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Freeze dry formulation of microelement and method for preparing the same

A technology for freeze-dried preparations and trace elements, which is applied in freeze-dried transportation, pharmaceutical formulations, medical preparations containing active ingredients, etc. The preparation method is simple and easy, and the production cost is low.

Active Publication Date: 2006-02-15
深圳市资福药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problems existing in the prior art, the object of the present invention is to provide a trace element additive preparation and its manufacturing method which are convenient to use and transport and stable in performance, which solves the problems of inconvenient use, storage and transport of the existing additives. , and the performance is stable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0028] Weigh out ferric chloride (FeCl 3 ·6H 2 O) 540mg, zinc chloride (ZnCl 2 ) 1.36g, manganese chloride (MnCl 2 4H 2 O) 99mg, copper chloride (CuCl 2 ·H 2 O) 340mg, sodium selenite (Na 2 SeO 3 ·5H 2 O) 10.5mg, sodium molybdate (Na 2 MoO 4 2H 2 O) 4.88mg, potassium iodide (KI) 19.9mg, chromium chloride (CrCl 3 ·6H 2 O) 5.33 mg, sodium fluoride (NaF) 210 mg, and mannitol 20 g. Add 140ml of water for injection to mannitol, heat to 78°C, and stir until completely dissolved. Ferric chloride (FeCl 3 ·6H 2 (0) 540mg was dissolved in 5ml of water for injection that had been added with 10ul1M hydrochloric acid in advance, and zinc chloride (ZnCl 2 ) 1.36g, manganese chloride (MnCl 2 4H 2 O) 99mg, copper chloride (CuCl 2 ·H 2 O) 340mg, sodium selenite (Na 2 SeO 3 ·5H 2 O) 10.5mg, sodium molybdate (Na 2 MoO 4 2H 2 O) 4.88mg, potassium iodide (KI) 19.9mg were dissolved in 5ml water for injection respectively, and each solution was added in the aforementioned m...

Embodiment 4-6

[0031] Weigh three parts of zinc chloride (ZnCl 2 )521mg, copper chloride (CuCl 2 ·H 2 O) 53.7mg, manganese chloride (MnCl 2 4H 2 O) 3.60mg, sodium fluoride (NaF) 126mg, sodium selenite (Na 2 SeO 3 ·5H2 O) 6.66mg, potassium iodide (KI) 1.31mg, and a portion of mannitol 8g; a portion of glycine 8g, a portion of lactose 8g. Add 70ml of water for injection to glycine, mannitol, and lactose respectively, heat to 70°C, and stir until completely dissolved. Zinc chloride (ZnCl 2 )521mg, copper chloride (CuCl 2 ·H 2 O) 53.7mg, manganese chloride (MnCl 2 4H 2 O) 3.60mg, sodium selenite (Na 2 SeO 3 ·5H 2 O) 6.66mg, potassium iodide (KI) 1.31mg are dissolved in 3ml water for injection respectively, and each solution is added in the aforementioned mannitol solution respectively, in the glycine solution, sodium fluoride (NaF) 126mg is dissolved in the lactose solution again Add 6ml of water for injection to mannitol solution, glycine solution, and lactose solution to 100ml of...

Embodiment 7

[0033] The solutions obtained in Examples 1 to 3 were freeze-dried according to the following method to prepare various trace element freeze-dried powder preparations of the present invention:

[0034] Pre-freezing: Reduce the temperature in the freeze-drying box to about -20°C, -25°C, and -35°C in advance, and put the subpackaged solution to be freeze-dried on the inner partition of the freeze-drying box for pre-freezing.

[0035] Sublimation drying: raise the vacuum in the freeze-drying box to below 13.33Pa (0.1mmHg column), and turn off the freezer. Slowly heat through the heating system under the partition, and properly heat the partition to about 10°C to supply the heat required for the sublimation of ice. The temperature of the condenser drops below -30°C, and sublimation and drying are carried out for 15, 11, and 13 hours. .

[0036] Re-drying: Control the drying temperature at 20°C, 30°C, and 10°C respectively, and control the plate temperature below 30°C until the pr...

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PUM

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Abstract

The invention relates to a freeze dried preparation of trace elements and its preparing process, wherein the preparation is prepared from compounds containing multiple trace elements and the solution of pharmaceutically acceptable excipient through freezing and drying, the excipient can be mannitol, glycine, lactose, sodium chloride, glucose and / or other pharmaceutically acceptable excipient.

Description

technical field [0001] The invention relates to a preparation for adding trace elements and a manufacturing method thereof, in particular to a freeze-dried preparation of various trace elements for injection and a manufacturing method thereof. Background technique [0002] Although the human body needs very little trace elements every day, they are very necessary to maintain the normal metabolism and function of the human body. Trace elements mainly exist in two forms in the human body: one is to form metal complexes such as protein, nucleic acid (RNA) and adenosine triphosphate (ATP); the other is to combine with the active site of the enzyme to form various enzymes and hormones. Or vitamins, such as hundreds of enzymes containing iron, copper, zinc, manganese and selenium, thyroid hormones containing iodine, cytochromes containing iron, etc., can make metal-organic complexes produce a variety of unique biological effects , Physiological functions and biochemical reactions...

Claims

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Application Information

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IPC IPC(8): A61K33/34A61K9/19A61P3/02A61K33/32A61K33/30A61K33/04A61K33/18A61K33/14
Inventor 吴良信
Owner 深圳市资福药业有限公司