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Calcitriol soft capsule preparation production method

A technology of calcitriol and soft capsules, which is used in capsule delivery, bone diseases, pharmaceutical formulations, etc., can solve the problems of long-term stable existence, light, heat and air sensitivity, and low bioavailability, so as to improve comprehensive performance. and market competitiveness, short half-life, eliminating the effect of absorbing excipients

Inactive Publication Date: 2017-01-04
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a special substance, calcitriol has low solubility to common organic solvents, is sensitive to light, heat and air, and has poor long-term storage stability. Therefore, it is urgent to provide a stable, high bioavailability, Inexpensive Calcitriol Preparations
However, the dosage form technology of calcitriol solution is not mature enough and has not been reported, because it cannot exist stably for a long time, and its bioavailability is not high.

Method used

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  • Calcitriol soft capsule preparation production method
  • Calcitriol soft capsule preparation production method
  • Calcitriol soft capsule preparation production method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1, a kind of preparation method of calcitriol soft capsule

[0027] Contents:

[0028]

[0029] Preparation Process:

[0030] (1) Place the above-mentioned prescription amount of material in the batching tank, stir and mix for 30 minutes; grind it into a homogeneous mixture and mix it evenly to form a uniform and stable content and vacuumize it for later use;

[0031] (2) Put 20 parts by weight of glycerin and 40 parts by weight of purified water into the plastic tank, heat and stir to raise the temperature to 70-80°C, then put in 40 parts by weight of gelatin, and continue stirring for 20-30 minutes;

[0032] (3) Vacuumize to remove air bubbles, filter while it is hot, then discharge and cool to 60-65°C, keep warm;

[0033] (4) Put the content obtained in the above step (1) and the glue solution obtained in step (2) respectively into a rotary molded soft capsule machine for pill pressing, and the rotational speed of the rotary molded soft capsule machin...

Embodiment 2

[0037] Embodiment two, the stability experiment of calcitriol soft capsule of the present invention:

[0038] Influencing factor test: take calcitriol soft capsules, respectively at 60 ℃, 25 ℃ and relative humidity 92.5%, illuminance 4500Ix 3 kinds of conditions for investigation. The result is that the samples are easy to absorb water and become soft under high humidity conditions, but under light conditions It is easy to harden, and its disintegration time limit and content have no obvious change. Accelerated test: Take 3 batches of samples under the market packaging conditions, place them for 12 months under the conditions of temperature (40±2) qC and relative humidity (75±10)%. , 9, 12 months, samples were taken for stability investigation. As a result, the appearance, disintegration time limit and content of the samples did not change significantly. Long-term test: 3 batches of samples were taken under the market packaging conditions, and 36 samples were placed at room te...

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Abstract

The present invention relates to a calcitriol soft capsule and a preparation method thereof. According to the preparation method, a content is prepared from calcitriol, medium chain triglyceride, butylhydroxy anisole (BHA), 2,6-di-tert-butyl-4-methylphenol (BHT) and dehydrated alcohol, a capsule skin material is prepared from gelatin, glycerol, sorbitol, purified water, methylparaben, propylparaben, sunset yellow and titanium dioxide, and the soft capsule is formed through a pressing method. According to the present invention, the calcitriol soft capsule has advantages of reasonable types and reasonable dose ratio of the auxiliary material and the main drug in the soft capsule dosage form, convenient medication, rapid effect, high bioavailability and low side effect, and the preparation method has characteristics of simple, easy control and stable product quality, and is suitable for large-scale production application.

Description

[0001] The invention provides a method for preparing calcitriol soft capsules. The soft capsules are composed of medium-chain triglycerides and capsule skins, wherein the medium-chain triglycerides are used as solvents, which can increase the dissolution effect of the product and improve the bioavailability of the product . The soft capsule provided by the invention has the advantages of convenient oral administration, accurate dosage, strong patient compliance, and has clinical practical value. [0002] Technical field: [0003] The invention relates to the treatment of postmenopausal and senile osteoporosis, chronic renal failure, especially renal osteodystrophy patients receiving hemodialysis, especially the preparation method of soft capsules. Background technique [0004] Calcitriol (Calcitriol), its chemical name: (5Z, 7E)-9,10-cyclocholesta-5,7,10(19)-triene-1α,3β,25-triol, it It is white to off-white crystalline powder, sensitive to light, heat and air, easily solubl...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/593A61K47/10A61K47/44A61P19/10A61P13/12A61P3/02A61P19/08
Inventor 钱勇项丽玲王超祥韩永春沙薇
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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