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A kind of idecalcitol soft capsule and preparation method thereof

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

Active Publication Date: 2021-01-29
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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  • A kind of idecalcitol soft capsule and preparation method thereof
  • A kind of idecalcitol soft capsule and preparation method thereof
  • A kind of idecalcitol soft capsule and preparation method thereof

Examples

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Effect test

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 idecalcitol soft capsules and a preparation method thereof. The idecalcitol soft capsule is composed of content and capsule skin; in parts by weight, the content consists of 0.05-0.5 parts of idecalcitol, 1-100 parts of dibutylphenol, and 20000-40000 parts of medium-chain glycerol Composed of triester; capsule skin includes 20000-30000 parts of gelatin, 100-2000 parts of tartrazine, 2000-5000 parts of glycerin, 50-500 parts of titanium dioxide. The soft capsule prepared by the invention has beautiful appearance, good stability, controllable quality, simple preparation method and process, and is suitable for industrialized production. Tachysterol, trans-type, and related substances are less than reference and comparison.

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 Patents(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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