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Production and preparation method of compound amino acid (15) dipeptide (2) injection
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A compound amino acid and injection technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of easily exceeding the standard of oxidative degradation impurities, exceeding the standard of aluminum salt, and the decrease of product light transmittance And other issues
Active Publication Date: 2021-09-14
SICHUAN KELUN PHARMA CO LTD
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Embodiment 1
[0035] This example provides a production and preparation method of compound amino acid (15) dipeptide (2) injection, and prepares 10L of compound amino acid (15) dipeptide (2) injection. The specific steps are as follows:
[0038] Lower the temperature of the liquid medicine to 60°C, and add glutamic a...
Embodiment 2
[0047] This example provides a production and preparation method of compound amino acid (15) dipeptide (2) injection, and prepares 2500L compound amino acid (15) dipeptide (2) injection. The specific steps are as follows:
[0049] Preparation: Add 1850L of water for injection into the preparation tank, continuously fill with nitrogen, and heat to 80°C. Adopt airtight feeding tank, input citric acid (0.25g / L), leucine, valine, threonine, tryptophan, arginine, alanine, isoleucine, phenylalanine, Methionine, lysine acetate, histidine, proline, serine, aspartic acid, stirred to ...
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Abstract
The invention discloses a production and preparation method of a compound amino acid (15) dipeptide (2) injection. The method comprises the following steps of adding water for injection to 70-80% of the total amount, continuously charging nitrogen, and heating to 80 DEG C or above; carrying out feeding by adopting a closed feeding tank, firstly, feeding citric acid, leucine, valine, threonine, tryptophan, arginine, alanine, isoleucine, phenylalanine, methionine, lysine acetate, histidine, proline, serine and aspartic acid, and stirring for dissolving; cooling to 60 DEG C or below, and adding glutamic acid, glycyl glutamyl and glycyl tyrosine; stirring for dissolving, adding water for injection to the full amount, and adding citric acid to adjust the pH value to 5.5-6.0; filling a three-layer co-extrusion infusion film bag with chemical liquid, and carrying out sealing; carrying out hot-pressing sterilization and packaging on a filled sample; and controlling the dissolved oxygen amount and residual oxygen amount of the chemical liquid in the preparation process. According to the invention, the quality stability of the product in the effective period and the safety of clinical medication can be ensured.
Description
technical field [0001] The invention relates to the technical field of medicine, in particular to the technical field of parenteral nutrition preparations, and more specifically to a production and preparation method of compound amino acid (15) dipeptide (2) injection. Background technique [0002] Compound Amino Acid (15) Dipeptide (2) Injection is a parenteral nutritiondrug, suitable for patients who cannot be given oral or enteral nutrition, and those who cannot meet their needs through these ways of supplementing nutrition, especially for moderate to severecatabolism condition of patients. [0003] This product was developed by Fresenius Kabi, and its product name is Glamin (Gu Anguang). It was approved in May 1995 and is available in Germany, Switzerland, Sweden, Finland, Denmark, and Austria. It was first approved for import registration in China in April 2004. [0004] However, the original research products may have problems such as excessive aluminum salts, oxid...
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