Formula of non-gelatin soft capsule shell

Abstract

The invention discloses a formula of a non-gelatin soft capsule shell. The soft capsule shell is prepared from the following components in percentage by weight: 25-75 percent of modified starch, 10-30 percent of carrageenan, 10-25 percent of a plasticizer, 40-50 percent of water, 2-12 percent of a thickening agent and the balance of pigment which can be added according to the required color of the soft capsule pill. According to the formula, the main component gelatin of a traditional capsule shell material is replaced by modified starch and carrageenan, so that multiple defects of gelatin can be overcome, the modified starch has the characteristics of film performance, air resistance, adhesion and the like, has high safety performance and good elasticity, and has the dissolving speed superior to that of gelatin; the soft capsule prepared from modified starch and carrageenan has stable property, and cannot easily perform a crosslinking phenomenon; and the soft capsule prepared by using gelatin replacing materials does not have the problem of oxidation crosslinking, and an antioxidant does not need to be added.

Description

【Technical field】 [0001] The invention relates to the technical field of pharmaceutical industrial production, in particular to the technical field of the formulation of a non-gelatin soft capsule shell. 【Background technique】 [0002] Soft capsules refer to dosage forms in which medicinal material extracts, liquid medicines or mixed with suitable excipients are sealed in a hydrophilic soft shell by dropping method or compression method to make spherical, elliptical or other shapes. Soft capsules are suitable for unstable medicinal substances, such as chemical components that are sensitive to light, volatile, unstable and easily oxidized when exposed to heat and humidity, and medicinal substances with unpleasant taste and bad smell. [0003] Soft capsules are a common dosage form for nutritional supplements and western medicines. Soft capsules have become one of the directions for the reform of traditional Chinese medicine formulations. The capsule shell prescription include...

AI Technical Summary

Problems solved by technology

[0004] The sizing material of existing soft capsule shell comprises owing to the shortcoming of using gelatin: (1) cross-linking reaction: gelatin easily takes place cross-linking reaction, causes the instability of soft capsule, as aldehyde, polyphenol, reducing sugar, multiply charged cation, Electrolytes, cationic or anionic polymers, etc., to change the mechanical properties or biological functions of the capsule

[0005] (2) Safety issues: Gelatin is a material derived from animals. The raw material comes from animal skin and bone. Gelatin is an animal protein colloid and contains a small amount of animal fat.

[0006] (3) Disintegration and leakage problems: During the storage period, the disintegration time limit is often unqualified, and this phenomenon is mostly caused by aging and crosslinking of gelatin

Storage is also poor, long-term storage will cause the capsule shell to become brittle due to water loss

Due to the hydrophilicity of gelatin, it is easy to absorb water and dehydrate, so as to prevent the soft capsule from absorbing the moisture in the liquid medicine, resulting in capsule deformation and leakage, and the filling capacity is unqualified. Gelatin cannot be used for the packaging of hydrophilic or hygroscopic drugs.