Witamin D2 calcium levulinate freeze-dried emulsion and its preparing method

A technology of calcium fructonate and freeze-dried emulsion, which is applied in the field of medicine to achieve the effects of simple production process, simplified preparation process and improved stability

Inactive Publication Date: 2011-08-10
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of injection requires aseptic operation, high requirements on technology and equipment, emulsion droplets are easy to aggregate, and the drug has poor stability and short validity period in liquid

Method used

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  • Witamin D2 calcium levulinate freeze-dried emulsion and its preparing method
  • Witamin D2 calcium levulinate freeze-dried emulsion and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] 1. In the preparation equipment, vitamin D 2 Dissolve 0.125g in 1ml soybean oil for injection and mix well;

[0052] 2. Mix 8.8ml of Tween-80, 10ml of glycerin (anhydrous) and an appropriate amount of water for injection, and add 0.1g of anhydrous sodium sulfite;

[0053] 3. Dissolve 3.85g calcium fructonate in an appropriate amount of water for injection;

[0054] 4. Add 2 to 1 under the condition of stirring, and then pass through the homogenizer after stirring at 20°C to homogenize the solution repeatedly to obtain a uniform solution;

[0055] 5. Mix 3 and 4 evenly, and adjust the pH to 4.0 with sodium hydroxide and hydrochloric acid. Make medicinal liquid altogether 1000ml.

[0056] 6. Add 4% mannitol as a freeze-drying protective agent, remove moisture by freeze-drying, and obtain dry vitamin D 2 Calcium fructonate freeze-dried emulsion;

[0057] 7. Add water to the prepared freeze-dried emulsion according to the required amount, and revert to emulsion after hyd...

Embodiment 2

[0059] 1. In the preparation equipment, vitamin D 2 0.125g dissolved in 10ml tea oil for injection;

[0060] 2. Mix 10g of Tween-80 with an appropriate amount of water for injection, and add 0.1g of paraben B;

[0061] 3. Dissolve 3.85g calcium fructonate in an appropriate amount of water for injection;

[0062] 4. Add 1 to 2 under the condition of stirring, and after stirring at 40°C, pass through the homogenizer to homogenize the solution repeatedly to obtain a uniform solution;

[0063] 5. Mix 3 and 4 evenly, and adjust the pH to 7.0 with sodium acetate. Prepare a total of 2000ml of liquid medicine;

[0064] 6. Add 5% glucose as a freeze-drying protective agent, remove moisture by freeze-drying, and obtain dry vitamin D 2 Calcium fructonate freeze-dried emulsion;

[0065] 7. Add water to the prepared freeze-dried emulsion according to the required amount, and revert to emulsion after hydration and shaking.

Embodiment 3

[0067] 1. In the preparation equipment, vitamin D 2 0.125g dissolved in 50ml olive oil for injection;

[0068] 2. Mix 10g of poloxamer with an appropriate amount of water for injection, and add 1g of ethylparaben;

[0069] 3. Dissolve 3.85g calcium fructonate in an appropriate amount of water for injection;

[0070] 4. Add 2 into 1 under the condition of stirring, and then pass through the homogenizer after stirring at 60°C to homogenize the solution repeatedly to obtain a uniform solution;

[0071] 5. Mix 3 and 4 evenly, and adjust the pH to 6.5 with acetic acid. Prepare a total of 3000ml of liquid medicine;

[0072] 6. Add 40% sucrose as a freeze-drying protective agent, remove moisture by freeze-drying, and obtain dry vitamin D 2 Calcium fructonate freeze-dried emulsion;

[0073] 7. Add water to the prepared freeze-dried emulsion according to the required amount, and revert to emulsion after hydration and shaking.

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Abstract

The present invention discloses a vitamin D2 calcium levulinate freeze-dried emulsion and a preparing method thereof, with simple craft and high stability. The ingredients of the freeze-dried are selected from medicaments and pharmaceutic adjuvant, wherein the pharmaceutic adjuvants are oil phase (the oil for injection), stabilizer, emulsifier, pH regulator, freeze-drying protector, antiseptic and the water for injection. Per 1000 to 5000ml of liquor contains 3.85g of fructose acid, 0.125g of Vitamin D2, 1 to 50ml of oil for injection and defined amount of adjuvant, such as emulsifier and the like. The preparing method comprises the following steps: in the matched device, dissolving Vitamin D2 into the oil for injection; adding the emulsifier in defined amount of the water for injection, and adding the stabilizer; dissolving the calcium levulinate in the defined amount of the water for injection; adding 2 in 1 under the condition of stirring; obtaining a uniform solution through a homogeneous instrument after stirring in a temperature of 20 to 60 DEG; mixing 3 with 4 uniformly; adding defined amount of freeze-drying protector, thus obtaining dry vitamin D2 calcium levulinate freeze-dried emulsion; and after hydration vibration, being recovered into an emulsion.

Description

Technical field: [0001] The invention relates to the technical field of medicine, specifically, it is a vitamin D2 calcium fructonate freeze-dried emulsion and a preparation method thereof Background technique: [0002] Vitamin D 2 (calciferol or ergocalciferol) for rickets, osteomalacia and hypoparathyroidism, and for vitamin D 2 Tetany and dental caries caused by deficiency. [0003] The need for vitamin D increases in the following situations: reduced intake and lack of sun exposure, especially in nursing mothers and infants; malabsorption syndrome with pancreatic insufficiency; hepatobiliary system disease and liver dysfunction, cirrhosis, obstructive jaundice ; Small bowel diseases such as Crohn's disease, persistent diarrhea, after gastrectomy; Intestinal fat malabsorption affects the absorption of vitamin D. [0004] Vitamin D 2 In order to promote the absorption and utilization of calcium, phosphorus and the normal calcification of bone, it is necessary to regul...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/592A61K9/107A61P3/02
Inventor 邓意辉赵妍雷杰杰郑少辉王绍宁吴琼
Owner SHENYANG PHARMA UNIVERSITY
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