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Preparation method of vitamin complex freeze-dried powder injection

A technology for compound vitamins and vitamins, which is applied in the direction of freeze-drying transportation, medical preparations containing active ingredients, powder transportation, etc. It can solve the problems of slow reconstitution speed and poor clarity of compound vitamin freeze-dried preparations, and achieve full appearance, Good clarity and stability, quick reconstitution

Inactive Publication Date: 2011-04-20
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
  • Preparation method of vitamin complex freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] craft prescription

[0022]

[0023] The preparation process is as follows:

[0024] Preprocessing:

[0025] 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; Take the vitamin C of prescription quantity, vitamin B 1 , riboflavin sodium phosphate, vitamin B 6 , Niacinamide, Dexpanthenol, Folic Acid, Biotin, Vitamin B 12 Add to the above solution, stir to dissolve, add water for injection to 80% of the total amount, measure the pH of the solution, adjust the pH value of the solution with 2mol / L sodium hydroxide between 5.5 and 6.5, and then add water for injection to the total volume, Add 0.05% activated car...

Embodiment 2

[0030]

[0031] The preparation process is as follows:

[0032] Preprocessing:

[0033] 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; Take the vitamin C of prescription quantity, vitamin B 1 , riboflavin sodium phosphate, vitamin B 6 , Niacinamide, Dexpanthenol, Folic Acid, Biotin, Vitamin B 12 Add to the above solution, stir to dissolve, add water for injection to 80% of the total amount, measure the pH of the solution, adjust the pH value of the solution with 2mol / L sodium hydroxide between 5.5 and 6.5, and then add water for injection to the total volume, Add 0.05% activated carbon to the liquid medicine, s...

Embodiment 3

[0043] Embodiment 3 product quality investigation:

[0044] Under the conditions of 50℃±3℃, relative humidity 75%±5% and 25℃±3℃; relative humidity 60%±10%, the accelerated test is carried out.

[0045] The results are detailed in Table 1.

[0046] Table 1 (clarity > No. 2 unqualified)

[0047]

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PUM

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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 for dissolving 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 Applications(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
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