Pediatric compound amino acid injection and preparation method therefor
By controlling dissolved oxygen and residual oxygen, an antioxidant-free compound amino acid injection solution was prepared, which solved the potential health threats posed by antioxidants and improved the safety and efficacy of the product, especially for infants and young children.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SICHUAN KELUN PHARMA CO LTD
- Filing Date
- 2025-10-17
- Publication Date
- 2026-04-30
AI Technical Summary
Antioxidants in existing compound amino acid injections may cause allergic reactions, posing a potential threat to human health and affecting product safety and efficacy.
By controlling dissolved oxygen and residual oxygen during the preparation process to prevent the oxidation of amino acids, and by using low-oxygen water and oxygen absorbers during sterilization, an antioxidant-free compound amino acid injection solution can be prepared.
This improved the safety and efficacy of the product, reduced the risks of clinical use, ensured the stability and activity of the amino acids, and avoided the toxic effects of antioxidants.
Smart Images
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Abstract
Description
A pediatric compound amino acid injection and its preparation method Technical Field
[0001] This invention relates to the field of pharmaceutical technology, specifically to a pediatric compound amino acid injection and its preparation method. Background Technology
[0002] Pediatric Compound Amino Acid Injection (19AA-Ⅰ) is suitable for nutritional support of infants (including low birth weight infants) and pediatric patients requiring total parenteral nutrition via central or peripheral infusion. There are three main types of pediatric compound amino acid injections on the market: Pediatric Compound Amino Acid Injection (18AA-Ⅰ), Pediatric Compound Amino Acid Injection (18AA-Ⅱ), and Pediatric Compound Amino Acid Injection (19AA-Ⅰ). The pediatric compound amino acid injection (19AA-Ⅰ) involved in this invention is specifically designed for parenteral nutrition infusion in premature infants and children who cannot receive oral administration or have experienced various injuries. Its essential amino acid (EAA) content is as high as 52%, and the formulation reduces the amounts of phenylalanine, methionine, and glycine while increasing the amounts of tyrosine and histidine. It also contains taurine. Taurine is a metabolite of methionine and cysteine, which can protect cell membranes, promote brain development, maintain normal retinal function, prevent cholestasis, and enhance myocardial cell function; it is an essential element in pediatric amino acids.
[0003] This product contains highly reducing amino acids such as cysteine hydrochloride, which are easily oxidized during the production process. Therefore, most commercially available products contain sulfite antioxidants. However, sulfite antioxidants in injections may cause allergic reactions in clinical practice, posing a potential threat to human health. Studies have also found that sulfite antioxidants in injections can lead to an increase in amino acid-related substances. Currently, European and American countries have officially required pharmaceutical manufacturers to label the content of added antioxidants and their adverse reactions in the drug instructions. The "Announcement of the State Food and Drug Administration on Revising the Instructions for Compound Amino Acid Injection (18AA) and Similar Preparations" issued by the China Food and Drug Administration (CFDA) in September 2016 also made the same requirement. Therefore, how to reduce the amount of antioxidants in compound amino acid injections or even eliminate the use of antioxidants altogether is a current research focus.
[0004] In view of this, it is very necessary to design an improved compound amino acid injection solution without antioxidants for children to solve the above problems. Summary of the Invention
[0005] The technical problem to be solved by this invention is that antioxidants in compound amino acids pose a potential threat to health.
[0006] On the one hand, the purpose of this invention is to provide a method for preparing a pediatric compound amino acid injection, so as to improve the safety of the compound amino acid without adding antioxidants.
[0007] On the other hand, the purpose of this invention is to provide a compound amino acid injection solution that does not contain antioxidants.
[0008] This invention is achieved through the following technical solution:
[0009] This invention provides a method for preparing a pediatric compound amino acid injection, comprising the following steps:
[0010] The pipelines and mixing tanks used for preparation were evacuated and purged with nitrogen.
[0011] Add hypoxic water for injection to the preparation tank, heat, continuously purge with nitrogen, and add isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, valine, histidine, tyrosine, acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, and taurine, and stir to dissolve.
