Stable composite fat-soluble vitamin composition and preparation method thereof

Abstract

The invention relates to a stable composite fat-soluble vitamin composition and an injection and a preparation method thereof. The composition comprises vitamin A palmitate or analogue thereof, vitamin E or analogue thereof, vitamin K1 or analogue thereof, vitamin D2 and medically acceptable adjuvants, wherein the medically acceptable adjuvants comprise an acidity buffering agent. The injection is prepared by using aseptic filtration and an aseptic production process or a freeze drying process. Compared to the prior art, the composition provided in the invention has better stability and makes substantial progress.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an aqueous solution for preparing a stable compound fat-soluble vitamin composition, a compound fat-soluble vitamin composition injection and a preparation method thereof. Background technique [0002] Vitamins are a kind of trace organic substances necessary to maintain human life activities, and also important active substances to maintain human health. The difference between vitamins and other nutrients is that they neither supply energy nor constitute body tissues, and only a small amount can meet the needs. Generally, they cannot be synthesized by their own assimilation in the human body, and some of them participate in the form of coenzymes or coenzyme precursors. The role of the enzyme system. A normal human body can obtain the vitamins needed by the human body through food. Burns, surgery, severe trauma, infection, etc. may cause hypermetabolism and...

AI Technical Summary

Problems solved by technology

[0006] Existing technologies have shown that most of the vitamin components are unstable in physical and chemical properties, and are sensitive to light, heat, oxygen, metal ions, acidity, etc., and their storage conditions are often more stringent. For example, vitamin D requires protection from light, sealing, nitrogen filling, and cooling storage, and vitamin D 2 not as good as vitamin D 3 Stable, more prone to degradation

[0007] Some literatures have reported some methods for improving drug stability. In order to prepare stable and reliable multivitamin injections, solving its stability and solubility is the main means. The fat-soluble vitamin injections on the market use soybean oil and lecithin as excipients. prepared into a stable emulsion and stored in a cold place (2-10°C); fat-soluble vitamins for injection use polysorbate 80 as a cosolvent; CN200510029352.0 discloses a soybean lecithin and sodium cholate Freeze-dried preparations of fat-soluble vitamins as auxiliary materials, but do not provide their stability data; CN200510085714.8 discloses a fat-soluble vitamin preparation and preparation method, using polysorbate as a co-solvent, its stability data can be seen, its freeze-dried The dry preparation is still unstable; CN200610054218.0 discloses the development of a fat-soluble vitamin and compound 13 kinds of vitamin freeze-dried preparations using phospholipids and cholate as cosolvents, and the stability of the main drug is better than the samples prepared by conventional prescriptions at present; .6 discloses a method for preparing a compound recipe of 13 vitamins, the cosolvent is polysorbate, and the main drug contains vitamin D 2 , from its stability data, vitamin D 2 The stability is not ideal yet; CN200810223046.4 discloses a kind of with polysorbate 80, polysorbate 20, mannitol, glycine as excipient, with ethanol, cysteine ​​hydrochloride, sodium bisulfite as stabilizer The fat-soluble vitamin lyophilized preparation, its stability data shows that its main drug has good stability; CN200910089635.2 discloses the influence of polysorbate and product moisture on the stability of the fat-soluble vitamin main drug for injection, and its stability data is 5 Stored at ℃, the stability is good, but the stability at room temperature or 40 ℃ is unknown; CN200910130919.1 discloses a kind of polysorbate 80, mannitol as auxiliary materials, dibutyl hydroxytoluene, p-hydroxy tert-butyl One or more of anisole, propyl gallate, and ascorbyl palmitate are used as stabilizers to make fat-soluble vitamin freeze-dried preparations. As can be seen from the stability test data of CN200910130919.1, the freeze-dried preparations are still unstable

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