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Composite fat-soluble vitamin freeze-dried powder injection and preparation method thereof

A technology for freeze-dried powder injections and vitamins, which is applied in freeze-dried delivery, powder delivery, drug combination, etc. It can solve the problems of drug effectiveness and safety, unreasonable prescription and preparation process, and unqualified foreign matter detection. To achieve the effects of enhanced effectiveness and safety, light weight and stable product quality

Inactive Publication Date: 2012-02-22
河北智同医药控股集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, injections for supplementing fat-soluble vitamins mainly include water injections and freeze-dried powder injections. Due to the extreme instability of vitamins, powder injections can make the drugs more stable, but the actual commercially available compound fat-soluble vitamins Preparations often have unreasonable prescriptions and preparation processes, and contain many excipients. For example, glycerin, lecithin, soybean oil, ethanol, etc. are mixed as co-solvents in marketed products, and the dissolution situation is not ideal, resulting in the detection of visible foreign matter Unqualified; and when the ambient temperature and humidity increase during storage and transportation, the active ingredients, especially vitamin D 2 The content of the drug can easily decrease, forming ineffective or even harmful degradation products, which will seriously affect the effectiveness and safety of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0025] Prescription (prepared 1000 bottles):

[0026] Vitamin A 3.3 million IU, Vitamin E 10,000 IU, Vitamin K 1 150mg, Vitamin D 2 200,000 IU, polysorbate-80 50mg, mannitol 120mg, the balance is water for injection.

[0027] Preparation:

[0028] ①Weigh unit doses of vitamin A, vitamin E, and vitamin K 1 , add 42g of polysorbate-80, stir and dissolve to obtain solution A; weigh the unit dose of vitamin D 2 , add 8g (remaining amount of the prescription) of polysorbate-80, and ultrasonically dissolve while stirring to obtain solution B; combine solution A and solution B, stir the above mixture with a glass rod, make the mixture evenly add water for injection to 40% of the total amount , stir evenly to obtain solution C;

[0029] ② Weigh 120g of mannitol and add 40% of the total volume of water for injection at room temperature to prepare the total volume, stir to dissolve, add to the above solution C, and stir until completely dissolved;

[0030] ③Measure PH, adjust to...

preparation Embodiment 2

[0034] Prescription (prepared 1000 bottles):

[0035] Vitamin A 3.3 million IU, Vitamin E 10,000 IU, Vitamin K 1 150mg, Vitamin D 2 200,000 IU, polysorbate-80 50mg, mannitol 150mg, the balance is water for injection.

[0036] Preparation:

[0037] ①Weigh unit doses of vitamin A, vitamin E, and vitamin K 1 , add 43g of polysorbate-80, stir and dissolve to obtain solution A; weigh the unit dose of vitamin D 2 , add 7g (remaining amount of the prescription) of polysorbate-80, and ultrasonically dissolve while stirring to obtain solution B; combine solution A and solution B, stir the above mixture with a glass rod, make the mixture evenly add water for injection to 40% of the total amount , stir evenly to obtain solution C;

[0038] ②Weigh 150g of mannitol and add 40% of the total volume of water for injection at room temperature to prepare the total volume, stir to dissolve, add to the above solution C, and stir until completely dissolved;

[0039] ③Measure PH, adjust to ...

preparation Embodiment 3

[0043] Prescription (prepared 1000 bottles):

[0044] Vitamin A 3.3 million IU, Vitamin E 10,000 IU, Vitamin K 1 150mg, Vitamin D 2200,000 IU, polysorbate-80 50mg, mannitol 180mg, the balance is water for injection.

[0045] Preparation:

[0046] ①Weigh unit doses of vitamin A, vitamin E, and vitamin K 1 , add 44g of polysorbate-80, stir and dissolve to obtain solution A; weigh the unit dose of vitamin D 2 , add 6g (the remaining amount of the prescription) of polysorbate-80, and ultrasonically dissolve while stirring to obtain solution B; combine solution A and solution B, stir the above mixture with a glass rod, make the mixture evenly add water for injection to 40% of the total amount , stir evenly to obtain solution C;

[0047] ② Weigh 180g of mannitol and add 40% of the total volume of water for injection at room temperature to prepare the total volume, stir to dissolve, add to the above solution C, and stir until completely dissolved;

[0048] ③Measure PH, adjust ...

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Abstract

The invention discloses a preparation method of a composite fat-soluble vitamin freeze-dried powder injection. The preparation method comprises the following steps of: firstly, respectively adding fat-soluble vitamins A, E, K and D2 to polysorbate-80 to form two groups of micelle, and dissolving and mixing the two groups of micelle; secondly, adding water for injection, mixing with a mannitol aqueous solution, adding active carbon for adsorption, and regulating pH value; finally, filtering, bottling, freeze-drying, cover-pressing and sealing to obtain the finished freeze-dried powder injection product, wherein each 3.5 ml of freeze-dried powder injection solution contain 2970-3960 IU of vitamin A, 9-11 IU of vitamin E, 1135-180 ug of vitamin K, 2180-240 IU of vitamin D2, 50 mg of polysorbate-80, 120-180 mg of mannitol and the balance of water for injection. According to the invention, the composite fat-soluble vitamin freeze-dried powder injection and the preparation method thereof have the advantages of little auxiliary materials, simple preparation process, low production cost, safe and reliable quality and convenience for storage and transportation and the like.

Description

technical field [0001] The invention relates to a vitamin preparation and a preparation method thereof, in particular to a preparation method of a compound fat-soluble vitamin freeze-dried powder injection. Background technique [0002] Parenteral nutrition (PN) is widely used in the treatment of various diseases and the nutritional support of patients during surgery. Vitamins, as an important cofactor of metabolism, are the main components of parenteral nutrition. Clinically, it is mainly used for patients who cannot eat due to surgery, large area burns, fractures and other traumas, severe infections and coma, and need parenteral nutrition. [0003] At present, injections for supplementing fat-soluble vitamins mainly include water injections and freeze-dried powder injections. Due to the extreme instability of vitamins, powder injections can make the drugs more stable, but the actual commercially available compound fat-soluble vitamins Preparations often have unreasonable ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/592A61K47/26A61P3/02A61K31/355A61K31/07A61K31/122
Inventor 齐兴忠任保华侯磊刘衡张敏
Owner 河北智同医药控股集团有限公司
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