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Fat-soluble composite vitamin I composition freeze-dried powder injection and preparation method thereof

A technology for compound vitamins and freeze-dried powder injections, which is applied in freeze-dried delivery, drug combination, powder delivery, etc. It can solve the problems of difficulty in fully grasping the interaction, difficulty in meeting expectations, and decrease in drug content, so as to achieve the goal of being suitable for large-scale production, Reduce production costs, use the effect of safety

Active Publication Date: 2013-05-08
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, after studying the above-mentioned patents, the inventor believes that the dissolution of these preparations is not good, and the content of related substances is still relatively high after long-term storage, which is easily affected by the environment and causes a decline in drug content, especially in the hereinafter described In the comparative test, the inventors found that after long-term storage, the products described in the above two documents did not reach the qualified standards in the two tests of visible foreign matter and insoluble particles. It can be seen that only polysorbate 80 and mannitol The preparation of fat-soluble vitamin injections is difficult to achieve the intended purpose in terms of safety and effectiveness
However, other related patents add a wide variety of additives, which not only increases the cost, but also makes quality control difficult, and it is difficult to fully grasp the interaction between the components.

Method used

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  • Fat-soluble composite vitamin I composition freeze-dried powder injection and preparation method thereof
  • Fat-soluble composite vitamin I composition freeze-dried powder injection and preparation method thereof
  • Fat-soluble composite vitamin I composition freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Raw material composition:

[0022]

[0023] Preparation method: Weigh mannitol, add appropriate amount of water, heat to dissolve, cool, and set aside; weigh povidone, propyl perate, vitamin A palmitate, vitamin K 1 , vitamin E, vitamin D 2 and polysorbate 80, mix well, add water to dissolve, add to the mannitol solution, check the pH value of the liquid (if necessary, use sodium hydroxide or hydrochloric acid solution to adjust the pH value to 6.5-9.0), add water for injection to the full amount, Add 0.01% (g / ml) gac, at room temperature, stir for 30 minutes, filter with a titanium filter stick, filter with a 0.22 μm microporous membrane, and carry out semi-finished product inspection to the gained clear filtrate; Pack; press half the stopper, place in a freeze-drying box, cool down to -40°C, keep warm for 4 hours, turn on the vacuum pump, sublimate and dry, heat up to 30°C and then dry, fill the freeze-drying box with nitrogen, press the stopper, Capping, packagi...

Embodiment 2

[0024] Embodiment 2: Stability and safety test

[0025] Table 1 Accelerated test results

[0026]

[0027] Table 2 Room temperature test results

[0028]

Embodiment 3

[0029] Embodiment 3 and the contrast of prior art

[0030] The present inventor has compared the preparation of the present invention with the preparations of CN102358081 and CN1903207, that is, the product of their embodiment 1 and the product of the embodiment 1 of the present invention are tested as described in embodiment 2, and the results show that the embodiment of the present invention 1 Product in Vitamin A Palmitate, Vitamin K 1 , vitamin E, vitamin D 2 Content aspect is equivalent or better (not listed in the table) with the product of above-mentioned two kinds of patents, especially after long-term storage i.e. room temperature test 12 months, the preparation of CN102358081, CN1903207 (the following table is referred to as contrast 1 and contrast respectively 2) The detection of visible foreign matter and insoluble particles after reconstitution showed that it was unqualified. This is the biggest difference between it and the product of the present invention. Th...

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Abstract

The invention discloses a fat-soluble composite vitamin I composition freeze-dried powder injection. The fat-soluble composite vitamin I composition freeze-dried powder injection is safe and reliable, has stable quality and is prepared from vitamin A palmitate, vitamin K1, vitamin E, vitamin D2, povidone, propyl gallate, polysorbate 80, mannitol and injection water. The fat-soluble composite vitamin I composition freeze-dried powder injection and the preparation method thereof thoroughly solve that the existing fat-soluble composite vitamin freeze-dried powder injection can not be stored for a long time and the content of related substances is very high and can not be controlled so that injection safety problems and active substance degradation problems are caused. In the clinical use, the fat-soluble composite vitamin I composition freeze-dried powder injection is safe, has stable quality and can be stored for a long time.

Description

technical field [0001] The invention relates to a fat-soluble compound vitamin I composition, a freeze-dried powder 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; only a small amount can meet the needs; generally cannot be synthesized by their own assimilation in the human body; some of them participate in the form of coenzymes or coenzyme precursors The role of the enzyme system. The normal human body can obtain the vitamins needed by the human body through food. Burns, surgery, severe trauma, infection, etc. may cause hypermetabolism and iatrogenic hunger or starvation, which will lead to malnutrition in the human body, including vitamin deficiency, and the nutritional status h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/592A61K31/355A61K31/23A61K31/122A61K47/32A61K9/19A61P3/02
Inventor 宁辉
Owner REYOUNG PHARMA
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