[0012] Cool the preparation vessel, add glacial acetic acid, then add glutoprene, glutamic acid, and cysteine hydrochloride, stir to dissolve, add the remaining water for injection, and then add glacial acetic acid to adjust the pH value to obtain the drug solution.
[0013] The drug solution was subjected to intermediate determination, filtered, filled, and sealed.
[0014] The sealed liquid medicine is sterilized by heat pressing and then vacuum-sealed together with the oxygen absorber in a barrier bag.
[0015] As one possible design, the residual oxygen in the above-mentioned preparation tank is ≤0.5% after vacuuming and nitrogen filling.
[0016] As one possible design, the amount of low-oxygen water for injection added to the above-mentioned configuration tank before heating is 70-80% of the weight of low-oxygen water for injection.
[0017] As one possible design, the dissolved oxygen content of the aforementioned low-oxygen water for injection is ≤0.5 mg / L.
[0018] As one possible design, the heating temperature is 80–100°C.
[0019] As one possible design, the above-mentioned preparation tank is cooled to below 60°C.
[0020] As one possible design, the pH value of the above-mentioned drug solution is 5.2 to 5.8.
[0021] As one possible design, each 1000ml of the above-mentioned solution contains:
[0022] Isoleucine 8–8.4g, leucine 12–16g, lysine acetate 11–13g, methionine 3.3–3.5g, phenylalanine 4.5–5g, threonine 4–4.4g, tryptophan 1.8–2.2g, valine 7.5–8g, cysteine hydrochloride 0.2–0.28g, histidine 4.5–5g, tyrosine 0.4–0.48g, acetyltyrosine 2.2–2.6g, alanine 5.2–5.6g, arginine 11.5–12.5g, proline 6.5–7g, serine 3.5–4g, glycine 3.4–3.8g, aspartic acid 3–3.4g, glutamic acid 4.8–5.2g, taurine 0.2–0.3g, glacial acetic acid 1.0ml–4.0ml, with the remainder being hypoxic water for injection.
[0023] As one possible design, the above autoclaving conditions are: heat treatment at 121°C for 12 minutes.
[0024] The present invention also provides a compound amino acid injection prepared by any of the above preparation methods.
[0025] Compared with the prior art, the present invention has the following advantages and beneficial effects:
[0026] This invention provides a weakly acidic environment for cysteine hydrochloride by adding glacial acetic acid in advance, thus ensuring the stability of cysteine hydrochloride preparation. Furthermore, by controlling dissolved oxygen and residual oxygen during preparation, the oxidation of amino acid raw materials is effectively prevented. Oxidation of amino acids produces degradation impurities, leading to a decrease in API content and affecting product safety and efficacy; therefore, preventing oxidation improves product safety and efficacy. Finally, by controlling the dissolved oxygen in the sterilization water and the residual oxygen in the sterilization chamber during sterilization, the oxidation of amino acid raw materials during sterilization is also effectively prevented.
[0027] The pediatric compound amino acid formula prepared by this method is antioxidant-free, thus avoiding the toxic effects caused by antioxidants. This is particularly beneficial for infants and young children with low tolerance, fundamentally addressing the clinical risks associated with antioxidant-containing products and improving the safety of clinical use. Furthermore, the elimination of antioxidants ensures the preservation of the content of each active amino acid during production, storage, transportation, and use, guaranteeing the effectiveness of clinical medication. These advantages make the product of this invention superior in quality to currently available commercially available products containing antioxidants. Detailed Implementation
[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments. The illustrative embodiments and descriptions of this invention are only for explaining this invention and are not intended to limit this invention.
[0029] A method for preparing a pediatric compound amino acid injection includes the following steps:
[0030] S1. Vacuum and nitrogen-fill the pipes and preparation tanks used for preparation.
[0031] By evacuating and purging the preparation tanks and pipelines with nitrogen, residual oxygen can be reduced, thus avoiding any impact on subsequent preparation and effectively preventing the amino acid raw materials from being oxidized during sterilization.
[0032] Preferably, after vacuuming and nitrogen purging, the residual oxygen in the preparation tank is ≤0.5%. More preferably, the residual oxygen is ≤0.3%.
[0033] When the residual oxygen content is ≤0.5%, the impact of oxygen on the raw materials during the preparation process can be reduced.
