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Calcitriol soft capsules and preparation method thereof

A technology of calcitriol and soft capsules, which can be used in capsule delivery, bone diseases, pharmaceutical formulations, etc., and can solve problems such as poor stability, sensitivity to light and air, etc.

Active Publication Date: 2013-07-17
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a special species, calcitriol is sensitive to light and air and has poor stability in long-term storage. Therefore, it is urgent to provide a calcitriol preparation with good stability, high bioavailability and low cost.

Method used

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  • Calcitriol soft capsules and preparation method thereof
  • Calcitriol soft capsules and preparation method thereof
  • Calcitriol soft capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Preparation of soft capsule material:

[0055] Weigh 100 parts of gelatin in the prescribed quantity, put 3.5 parts of glycerin; swell in a mixed solution of 9 parts of water, heat until the gelatin dissolves, the heating temperature is 80°C, stir evenly and filter (70-80 mesh), vacuum defoaming: vacuum The temperature is -0.06~-0.1MPa, and the holding temperature is 60°C to obtain the soft capsule material.

[0056] Preparation of content solution:

[0057] Weigh 1 part of calcitriol, 30000 parts of isopropanol; 20000 parts of coconut oil and 80000 parts of polyoxyethylene hydrogenated castor oil (Cremophor-RH40), mix calcitriol, co-emulsifier, oil phase, Mix the emulsifier evenly, heat to 50°C for 30 minutes, stir, evacuate to remove all air bubbles, dissolve the drug until a uniform and clear solution is obtained, and then put it into a barrel for later use.

[0058] Compress it into soft capsules with a rotary molding machine, and dry them with cold air in a tumbl...

Embodiment 2

[0060] Take 100 parts of gelatin by weight, put 3.5 parts of glycerin; 9 parts of water, prepare the soft capsule material according to the method of Example 1, then weigh 2 parts of calcitriol, 33000 parts of polyethylene glycol 400; palmitic acid 25,000 parts of isopropyl ester, 90,000 parts of polyoxyethylene (20) sorbitan oleate (Tween80), prepared content solution according to the method of Example 1, and then prepared soft capsule according to the method of Example 1.

Embodiment 3

[0062] Take 100 parts of gelatin by weight, put 3.5 parts of glycerin; 9 parts of water, prepare soft capsule material according to the method of Example 1, then weigh 2 parts of calcitriol, 400 parts of propylene glycol; 35000 parts of propylene glycol; isopropyl myristate 24,000 parts of ester, 100,000 parts of polyoxyethylene castor oil (Cremophor-EL-80), the content solution was prepared according to the method of Example 1, and then soft capsules were prepared according to the method of Example 1.

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Abstract

The invention provides calcitriol soft capsules with high bioavailability, high stability, convenience in administration, moisture absorption prevention, good sealing property and low price, which improves the bioavailability and the compliance of patients. In order to fulfill the aims, the calcitriol soft capsules and a preparation method thereof are finally obtained through a lot of experimental research; the calcitriol soft capsules comprise a soft capsule material and inclusion liquor, wherein the soft capsule material comprises gelatin, glycerol and water in a weight ratio of 10:3.5:9; and the inclusion liquor comprises calcitriol, co-emulsifier, oil phase and emulsifier in a weight ratio of (1-4): (30,000-35,000): (20,000-25,000): (80,000-100,000). The weight ratio of the soft capsule material to the inclusion liquor is 5:4.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a calcitriol soft capsule for treating osteoporosis and a preparation method thereof. Background technique [0002] Calcitriol, other names: 1α, 25-dihydroxyvitamin D 3 , 1α, 25-DihydroxyvitaminD 3 , calcitriol. It was developed by the Swiss Roche company and was first listed in June 1982 (Switzerland). It was first registered in China in 1988, and the registration number is X880091. Slightly soluble in methanol, ethanol, ethyl acetate. The melting point is 111-115°C. This product is vitamin D 3 One of the most important active metabolites. This metabolite is normally formed in the kidney. In recent years, it has been found that calcitriol can also be produced outside the kidney. It has been confirmed that placenta, monocytes, macrophages, tumor cell supernatants, lymph nodes and keratinocytes of patients with sarcoidosis all have 1α hydrox...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/593A61K47/42A61K47/10A61P19/10A61P19/08A61P17/06
Inventor 王明刚任莉翟翠云孙桂玉刘晓霞
Owner CP PHARMA QINGDAO CO LTD
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