of each embodiment is much higher than that of the control group and the comparative example compositions under the same temperature and for the same period of time. Therefore, the lysine aspirin composition prepared by the present invention can improve the stability of lysine aspirin and prevent lysine aspirin from hydrolysis.

[0101] In order to test the stability of the lysine aspirin composition prepared by the present invention in a high humidity environment, the following experiment was designed:

[0102] The drugs used in the experimental group are 10g of each of the lysine aspirin compositions of Examples 1-3 and Comparative Examples 1-8, and the pH value of the drugs is controlled to be 5; the preparation method of the control group is to take 8.3g of lysine aspirin and 1.7g of glycine, and adjust the pH to 5 after sufficient mixing, and the initial content of lysine aspirin is measured to be 83.07%. The pH regulator used in the experimental group and the control group is the same. The experimental operation is as follows:

[0103] The experimental group and the control group were placed in a constant temperature box with a relative humidity of 52.30% and a temperature of 25°C. The contents of lysine in each experimental group and the control group were measured after 24h and 48h, respectively. The experimental results are shown in Table 2.

[0104] Table 2 Stability test in humid environment

[0105]

[0106]

[0107] It can be seen from Table 2 that under the conditions of 25°C and 52.30% relative humidity, after 24 hours, the lysine aspirin content of each embodiment group changed very little, and the lysine aspirin content of each comparative example was much reduced relative to the initial content; after 48 hours, the lysine aspirin content of each embodiment group still changed little, and the lysine aspirin content of each comparative example was reduced more relative to the initial content. It can be seen that the lysine aspirin composition prepared by the present invention has better stability in a humid environment.

[0108] Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

Claims

1. A method for preparing a hydrolysis-resistant lysine aspirin composition for injection, It is characterized in that The following steps are involved: Step S1: add 1000 parts by weight of deionized water and 6 parts by weight of glacial acetic acid to container 1, stir evenly, then add 8-12 parts by weight of chitosan and 6-10 parts by weight of calcium chloride, stir evenly, and adjust the pH to 5 with disodium hydrogen phosphate to obtain solution 1; Step S2: taking 14 parts by weight of lysine aspirin and 1 part by weight of glycine, mixing them thoroughly and uniformly to obtain powder 1; Step S3: adding 1000 parts by weight of deionized water and 18-22 parts by weight of sodium alginate into container 2, stirring evenly, and adjusting the pH to 10 with sodium hydroxide to obtain solution 2; Step S4: immersing the ring for producing the film into the solution 1 and then placing it above the liquid surface of the solution 2, slowly and evenly sprinkling the powder 1 on the film, and letting it stand to obtain an intermediate product solution; Step S5: filtering the intermediate product solution using a microporous filtration membrane to obtain product 1, and washing product 1 with distilled water; Step S6: freeze-drying the washed product 1 to obtain a final product; In step S4, the ring immersed in solution 1 is placed 0.5 cm above the liquid surface of solution 2, and the ratio of the mass of powder 1 to the diameter of the ring is 1 mg:1 cm; the standing time is 30-40 minutes starting from the time when powder 1 falls into solution 2.

2. A method for preparing a hydrolysis-resistant lysine aspirin composition for injection according to claim 1, It is characterized in that The amount of chitosan added in step S1 is 10 parts by weight.

3. A method for preparing a hydrolysis-resistant lysine aspirin composition for injection according to claim 1, It is characterized in that The amount of calcium chloride added in step S1 is 8 parts by weight.

4. A method for preparing a hydrolysis-resistant lysine aspirin composition for injection according to claim 1, It is characterized in that The amount of sodium alginate used in step S3 is 20 parts by weight.

5. A method for preparing a hydrolysis-resistant lysine aspirin composition for injection according to claim 1, It is characterized in that The standing time is 35 minutes.

6. A method for preparing a hydrolysis-resistant lysine aspirin composition for injection according to claim 1, It is characterized in that In step S5, the microporous filtration membrane is a microporous filtration membrane of 3-10 microns.

7. A method for preparing a hydrolyzable lysine aspirin composition for injection according to claim 1, It is characterized in that In step S6, freeze drying is performed according to the following steps: Step 1: pre-freeze the washed product 1 at a temperature of -40°C for 4 hours; Step 2: Maintain the temperature at 0°C and the pressure at 0.15 mbar for 4 hours. Step 3: Maintain the temperature at 30°C and the pressure at 0.05 mbar for 4 hours of analytical drying.

8. A lysine aspirin composition produced by the method for preparing a hydrolyzable lysine aspirin composition for injection according to any one of claims 1 to 7, It is characterized in that The invention comprises the following components in percentage by mass: 70%-85% of lysine, 5%-5.68% of glycine and 9.32%-25% of auxiliary materials.

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