[0034] S2. Add hypoxic water for injection to the preparation tank, heat, continuously purge with nitrogen, and add isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, valine, histidine, tyrosine, acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, and taurine, and stir to dissolve.
[0035] Preferably, the amount of low-oxygen water for injection added to the preparation tank before heating is 70-80% of the weight of the low-oxygen water for injection.
[0036] Preferably, the heating temperature is 80–100°C.
[0037] Preferably, the dissolved oxygen content of the hypoxic water for injection is ≤0.5 mg / L.
[0038] Preferably, the preparation tank is cooled to below 60°C.
[0039] Preferably, all materials are added to the preparation tank through a sealed feeding tank.
[0040] S3. Cool the preparation vessel, add glacial acetic acid, then add glutoprene, glutamic acid, and cysteine hydrochloride, stir to dissolve, add the remaining water for injection, and then add glacial acetic acid to adjust the pH value to obtain the drug solution.
[0041] Preferably, the pH value of the drug solution is 5.2 to 5.8. At this pH value, the product quality is more stable.
[0042] Preferably, the amount of glacial acetic acid added for the first time in step S3 is 1.8 mL / L.
[0043] S4. Perform intermediate determination on the drug solution, and then fill and seal it after filtration.
[0044] Preferably, the dissolved oxygen content of the drug solution is controlled to be ≤0.5mg / L throughout the entire preparation and bottling process.
[0045] Preferably, the intermediates are tested in accordance with the finished product standard. The test can preliminarily confirm the product quality and prevent the waste of resources caused by unqualified final products.
[0046] S5. Sterilize the sealed liquid medicine by heat pressing, and then put it together with the oxygen absorber into a barrier bag for vacuum sealing.
[0047] Preferably, the autoclaving conditions are: holding at 121°C for 12 minutes.
[0048] Preferably, the spray water used for autoclaving should be low-oxygen water for injection, with a dissolved oxygen content of ≤0.5mg / L.
[0049] Preferably, the residual oxygen inside the autoclave should be controlled to be ≤0.1%.
[0050] Preferably, the filling is specifically done by filling into a three-layer co-extruded infusion film bag.
[0051] Preferably, each 1000ml of the solution contains:
[0052] Isoleucine 8–8.4g, leucine 12–16g, lysine acetate 11–13g, methionine 3.3–3.5g, phenylalanine 4.5–5g, threonine 4–4.4g, tryptophan 1.8–2.2g, valine 7.5–8g, cysteine hydrochloride 0.2–0.28g, histidine 4.5–5g, tyrosine 0.4–0.48g, acetyltyrosine 2.2–2.6g, alanine 5.2–5.6g, arginine 11.5–12.5g, proline 6.5–7g, serine 3.5–4g, glycine 3.4–3.8g, aspartic acid 3–3.4g, glutamic acid 4.8–5.2g, taurine 0.2–0.3g, glacial acetic acid 1.0ml–4.0ml, with the remainder being hypoxic water for injection.
[0053] Preferably, the above-mentioned medicinal solution does not contain antioxidants. This invention, without adding antioxidants, eliminates the threat of antioxidants to human health, reduces the risks of clinical use, and reduces impurities in the medicinal solution compared to solutions containing antioxidants.
[0054] Example 1
[0055] This embodiment prepares 300L of pediatric compound amino acid injection solution. The preparation method includes the following steps:
[0056] Ingredients: Isoleucine 2.46 kg, Leucine 4.2 kg, Lysine acetate 3.6 kg, Methionine 1.02 kg, Phenylalanine 1.44 kg, Threonine 1.26 kg, Tryptophan 0.6 kg, Valine 2.34 kg, Cysteine hydrochloride 0.072 kg, Histidine 1.44 kg, Tyrosine 0.132 kg, Acetyltyrosine 0.72 kg, Alanine 1.62 kg, Arginine 3.6 kg, Proline 2.04 kg, Serine 1.14 kg, Glycine 1.08 kg, Aspartic acid 0.96 kg, Glutamic acid 1.5 kg, Taurine 0.075 kg.
[0057] Before preparation, the pipelines and containers are evacuated and filled with nitrogen to control the residual oxygen in the preparation tank to ≤0.5%.
