Alfacalcidol soft capsule and preparation method thereof

A technology of alfacalcidol and soft capsules, which is applied in capsule delivery, bone diseases, pharmaceutical formulations, etc., and can solve the problems of poor stability, unsatisfactory stability, and low bioavailability of alfacalcidol, and achieve improved Drug stability, improve bioavailability, improve the effect of interaction

Inactive Publication Date: 2019-04-05
GUANGZHOU XINGQUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The stability of alfacalcidol is relatively poor, although its stability can be improved to a certain extent after being prepared into soft capsules,

Method used

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  • Alfacalcidol soft capsule and preparation method thereof
  • Alfacalcidol soft capsule and preparation method thereof
  • Alfacalcidol soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The present embodiment provides a kind of alfacalcidol soft capsule, and its content is made up of following components:

[0049] Medium chain triglycerides 105 parts

[0050] Ascorbyl palmitate 0.08 parts

[0051] Alfacalcidol 0.0000025 parts

[0052] The preparation method is as follows:

[0053] 1. Get the antioxidant (ascorbyl palmitate) and 8% oily base (medium-chain triglyceride) and fully mix to obtain a mixture.

[0054] 2. Pour the remaining amount of oily base into the liquid mixing tank, and add the mixture obtained in 1 into the liquid mixing tank, then stir for 20 minutes (rotation speed is 120r / min), and mix well.

[0055] 3. Protect from light, add alfacalcidol in the liquid mixing tank, and stir (120r / min) under the protection of nitrogen (the pressure after nitrogen filling) for 1 hour to obtain the content.

[0056] 4. Protect from light, put the content into the liquid storage tank, use a fully automatic soft capsule machine to prepare soft capsul...

Embodiment 2

[0058] The present embodiment provides a kind of alfacalcidol soft capsule, and its content is made up of following components:

[0059] Medium chain triglycerides 105 parts

[0060] Ascorbyl palmitate 0.16 parts

[0061]Alfacalcidol 0.0000025 parts

[0062] The preparation method is as follows:

[0063] 1. Get the antioxidant (ascorbyl palmitate) and 8% oily base (medium-chain triglyceride) and fully mix to obtain a mixture.

[0064] 2. Pour the remaining amount of oily base into the liquid mixing tank, and add the mixture obtained in 1 into the liquid mixing tank, then stir for 20 minutes (rotation speed is 120r / min), and mix well.

[0065] 3. Protect from light, add alfacalcidol in the liquid mixing tank, and stir (120r / min) under the protection of nitrogen (the pressure after nitrogen filling) for 1 hour to obtain the content.

[0066] 4. Protect from light, put the content into the liquid storage tank, use a fully automatic soft capsule machine to prepare soft capsule...

Embodiment 3

[0068] The present embodiment provides a kind of alfacalcidol soft capsule, and its content is made up of following components:

[0069] Medium chain triglycerides 105 parts

[0070] Ascorbyl palmitate 0.04 parts

[0071] Alfacalcidol 0.0000025 parts

[0072] The preparation method is as follows:

[0073] 1. Get the antioxidant (ascorbyl palmitate) and 8% oily base (medium-chain triglyceride) and fully mix to obtain a mixture.

[0074] 2. Pour the remaining amount of oily base into the liquid mixing tank, and add the mixture obtained in 1 into the liquid mixing tank, then stir for 20 minutes (rotation speed is 120r / min), and mix well.

[0075] 3. Protect from light, add alfacalcidol in the liquid mixing tank, and stir (120r / min) under the protection of nitrogen (the pressure after nitrogen filling) for 1 hour to obtain the content.

[0076] 4. Protect from light, put the content into the liquid storage tank, use a fully automatic soft capsule machine to prepare soft capsul...

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Abstract

The invention relates to an alfacalcidol soft capsule and a preparation method thereof. The contents of the alfacalcidol soft capsule comprise the following components in parts by weight: 85-125 partsof oily substrate, 0.01-0.2 part of antioxidant and 0.000001-0.000015 part of alfacalcidol, wherein the oily substrate is midchain triglyceride fatty acid. The preparation method comprises the following steps: (1) mixing antioxidant with a part of oily substrate to obtain a mixture; (2) pouring the rest oily substrate into a liquid preparation tank, and then adding the mixture acquired in step (1) into the liquid preparation tank, stirring and uniformly mixing; (3) placing the tank in a dark place, adding alfacalcidol into the liquid preparation tank, and uniformly stirring and mixing under the atmosphere of protective gas to obtain contents of the alfacalcidol soft capsule; (4) preparing the contents into the soft capsule in a dark place. The alfacalcidol soft capsule is high in stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an alfacalcidol soft capsule and a preparation method thereof. Background technique [0002] The soft capsule is composed of the contents and the capsule shell. The composition of the capsule shell is generally composed of matrix, plasticizer, preservative, opacifier, pigment, and solvent. The matrix is ​​generally gelatin, and the plasticizer is glycerin, sorbitol, sorbitol, etc. , the preservatives are methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, potassium sorbate, etc., the opacifying agent is titanium dioxide, the pigments include quinine blue, red iron oxide , manganese dioxide, black iron oxide, amaranth, etc., the solvent is water. The contents are generally composed of drugs and solvents. The characteristics of this dosage form determine that the medicine contained in the capsule shell is isola...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/14A61K47/22A61K47/10A61K31/593A61P3/14A61P19/10A61P19/08
CPCA61K9/4858A61K31/593A61P3/14A61P19/08A61P19/10
Inventor 姚江雄郑艳芳刘艳平钟小天黎志坚郝守祝邓攀刘琴玲曾娴静杨轶环熊雁鸣高建胜
Owner GUANGZHOU XINGQUN PHARMA
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