Eldecalcitol soft capsule and preparing method thereof

A technology of idecalcidol and soft capsules is applied in the directions of capsule delivery, bone diseases, pharmaceutical formulations, etc., to achieve the effects of convenient operation, good stability and beautiful appearance

Active Publication Date: 2019-11-22
HENAN TAIFENG BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after the preparation was stored at 30°C for 12 months, the amount of tachysterol and trans form exceeded 1%.

Method used

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  • Eldecalcitol soft capsule and preparing method thereof
  • Eldecalcitol soft capsule and preparing method thereof
  • Eldecalcitol soft capsule and preparing method thereof

Examples

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preparation example Construction

[0049] Its preparation method comprises the following steps:

[0050] (1) Weighing: weigh idecalcitol, dibutylphenol, medium chain triglycerides, gelatin, glycerin, tartrazine, titanium dioxide, purified water;

[0051] (2) Dosing: dissolve dibutylphenol and idecalcitol in medium-chain triglycerides, sieve, and set aside; dissolve tartrazine in an appropriate amount of purified water, stir to dissolve, sieve, and set aside; disperse titanium dioxide Add an appropriate amount of purified water, sieve, and set aside;

[0052] (3) Chemical glue: add an appropriate amount of purified water to the chemical glue tank, heat to 60-80°C, add glycerin and stir to completely dissolve, then add gelatin to dissolve, add tartrazine solution and titanium dioxide dispersion after fully dissolved, heat and stir, Disperse evenly, vacuum 0.06~0.1Mpa, remove air bubbles for 20~120min;

[0053] (4) Pill making: heat preservation of the glue solution at 50-60°C, fill the above-mentioned medicinal...

Embodiment 1

[0069] A kind of idecalcitol soft capsule, its prescription is as follows:

[0070] Contents:

[0071] Idecalcitol 15mg main ingredient

[0072] Dibutylphenol 1g Antioxidant

[0073] Medium Chain Triglycerides 3kg Solvent

[0074] Bursa skin:

[0075]

[0076] Its preparation method comprises the following steps:

[0077] Weighing: weigh idecalcitol, dibutylphenol, medium chain triglycerides, gelatin, glycerin, tartrazine, titanium dioxide, purified water;

[0078] Dosing: Dissolve dibutylphenol and idecalcitol in medium-chain triglycerides, sieve, and set aside; dissolve tartrazine in an appropriate amount of purified water, stir to dissolve, sieve, and set aside; disperse titanium dioxide in an appropriate amount of purified water water, sieved, set aside;

[0079] Chemical glue: add an appropriate amount of purified water to the chemical glue tank, heat to 75°C, add glycerin and stir to dissolve completely, then add gelatin to dissolve, after fully dissolve, add le...

Embodiment 2

[0084] A kind of idecalcitol soft capsule, its prescription is as follows:

[0085] Contents:

[0086] Idecalcitol 150mg main ingredient

[0087] Dibutylphenol 10g Antioxidant

[0088] Medium Chain Triglycerides 30kg Solvent

[0089] Bursa skin:

[0090]

[0091] Its preparation method comprises the following steps:

[0092] Weighing: weigh idecalcitol, dibutylphenol, medium chain triglycerides, gelatin, glycerin, tartrazine, titanium dioxide, purified water;

[0093] Dosing: Dissolve dibutylphenol and idecalcitol in medium-chain triglycerides, sieve, and set aside; dissolve tartrazine in an appropriate amount of purified water, stir to dissolve, sieve, and set aside; disperse titanium dioxide in an appropriate amount of purified water water, sieved, set aside;

[0094] Chemical glue: add an appropriate amount of purified water to the chemical glue tank, heat to 67°C, add glycerin and stir to dissolve completely, then add gelatin to dissolve, after fully dissolve, add...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to an eldecalcitol soft capsule and a preparing method thereof. The eldecalcitol soft capsule is composed ofa content and capsule skin. The content comprises, by weight, 0.05-0.5 parts of eldecalcitol, 1-100 parts of butyl phenol and 20000-40000 parts of medium chain triglyceride. The capsule skin comprises, by weight, 20000-30000 parts of gelatin, 100-2000 parts of lemon yellow, 2000-5000 parts of glycerinum and 50-500 parts of titanium dioxide. The prepared soft capsule is attractive in appearance, high in stability, controllable in quality and suitable for industrial production, and the preparing method is simple in process. There are fewer tachysterol trans-type related substances compared withthe reference and contrast.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to idecalcitol soft capsules and a preparation method thereof. Background technique [0002] Osteoporosis (OP) is a systemic disease characterized by low bone mass and destruction of bone microarchitecture, leading to increased bone fragility and susceptibility to fracture. It can occur in different genders and ages, but it is more common in postmenopausal women and older men. Studies have shown that the incidence of OP over the age of 40 in mainland China is about 20%, and it is estimated that there are 112 million patients in total. The serious consequence of OP is the occurrence of fragility fractures, which not only seriously affects the quality of life of patients, but also brings a heavy economic burden to patients and their families. Hip fracture is the leading cause of death and disability among all fractures. Within 1 year after hip fracture, 20% of th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/593A61P19/10
CPCA61K9/4858A61K31/593A61P19/10
Inventor 黄普广沙薇吕中超常新义
Owner HENAN TAIFENG BIOTECH CO LTD
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