[0058] Start the mixing tank and add low-oxygen water for injection to a total volume of 240L. Heat to above 80℃ and continuously purge with nitrogen. Before adding the ingredients, control the dissolved oxygen content of the water for injection to ≤0.5mg / L. Add isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, valine, histidine, tyrosine, acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, and taurine in sequence and stir until dissolved.
[0059] Cool to 50℃, add 540mL of glacial acetic acid to lower the pH of the solution, stir for 5 minutes, then add glutoprepôt, glutamic acid and cysteine hydrochloride, stir to dissolve, add water for injection to 300L, and then add glacial acetic acid to adjust the pH to 5.5 to obtain the solution.
[0060] The drug solution was sampled and tested for intermediates. After passing the test, it was filtered and filled into a three-layer co-extruded infusion film bag and sealed.
[0061] The samples were autoclaved at 121℃ for 12 minutes. Low-oxygen water was used for sterilization; dissolved oxygen ≤0.5 mg / L; residual oxygen in the sterilization cabinet was controlled to be ≤0.1% during the sterilization process.
[0062] The sterilized sample and oxygen absorber are placed in a barrier bag and vacuum sealed to obtain the compound amino acid injection solution.
[0063] Three batches of trial-produced samples were tested in accordance with the quality standards of the National Pharmacopoeia Commission's "Draft for Comments on Pediatric Compound Amino Acid Injection (19AA-Ⅰ)", and the results are shown in Table 1.
[0064] Table 1
[0065]
[0066]
[0067] The molecular structures of impurities B, C, D, E, and G in this invention are shown in Table 2 below.
[0068] Table 2
[0069]
[0070] Example 2
[0071] This embodiment is basically the same as the remaining operations in Embodiment 1, except that: acetyltyrosine, tyrosine, aspartic acid, isoleucine, leucine, threonine, valine, histidine, methionine, lysine acetate, phenylalanine, alanine, arginine, proline, serine, glycine, and taurine are added, stirred and dissolved, and after complete dissolution, three batches are treated at different cooling temperatures (40℃, 50℃, and 60℃) in sequence.
[0072] The three batches of samples prepared at three different cooling temperatures in this embodiment were tested according to the quality standards of the National Pharmacopoeia Commission's "Draft for Comments on Pediatric Compound Amino Acid Injection (19AA-Ⅰ)". The results are shown in Table 3.
[0073] Table 3
[0074]
[0075] Example 3
[0076] This embodiment prepares 300L of pediatric compound amino acid injection solution. The preparation method includes the following steps:
[0077] Ingredients: Isoleucine 2.4 kg, Leucine 3.6 kg, Lysine acetate 3.3 kg, Methionine 0.99 kg, Phenylalanine 1.35 kg, Threonine 1.2 kg, Tryptophan 0.54 kg, Valine 2.25 kg, Cysteine hydrochloride 0.06 kg, Histidine 1.35 kg, Tyrosine 0.12 kg, Acetyltyrosine 0.66 kg, Alanine 1.56 kg, Arginine 3.45 kg, Proline 1.95 kg, Serine 1.05 kg, Glycine 1.02 kg, Aspartic acid 0.9 kg, Glutamic acid 1.44 kg, Taurine 0.06 kg.
[0078] Before preparation, the pipelines and containers are evacuated and filled with nitrogen to control the residual oxygen in the preparation tank to ≤0.5%.
[0079] Start the mixing tank and add low-oxygen water for injection to a total volume of 240L. Heat to above 80℃ and continuously purge with nitrogen. Before adding the ingredients, control the dissolved oxygen content of the water for injection to ≤0.5mg / L. Add isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, valine, histidine, tyrosine, acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, and taurine in sequence and stir until dissolved.
[0080] Cool to 40℃, add 500mL of glacial acetic acid to lower the pH of the drug solution, stir for 5min, then add glutoprepôse, glutamic acid and cysteine hydrochloride, stir to dissolve, add water for injection to 300L, then add glacial acetic acid to adjust the pH to 5.2 to obtain the drug solution.
[0081] The drug solution was sampled and tested for intermediates. After passing the test, it was filtered and filled into a three-layer co-extruded infusion film bag and sealed.
