A kind of mineral soft capsule and preparation method thereof

A technology of soft capsules and minerals, applied in the field of medicine, can solve problems such as poor suspending effect of beeswax, uneven product components, and consumers' unsuitability to the taste of vegetable oil, etc., to achieve increased acidity and flavor, good pH adjustment performance, and deterrence The effect of corruption product generation

Active Publication Date: 2020-02-21
湖北聚瑞生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Mineral iron and zinc nutritional supplements are usually made into solid preparations (such as tablets, granules, etc.), soft capsules, and oral liquids, but solid preparations require a large amount of auxiliary materials to help them form, and the process generally requires granulation, which is not easy Molding, bad taste
Conventional soft capsules use vegetable oil (such as soybean oil, corn oil, peanut oil, etc.) It is basically insoluble in vegetable oil medium, the suspending effect of beeswax is poor, solid-liquid separation often occurs, layered precipitation occurs during the production process, the product components are not uniform, and many consumers are not used to the taste of vegetable oil
Vegetable oil is suitable for water-insoluble drugs or fat-soluble drugs. Conventional vegetable oils include soybean oil, corn oil, rapeseed oil, etc. Currently, most vegetable oils are used as diluents for soft capsules, such as cod liver oil and vitamin A capsules. Mix oily medicine with vegetable oil and other excipients in proportion to fill it evenly. There is a lot of oil, low thixotropic value, and easy to leak; less oil, good stability, but poor fluidity, poor dispersion, and difficult to press pills
There are also some soft capsule contents that use polyethylene glycol 400 as the diluent. However, PEG400 has a water absorption effect on the capsule shell, which will cause the water in the capsule shell to migrate to the contents, resulting in the recrystallization of some dissolved hydrophobic drugs during the production process. Precipitation, the water-soluble drug in the content will continue to penetrate into the capsule wall, causing the capsule shell to fade, harden the capsule shell, and affect the disintegration time limit
[0003] Oral liquid dosage forms are basically liquid-filled glass bottles. The preparation process requires the use of purified water to dilute dissolved mineral iron and zinc, and glass bottles are not easy to carry, and the oral process is opened repeatedly, which is easy to contaminate

Method used

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  • A kind of mineral soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] 1. Mineral soft capsules: composed of soft capsule contents and soft capsule shell;

[0039] 1. The contents of the soft capsule include mineral active ingredients and pharmaceutical adjuvants. In parts by weight, the mineral active ingredients are ferrous gluconate and zinc gluconate, and the ferrous gluconate is 5.5 parts, gluconic acid Zinc is 4 parts;

[0040] Described pharmaceutical excipient comprises diluent, suspending agent and additive, and described diluent is 60 parts of glycerin, 0.5 part of sorbitol liquid and 6 parts of maltitol; Described suspending agent is 3 parts of mono- and diglyceride fatty acids ester; the additives include sour agent: 0.5 parts of sodium citrate and 0.5 parts of citric acid; oligosaccharides: 3 parts of stachyose and 2 parts of fructose; 3 parts of soybean lecithin; 0.5 part of fruity essence.

[0041] 2. Soft capsule shell: 10 parts of gelatin, 4 parts of glycerin, and 10 parts of purified water.

[0042] Two, the preparation...

Embodiment 2

[0047] 1. Mineral soft capsules: composed of soft capsule contents and soft capsule shell;

[0048] 1. The contents of the soft capsule include mineral active ingredients and pharmaceutical adjuvants. In parts by weight, the mineral active ingredients are ferrous gluconate and zinc gluconate, and the ferrous gluconate is 4 parts, gluconate Zinc is 2.5 parts;

[0049] Described pharmaceutical excipient comprises diluent, suspending agent and additive, and described diluent is 30 parts of glycerin, 1 part of sorbitol liquid and 1.5 parts of maltitol; Described suspending agent is 1.3 parts of mono- and diglycerin fatty acids ester; the additives include sour agent: 1 part of sodium citrate and 1 part of citric acid; oligosaccharides: 5 parts of stachyose and 4.5 parts of fructose; 1 part of soybean lecithin; 0.5 part of fruity essence.

[0050] 2. Soft capsule shell: 10 parts of gelatin, 3 parts of glycerin, and 10 parts of purified water.

[0051] Two, the preparation method ...

Embodiment 3

[0056] 1. Mineral soft capsules: composed of soft capsule contents and soft capsule shell;

[0057] 1. The contents of soft capsules include mineral active ingredients and pharmaceutical excipients, calculated in parts by weight,

[0058] Described mineral active ingredient is ferrous gluconate and zinc gluconate, and described ferrous gluconate is 7 parts, and zinc gluconate is 5.5 parts;

[0059] Described pharmaceutical excipient comprises diluent, suspending agent and additive, and described diluent is 70 parts of glycerin, 5 parts of sorbitol liquids and 12.5 parts of maltitol; ester; the additives include sour agent: 0.1 part of sodium citrate and 0.1 part of citric acid; oligosaccharides: 5 parts of stachyose and 5 parts of fructose; 2.3 parts of soybean lecithin.

[0060] 2. Soft capsule shell: 10 parts of gelatin, 5 parts of glycerin, and 10 parts of purified water.

[0061] Two, the preparation method of described mineral soft capsule comprises the steps:

[0062]...

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Abstract

The invention discloses a mineral substance soft capsule which is composed of two parts, namely soft capsule content and a soft capsule shell, wherein the content comprises a mineral active ingredientand pharmaceutical adjuvants, wherein the pharmaceutical adjuvants comprise diluents, suspending agents and an additive; a weight ratio of the mineral active ingredient to the diluents to the suspending agents to the additive is 1:(5-7):(0.2-0.4):(1-2); the diluents comprise glycerin and sugar alcohol; the weight ratio of the glycerin to sugar alcohol is (15-35):(1-10); and the suspending agentscomprise fatty acid monoglyceride and diglyceride. The invention further discloses a preparation method of the soft capsule. The glycerin and sugar alcohol replace the conventional vegetable oil or PEG-400 to serve as the diluents of the soft capsule content, mineral substances such as iron and zinc are dissolved, layering is difficultly caused after dissolving, the components are homogeneous, theemulsification effect is excellent, and disintegration time limit is not influenced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a mineral soft capsule and a preparation method thereof. Background technique [0002] Mineral iron and zinc nutritional supplements are usually made into solid preparations (such as tablets, granules, etc.), soft capsules, and oral liquids, but solid preparations require a large amount of auxiliary materials to help them form, and the process generally requires granulation, which is not easy Molding, poor taste. Conventional soft capsules use vegetable oil (such as soybean oil, corn oil, peanut oil, etc.) It is basically insoluble in vegetable oil medium, the suspension effect of beeswax is poor, solid-liquid separation often occurs, layered precipitation occurs during the production process, the product components are not uniform, and many consumers are not used to the taste of vegetable oil. Vegetable oil is suitable for water-insoluble drugs or fat-soluble drugs. Conventio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/10A61K47/26A61K47/14A61K33/26A61K33/30A61P3/02
CPCA61K9/4808A61K9/4825A61K9/4858A61K33/26A61K33/30A61P3/02A61K2300/00
Inventor 王劲松刘华朱德艳易庆平陈清婵简清梅李容缪园欣张喜才
Owner 湖北聚瑞生物科技有限公司
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