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Calcitriol sustained-release pellet and preparation method thereof

A technology of calcitriol and sustained-release pellets, applied in microcapsules, digestive systems, pharmaceutical formulations, etc., can solve the problems of poor sustained-release effect and decreased sustained-release effect, and achieve the improvement of compliance, overcoming poor stability, Good slow release effect

Pending Publication Date: 2022-05-31
郑州市中医院(郑州市红十字医院) +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a calcitriol sustained-release pellet and a preparation method thereof. The present invention provides a calcitriol with good sustained-release effect and stable product quality by constructing a binary system of a sustained-release pellet core and a sustained-release coating Sustained-release preparations, wherein it is found through research that the existence of the coating film in the process of preparing calcitriol sustained-release preparations will lead to a decrease in the sustained-release effect, but the sustained-release effect can be effectively resolved by adding an appropriate amount of sodium carboxymethylcellulose Poor problem, in addition, by reasonably matching the ratio of the sustained-release preparation and other pharmaceutical excipients, the presentation of the sustained-release effect can be effectively realized. The specific invention adopts the following technical scheme:

Method used

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  • Calcitriol sustained-release pellet and preparation method thereof
  • Calcitriol sustained-release pellet and preparation method thereof
  • Calcitriol sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1: preparation prescription

[0035] Ball core prescription:

[0036]

[0037] Extended Release Coating Prescription:

[0038]

[0039] Preparation:

[0040] 1) Put calcitriol and sodium carboxymethyl cellulose in an ethanol solution, stir, spray dry, fully mix the mixture of calcitriol and sodium carboxymethyl cellulose and the filler after drying, and pour into Add the diluted binder solution to the mixing system to prepare a soft material; the soft material is extruded and spheronized to obtain pellets;

[0041] 2) Mix the prescription amount of slow-release matrix material, opacifier, plasticizer, and lubricant evenly, add an appropriate amount of purified water, and stir evenly to obtain a coating solution;

[0042] 3) Sieve the pellets after spheronization, fluidized bed drying, and fluidized bed slow-release coating to obtain calcitriol sustained-release pellets.

[0043] The obtained pellets can be further prepared into compressed tablets or...

Embodiment 2

[0044] Embodiment 2: preparation prescription

[0045] Ball core prescription:

[0046]

[0047] Extended Release Coating Prescription:

[0048]

[0049] Preparation method is the same as Example 1 Example 3: preparation prescription

[0050] Ball core prescription:

[0051]

[0052] Extended Release Coating Prescription:

[0053]

[0054] Preparation method is the same as embodiment 1

Embodiment 4

[0055] Embodiment 4: preparation prescription

[0056] Ball core prescription:

[0057]

[0058]

[0059] Extended Release Coating Prescription:

[0060]

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Abstract

The invention discloses a calcitriol sustained-release pellet and a preparation method thereof, the sustained-release pellet is composed of a drug-containing pellet core and a sustained-release coating layer, the drug-containing pellet core contains calcitriol, sodium carboxymethyl cellulose, a filler and an adhesive; the sustained-release coating film comprises a sustained-release framework material, an opacifying agent, a plasticizer, a lubricant and purified water. The preparation prepared from the sustained-release pellet is good in sustained-release effect, the core component can be slowly released within 24 hours, the blood concentration of the product is effectively maintained, and the compliance of a patient to the product is remarkably improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically relate to a kind of calcitriol sustained-release pellets and preparation method thereof Background technique [0002] Calcitriol, also known as 1,25-dihydroxyvitamin D3, is the 1,25-dihydroxy metabolite with the strongest anti-rickets activity through the metabolism of vitamin D3 by hydroxylase in the liver and kidney. Calcitriol was first produced by Roche, Switzerland, and was launched in 1978 under the trade name "Rocaltrol". It is used for the treatment of postmenopausal osteoporosis, chronic renal insufficiency, postoperative hypothyroidism, and idiopathic hypoparathyroidism. , Pseudohypothyroidism, vitamin D-dependent rickets, hypophosphatemic vitamin D-resistant rickets, etc. [0003] The biosynthetic pathway of calcitriol is that 7-dehydrocholesterol is irradiated by ultraviolet rays in the skin to generate vitamin D3, and vitamin D3 forms 25-hydroxychol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/38A61K47/32A61K31/593A61P15/00A61P19/10A61P1/12A61P5/14A61P3/02
CPCA61K9/5026A61K9/5089A61K47/38A61K31/593A61P15/00A61P19/10A61P1/12A61P5/14A61P3/02
Inventor 田纪涛王斌
Owner 郑州市中医院(郑州市红十字医院)