A kind of mineral soft capsule and preparation method thereof

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...

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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

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