Softgel containing calcitriol and preparation method

A technology of calcitriol and soft capsules, applied in the field of pharmaceutical preparations, can solve the problems of high dosage of antioxidants BHT and BHA, cumbersome, excessive increase of unknown impurities in the preparation process, etc.

Active Publication Date: 2014-05-14
SICHUAN GOWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The technical problem to be solved in the present invention is that the amount of antioxidants BHT and BHA in the existing calcitriol soft capsules is ...

Method used

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  • Softgel containing calcitriol and preparation method
  • Softgel containing calcitriol and preparation method
  • Softgel containing calcitriol and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] Content Content (per pill)

[0105] Calcitriol 1.0μg

[0106] Medium Chain Triglycerides 1.0g

[0107] BHT 0.05mg

[0108] BHA 0.05mg

[0109] Rubber content (per pill)

[0110] Gelatin 0.4g

[0111] Glycerin 0.18g

[0112] Titanium dioxide 0.01g

[0113] Iron oxide brown 0.004g

[0114] Take calcitriol, medium-chain triglycerides, BHT and BHA, and mix them uniformly to obtain the contents; mix gelatin, glycerin, titanium dioxide, iron oxide brown with appropriate amount of water and heat to make a glue, and mix the contents with The glue solution is respectively loaded into a soft capsule pill pressing machine, pressed into a soft capsule, shaped, dried, washed with absolute ethanol, and finally dried to obtain the product.

Embodiment 2

[0116] Content Content (per pill)

[0117] Calcitriol 0.25μg

[0118] Medium Chain Triglycerides 0.1g

[0119] BHT0.003mg

[0120] BHA 0.003mg

[0121] Rubber content (per pill)

[0122] Gelatin 0.04g

[0123] Glycerin 0.018g

[0124] Titanium dioxide 0.001g

[0125] Iron oxide violet 0.0004g

[0126] Take calcitriol, medium-chain triglycerides, BHT and BHA, and mix them uniformly to obtain the content; mix gelatin, glycerin, titanium dioxide, iron oxide violet and appropriate amount of water and heat to make a glue, and mix the content with The glue solution is respectively loaded into a soft capsule pill pressing machine, pressed into a soft capsule, shaped, dried, washed with absolute ethanol, and finally dried to obtain the product.

Embodiment 3

[0128] Content Content (per pill)

[0129] Calcitriol 0.25μg

[0130] Medium Chain Triglycerides 0.5g

[0131] BHT0.02mg

[0132] BHA 0.03mg

[0133] Rubber content (per pill)

[0134] Gelatin 0.25g

[0135] Glycerin 0.08g

[0136] Xylitol 0.03g

[0137] Titanium dioxide 0.006g

[0138]Iron oxide red 0.0037g

[0139] Take calcitriol, medium-chain triglycerides, BHT and BHA, and mix them uniformly to obtain the content; mix gelatin, glycerin, xylitol, titanium dioxide, iron oxide red with appropriate amount of water and heat to make a glue solution. Put the content and the glue into a soft capsule pill press machine respectively, press the soft capsule, set the shape, dry, wash the pill with absolute ethanol, and finally dry it.

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Abstract

The invention relates to a softgel containing calcitriol, and the softgel comprises the following raw materials: calcitriol, middle chain triglyceride, 2,6-di-tert-butyl-4-methylphenol and butylated hydroxyanisole. The rubber of the softgel contains gelatin, glycerin, a light-screening agent and a colouring agent, and sorbitol is not contained. The preferably calcitriol amount is 0.25 mum/pill-1.00 mum/pill, middle chain triglyceride amount is 0.10g/pill-1.00g/pill, the amount of 2,6-di-tert-butyl-4-methylphenol and butylated hydroxyanisole respectively account 0.0030%-0.0090% of weight of middle chain triglyceride. The softgel containing calcitriol has the advantages of simple preparation, little impurity increase in a storage process, stable quality and high security.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a soft capsule containing calcitriol and a preparation method thereof. Background technique [0002] Calcitriol (Calcitriol, 9,10-cyclocholesterol-5Z,7E,10(19)-triene-1α,3β,25-triol) is one of the most important metabolically active products of vitamin D3 in the human body 1. It can promote the intestinal absorption of calcium and regulate bone calcification. Its structural formula is: [0003] . [0004] Calcitriol was researched and developed by Roche Company, and it was first listed in Switzerland in June 1982. hypoparathyroidism, pseudohypothyroidism, vitamin D-dependent rickets, hypophosphatemic vitamin D-resistant rickets, etc. [0005] The physiological activity of calcitriol is very high, and the single dose is extremely small. The general therapeutic dose is only 0.25μg / day to 1.0μg / day. Compared with other oral solid dosage forms, calcitriol is dissolved in an approp...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/593A61K47/14A61K47/10A61P19/10A61P3/12A61P19/08A61P13/12A61P5/14
Inventor 贾朝宇黄毅郭礼新郭晖
Owner SICHUAN GOWELL PHARMA
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