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Alfacalcidol powder and preparation method thereof

A technology of alfacalcidol and alcohol powder, which is applied in bone diseases, medical formulas, medical preparations of non-active ingredients, etc., can solve the problems of long-term stable existence and low bioavailability, and achieve the highest bioavailability Good, reduced dose, increased stability

Active Publication Date: 2015-07-29
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alfacalcidol powder is not reported in the prior art, because its bioavailability is low, can not exist stably for a long time

Method used

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  • Alfacalcidol powder and preparation method thereof
  • Alfacalcidol powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] formula:

[0033] Alfacalcidol 7g

[0034] PVPK30 18g

[0035] Starch 65g

[0036] 65g powdered sugar

[0037] Microcrystalline Cellulose 13g

[0038] Micronized silica gel 7g.

[0039] The preparation method comprises the following steps:

[0040] 1) Weigh the raw and auxiliary materials, and pass through a 120-mesh sieve for later use;

[0041] 2) Deliver the sieved alfacalcidol, polyvinylpyrrolidone, starch, powdered sugar and microcrystalline cellulose in equal amounts

[0042] Stir and mix evenly by increasing method, after adding micropowder silica gel, the alfacalcidol powder is obtained.

Embodiment 2

[0044] formula:

[0045] Alfacalcidol 5g

[0046] PVPK25 15g

[0047] Starch 60g

[0048] 60g powdered sugar

[0049] Microcrystalline Cellulose 10g

[0050] Micronized silica gel 8g.

[0051] The preparation method comprises the following steps:

[0052] 1) Weigh the raw and auxiliary materials, and pass through a 100-mesh sieve for later use;

[0053] 2) Deliver the sieved alfacalcidol, polyvinylpyrrolidone, starch, powdered sugar and microcrystalline cellulose in equal amounts

[0054] Stir and mix evenly by increasing method, after adding micropowder silica gel, the alfacalcidol powder is obtained.

Embodiment 3

[0056] formula:

[0057] Alfacalcidol 8g

[0058] PVPK90 20g

[0059] Starch 70

[0060] 70g powdered sugar

[0061] Microcrystalline Cellulose 15g

[0062] Micronized silica gel 5g.

[0063] The preparation method comprises the following steps:

[0064] 1) Weigh the raw and auxiliary materials, and pass through a 140-mesh sieve for later use;

[0065] 2) Deliver the sieved alfacalcidol, polyvinylpyrrolidone, starch, sugar powder and microcrystalline cellulose in equal amounts

[0066] Stir and mix evenly by increasing method, after adding micropowder silica gel, the alfacalcidol powder is obtained.

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Abstract

The invention discloses an alfacalcidol powder and a preparation method thereof. The alfacalcidol powder is prepared from the following ingredients in parts by weight: 5-8 parts of alfacalcidol, 15-20 parts of polyvinylpyrrolidone, 60-70 parts of starch, 60-70 parts of powdered sugar, 10-15 parts of microcrystalline cellulose and 5-8 parts of aerosil. The preparation method has the benefits that the content of alfacalcidol in the preparation is increased and the medicine dose for patients is decreased; with the addition of the polyvinylpyrrolidone, the bioavailability and stability of the alfacalcidol powder are increased and the clinical effect is remarkable.

Description

technical field [0001] The invention relates to an alfacalcidol powder and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Alfacalcidol plays a role in regulating the balance of calcium and phosphorus in the human body, and can increase the absorption of calcium and phosphorus in the intestine, reduce the level of parathyroid hormone in plasma, and improve bone quality caused by women's menopause and the use of hormone drugs. loose. It is suitable for osteoporosis and rickets and osteomalacia caused by various reasons. [0003] The existing oral preparations of alfacalcidol have the defects of poor disintegration and dissolution effects and low bioavailability, which affect its clinical therapeutic effect and need to be improved. And when long-term large doses of alfacalcidol or patients with kidney damage may appear nausea, dizziness, constipation, anorexia, vomiting, abdominal pain and other signs of hype...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/593A61K47/32A61P3/14A61P3/12A61P19/10
Inventor 王明刚陈阳生任莉孙桂玉翟翠云刘晓霞付全磊
Owner CP PHARMA QINGDAO CO LTD
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