[0082] The samples were autoclaved at 121℃ for 12 minutes. Low-oxygen water was used for sterilization; dissolved oxygen ≤0.5 mg / L; residual oxygen in the sterilization cabinet was controlled to be ≤0.1% during the sterilization process.
[0083] The sterilized sample and oxygen absorber are placed in a barrier bag and vacuum sealed to obtain the compound amino acid injection solution.
[0084] Example 4
[0085] This embodiment prepares 300L of pediatric compound amino acid injection solution. The preparation method includes the following steps:
[0086] Ingredients: Isoleucine 2.52 kg, Leucine 4.8 kg, Lysine acetate 3.9 kg, Methionine 1.05 kg, Phenylalanine 1.5 kg, Threonine 1.32 kg, Tryptophan 0.66 kg, Valine 2.4 kg, Cysteine hydrochloride 0.084 kg, Histidine 1.5 kg, Tyrosine 0.144 kg, Acetyltyrosine 0.78 kg, Alanine 1.68 kg, Arginine 3.75 kg, Proline 2.1 kg, Serine 1.2 kg, Glycine 1.14 kg, Aspartic acid 1.02 kg, Glutamic acid 1.56 kg, Taurine 0.09 kg.
[0087] Before preparation, the pipelines and containers are evacuated and filled with nitrogen to control the residual oxygen in the preparation tank to ≤0.5%.
[0088] Start the mixing tank and add low-oxygen water for injection to a total volume of 240L. Heat to above 90℃ and continuously purge with nitrogen. Before adding the ingredients, control the dissolved oxygen content of the water for injection to ≤0.3mg / L. Add isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, valine, histidine, tyrosine, acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, and taurine in sequence and stir until dissolved.
[0089] Cool to 50℃, add 580mL of glacial acetic acid to lower the pH of the solution, stir for 5 minutes, then add glutoprepine, glutamic acid and cysteine hydrochloride, stir to dissolve, add water for injection to 300L, and then add glacial acetic acid to adjust the pH to 5.8 to obtain the solution.
[0090] The drug solution was sampled and tested for intermediates. After passing the test, it was filtered and filled into a three-layer co-extruded infusion film bag and sealed.
[0091] The samples were autoclaved at 121℃ for 12 minutes. Low-oxygen water was used for sterilization; dissolved oxygen ≤0.5 mg / L; residual oxygen in the sterilization cabinet was controlled to be ≤0.1% during the sterilization process.
[0092] The sterilized sample and oxygen absorber are placed in a barrier bag and vacuum sealed to obtain the compound amino acid injection solution.
[0093] Comparative Example 1
[0094] The formulation and preparation method of the pediatric compound amino acid injection in Comparative Example 1 are the same as those in Example 1, except that all the glacial acetic acid in Comparative Example 1 is added after the feeding is completed.
[0095] The cystine hydrochloride content in the pediatric compound amino acid injection prepared in Comparative Example 1 was detected to be 86.4%.
[0096] The cystine hydrochloride content in the example is 88.0% to 89.6%, while the content in Comparative Example 1 is 86.4%. The comparison shows that adding it in batches can increase the cystine hydrochloride content. Due to the marginal effect, when the cystine hydrochloride content is already at a high concentration, the concentration of cystine hydrochloride tends to stabilize and is difficult to increase. The 3.2% increase in Example 1 of the present invention compared to Comparative Example 1 is a significant improvement.
[0097] Comparative Example 2
[0098] The formulation and preparation method of the pediatric compound amino acid injection in Comparative Example 2 are the same as those in Example 1, except that dissolved oxygen was not controlled during the preparation and filling process of Comparative Example 2.
[0099] The cystine hydrochloride content in the pediatric compound amino acid injection prepared in Comparative Example 2 was detected to be 81.2%.
[0100] Comparative Example 3
[0101] The formulation and preparation method of the pediatric compound amino acid injection in Comparative Example 3 are the same as those in Example 1, except that residual oxygen was not controlled during the preparation and filling process of Comparative Example 3.
[0102] The cystine hydrochloride content in the pediatric compound amino acid injection prepared in Comparative Example 3 was detected to be 73.5%.
