Parenteral ketogenic nutrient solution and preparation method thereof

Abstract

The invention relates to a parenteral ketogenic nutrient solution and a preparation method thereof. The nutrient solution is prepared from in per 100 mL of injection water, by mass, 1.80-3.3 g of amino acid, 6.5-8.0 g of fatty substances, 0.2-0.7 g of glucose, 28.93 mg of vitamins, 327.33 mg of mineral substances, 1.32-1.49 g of an emulgator and 2.34-4.29 mmol of sodium acetate, and all the substances are dissolved in the injection water. According to the formula of the high-fat low-sugar low-amino acid nutrient solution, the nutrient solution is used for well treating intractable epilepsy andother hereditary metabolic diseases such as glucose carrier deficiency disease, pyruvate dehydrogenase deficiency disease and part of tumors and fills the gap of a parenteral ketogenic nutrient solution technology.

Description

Technical field [0001] The invention relates to a medical parenteral nutrition preparation, in particular to a ketogenic parenteral nutrition solution and a preparation method thereof. Background technique [0002] The ketogenic diet is a high-fat, low-carbohydrate diet. It was first proposed by Dr. Wilder of Mayo Clinic in 1921 and used to treat intractable epilepsy, and achieved good results (Chen Wenjie, Qin Jiong. Ketogenic diet therapy for children Research progress in the mechanism of refractory epilepsy[J]. Chinese Journal of Practical Pediatrics,2017,32(24):1912-1914.). Since then, other genetic metabolic diseases such as glucose carrier deficiency, pyruvate dehydrogenase deficiency, and some tumors (Vidali S, Aminzadeh S, Lambert B, et al. Mitochondria: the ketogenic diet-ametabolism-based therapy. Int J Biochem Cell Biol.2015;63:55-59.) and so on, have achieved good results. However, regardless of the above-mentioned patients, once gastrointestinal obstruction, intest...

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Problems solved by technology

[0006] The beneficial effects of the present invention are: the present invention is mainly used for patients who have adopted a ketogenic diet to control their diseases (such as controlling epileptic seizures) and fasting for severe gastrointestinal dysfunction (such as intestinal obstruction, active bleeding, etc.) Ordinary parenteral nutrition formulas such as high-sugar and low-fat cannot be used. The present invention can effectively maintain the blood ketone level of fasting children, avoid the onset of diseases, and ensure the total energy intake at the same time. At the same time, the present invention is a high-fat, low-sugar and low-amino acid formula, which is different from ordinary parenteral nutrition solutions with high-sugar, low-fat, and moderate amino acid formulas. For the special needs of energy-supplying nutrients, the ratio of fat emulsion in the parenteral nutrition formula is increased, the ratio of amino acids and glucose is reduced, and the requirements of vitamins and minerals are determined. It is safe and effective to use in children, and can maintain the blood of patients after infusion. Ketones are in the ideal range, blood sugar is also in the normal range, and it does not induce seizures in patients (or induce hyperlactatemia in patients with abnormal glucose metabolism), effectively solving the nutritional needs of patients taking a ketogenic diet during fasting; the fat in this formula Similar substances can prevent hyperlipidemia, liver damage, cholestasis, and reduce the adverse reactions of high-fat formula as much as possible; vitamin B is strengthened in the formula 2 , niacin, and pantothenic acid can speed up fat β-oxidation and further reduce the possibility of fat overload; the osmotic pressure of the parenteral nutrition formula is less than 600mOsm / L, which is within the tolerance range of peripheral veins (900mOsm / L), The patient feels less pain during infusion, and it is not easy to cause vasculitis; the glucose is the glucose in the medical glucose solution, a small amount of glucose solution can balance fat metabolism, does not affect ketone production, and at the same time reduces the probability of hypoglycemia; emulsifier Make fatty substances absorbable form; the role of minerals is to maintain the normal physiological functions of the human body; the role of amino acids to ensure children's demand for essential amino acids and avoid negative nitrogen balance; sodium acetate is the mode of existence of anhydrous acetic acid in the final solution , anhydrous acetic acid is to stabilize the pH of the ketogenic nutrient solution within the acceptable range of the human body and ensure the safety of infusion

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