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Stable freeze-dried formulation containing multiple kinds of vitamin and its preparation method

A technology for freeze-dried preparations and vitamins, which is applied in the field of pharmaceutical preparations and can solve the problems of unsafe human body and poor stability.

Inactive Publication Date: 2006-10-11
CHONGQING PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Fat emulsion for injection containing four fat-soluble vitamins has been marketed at home and abroad, but it is a fat emulsion rather than a transparent solution, and its stability is poor
The thirteen vitamins M.V.I.-pediatricd, M.V.I.-Adult, Infuvite-pediatic, and Infuvite-Adult preparations listed in the United States contain four fat-soluble vitamins, but the solubilizers for the four fat-soluble vitamins are Tween-80 and Tween-20 , among which M.V.I.-Adult, Infuvite-pediatic, Infuvite-Adult also contains exogenous substances such as propylene glycol, which is suspected to be unsafe for human body

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: Four kinds of fat-soluble vitamins for injection (glycocholic acid and soybean lecithin are used as solubilizers)

[0052] prescription:

[0053] Vitamin A (Vitamin A Palmitate) 3,300,000 IU

[0054] Vitamin D 2 200,000 IU

[0055] Vitamin E 10,000 IU

[0056] Vitamin K 1 0.15g

[0057] Glycocholic Acid 140g

[0058] Soy Lecithin 112.5g

[0059] Glycine 250g

[0060] Sodium hydroxide solution, hydrochloric acid solution to adjust the pH to 5.9

[0061] 1000 bottles

[0062] Preparation method: weigh vitamin A palmitate, vitamin E, and vitamin K in prescribed quantities 1 and vitamin D 2 Dissolved with 50ml of ethanol to obtain solution 1; take the prescribed amount of glycocholic acid, dissolve it with water for injection, and adjust the pH to 5.8-6.0 with 4mol / L sodium hydroxide solution and 0.1mol / L hydrochloric acid solution to obtain solution 2. Add the prescription amount of...

Embodiment 2

[0078] Vitamin A (Vitamin A Palmitate) 3,300,000 IU

[0079] Vitamin D 3 200,000 IU

[0080] Vitamin E 10,000 IU

[0081] Vitamin K 1 0.15g

[0082] Vitamin C 200.00g

[0083] Thiamine Hydrochloride 6.73g

[0084] Equivalent to Thiamin 6.00g

[0085] Riboflavin Sodium Phosphate 4.92g

[0086] Equivalent to Vitamin B 2 (Riboflavin) 3.6g

[0087] Vitamin B 6 6.00g

[0088] Niacinamide 40.00g

[0089] Panthenol 15.00g

[0090] Glycine 250.00g

[0091] Glycocholic acid 140.00g

[0092] Soy Lecithin 112.50g

[0093] Sodium hydroxide solution, hydrochloric acid Adjust to pH5.9

[0094] 1000 bottles

[0095] Preparation method: Weigh soybean lecithin, vitamin A palmitate, vitamin E, and vitamin K for injection in prescription quantities 1 and vitamin D 3 Dissolve in 60ml of ethanol to obtain solution 1; weigh the prescribed amount of glycocholic acid and add an appropriate amount o...

Embodiment 3

[0122] Vitamin A 3.3 million IU

[0123] Vitamin D 3 200,000 IU

[0124] Vitamin E 10,000 IU

[0125] Vitamin K 1 0.15g

[0126] Vitamin C 200.00g

[0127] Thiamine Hydrochloride 6.73g

[0128] Equivalent to Thiamin 6.00g

[0129] Riboflavin Sodium Phosphate 4.92g

[0130] Equivalent to Vitamin B 2 (Riboflavin) 3.6g

[0131] Vitamin B 6 6.00g

[0132] Niacinamide 40.00g

[0133] Panthenol 15.00g

[0134] Folic acid 0.60g

[0135] Biotin 0.060g

[0136] Vitamin B 1 5.0mg

[0137] Glycine 250.00g

[0138] Glycocholic acid 140.00g

[0139] Soy Lecithin 112.50g

[0140] NaOH Adjust to pH 5.9

[0141] 1000 bottles

[0142] Weigh the prescribed amount of soybean lecithin for injection and dissolve it in 100ml ethanol to obtain solution 1; weigh the prescribed amount of glycocholic acid and add appropriate amount of water for injection to dissolve, and adjust the pH to 5...

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PUM

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Abstract

The invention relates to a stable compound containing a plurality of vitamins and the method for preparing same. The compound comprises at least four kinds of fat-soluble vitamin, cholate, phosphatide and carriers or findings acceptable by pharmacy. The compound also comprises water soluble vitamins. The compound is a clear and transparent solution. The preparing method comprises: (1) dissolving the fat-soluble vitamin with liquid containing ethanol; (2) removing ethanol. The compound is used as nutriment for patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a stable freeze-dried preparation containing multiple vitamins and a preparation method thereof, wherein the freeze-dried preparation contains at least four fat-soluble vitamins, bile acids, phospholipids and pharmaceutically acceptable carrier or excipient. The lyophilized preparation was dissolved in water as a clear and transparent solution. A preparation method of the freeze-dried preparation comprises at least two steps in the preparation process: (1) dissolving fat-soluble vitamins in liquid containing ethanol; (2) removing ethanol. Background technique [0002] Cholic acid and phospholipids have been reported as solubilizers for insoluble substances: a kind of intravenous infusion containing cholate, phospholipids and ethanol is described in GB1502929; twelve kinds of vitamin Cernevit for injection of Baxter Company use cholic acid Salt and lecithin are used as...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/19A61K31/07A61K31/122A61K31/355A61K31/59
Inventor 王显著李波冉伟陈振华赵小萍
Owner CHONGQING PHARMA RES INST
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