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Menatetrenone soft capsule and preparation method thereof

A technology of menatetrenone and soft capsules, which is applied in capsule delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve problems such as inapplicability, reduce raw material costs, simple preparation method, and suitable for long-term storage and the effect of long-distance transport

Inactive Publication Date: 2011-08-31
天津康鸿医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, menadione is an oily substance, and it has the characteristics of being easy to decompose when exposed to light. The above-mentioned dosage form is not applicable, so it is necessary to develop a new oral dosage form suitable for menadione.

Method used

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  • Menatetrenone soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Composition of medicinal liquid materials: 15g of menaquinone, 181g of corn oil, 3g of polysorbate 80, 3g of ethyl p-hydroxybenzoate, 3g of propyl p-hydroxybenzoate.

[0023] Capsule skin material composition: gelatin 80g, glycerin 24g, sorbitol 20g, water 80g, titanium dioxide 1g, tartrazine 0.12g.

[0024] Preparation:

[0025] (1) Preparation of capsule skin solution

[0026] First put water into the plastic tank and heat to 85°C, then put gelatin, glycerin, sorbitol, titanium dioxide, and tartrazine into the plastic tank in proportion and heat to a suitable temperature, stir well to completely dissolve the materials to obtain the capsule skin solution, set aside.

[0027] (2) Preparation of liquid medicine

[0028] Accurately weigh menatetrenone, corn oil, polysorbate 80, ethyl p-hydroxybenzoate and propyl p-hydroxybenzoate to dissolve, and mix well to obtain the oily liquid of the content of this product, which is set aside.

[0029] (3) Compression molding

...

Embodiment 2

[0032] Composition of medicinal liquid materials: 15g of menaquinone, 250g of corn oil, 5g of polysorbate 80, 5g of ethyl p-hydroxybenzoate, 5g of propyl p-hydroxybenzoate.

[0033] Capsule skin material composition: gelatin 100g, glycerin 30g, sorbitol 25g, water 100g, titanium dioxide 1.2g, tartrazine 0.2g.

[0034] The preparation method is the same as in Example 1.

Embodiment 3

[0036] Composition of medicinal liquid materials: 15g of menaquinone, 181g of soybean oil, 3g of polysorbate 60, 3g of ethyl p-hydroxybenzoate, and 3g of propyl p-hydroxybenzoate.

[0037] Capsule skin material composition: gelatin 80g, glycerin 24g, sorbitol 20g, water 80g, titanium dioxide 1g, tartrazine 0.12g.

[0038] The preparation method is the same as in Example 1.

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Abstract

The invention provides soft capsules of menatetrenone and a preparation method thereof. The medicinal liquid of the capsules contains menatetrenone, vegetable oil and cosolvent between which the ratio is 1:10-30:0.1-0.5. The cosolvent is polysorbate 80 and / or polysorbate 60. Through lots of experiments, the invention optimizes the proportion of effective components and cosolvent in the soft capsules of menatetrenone and further determines the preferable cosolvent, thus making the soft capsules of menatetrenone provided by the invention have good stability while reducing cost of raw materials,especially stable quality under conditions of a high temperature, high humidity and strong light, suitable for storage for a long time and long distance transportation as well as convenient for carrying out and administration, and effectively treat osteoporosis. Furthermore, the invention is simple in preparation method, reduced in manufacturing cost and favourable for mass production of soft capsules of menatetrenone.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical preparation of menadione and a preparation method thereof, in particular to a menatetrenone soft capsule and a preparation method thereof. Background technique [0002] Vitamin K is a class of compounds with a quinone structure, including five types of compounds with different structures, namely vitamin K1, K2, K3, K4 and K5. Studies have shown that vitamin K2 has an osteogenic effect, promotes calcium metabolism, and can also inhibit bone resorption caused by osteoclasts, thereby increasing bone density and preventing osteoporosis. The structure of vitamin K2 is shown in the following formula: [0003] [0004] In the above formula, n ranges from 1-10. Wherein, when n=4, the vitamin K2 shown in the above formula is menatetrenone, its side chain contains 20 carbons, and is also called vitamin K2 (20). [0005] Vitamin K1, K3, and K4 are all on the m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61P7/04A61K47/44A61P3/02A61K31/122
Inventor 夏锦辉邹美香金松子孙歆慧蒋庆峰吴疆宋丽明蔡振华刘谨
Owner 天津康鸿医药科技发展有限公司
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