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Alfacalcidol soft capsule and preparation method thereof

A technology of alfacalcidol and soft capsules, which is applied in capsule delivery, bone diseases, and pharmaceutical formulations, and can solve problems such as poor stability and bioavailability, and achieve improved bioavailability, good release, and good bioavailability Effect

Active Publication Date: 2020-06-02
GUANGZHOU XINGQUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Therefore, it is necessary to carry out further research and improvement on the preparation of alfacalcidol soft capsules in order to obtain a technology with poor stability and good bioavailability.

Method used

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  • Alfacalcidol soft capsule and preparation method thereof

Examples

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Effect test

Embodiment 1

[0034] A kind of alfacalcidol soft capsule, is prepared from capsule shell liquid and capsule content;

[0035] Wherein, in terms of parts by weight, the contents of the capsule include: 0.0005 parts of alfacalcidol, 1000 parts of medium-chain triglycerides, 0.8 parts of ascorbyl palmitate, 80 parts of gliadin, polyethylene glycol 30 parts, 20 parts of phospholipids, 10 parts of monoglyceride laurate;

[0036] The components of the capsule shell liquid include: gelatin, glycerin, water, ethylparaben, sodium alginate, chitosan;

[0037] The consumption of described ethylparaben is 0.4% of gelatin quality;

[0038] The total mass of the sodium alginate and chitosan is 7% of the gelatin mass, and the mass ratio of the sodium alginate to the chitosan is 1.5:1; the consumption of the glycerol is 30% of the gelatin mass; the water The mass ratio with gelatin is 1:1;

[0039] The molecular weight M=800 of the polyethylene glycol;

[0040] The preparation method of described alfac...

Embodiment 2

[0046] A kind of alfacalcidol soft capsule, is prepared from capsule shell liquid and capsule content;

[0047] Wherein, in parts by weight, the contents of the capsule include: 0.0001 part of alfacalcidol, 500 parts of medium-chain triglyceride, 0.5 part of ascorbyl palmitate, 50 parts of gliadin, polyethylene glycol 10 parts, 5 parts of phospholipids, 1 part of monoglyceride laurate;

[0048] The components of the capsule shell liquid include: gelatin, glycerin, water, ethylparaben, sodium alginate, chitosan;

[0049] The consumption of described ethylparaben is 0.2% of gelatin quality;

[0050] The total mass of the sodium alginate and chitosan is 5% of the gelatin quality, and the mass ratio of the sodium alginate and the chitosan is 1:1; the consumption of the glycerol is 20% of the gelatin quality; the water The mass ratio to gelatin is 2:1;

[0051] The molecular weight M=400 of the polyethylene glycol;

[0052] The preparation method of described alfacalcidol soft ...

Embodiment 3

[0058] A kind of alfacalcidol soft capsule, is prepared from capsule shell liquid and capsule content;

[0059] Wherein, in parts by weight, the contents of the capsule include: 0.005 parts of alfacalcidol, 1200 parts of medium-chain triglycerides, 2 parts of ascorbyl palmitate, 100 parts of gliadin, polyethylene glycol 50 parts, 6 parts of phospholipids, 2 parts of monoglyceride laurate;

[0060] The components of the capsule shell liquid include: gelatin, glycerin, water, ethylparaben, sodium alginate, chitosan;

[0061] The consumption of described ethylparaben is 0.5% of gelatin quality;

[0062] The total mass of the sodium alginate and chitosan is 10% of the gelatin quality, and the mass ratio of the sodium alginate and the chitosan is 2:1; the consumption of the glycerol is 50% of the gelatin quality; the water The mass ratio with gelatin is 1:1;

[0063] The molecular weight M=2000 of the polyethylene glycol;

[0064] The preparation method of described alfacalcido...

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Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to an alfacalcidol soft capsule and a preparation method thereof. The capsule is prepared from a capsuleshell solution and capsule contents, wherein the capsule contents comprise alfacalcidol, medium-chain triglyceride, ascorbyl palmitate, gliadin, polyethylene glycol, phospholipid and glycerol monolaurate; and the capsule shell solution comprises gelatin, glycerol, water, ethylparaben, sodium alginate and chitosan. The preparation method of the alfacalcidol soft capsule is simple, and the preparedalfacalcidol soft capsule is good in stability and bioavailability and suitable for promotion and application.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to an alfacalcidol soft capsule and a preparation method thereof. Background technique [0002] Alfacalcidol (Alfacalcidol) is a calcitriol analogue, which only needs to be hydroxylated in the liver to become active 1α, 25-(OH)2D3. It can increase the reabsorption of calcium in 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. Alfacalcidol plays a role in regulating the balance of calcium and phosphorus in the human body, and can increase...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/14A61K47/24A61K47/10A61K47/42A61K31/593A61P19/10A61P19/08A61P3/14
CPCA61K9/4808A61K9/4825A61K9/4858A61K9/4866A61K31/593A61P3/14A61P19/08A61P19/10
Inventor 高建胜孙维广刘琴玲黄志云黎志坚梁贝尔苏草茵邝安安钟小天
Owner GUANGZHOU XINGQUN PHARMA
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