[0103] Comparative Example 4
[0104] The formulation and preparation method of the pediatric compound amino acid injection in Comparative Example 4 are the same as those in Example 1, except that the residual oxygen in the sterilization cabinet in Comparative Example 4 was not controlled.
[0105] The cystine hydrochloride content in the pediatric compound amino acid injection prepared in Comparative Example 4 was detected to be 74.9%.
[0106] Comparative Example 5
[0107] The formulation and preparation method of the pediatric compound amino acid injection in Comparative Example 5 are the same as those in Example 1. The only difference is that the dissolved oxygen in the spray water inside the sterilization chamber in Comparative Example 5 was not controlled.
[0108] The cystine hydrochloride content in the pediatric compound amino acid injection prepared in Comparative Example 5 was detected to be 84.5%.
[0109] The content of cysteine hydrochloride in the compound amino acid injections of Example 1 and Comparative Examples 1-5 is shown in Table 4.
[0110] Table 4
[0111]
[0112] As can be seen from Table 2, the cysteine hydrochloride content was the highest in Example 1, which indicates that the compound amino acid injection obtained by this method can minimize the oxidation of cysteine hydrochloride.
[0113] Comparative Example 6
[0114] The formulation and preparation method of the pediatric compound amino acid injection of Comparative Example 6 are the same as those of Example 1, the only difference being that 0.2 g / L of sodium bisulfite (antioxidant) is added when the feed is added at low temperature in Comparative Example 6.
[0115] The tryptophan-related substances in Comparative Example 6 were detected, and the results are shown in Table 5.
[0116] Table 5
[0117]
[0118] According to the data above, compared with the simultaneous preparation example 1, the levels of all impurities related to tryptophan in Comparative Example 6 were increased to varying degrees, which also increased the risk of clinical use.
[0119] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.
Claims
1. A method for preparing a pediatric compound amino acid injection, characterized in that, Includes the following steps: The pipelines and mixing tanks used for preparation were evacuated and purged with nitrogen. Add hypoxic water for injection to the preparation tank, heat, continuously purge with nitrogen, and add isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, valine, histidine, tyrosine, acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, and taurine, and stir to dissolve. Cool the preparation vessel, add glacial acetic acid, then add glutoprene, glutamic acid, and cysteine hydrochloride, stir to dissolve, add the remaining water for injection, and then add glacial acetic acid to adjust the pH value to obtain the drug solution. The drug solution was subjected to intermediate determination, filtered, filled, and sealed. The sealed liquid medicine is sterilized by heat pressing and then vacuum-sealed together with the oxygen absorber in a barrier bag.
2. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, After vacuuming and nitrogen filling, the residual oxygen in the preparation tank is ≤0.5%.
3. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, The amount of hypoxic water for injection added to the preparation tank before heating is 70-80% of the weight of hypoxic water for injection.
4. A method for preparing a pediatric compound amino acid injection according to claim 1 or 3, characterized in that, The dissolved oxygen content of the hypoxic water for injection is ≤0.5mg / L.
5. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, The heating temperature is 80–100°C.
6. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, The preparation tank is cooled to below 60°C.
7. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, The pH value of the solution is 5.2 to 5.
8.
8. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, The solution contains: per 1000ml Isoleucine 8–8.4g, leucine 12–16g, lysine acetate 11–13g, methionine 3.3–3.5g, phenylalanine 4.5–5g, threonine 4–4.4g, tryptophan 1.8–2.2g, valine 7.5–8g, cysteine hydrochloride 0.2–0.28g, histidine 4.5–5g, tyrosine 0.4–0.48g, acetyltyrosine 2.2–2.6g, alanine 5.2–5.6g, arginine 11.5–12.5g, proline 6.5–7g, serine 3.5–4g, glycine 3.4–3.8g, aspartic acid 3–3.4g, glutamic acid 4.8–5.2g, taurine 0.2–0.3g, glacial acetic acid 1.0ml–4.0ml, with the remainder being hypoxic water for injection.
9. The method for preparing a pediatric compound amino acid injection according to claim 1, characterized in that, The autoclaving conditions are: heat treatment at 121°C for 12 minutes.
10. A compound amino acid injection prepared by any one of claims 1 to 9.