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Alfacalcidol sustained-release capsule and preparation method thereof

A technology of alfacalcidol and sustained-release capsules, which is used in bone diseases, pharmaceutical formulations, medical preparations with inactive ingredients, etc. Short intervals and other problems, to achieve the effect of being suitable for large-scale production applications, stable product quality, and reducing dosage

Active Publication Date: 2013-06-12
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alfacalcidol products produced by Danish Leo Pharmaceutical Company are currently the most sold in the world. my country has domestically produced products on the market since 1997. At present, there are mainly tablets and capsules of alfacalcidol in the domestic market. Monotonous and ordinary, affected by factors such as disintegration and drug release, short dosing intervals, large fluctuations in effective blood drug concentration, unsatisfactory absorption and therapeutic effects

Method used

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  • Alfacalcidol sustained-release capsule and preparation method thereof
  • Alfacalcidol sustained-release capsule and preparation method thereof

Examples

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preparation example Construction

[0021] A preparation method for alfacalcidol sustained-release capsules, comprising the following steps:

[0022] (1) Get a certain amount of microcrystalline cellulose powder and put it in a centrifugal granulator, and use water as a binder to prepare a blank pellet core with a particle size of 50 mesh;

[0023] (2) take alfacalcidol, filler and binder by weight percentage, binder is made into 5% aqueous solution, alfacalcidol and filler are put in the powder supply chamber of centrifugal granulator , take an appropriate amount of the blank pellet core obtained in step (1) and put it in a granulation pot, use the aqueous solution of the binder as the binder to prepare drug-containing pellets, dry the pellets at 60°C after they are taken out of the pot, and sieve them into 20 meshes. Next step coating;

[0024] (3) Dissolving the slow-release material, plasticizer, porogen, and anti-tack agent with 80% ethanol solution to make a slow-release coating solution;

[0025] (4) Ev...

Embodiment 1～3

[0027] The preparation of embodiment 1~3 alfacalcidol sustained release capsule

[0028] According to the raw and auxiliary materials in the following table, according to the above-mentioned preparation method, 2000 alfacalcidol sustained-release capsules were respectively prepared in each embodiment. Among them, " / " means not used.

[0029]

[0030]

[0031] Test Example 1 Determination of Release of Alfacalcidol Sustained-release Capsules Gained in Examples 1-3

[0032] According to the "Guidelines for Sustained and Controlled Release Preparations" in the appendix of the 2010 edition of the Pharmacopoeia of the People's Republic of China (Part II), 0.25% sodium lauryl sulfate was used as the release medium, and the preparations in Examples 1 to 3 were accurately weighed. An appropriate amount of alfacalcidol sustained-release pellets (about 100 mg) was determined according to the first method of appendix XD of the 2010 edition of the Pharmacopoeia of the People's Repu...

Embodiment 4～6

[0036] The preparation of embodiment 4~6 alfacalcidol sustained-release capsules

[0037] According to the raw and auxiliary materials in the following table, according to the above-mentioned preparation method, 2000 alfacalcidol sustained-release capsules were respectively prepared in each embodiment. The weight ratio of the slow-release material of embodiment 4 and the plasticizer is 8:1, the weight ratio of the slow-release material of embodiment 5 and the plasticizer is 7:1, and the weight ratio of the slow-release material of embodiment 6 and the plasticizer The weight ratio is 6:1.

[0038]

[0039] plasticizer

[0040] Test example 2 Determination of the release rate of alfacalcidol sustained-release capsules obtained in Examples 4-6

[0041] The measuring method is the same as that of Test Example 1. The measurement results are shown in Table 2.

[0042] Table 2 Example 4-6 Alfacalcidol Sustained-release Capsules Release Evaluation Form (Dissol...

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Abstract

The invention discloses an alfacalcidol sustained-release capsule and a preparation method thereof. The alfacalcidol sustained-release capsule disclosed by the invention is prepared through filling an alfacalcidol sustained-release pellet in a capsule shell; and during preparation, the alfacalcidol sustained-release pellet is obtained through coating a drug-containing layer and a coating layer outside a blank pellet core and then filled in the capsule shell, thereby obtaining the alfacalcidol sustained-release capsule. According to the alfacalcidol sustained-release capsule and the preparation method of the alfacalcidol sustained-release capsule, the drug release is uniform, the aims of long acting and curative effect improving can be reached, and the dosage can be reduced while the same drug action is maintained, so that side effects to patients caused by drug taking are reduced; and the preparation method is simple, the quality of obtained products is stable, and thus, the method is applicable to large-scale production application.

Description

technical field [0001] The invention relates to the technical field of western medicine preparations, in particular to an alfacalcidol sustained-release capsule, and also relates to a preparation method of the sustained-release capsule. Background technique [0002] The chemical name of alfacalcidol is 9,10-cyclocholesteryl-5Z,7E,10(19)-triene-1α,3β-diol, which was first developed by Bone Health International Corporation of the United States, and has been established in Israel ( 1979), Germany (1979), Japan (1982), Italy (1985) were approved for marketing. Alfacalcidol is mostly used for calcium metabolism disorders caused by vitamin D metabolic disorders, clinically used for the treatment of osteoporosis, chronic renal insufficiency, hypothyroidism, anti-vitamin D rickets, osteomalacia, etc. Alfacalcidol products produced by Danish Leo Pharmaceutical Company are currently the most sold in the world. my country has domestically produced products on the market since 1997. At...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/593A61K47/38A61P3/14A61P13/12A61P19/10A61P19/08
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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