Alfacalcitol soft capsule and preparation method thereof

A technology of alfacalcidol and soft capsules, which is applied in capsule delivery, bone diseases, and pharmaceutical formulations, etc. It can solve the problems affecting patients' absorption of drugs, increase the curing effect of the matrix, meet the needs of taking, and prolong the storage time. Effect

Inactive Publication Date: 2020-07-17
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, because the existing alfacalcidol is made of soft capsules, the oil base needs to be added more thickeners and curing agents during processing in order to place it stably, which will affect the patient's absorption of the drug after taking it.

Method used

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  • Alfacalcitol soft capsule and preparation method thereof
  • Alfacalcitol soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The invention provides an alfacalcidol soft capsule, which comprises a soft capsule filling liquid and a soft capsule shell, and the content filling liquid of the soft capsule is prepared from the following components in parts by weight: alfacalcidol 35 parts, 5 parts of polyethylene glycol, 50 parts of coconut oil base, 10 parts of digestive enzymes, described adjuvant comprises by weight: 10 parts of accelerator, 30 parts of antioxidant, and described soft capsule shell is gelatin by weight 70 parts, glycerin 28 parts, beeswax 35 parts and water 45 parts;

[0024] Above-mentioned accelerant is pectin and sodium citrate, and the consumption ratio of pectin and sodium citrate is 3:1, is used to mix with coconut oil base after fully contacting alfacalcidol granules;

[0025] The above-mentioned antioxidant is any one of butyl hydroxyanisole, dibutyl hydroxytoluene, tert-butyl hydroquinone and propyl gallate, and is used to improve the oxidation resistance of the capsule ...

Embodiment 2

[0039]Different from Example 1, the present invention provides an alfacalcidol soft capsule, comprising a soft capsule filling liquid and a soft capsule shell, and the content filling liquid of the soft capsule is prepared from the following components in parts by weight Form: 50 parts of alfacalcidol, 10 parts of polyethylene glycol, 80 parts of coconut oil base, 15 parts of digestive enzymes, and described adjuvant comprises by weight: 20 parts of accelerator, 60 parts of antioxidant, described The soft capsule shell comprises 70 parts of gelatin, 28 parts of glycerin, 35 parts of beeswax and 45 parts of water in parts by weight.

[0040] When the alfacalcidol soft capsules prepared in this example are stored at a temperature of 15-20 degrees, the filling liquid solidifies into a solid state due to the characteristics of the coconut oil matrix, and when the temperature rises at 20-25 degrees, the external solid is still solidified near the capsule shell Form, after standing ...

Embodiment 3

[0042] All different from Embodiment 1-2, the present invention provides a kind of alfacalcidol soft capsule, comprises soft capsule filling liquid and soft capsule shell, and the content filling liquid of described soft capsule is made up of the following each The components are prepared from: 40 parts of alfacalcidol, 8 parts of polyethylene glycol, 70 parts of coconut oil base, and 13 parts of digestive enzymes. The auxiliary materials include by weight: 15 parts of accelerator and 45 parts of antioxidant , the soft capsule shell is 70 parts by weight of gelatin, 28 parts of glycerin, 35 parts of beeswax and 45 parts of water.

[0043] When the alfacalcidol soft capsules prepared in this example are stored at a temperature of 15-20 degrees, the filling liquid is completely solidified into a solid state due to the characteristics of the coconut oil matrix, and when the temperature rises at 20-25 degrees, the external solid state is still close to the capsule shell. Solidifie...

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Abstract

The invention discloses an alfacalcitol soft capsule and a preparation method thereof, and particularly relates to the technical field of pharmaceutical preparations. The alfacalcitol soft capsule comprises a soft capsule filling liquid and a soft capsule shell, wherein the soft capsule filling liquid is prepared from the following components in parts by weight: 35-50 parts of alfacalcitol, 5-10 parts of polyethylene glycol, 50-80 parts of a coconut oil matrix and 10-15 parts of a digestive enzyme; auxiliary materials comprise 10-20 parts by weigh of an accelerator and 30-60 parts by weigh ofan antioxidant; and the soft capsule shell comprises the following components in parts by weight: 60-70 parts of gelatin, 20-28 parts of glycerol, 25-35 parts of beeswax and 30-45 parts of water. According to the invention, the filling liquid is prepared from the coconut oil matrix and the digestive enzyme, so that the alfacalcitol soft capsule has excellent waterproof and heat-resistant performance and is convenient to store. In addition, a curing agent and a thickening agent do not need to be added, and the added auxiliary digestive enzyme can help a user to decompose the coconut oil matrix,so that the absorption effect of alfastatol is effectively improved, and the taking requirement of a patient is met.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, more specifically, the invention relates to an alfacalcidol soft capsule and a preparation method thereof. Background technique [0002] Alfacalcidol is an analogue of calcitriol, which only needs to be hydroxylated in the liver to become active 1α, 25~(0H)2D3. This product can increase the reabsorption of calcium by the small intestine and renal tubules, inhibit parathyroid hyperplasia, reduce the synthesis and release of parathyroid hormone, and inhibit bone resorption; increase transforming growth factor ~B (TGF-B) and insulin-like growth factor ~ I (1GF~I) synthesis, promote collagen and bone matrix protein synthesis; regulate muscle calcium metabolism, promote muscle cell differentiation, enhance muscle strength, increase neuromuscular coordination, and reduce the tendency to fall. [0003] However, the existing alfacalcidol is made of soft capsules, and the oil base nee...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/44A61K47/42A61K47/10A61K47/36A61K47/12A61K47/14A61K31/593A61P19/10A61P19/08A61P3/14
CPCA61K9/4816A61K9/4833A61K9/4858A61K9/4866A61K31/593A61K47/44A61P3/14A61P19/08A61P19/10
Inventor 陈阳生孙桂玉刘晓霞臧云龙杜昌余王清亭刘振玉牛建兴张从丛
Owner CP PHARMA QINGDAO CO LTD
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