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Preparation method of vitamin complex freeze-dried powder injection

A technology for multivitamins and vitamins, which is applied in the directions of freeze-drying delivery, medical preparations containing active ingredients, powder delivery, etc. Good stability, plump appearance and quick reconstitution effect

Inactive Publication Date: 2012-05-23
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the multivitamin freeze-dried preparation prepared by current method has poor clarity and slow redissolving speed

Method used

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  • Preparation method of vitamin complex freeze-dried powder injection
  • Preparation method of vitamin complex freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] craft prescription

[0033] Vitamin C 260mg

[0034] Vitamin A (acetate) 3800IU

[0035] Vitamin D 2 160IU

[0036] Vitamin B 1 8mg

[0037] Riboflavin Sodium Phosphate 2mg

[0038] Vitamin B 6 4mg

[0039] Niacinamide 30mg

[0040] Dexpanthenol 25mg

[0041] Vitamin E 20IU

[0042] Folic Acid 10mg

[0043] Biotin 70μg

[0044] Vitamin B 12 8μg

[0045] Polysorbate 80 60g

[0046] Water for injection 2000ml

[0047] Made 400

[0048] The preparation process is as follows:

[0049] Preprocessing:

[0050] The antibiotic glass bottles, rubber stoppers, aluminum caps, funnels, containers for liquid preparation and microporous membranes used in the preparation were routinely washed and aseptically treated. Weigh the prescribed amount of vitamin A, vitamin D 2 , vitamin E, add polysorbate 80 of prescription quantity, stir and dissolve, add the water for injection of 40% of prescription quantity, stir and dissolve...

Embodiment 2

[0055] Process prescription:

[0056] Vitamin C 200mg

[0057] Vitamin A (acetate) 3300IU

[0058] Vitamin D 2 200IU

[0059] Vitamin B 1 6.0mg

[0060] Riboflavin Sodium Phosphate 3.6mg

[0061] Vitamin B 6 6.0mg

[0062] Niacinamide 40mg

[0063] Dexpanthenol 15mg

[0064] Vitamin E 10IU

[0065] Folic Acid 6mg

[0066] Biotin 60μg

[0067] Vitamin B 12 5μg

[0068] Polysorbate 80 70g

[0069] Water for injection 2000ml

[0070] Prepare 400 bottles

[0071] The preparation process is as follows:

[0072] Preprocessing:

[0073] The antibiotic glass bottles, rubber stoppers, aluminum caps, funnels, containers for liquid preparation and microporous membranes used in the preparation were routinely washed and aseptically treated. Weigh the prescribed amount of vitamin A, vitamin D 2 , vitamin E, add polysorbate 80 of prescription quantity, stir and dissolve, add the water for injection of 40% of pr...

Embodiment 3

[0083] Embodiment 3 product quality investigation:

[0084] Under the conditions of 50℃±3℃, relative humidity 75%±5% and 25℃±3℃; relative humidity 60%±10%, the accelerated test is carried out.

[0085] The results are detailed in Table 1.

[0086] Table 1 (clarity > No. 2 unqualified)

[0087] Clarity

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Abstract

The invention discloses a preparation method of a vitamin complex freeze-dried powder injection. The method comprises the following steps of: weighing 12 types of vitamins; adding a part of principle medicaments into polysorbate 80, stirring for dissolving, adding 40 percent water for injection and stirring for dissolving; adding the remaining principle medicaments into the solution, stirring fordissolving and replenishing water for injection to 80 percent of the total amount of the water for injection; measuring the pH of the solution and filtering by using a filter membrane; pre-freezing, namely, lowering the temperature of the injection to 15 DEG C below zero and oscillating and refrigerating at the temperature of between 6 DEG C below zero and 15 DEG C below zero; lowering the temperature to 33 DEG C below zero and 35 DEG C below zero and oscillating and refrigerating at the temperature of between 25 DEG C below zero and 35 DEG C below zero for 40 to 60 minutes; performing sublimation drying; drying once again; and gradually raising the temperature of a medicament to 40 DEG C and preserving heat for 1 to 2 hours. A product prepared by the method has full appearance, looseness, high dissolubility, quick re-dissolution, high clarity and high stability.

Description

technical field [0001] The invention relates to a method for preparing medicines. Specifically, it relates to a preparation method of compound vitamin freeze-dried powder for injection. Background technique [0002] Vitamins are a large group of indispensable nutrients in people's diet. They are a group of organic compounds that cannot be synthesized in the human body and must be obtained from food. Although the human body needs very little, it is indispensable for maintaining the normal progress of metabolism. Deficiency of any one vitamin will inevitably lead to a series of characteristic symptoms. [0003] Vitamins are divided into fat-soluble and water-soluble according to their solubility characteristics. The fat-soluble vitamins are A, D, E, and K, and the water-soluble vitamins are B 1 , B 2 , B 6 , B 12 , biotin, folic acid and vitamin C. In recent years, more and more experimental data have shown that although the human body's requirement for vitamins is ver...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/714A61K31/675A61K31/592A61K31/519A61K31/51A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/355A61K31/164A61K31/07A61K9/19A61P3/02
Inventor 路玉锋王志良刘书睿赵霞
Owner NORTH CHINA PHARMA COMPANY