Rapid-to-disintegrate vaginal soft capsule composition and preparation method thereof

Abstract

The invention relates to a rapid-to-disintegrate hormone vaginal soft capsule shell. The hormone vaginal soft capsule shell consists of a compound capsule shell capable of rapidly disintegrating in asmall amount of weakly acidic vaginal fluid and a functional content; the capsule shell consists of 6%-12% of carrageenan, 10%-40% of modified starch, 10%-25% of plasticizer, 3%-5% of disintegrating agent, 0%-0.2% of preservative and water; and the functional content can be hormone drugs including progesterone, estriol, norethindrone, megestrol and the like. The invention further discloses a method for preparing the soft capsule shell by using the composition and a soft capsule prepared from the soft capsule shell. The vagina soft capsule shell provided by the invention has the advantages of rapid disintegration, excellent aging resistance, stable components and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a composition of a composite soft capsule shell and a preparation method thereof, in particular to a hormone soft capsule shell capable of rapidly disintegrating in the vagina. Background technique [0002] Soft capsules are capsules in which liquid drugs or semi-solid drugs are sealed in soft capsules. This dosage form has been widely used in the fields of medicine, food, health products, cosmetics, etc. Most of its rubber formulas use gelatin, glycerin, The traditional way of preparing water. However, in the soft capsules prepared by this method, the polypeptide chains of gelatin molecules are prone to cross-linking during storage, forming a network structure, resulting in a decrease in the solubility of gelatin in water. Although it does not affect the release of drugs in vivo, the drug release in vitro Delay. Especially in an acidic solution, such as a wea...

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Problems solved by technology

However, in the soft capsules prepared by this method, the polypeptide chains of gelatin molecules are prone to cross-linking during storage, forming a network structure, resulting in a decrease in the solubility of gelatin in water. Although it does not affect the release of drugs in vivo, the drug release in vitro Delay

Especially in acidic solution, such as artificially simulated weakly acidic medium of vaginal fluid, the cross-linking phenomenon is more obvious, which reduces the in vivo-in vitro correlation and affects the evaluation of preparations

In addition, since the gelatin soft capsule shell contains a large amount of water (up to 35%), the water in the capsule shell will gradually enter the contents during storage, which may cause a decrease in drug solubility and crystallization

As the main capsule material of traditional soft capsule shells, gelatin is prepared from animal skins, bones and other raw materials. It is difficult to be accepted by vegetarians and people with related religious beliefs. At the same time, there is a risk of spreading mad cow disease.

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