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

A soft capsule and vaginal technology, applied in capsule delivery, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of delayed drug release in vitro, decreased gelatin solubility, decreased drug solubility, etc., to achieve Reduce difficulty, facilitate industrial production, and have low hydrophilicity

Inactive Publication Date: 2021-02-09
南京科宁检测科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Prescription Dosage (g)

[0027] kappa carrageenan 4

[0028] iota type carrageenan 140

[0029] Hydroxypropyl modified corn starch 300

[0030] Glycerin 150

[0031] Sodium carboxymethyl starch 48

[0032] Ethylparaben 2.2

[0033] Purified water 600

[0034] Made into 1000 softgels

[0035] (1) Add the prescribed amount of purified water into the glue pot, heat it to 50°C-80°C, add ethylparaben, glycerin, and sodium carboxymethyl starch and stir until completely dissolved, then stop heating;

[0036] (2) Under stirring, within 10 minutes, quickly add hydroxypropyl cornstarch, kappa type carrageenan, and iota type carrageenan to the above solution in batches. Stir continuously in a vacuum state, and heat through circulating water at 60°C-80°C; the stirring speed is 25r / min, and the stirring time is 3h;

[0037] (3) Turn on the vacuum pump to eliminate the air bubbles in the glue, defoaming until the vacuum degree is -0.09MPa, and put it in the heat preservation...

Embodiment 2

[0040] Prescription Dosage (g)

[0041] kappa carrageenan 4

[0042] iota type carrageenan 140

[0043] Hydroxyethyl modified corn starch 300

[0044] Glycerin 110

[0045] Sorbitol 14

[0046] Sodium carboxymethyl starch 48

[0047] Ethylparaben 2.2

[0048] Purified water 600

[0049] Made into 1000 softgels

[0050] (1) Add the prescribed amount of purified water into the glue pot, heat it to 50°C-80°C, add ethylparaben, glycerin, sorbitol, and sodium carboxymethyl starch and stir until completely dissolved, then stop heating;

[0051] (2) Under stirring, within 10 minutes, quickly add hydroxyethyl-modified cornstarch, kappa-type carrageenan, and iota-type carrageenan to the above solution in batches. Stir continuously in a vacuum state, and heat through circulating water at 60°C-80°C; the stirring speed is 25r / min, and the stirring time is 3h;

[0052] (3) Turn on the vacuum pump to eliminate the air bubbles in the glue, defoaming until the vacuum degree is -0.09M...

Embodiment 3

[0055] Prescription Dosage (g)

[0056] kappa carrageenan 4

[0057] iota type carrageenan 200

[0058] Hydroxypropyl modified corn starch 300

[0059] Glycerin 150

[0060] Sodium carboxymethyl starch 48

[0061] Ethylparaben 2.2

[0062] Purified water 600

[0063] Made into 1000 softgels

[0064] (1) Add the prescribed amount of purified water into the glue pot, heat it to 50°C-80°C, add ethylparaben, glycerin, and sodium carboxymethyl starch and stir until completely dissolved, then stop heating;

[0065](2) Under stirring, quickly add hydroxypropyl modified cornstarch, kappa type carrageenan, and iota type carrageenan to the above solution within 10 minutes. Stir continuously in a vacuum state, and heat through circulating water at 60°C-80°C; the stirring speed is 25r / min, and the stirring time is 3h;

[0066] (3) Turn on the vacuum pump to eliminate the air bubbles in the glue, defoaming until the vacuum degree is -0.09MPa, and put it in the heat preservation buc...

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/36A61K47/38A61K31/57A61K31/565A61K31/567
CPCA61K9/4816A61K9/0034A61K47/36A61K47/38A61K31/57A61K31/565A61K31/567
Inventor 孙军娣姚建旭
Owner 南京科宁检测科技有限公司
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