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Preparation method of soft capsule capable of resisting histamine and promoting sleep

A sleep-promoting, soft capsule technology, applied in capsule delivery, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as insufficient effects, unsatisfactory needs, poor product stability, etc., and achieve ingenious design , Conducive to dissolution and absorption, beautiful appearance

Active Publication Date: 2014-03-12
安士制药(中山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For such a variety of insomnia patients, the existing antihistamines not only have complicated prescriptions, but also fail to obtain sufficient effects when used as sleep-improving pharmaceutical compositions
[0005] Moreover, when users use existing antihistamines, the body's reaction to histamine is more obvious, and the vascular reaction to bronchi, nose, skin, and gastrointestinal tract is relatively strong, and certain side effects are arranged.
[0006] The existing preparation methods of antihistamine and sleep-promoting soft capsules are relatively complicated in technology, and the stability of the produced products is relatively poor, which cannot meet the demand

Method used

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  • Preparation method of soft capsule capable of resisting histamine and promoting sleep
  • Preparation method of soft capsule capable of resisting histamine and promoting sleep
  • Preparation method of soft capsule capable of resisting histamine and promoting sleep

Examples

Experimental program
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Effect test

Embodiment 1

[0030] The soft capsule of the present invention comprises a soft capsule rubber and a content wrapped in the soft capsule rubber, and the content comprises the following components by weight percentage:

[0031]

[0032] Wherein said soft capsule rubber consists of the following components by weight percentage:

[0033] Gelatin 50%

[0034] Plasticizer 45%

[0035] Purified water 5%.

[0036] Wherein said polyethylene glycol is polyethylene glycol 400; said polyhydric alcohol is glycerol. Described plasticizer is glycerol. Described antioxidant is citric acid.

[0037] Soft capsule of the present invention can be prepared by following process:

[0038] 1. Preparation of gelatin solution:

[0039] Dissolve the plasticizer in water, add it to the glue tank and heat it to 60°C, add gelatin, stir to dissolve at 60°C, set aside;

[0040] 2. Preparation of contents:

[0041] Mix polyethylene glycol, polyol. Add diphenhydramine hydrochloride to the above solution, and he...

Embodiment 2

[0045] The soft capsule of the present invention comprises a soft capsule rubber and a content wrapped in the soft capsule rubber, and the content comprises the following components by weight percentage:

[0046]

[0047] Wherein said soft capsule rubber consists of the following components by weight percentage:

[0048] Gelatin 80%

[0049] Plasticizer 15%

[0050] Purified water 5%

[0051] Wherein said polyethylene glycol is the mixture of polyethylene glycol 200 and polyethylene glycol 400. Described polyhydric alcohol is the mixture of propylene glycol, glycerin. The plasticizer is a mixture of glycerin, sorbitol, part of sorbitan, maltitol, mannitol, propylene glycol, polyethylene glycol 200, and polyethylene glycol 400. The antioxidant is a mixture of 2,6-di-tert-butyl-4-methylphenol, butylhydroxyanisole and sodium metabisulfite.

[0052] Soft capsule of the present invention can be prepared by following process:

[0053] 1. Preparation of gelatin solution:

...

Embodiment 3

[0060] The soft capsule of the present invention comprises a soft capsule rubber and a content wrapped in the soft capsule rubber, and the content comprises the following components by weight percentage:

[0061]

[0062] Wherein said soft capsule rubber consists of the following components by weight percentage:

[0063]

[0064] Wherein said polyethylene glycol is the mixture of polyethylene glycol 200, polyethylene glycol 400 and polyethylene glycol 600. Described polyhydric alcohol is propylene glycol. Described plasticizer is maltitol. Described colorant is FD&C Blue No.1. The antioxidant is a mixture of glycine and citric acid.

[0065] Soft capsule of the present invention can be prepared by following process:

[0066] 1. Preparation of gelatin solution:

[0067]Dissolve the plasticizer in water, add it to the glue tank and heat it to 40°C, add gelatin, stir to dissolve at 80°C. Add the coloring agent into the water, stir evenly to obtain a pigment solution, ...

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Abstract

The invention discloses a preparation method of a soft capsule capable of resisting histamine and promoting sleep. The preparation method is characterized by comprising the following steps of: A, preparing liquid gelatin, namely dissolving a plasticizer with water, then transferring into a glue tank, heating to reach 40 to 80 DEG C, adding gelatin, agitating at 60 to 80 DEG C to dissolve, agitating, pumping vacuum, and removing bubble to obtain the liquid gelatin; B, preparing contents, namely, mixing, agitating and dissolving polyethylene glycol and polyhydric alcohol, adding diphenhydramine hydrochloride, agitating to obtain suspension, then transferring to a mixing liquid tank, pumping vacuum, charging nitrogen to form nitrogen protection, heating to reach 50 to 90 DEG C to dissolve, and cooling to be below 40 DEG C after the diphenhydramine hydrochloride is dissolved, so as to obtain a content solution; and C, preparing the soft capsule, namely, respectively adding the liquid gelatin obtained in step A and the content medicine solution obtained in step B to a pelleting press, adjusting the packing volumes and thickness of gelatin coating, pelleting, drying, wiping and packing. The preparation method of the soft capsule capable of resisting histamine and promoting sleep is simple in process, convenient to manufacture, and high in product stability.

Description

technical field [0001] The invention relates to a preparation method of an antihistamine and sleep promoting soft capsule. Background technique [0002] Many people suffer from insomnia due to social pressure and unfavorable environment. After investigation, about 80% of modern people have the experience of insomnia. [0003] For such insomnia, antihistamines are used as active ingredients in the U.S., U.K., Germany, Canada, and other European and American countries, as well as in Japan, as general medicines or sleep-improving pharmaceutical compositions that do not require a prescription. To reduce temporary insomnia symptoms. [0004] However, depending on the state of insomnia, there are various forms such as trouble falling asleep, trouble falling asleep, waking up midway, or waking up early. For such a variety of insomnia patients, the existing antihistamines not only have complex prescriptions, but also fail to obtain sufficient effects when used as sleep-improving ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/135A61P37/08A61P25/20
Inventor 余凯琳贾卫东
Owner 安士制药(中山)有限公司
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