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Algae-based gastric pH response disintegrative empty capsule and preparation method thereof

A technology of hollow capsules and disintegration, which is applied in the field of seaweed-based gastric pH-responsive disintegration hollow capsules and its preparation, which can solve the risks of raw material sources and safety, easy to be infected and hydrolyzed by microorganisms, and capsules are volatile Brittle and broken problems, to achieve the effect of promoting reasonable and efficient utilization, not easy to grow microorganisms, and improving over-reliance

Inactive Publication Date: 2014-12-24
ZHEJIANG WANLI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, gelatin capsules have the following disadvantages: (1) limited scope of use: cannot be accepted by some special cultural groups such as Jews, Muslims or vegetarians; (2) poor storage performance: easy to absorb water and become soft, capsules are variable at low temperatures Brittle and broken, easy to be infected and hydrolyzed by microorganisms, preservatives are often added or ethylene oxide is used to sterilize the product during production, and there are residues of sterilizing agents; (3) There are risks in the source of raw materials and safety: first, there are The risk of mad cow disease and foot-and-mouth disease; the second is that black gelatin incidents have been common in the past two years, such as the poisonous capsule incident in 2012: the industrial gelatin made by processing leather waste with quicklime contained heavy metals such as Cr and As seriously exceeded the standard. The black gelatin incident reported on March 15, 2014: the dirty scraps of the following scraps were used as raw materials to prepare medicinal gelatin
Therefore, gelatin capsules have more potential quality and safety hazards, leading to a greater potential threat to the pharmaceutical hollow capsule industry

Method used

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  • Algae-based gastric pH response disintegrative empty capsule and preparation method thereof
  • Algae-based gastric pH response disintegrative empty capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: A method for preparing a seaweed polysaccharide-based gastric pH-responsive disintegrating hollow capsule, comprising the following steps:

[0022] 1) Dosing and sol: According to the high G type sodium alginate 11.2% with a viscosity of 5cP (G / M ratio is 1.0), the high M type sodium alginate with a viscosity of 14cP 4% (G / M ratio is 0.60), κ-carrageenan 1.8%, maltodextrin 2%, potassium chloride 0.03%, sodium carboxymethyl starch 0.65%, glycerin 1.5%, sodium lauryl sulfate 0.05%, triethyl citrate 0.3% by weight volume Ratio (w / v) for the ingredients of each raw material, and all raw materials and 100mL deionized water for solution, sol, and sol in a constant temperature water bath at 80 ° C, stirring during the sol process to make the raw materials absorb water and swell and dissolve, sol Properly stir for 1.5hr during the process;

[0023] 2) Degassing the gelatin: After the sol is completed, put the gelatin in a constant temperature water bath at 50°C t...

Embodiment 2

[0026] The preparation method of the seaweed polysaccharide-based stomach pH-responsive disintegrating hollow capsule of Example 2 comprises the following steps:

[0027] 1) Liquid preparation and sol: according to the viscosity of 7cP high G type sodium alginate 9.5% (G / M ratio is 1.0), the viscosity of 10cP high M type sodium alginate 5.5% (G / M ratio is 0.60), Low acyl gellan gum 0.5%, maltodextrin 1.5%, potassium chloride 0.02%, crospovidone 0.5%, glycerin 1%, water-soluble silicone oil 0.2% weight-volume ratio (w / v) carries out each raw material Batching, and all raw materials and 100mL deionized water for solution, sol. First, dissolve low-acyl gellan gum in 100mL deionized water at 95°C to form a transparent solution, then lower the temperature of the solution to 80°C, then add the rest of the ingredients, stir to make the raw materials absorb water and swell and dissolve, and stir for 1.0hr during the sol process ;

[0028] 2) Degassing the gelatin: After the sol is c...

Embodiment 3

[0031] The preparation method of the seaweed polysaccharide-based stomach pH-responsive disintegrating hollow capsule of Example 3 comprises the following steps:

[0032] 1) Dosing and sol: according to the viscosity of 9cP high-G sodium alginate 8.8% (G / M ratio is 1.0), the viscosity of 7cP high-M sodium alginate 5.2% (G / M ratio is 0.60), κ-carrageenan 2.0%, potassium chloride 0.05%, glycerin 0.3%, PEG 0.2%, crospovidone 0.25%, carboxymethyl starch sodium 0.25%, sodium lauryl sulfate 0.03% weight-volume ratio (w / v) Do the batching of each raw material, mix all the raw materials with 100mL deionized water, sol, and sol in a constant temperature water bath at 75°C, stir during the sol process to make the raw materials absorb water and swell and dissolve, the sol process Properly stir in medium for 0.5hr;

[0033] 2) Degassing of gelatinization: After the sol is completed, put the gelatinization in a constant temperature water bath at 60°C to degas for 6 hours, and set aside; ...

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Abstract

The invention relates to an algae-based gastric pH response disintegrative empty capsule, wherein an empty capsule body comprises the following materials in percentage by weight: 60-90% of sodium alginate, 0.3-12% of a gel, 0.01-2.5% of a setting agent, 0.02-5% of a plasticizer, 0.02-4% of a moisturizer, 0.1-5% of a pore forming disintegrating agent, 0-0.5% of a surfactant and the balance of de-ionized water. The empty capsule disclosed by the invention, which is mainly prepared from polysaccharide substances extracted from algae, has such characteristics as being stable to charge, not easy to absorb moisture under normal room temperature and humidity, and not easy to grow microorganisms through a scientific formula. Cutting leftovers of the capsule can be recycled, and zero pollution discharge is realized in a production process. The pore forming disintegrating agent contained in the empty capsule disclosed by the invention is easy to dissolve or swell in body liquid at pH value of 0.9-1.5 so that the empty capsule has a disintegrating property matched with a pH physiological property of a gastric area, thus enhancing administration precision to the gastric area in clinic.

Description

technical field [0001] The invention relates to a seaweed plant-type hollow capsule and its preparation, in particular to a seaweed-based stomach pH-responsive disintegrating hollow capsule and a preparation method thereof. Background technique [0002] Empty capsules are one of the most commonly used filling carriers for modern medicines, health products and dietary supplements, and have been widely used. The pH of the stomach region of the human body is 0.9-1.5, which is different from 4.8-8.2 in the small intestine region. In order to match the pH physiological characteristics of the stomach or small intestine region, hollow capsules are generally divided into gastric-soluble (or disintegrating) and intestinal Soluble two types. For stomach-dissolving hollow capsules, it is required to dissolve or disintegrate and release drugs after entering the stomach of the human body. There are two main types of gastric-dissolving hollow capsules in the market: gelatin capsules and...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/36A23P1/04A23P10/30
Inventor 刘利萍钱国英路春玲高璐璐汪财生周旭静
Owner ZHEJIANG WANLI UNIV
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