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Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof

A slow-release capsule, heat-clearing and stagnation-clearing technology, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of complex components of traditional Chinese medicine extracts and difficulties in the preparation of sustained-release preparations, and improve the dissolution rate , Reduce the dosage and frequency of medication, and reduce the effect of taking the frequency

Inactive Publication Date: 2016-09-21
PROZIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the complexity of the composition of traditional Chinese medicine extracts in sustained-release preparations of traditional Chinese medicine, there are still difficulties in the preparation of sustained-release preparations.

Method used

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  • Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof
  • Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 1) Preparation of Senecio extract: The preparation method disclosed in the patent application document CN101249126A is used to prepare the Senecio extract. The specific method is as follows: Take 3000g of Senecio, add water to decoct twice, add 10 times the amount of water for the first time, add 8 times the amount of water for the second time, decoct for 2 hours each time, filter, combine the filtrates, and concentrate to 25°C When measuring the thick paste with a relative density of 1.18-1.19, add ethanol equivalent to 1 times the amount of thick paste, let it stand for 12 hours, filter, recover ethanol from the filtrate, and concentrate it to 80 ° C to measure the relative density of 1.30 Thick paste, dried at 70-80°C, ground into fine powder, set aside.

[0021] 2) Formula: Senecio extract 230.8g;

[0022] Hydroxypropylmethylcellulose K4M 75.7g;

[0023] Resistant starch 37.9g;

[0024] PVP-K30 18.9g;

[0025] PEG 6000 15.2g.

[0026] 3) Preparation process of ...

Embodiment 2

[0028] 1) Preparation of Senecio extract: Same as Example 1.

[0029] 2) Formula: Senecio extract 1154.0 g;

[0030] Hydroxypropylmethylcellulose K4M 291.0g;

[0031] Sodium carboxymethylcellulose 87.5g;

[0032] Resistant starch 189.5g;

[0033] PVP-K30 57.0g;

[0034] PEG 6000 113.5 g.

[0035] 3) Preparation process of sustained-release capsules: Take Senecio extract, hydroxypropylmethylcellulose K4M, carboxymethylcellulose, and resistant starch in the formula amount and mix evenly. Dissolve PVP-K30 and PEG 6000 with an appropriate amount of 80% ethanol, spray into the ethanol solution to make soft materials by wet method, granulate with 40 mesh; degas and dry under reduced pressure at 65℃~70℃, moisture <2%, granulate with 30 mesh, and fill , 0.5g / capsule, should get 3768 sustained-release capsules, actually get 3655 capsules.

Embodiment 3

[0037] 1) Preparation of Senecio extract: Same as Example 1.

[0038] 2) Formula: Senecio extract 2308.0g;

[0039] Hydroxypropylmethylcellulose K4M 632.0g;

[0040] Sodium Carboxymethyl Cellulose 315.0g

[0041] Resistant starch 189.0g;

[0042] PVP-K30 265.0g;

[0043] PEG 6000 76.0 g.

[0044] 3) Preparation process of sustained-release capsules: Take Senecio extract, hydroxypropylmethylcellulose K4M, carboxymethylcellulose, and resistant starch in the formula amount and mix evenly. Dissolve PVP-K30 and PEG6000 with an appropriate amount of 80% ethanol, spray into the ethanol solution to make soft materials by wet method, granulate with 40 mesh; degas and dry under reduced pressure at 65℃~70℃ until the water content is less than 2%, granulate with 30 mesh, fill, 0.5g / capsule, should get 7570 sustained-release capsules, actually get 7419 capsules.

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Abstract

The invention provides sustained-release capsules capable of clearing heat and resolving lumps and a preparation method thereof, and belongs to the field of pharmaceutic preparations. The sustained-release capsules are prepared from, by mass, 61 parts of climbing groundsel herb extract and 39 parts of auxiliaries. The preparation method of the sustained-release capsules comprises the steps that the climbing groundsel herb extract and a corresponding proportion of framework material and filling agent are mixed to be uniform, an appropriate amount of ethanol solution with dissolved PVP and PEG is sprayed into the mixture, a soft material is prepared through a wet method, and 40-mesh granulating is conducted; vacuum degassing drying is conducted at 65 DEG C to 70 DEG C till the water content is smaller than 2%, and 30-mesh size stabilization is conducted; if a glidant is micropowder silica gel or magnesium stearate, the glidant is added after size stabilization is conducted, and mixing is conducted to be uniform; capsules of 0.5 g for each capsule are filled, and the sustained-release capsules are obtained. According to the sustained-release capsules capable of clearing the heat and resolving the lumps and the preparation method thereof, the dissolution speed of effective ingredients is effectively increased, and the in vitro release rate of medicinal ingredients is increased; the drug dosage and drug use frequency are reduced, and great convenience is brought to patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a Qingre Sanjie sustained-release capsule and a preparation method thereof. Background technique [0002] Qingre Sanjie Capsule is a Chinese patent medicine registered in the State Food and Drug Administration, used for acute conjunctivitis, acute pharyngitis, acute tonsillitis, acute enteritis, acute bacillary dysentery, upper respiratory tract inflammation, acute bronchitis, lymphadenitis , Boil pain, otitis media, dermatitis and eczema. [0003] The preparation method of Yuanqingre Sanjie Capsules is to take 3000g of Senecio, add water to decoct twice, each time for 2 hours, filter, combine the filtrate, concentrate to a thick paste with a relative density of 1.18-1.19 (25°C), add the equivalent thick paste 1 times the amount of ethanol, let it stand for 12 hours to precipitate, filter, recover ethanol from the filtrate, concentrate to a thick paste with...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/28A61K9/52A61K47/38A61K47/36A61P27/02A61P11/04A61P1/00A61P1/12A61P31/04A61P17/02A61P27/16A61P17/00A61P31/14
CPCA61K36/28A61K9/0002A61K9/4866
Inventor 肖军平吴永忠杨伟庆陈梁康兴东其他发明人请求不公开姓名
Owner PROZIN PHARMA CO LTD
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