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

A calcium fructonate and freeze-dried emulsion technology, which is applied in the field of medicine, can solve the problems of high process and equipment requirements, poor drug stability, and easy aggregation of emulsion droplets, and achieve controllable drug content, good stability, and simplified preparation procedures. Effect

Inactive Publication Date: 2005-01-12
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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] 1. In the preparation equipment, vitamin D 2 Dissolve 0.125g in 1ml soybean oil for injection and mix well;

[0050]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;

[0051] 3. Dissolve 3.85g calcium fructonate in an appropriate amount of water for injection;

[0052] 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;

[0053] 5. Mix 3 and 4 evenly, and adjust the pH to 4.0 with sodium hydroxide and hydrochloric acid. Make medicinal liquid altogether 1000ml.

[0054] 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;

[0055] 7. Add water to the prepared freeze-dried emulsion according to the required amount, and revert to emulsion after h...

Embodiment 2

[0057] 1. In the preparation equipment, vitamin D 2 0.125g dissolved in 10ml tea oil for injection;

[0058] 2. Mix 10g of Tween-80 with an appropriate amount of water for injection, and add 0.1g of paraben B;

[0059] 3. Dissolve 3.85g calcium fructonate in an appropriate amount of water for injection;

[0060] 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;

[0061] 5. Mix 3 and 4 evenly, and adjust the pH to 7.0 with sodium acetate. Prepare a total of 2000ml of liquid medicine;

[0062] 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;

[0063] 7. Add water to the prepared freeze-dried emulsion according to the required amount, and revert to emulsion after hydration and shaking.

Embodiment 3

[0065] 1. In the preparation equipment, vitamin D 2 0.125g dissolved in 50ml olive oil for injection;

[0066] 2. Mix 10g of poloxamer with an appropriate amount of water for injection, and add 1g of ethylparaben;

[0067] 3. Dissolve 3.85g calcium fructonate in an appropriate amount of water for injection;

[0068] 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;

[0069] 5. Mix 3 and 4 evenly, and adjust the pH to 6.5 with acetic acid. Prepare a total of 3000ml of liquid medicine;

[0070] 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;

[0071] 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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PUM

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Abstract

A freeze-dried VD2 calcium pectate cream is prepared from VD2 calcium pectate, the oil for injection, stabilizer, emulsifier, pH regulator, freeze-drying protector, antiseptic and the water for injection. Its preparing process is also disclosed.

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 regula...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/592A61P3/02
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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