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Composite vitamin for injection and preparation method thereof

A compound vitamin and injection technology, applied in the field of injection vitamins and their preparation, can solve problems such as limitation and freeze-drying equipment damage, and achieve the effects of good stability, good stability, and small frozen crystals.

Inactive Publication Date: 2010-01-27
邓盛齐 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there has been a patent disclosure about compound vitamins in China. The patent name is "a compound vitamin freeze-dried powder injection and its preparation method", and the application number is: 200510029352.0. During the freeze-drying process, it will cause damage to the freeze-drying equipment, which will definitely limit the practical application of this patent

Method used

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  • Composite vitamin for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027] Vitamin A Palmitate 2125,000 units

[0028] Vitamin D2 170,000 units

[0029] Vitamin E 12.75g

[0030] Vitamin K1 1.7g

[0031] Tween-80 50g

[0032] p-Hydroxy-tert-butylanisole 0.01g

[0033] Ascorbyl Palmitate 0.01g

[0034] Mannitol 100g

[0035] Appropriate amount of water for injection

[0036] Full volume 2000ml

[0037]

[0038] Makes 1000 bottles

[0039] Avoid light operation. Weigh vitamin A palmitate, vitamin D2, vitamin E, vitamin K1, p-hydroxy tert-butyl anisole and ascorbyl palmitate according to the prescribed amount, stir at 60°C to dissolve, and set aside. Add Tween-80 to the above mixture and stir to mix well. Slowly add 1600ml of water for injection preheated to 60°C, and stir while adding. Add the prescribed amount of mannitol into the above solution, stir to dissolve completely, and set aside. Adjust the pH to 5.5 with 0.1 mol / NaOH solution. Add activated carbon for needles ac...

Embodiment 2

[0042] prescription:

[0043] Vitamin A Palmitate 2500,000 units

[0044] Vitamin D2 200,000 units

[0045] Vitamin E 15g

[0046] Vitamin K1 2g

[0047] Tween-80 100g

[0048] Dibutylhydroxytoluene 0.04g

[0049] Mannitol 100g

[0050] Appropriate amount of water for injection

[0051] Full volume 2000ml

[0052]

[0053] Makes 1000 bottles

[0054] Avoid light operation. Weigh vitamin A palmitate, vitamin D2, vitamin E, vitamin K1 and dibutyl hydroxytoluene according to the prescription amount, stir at 70°C to dissolve, and set aside. Add Tween-80 to the above mixture and stir to mix well. Slowly add 1600ml of water for injection preheated to 70°C, and stir while adding. Add the prescribed amount of mannitol into the above solution, stir to dissolve completely, and set aside. Adjust the pH to 6.0 with 0.1 mol / NaOH solution. Add activated carbon for needles according to 0.01% of the liquid volume, stir at 60°C for 15 minutes, ...

Embodiment 3

[0057] prescription:

[0058] Vitamin A Palmitate 3125,000 units

[0059] Vitamin D2 250,000 units

[0060]Vitamin E 18.75g

[0061] Vitamin K1 2.5g

[0062] Tween-80 150g

[0063] Propyl gallate 0.06g

[0064] Mannitol 80g

[0065] Appropriate amount of water for injection

[0066] Full volume 2000ml

[0067]

[0068] Makes 1000 bottles

[0069] Avoid light operation. Weigh vitamin A palmitate, vitamin D2, vitamin E, vitamin K1 and propyl gallate according to the prescription, stir at 80°C to dissolve, and set aside. Add Tween-80 to the above mixture and stir to mix well. Slowly add 1600ml of water for injection preheated to 80°C, and stir while adding. Add the prescribed amount of mannitol into the above solution, stir to dissolve completely, and set aside. Adjust the pH to 7.0 with 0.1 mol / potassium hydroxide solution. Add activated carbon for needles according to 0.01% of the liquid volume, stir at 60°C for 10 minutes, and f...

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Abstract

The invention provides a composite vitamin for injection and a preparation method thereof, in particular to a composite vitamin (4) refrigerating and drying preparation for injection, which contains vitamin A palmitate, vitamin D2, vitamin E, vitamin K1, tween-80, a stabilizing agent, a proppant, and a pH regulator. Products prepared by the formulation composition and the preparation process have good appearance, fine freeze crystal, short redissolution time and good stabilization. The hemolysis test, rabbit marginal vein infusion stimulation test, systemic anaphylaxis test of the composite vitamin (4) for injection all meet the safety requirements of injecting.

Description

Technical field: [0001] The invention relates to a vitamin for injection and a preparation method thereof, in particular to a freeze-dried preparation of compound vitamins for injection and a preparation method thereof. technical background: [0002] Vitamin A: It is an essential ingredient for promoting growth, maintaining the visual function of the retina, and maintaining the stability of normal cell membranes. If it is deficient, the body will stop growing, night blindness, dry eyeballs and corneal softening. Vitamin D 2 : Form bone tissue, increase the absorption of calcium and phosphorus, and osteomalacia will occur after deficiency. Vitamin E: Anti-oxidation of cell membranes, as an oxygen free radical scavenger, the lack of red blood cell destruction and hemolysis, skeletal muscle and myocardial degeneration. Vitamin K 1 : It can form prothrombin, maintain normal blood coagulation function, and cause prothrombin deficiency bleeding when lacking. [0003] Compound ...

Claims

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Application Information

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IPC IPC(8): A61K31/592A61K31/355A61K31/07A61K31/122A61K9/19A61J3/00A61P3/02
Inventor 邓盛齐王俊雄
Owner 邓盛齐
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