Alfacalcidol dry suspension and preparation method thereof

A technology of alfacalcidol and dry suspension, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of low bioavailability, alfacalcidol Problems such as poor water solubility, to achieve the effects of high bioavailability, fast onset of drug effect, and long validity period

Active Publication Date: 2014-03-19
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 water solubility and low bioavailability of existing alfacalcidol, the present invention invented alfacalcidol dry suspension

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of embodiment 1 alfacalcidol dry suspension

[0031] Alfacalcidol 50g

[0032] Mannitol 700g

[0033] Aspartame 50g

[0034] Methylcellulose: dextran (2:1 by weight) 50g

[0035] Anhydrous disodium hydrogen phosphate 10g

[0036] The preparation method is as follows:

[0037] (1) Accurately weigh the alfacalcidol of prescription quantity and pass through 80 mesh sieves;

[0038] (2) Precisely weigh mannitol, aspartame, methylcellulose, dextran, and anhydrous disodium hydrogen phosphate respectively, pass through an 80-mesh sieve, and mix uniformly in equal increments;

[0039] (3) Steps (1) and (2) are mixed in equal increments to obtain a mixed powder, and passed through a 40-mesh sieve;

[0040] (5) After passing the intermediate inspection, the finished product can be obtained by sub-packaging.

Embodiment 2

[0041] The preparation of embodiment 2 alfacalcidol dry suspension

[0042] Alfacalcidol 50g

[0043] Mannitol 700g

[0044] Aspartame 50g

[0045] Methylcellulose: dextran (1:1 by weight) 50g

[0046] Anhydrous disodium hydrogen phosphate 10g

[0047] The preparation method is the same as in Example 1.

Embodiment 3

[0048] The preparation of embodiment 3 alfacalcidol dry suspension

[0049] Alfacalcidol 50g

[0050] Mannitol 700g

[0051] Aspartame 50g

[0052] Methylcellulose: dextran (3:1 by weight) 50g

[0053] Anhydrous disodium hydrogen phosphate 10g

[0054] 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 dry suspension and a preparation method of the alfacalcidol dry suspension. The alfacalcidol dry suspension comprises 40-100 parts of alfacalcidol, 600-2200 parts of fillers, 50-200 parts of flavoring agents, 40-100 parts of suspending agents and 10-40 parts of flocculants. The alfacalcidol dry suspension disclosed by the invention is uniform in particle distribution, good in stability, large in gastrointestinal distribution area, fast in absorption, high in bioavailability and fast in drug effect, and has an efficacy superior to an alfacalcidol premix.

Description

technical field [0001] The invention relates to a dry suspension, in particular to an alfacalcidol dry suspension and a preparation method thereof, belonging to the field of alfacalcidol preparations. Background technique [0002] Dry suspensions refer to insoluble drugs and suitable excipients made into powders or granules, which can be dispersed into suspensions for oral administration by adding water and shaking before use. The dry suspension belongs to the suspension. After adding water to disperse, it should meet the quality requirements of the suspension. The particles in the suspension should be uniformly dispersed and should not be weighed quickly. It should be quickly redispersed. In addition to the effectiveness and chemical stability of the ideal suspension (mainly depends on the nature of the main drug), the ideal suspension should also (1) settle slowly, and can be redispersed by shaking gently after settling; The size should remain unchanged in long-term stor...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/592A61K47/38A61K47/36A61P3/02
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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