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Alfacalcidol dropping pill and preparation method thereof

A technology of alfacalcidol and dropping pills, which can be used in pill delivery, bone diseases, pharmaceutical formulations, etc., and can solve the problems of low bioavailability and poor stability.

Active Publication Date: 2014-05-21
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the shortcomings of poor stability and low bioavailability in the existing alfacalcidol oral preparations, the present invention invented alfacalcidol inclusion complex drop pills

Method used

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  • Alfacalcidol dropping pill and preparation method thereof
  • Alfacalcidol dropping pill and preparation method thereof
  • Alfacalcidol dropping pill and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The prescription for dropping pills is (by weight):

[0020]

[0021] Preparation:

[0022] 1. Prepare alfacalcidol inclusion compound according to the following method:

[0023] (1) In water or aqueous ethanol medium, react alfacalcidol with hydroxypropyl β-cyclodextrin in proportion, filter the resulting solution through a microporous membrane until clear, and separate the clathrate from the mixture thing; or

[0024] (2) in solid form, reacting alfacalcidol with hydroxypropyl beta-cyclodextrin; or

[0025] (3) Alfacalcidol reacts with hydroxypropyl β-cyclodextrin for high-energy grinding.

[0026] 2. Grind the alfacalcidol inclusion compound through a 100-200 mesh sieve; grind and mix polyethylene glycol 4000, poloxamer, dipotassium hydrogen phosphate and potassium dihydrogen phosphate evenly, heat and melt on a water-soluble surface, and mix well; add alfacalcidol clathrate into the melt of polyethylene glycol 4000, poloxamer, dipotassium hydrogen phosphate a...

Embodiment 2

[0028] The prescription for dropping pills is (by weight):

[0029]

[0030]

[0031] The preparation method is the same as in Example 1.

Embodiment 3

[0033] The prescription for dropping pills is (by weight):

[0034]

[0035] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses an alfacalcidol dropping pill and a preparation method thereof. The alfacalcidol dropping pill comprises an alfacalcidol clathrate compound, a matrix and a stabilizing agent. The alfacalcidol clathrate compound comprises active ingredients and clathration material. The clathration material is alpha-cyclodextrin, beta-cyclodextrin or hydroxy beta-cyclodextrin, and the matrix is a mixer formed by more than two of polyethylene glycol 6000, polyethylene glycol 4000, polyoxyethylene monostearate, sodium stearate, glycerin gelatin, poloxamer, stearic acid and the like. The weight ratio of the active ingredients to the clathration material is 4:2-2:3. The alfacalcidol dropping pill is good in rounding degree, high in medicine dissolving-out speed and high in biological availability.

Description

technical field [0001] The invention relates to a drop pill, in particular to a drop pill containing an inclusion compound of alfacalcidol and a preparation method thereof, belonging to the field of alfacalcidol preparations. Background technique [0002] Dropping pills have the following characteristics: 1. Simple equipment, convenient operation, beneficial to labor protection, short process cycle and high productivity; 2. Easy to control process conditions, stable quality, accurate dosage, short heating time, easy to oxidize and volatile After the medicine dissolves in the matrix, its stability can be increased; 3, the matrix holds a large amount of liquid medicine, so the liquid medicine can be solidified; 4, the drop pill prepared by solid dispersion technology has the characteristics of rapid absorption and high bioavailability. The clathrate has the following advantages: mask bad odor and reduce irritation; increase drug dissolution rate and bioavailability; improve dr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/593A61P3/14A61P3/12A61P19/10
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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