A kind of multivitamin parenteral nutrition nanosphere freeze-dried injection and preparation method thereof

Abstract

The invention discloses a multi-vitamin parenteral nutrition nanosphere freeze-dried injection, which is composed of 13 kinds of vitamins, medium-chain triglycerides, soybean lecithin, 15-hydroxystearic acid polyethylene glycol ester, glycerin , mannitol and water, wherein the mass ratio of soybean lecithin to polyethylene glycol 15-hydroxystearate is 1: (1.4-4); medium-chain triglycerides, soybean lecithin and 15-hydroxystearate The mass ratio of the total weight of polyethylene glycol stearate is 1: (1-4). In the present invention, fat-soluble vitamins are made into a lipid nanosphere solution, which can be co-dissolved with water-soluble vitamin solutions, and the problem of co-dissolution of fat-soluble vitamins and water-soluble vitamins is solved in an ingenious way. The multivitamin parenteral nutrition nanosphere freeze-dried finished product of the present invention is a clear and transparent liquid after reconstitution with water, and can be diluted with infinite aqueous solution. The product of the present invention has high safety, high quality, good stability, and easy operation of the production process. , low production cost.

Description

technical field [0001] The invention relates to a multivitamin parenteral nutrition agent nanosphere freeze-dried injection and a preparation method thereof. Background technique [0002] Vitamins are one of the essential nutrients for the human body, and can be divided into water-soluble vitamins and fat-soluble vitamins according to their solubility in aqueous solution. The main water-soluble vitamins are: thiamine (vitamin B 1 ), riboflavin (vitamin B 2 ), nicotinic acid (vitamin PP, niacin, nicotinamide), pyridoxine (vitamin B 6 ), cyanocobalamin (vitamin B 12 ), folic acid, pantothenic acid, biotin, ascorbic acid (vitamin C), etc., are easily soluble in water and can hardly be stored in the body. Fat-soluble vitamins mainly include vitamins A, D, E and K. As one of the necessary nutrients for the human body, all vitamins are contained in a small amount in the body, but they play an important role in the body's metabolism, growth, and development. The common charac...

AI Technical Summary

Problems solved by technology

The disadvantages of these two benefits are: ① Tween 80 co-solvent has certain toxicity, which affects the safety of injection; ② antioxidants are added in the prescription, which is not conducive to the safety of injection; ③ 2 sticks, high production cost, and easy clinical preparation and use cause secondary pollution

④ Injection, inconvenient to transport and store

[0012] 1. Fat-soluble vitamins are insoluble in water and difficult to dissolve with water-soluble vitamins;

[0013] 2. The resulting product has poor stability;

[0014] 3. The traditional method of preparing 13 kinds of multivitamins uses Tween-like solubilizers, which are highly toxic, and the antioxidants and preservatives used at the same time also have certain toxic and side effects;

[0015] 4. The osmotic pressure of the existing 13 kinds of multivitamin injections is not isotonic, which is easy to cause hemolysis;

[0016] 5. The injections of 13 kinds of multivitamins that are already on the market are packed in 2 bottles, and the clinical preparation may easily cause the risk of re-contamination;

[0017] 6. The current 13 multivitamin preparations require frozen storage, which is not conducive to storage and transportation

However, Tween-type cosolvents have certain toxic and side effects. In order to improve the stability of vitamins, antioxidants are usually added, but antioxidants also have certain toxic and side effects.

Among the disclosed microsphere patent technical solutions for 13 kinds of vitamin injections, all belong to submicroemulsion or microemulsion technology, and belong to the category of ordinary emulsion. The oil phase of the emulsion prescription basically uses long-chain triglycerides including soybean oil, emulsified Phospholipid-based emulsifiers are used as emulsifiers, and the particle size of the final emulsion is generally above 150nm, usually in the range of 200-500nm. Because the pore size of the sterile filtration membrane is 0.22μm, it cannot meet the requirements of sterile filtration for injections

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