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Method for preparing alginate soft capsule

An alginate gel, alginate technology, applied in microcapsule preparation, capsule delivery, microsphere preparation and other directions, can solve the problems of gelatin melting, easy rupture, aging, etc., and achieves small shrinkage and good firmness. , smooth surface effect

Active Publication Date: 2009-10-28
南京健辉生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. Gelatin is an animal extract, which is inconvenient for consumers with taboos (such as Muslims or vegetarians). In addition, the occurrence of zoonotic diseases also increases the risk of using animal materials
[0005] 2. The storage conditions of gelatin soft capsules are relatively high. Once the storage temperature, humidity and other conditions exceed the range, the gelatin will melt, age and other quality problems
[0006] 3. The preparation of gelatin soft capsules requires relatively complicated equipment or molds, and it is difficult to greatly increase the output
But the biggest disadvantage of this method is that due to the difference in specific gravity between the inner and outer layer solutions (oil phase and water phase), it is difficult to ensure that the sodium alginate solution formed in the air wraps the droplets of the oil solution and the oil in the soft capsule made of it. Drops are not eccentric, and as the proportion of the contained oil phase increases, the eccentricity will be more serious. The mechanical strength of the obtained alginate soft capsules is low, and the crushing pressure of the heavy object crushing test is less than 0.5 kg. , It is easy to break during transportation, so it is not suitable for the actual production of alginate soft capsules

Method used

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  • Method for preparing alginate soft capsule
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preparation example Construction

[0030] The steps of the invention include the preparation of the emulsion, dripping of the soft capsule and drying and dehydration of the soft capsule.

[0031] (1) Preparation of emulsion: drip and emulsify the oily liquid substance into the aqueous solution containing polyvalent metal ions under stirring (speed 800-1000 rpm) to form a high oil-water ratio oil-in-water emulsion. Wherein the polyvalent metal ion is a metal ion that reacts with a monovalent salt of alginic acid to form an insoluble gel;

[0032] The concentration (mass volume) of the multivalent metal ion aqueous solution is 0.5%~10%. If the concentration is too low, the gelation of the alginate is not enough, and if the concentration is too high, it will be wasteful and the stability of the formed emulsion will be too low; During the preparation process, since the emulsion droplets in the soft capsule made of emulsified liquid droplets will dehydrate and shrink in the subsequent de-emulsification process, the ...

Embodiment 1

[0042] (1), emulsion preparation: 1000mg calcium chloride, 300mg xanthan gum, 500mg Tween 80 are dissolved in 50ml water; 100ml soybean oil (being dissolved with 25g menthol) is slowly dripped in the above-mentioned calcium chloride mixed aqueous solution and Vigorous magnetic stirring (1000 rpm) to obtain a white oil-in-water emulsion;

[0043] (2), dripping of prototype alginate soft capsules: 30g sodium alginate (low molecular weight) and 1g Tween 80 are dissolved in 1000ml water to obtain a mixed aqueous solution with a viscosity of 400mPa·s; The emulsion was left to stand for 4 hours to remove air bubbles, dripped into the obtained mixed aqueous solution of sodium alginate under the state of stirring (600 rpm), stirred for 30 minutes after the end of the dripping, and carried out gelation reaction during stirring. Form a prototype alginate soft capsule that wraps emulsion droplets;

[0044] (3), dehydration and de-emulsification of the prototype alginate soft capsules: f...

Embodiment 2

[0048] Except that sodium alginate is ultra-low molecular weight sodium alginate used in step (2), and the usage amount is 30g (obtaining a mixed aqueous solution with a viscosity of 350mPa·s), all the other are the same as in Example 1.

[0049] The test results of the obtained calcium alginate soft capsules are shown in Table 2.

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Abstract

The invention relates to a method for preparing alginate soft capsule. By adopting a mode of emulsifying / de-emulsifying and emulsion dropping, oil-in-water emulsion containing polyvalent metal ions with high oil-water ratio is dropped into univalent soluble alginate solution, and then the polyvalent metal ions react with the univalent alginate solution to form insoluble alginate gel so as to obtain a primary soft capsule form of which outer layer is wrapped with the alginate gel; then, the primary soft capsule form is subjected to steps of drying and dehydrating so that the emulsion inside the soft capsule is de-emulsified; and finally, a circular soft capsule is obtained, wherein the interior of the circular soft capsule has oily liquid substances, the exterior of the circular soft capsule has an alginate gel wrapping layer, the radial size of the circular soft capsule is in millimeter scale, and the circular soft capsule can be directly taken orally. The soft capsule obtained by the method has the advantages of good mechanical property, even and round appearance, non-eccentric oil drops and high oil content; and the preparation method is simple and has low cost. Under the condition that the internal oily liquid substances are the same, the soft capsule which is prepared by the method and can be directly taken orally can be used for replacing gelatin soft capsules which are directly taken orally.

Description

Technical field: [0001] The invention relates to soft capsules, in particular to a method for preparing circular alginate soft capsules whose radial dimension is in the order of millimeters. Background technique: [0002] Soft capsule packaging is a new type of pharmaceutical dosage form developed after tablets, hard capsules, pills, oral liquids and other dosage forms. Soft capsules can quantitatively inject oil or suspensions of oily and powdery functional substances and encapsulate them in the film to form sealed capsules of various sizes and shapes. They have excellent light and oxygen isolation functions and good vision Effect. It is widely welcomed by consumers because of its advantages of masking bad smell, keeping oily substances stable, easy to use, and easy to carry. [0003] At present, most of the round soft capsules with a radial size of millimeters are made by using gelatin as the wrapping wall material and produced by dripping or pressing processes, such as ...

Claims

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Application Information

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IPC IPC(8): B01J13/14A61K9/48A61K47/36
Inventor 张文辉
Owner 南京健辉生物科技有限公司
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