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A kind of alfacalcidol soft capsule and preparation method thereof

An alfacalcidol and soft capsule technology, which is applied in the directions of capsule delivery, bone diseases, pharmaceutical formulations, etc., can solve the problems of low bioavailability and long-term stable existence, and achieves reduction of dosage, improvement of stability and biological stability. Availability, good absorption effect

Active Publication Date: 2017-07-14
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alfacalcidol soft capsules have not been reported in the prior art, because its bioavailability is low, and it cannot exist stably for a long time

Method used

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  • A kind of alfacalcidol soft capsule and preparation method thereof
  • A kind of alfacalcidol soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1: Alfacalcidol Soft Capsules

[0053] The alfacalcidol soft capsules described in this embodiment, the contents of the soft capsules are prepared from the following components by weight:

[0054] Alfacalcidol 43mg

[0055] Glycerin 19mg

[0056] Macrogol 4000 29mg

[0057] Macrogol 6000 16mg

[0058] Sodium Lauryl Sulfate 7mg

[0059] Menthol 8mg

[0060] Sodium Carboxymethyl Cellulose 21mg

[0061] Sodium Alginate 30mg

[0062] Gallic acid 20mg

[0063] Tocopherol 26mg.

[0064] The preparation method of the alfacalcidol soft capsule described in the present embodiment comprises the following steps:

[0065] 1) Pass alfacalcidol, polyethylene glycol 4000, and polyethylene glycol 6000 through a 120-mesh sieve, mix evenly, and obtain powder for later use;

[0066] 2) Mix glycerin, accelerator, thickener, and antioxidant, stir and dissolve at 60°C to obtain a matrix;

[0067] 3) Mix the powder in step 1) with the matrix in step 2), mix, stir and dis...

Embodiment 2

[0069] Embodiment 2: Alfacalcidol Soft Capsules

[0070] The alfacalcidol soft capsules described in this embodiment, the contents of the soft capsules are prepared from the following components by weight:

[0071] Alfacalcidol 40mg

[0072] Glycerin 17mg

[0073] Macrogol 4000 25mg

[0074] Macrogol 6000 13mg

[0075] Sodium Lauryl Sulfate 7mg

[0076]Menthol 6mg

[0077] Sodium Carboxymethyl Cellulose 28mg

[0078] Sodium Alginate 20mg

[0079] Gallic Acid 17mg

[0080] Tocopherol 17mg.

[0081] The preparation method of the alfacalcidol soft capsule described in the present embodiment comprises the following steps:

[0082] 1) Pass alfacalcidol, polyethylene glycol 4000, and polyethylene glycol 6000 through a 100-mesh sieve, mix evenly, and obtain powder for later use;

[0083] 2) Mix glycerin, accelerators, thickeners, and antioxidants, stir and dissolve at 65°C to obtain a matrix;

[0084] 3) Mix the powder in step 1) with the matrix in step 2), mix, stir and d...

Embodiment 3

[0086] Embodiment 3: Alfacalcidol Soft Capsules

[0087] The alfacalcidol soft capsules described in this embodiment, the contents of the soft capsules are prepared from the following components by weight:

[0088] Alfacalcidol 45mg

[0089] Glycerin 20mg

[0090] Macrogol 4000 38mg

[0091] Macrogol 6000 18mg

[0092] Sodium Lauryl Sulfate 7mg

[0093] Menthol 10mg

[0094] Sodium Carboxymethyl Cellulose 21mg

[0095] Sodium Alginate 33mg

[0096] Gallic acid 20mg

[0097] Tocopherol 30mg.

[0098] The preparation method of the alfacalcidol soft capsule described in the present embodiment comprises the following steps:

[0099] 1) Pass alfacalcidol, polyethylene glycol 4000, and polyethylene glycol 6000 through a 140-mesh sieve, mix evenly, and obtain powder for later use;

[0100] 2) Mix glycerin, accelerator, thickener, and antioxidant, stir and dissolve at 55°C to obtain a matrix;

[0101] 3) Mix the powder in step 1) with the matrix in step 2), mix, stir and di...

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Abstract

The invention relates to a soft alfacalcidol capsule and a preparation method thereof. The content of the soft capsule is prepared from the following ingredients in parts by weight: 35-50 parts of alfacalcidol, 15-20 parts of glycerinum, 20-40 parts of polyethylene glycol 4000, 10-20 parts of polyethylene glycol 6000, 10-20 parts of an accelerant, 45-57 parts of a thickener and 30-60 parts of an antioxygen. The preparation method improves the content of active ingredients in the preparation and reduces medicine dose; by adding specific ingredients including the glycerinum, polyethylene glycol 4000 and polyethylene glycol 6000, the stability and bioavailability of the soft capsule are effectively improved; the preparation formulation of conventional alfacalcidol preparations is successfully changed, so that alfacalcidol can be better taken and absorbed by patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an alfacalcidol soft capsule and a preparation method thereof. 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 sig...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/593A61K47/10A61P3/14A61P3/12A61P19/10
Inventor 王明刚陈阳生任莉孙桂玉刘晓霞翟翠云汪泓
Owner CP PHARMA QINGDAO CO LTD
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